Andrew K. Palmer, MD I am a physician who has also been involved with the medical device industry for a number of years. I feel that physicians play a very critical roll in new product developement and or improvement. We should be part of the team that also includes CEO's., finance people, marketing, engineering, manufacturing, distribution and sales. I have experienced that some CEO's and engineers do not share this view point. We, better than anyone know what works for patients, what patients want, what our fellow physicians will use and not use (many nuances here such as complexity of instrumentation, ease of use, gadgetness, sexiness etc) or know of unmet needs in the treatment of some conditions.

That said, even though some of us have advanced degrees in management, sales, engineering, manufacturing , patent work etc, this is usually not our area of expertise as it is that of CEO's, CTO's etc.

Often times, we may have a great idea or come up with a fabulous product but not understand that the product may not be viable in the market place for : it is already covered by issued patented technology that is not being employed; there may be too small a margin for the product to make it work; we may have an unrealistic expectation regarding the difficulty with regulatory processes and its changing nature; we may not realize that the customer may not be the patient or physician but the insurer or hospitals etc.

As I go to "meet up's" of people involved in the medical device industry, I find that I always learn something from each individual regardng the various facets of product developement that helps shape my ideas and activities in developing further new products and at the same time I hope the others in the group learn from me regarding the process.

Hope this helps. Andy Palmer

Hope this helps.

Ome Ogbru, PharmD There are several roles or physicians in the medical device industry, pharmaceuticals, or biotech. This article discusses role of physicians in Pharma but it applies to device companies as well. http://www.rxeconsult.com/articles/view.php?id=142

Christina Cherrill Great question. Both company and physician play an integral role in the medical device development and education process. In my experiences setting up cadaver workshops and working in surgical suites - the role of industry is to make sure that the operational systems have been developed in such a manner that they are safe, effective and compliant with industry standards. The physician helps to envision and develop the theoretical working side of the component and focus on its usefulness and need. Physicians who wish to get involved can do so - but it may not be for everyone. Personally, I believe once the product is in the physician’s hand you are part of the process - for instance when any medical device malfunctions it must be reported and so on. Cooperation should be viewed as important, after all we work together to make sure the patient outcomes are not negatively impacted by our misunderstandings or confusion. As technology continues to expand its horizons one will not be able to live without the other.

Hello I have the same feeling that producers has forgotten to be updated from surgeons
and surgeons accept to work with old fashion tools despite the problems that could be solved with special designed tools for sertain work.
I'm a veterinary surgeon who have designing new surgical instruments for my own use and for handsurgeons and dermatologists for some years as I belive that it should be the users who have to know how instruments should work and after that the design and production should follow. I have my production at some produces in asia and they are werry good in production but do not understand how the instruments are suposed to be used. I'm now about to start a veterinary clinic in Accra Ghana to be able to try out a new kind of plates for fracture repare that I'm developing. I can of course have any kind of surgical instruments produced with or without tungsten carbide or in some situations in Tianium.. Best regards Thomas Lundgren Atelpro Ltd

As CEO of a young medical device company (DermaFlow, www.derma-flow.com), our Chief Medical Officer (CMO), a cardiologist, plays a critical and multi-faceted role including: regulatory/reimbursement strategies, medical application priority strategy (we have a platform technology), product strategy, clinical strategy, interfacing with potential investors and partners, etc. I think it behooves start-up companies with new and interesting products to seek out an appropriate CMO early on to be an integral part of the management team. I have no doubt this will serve us well going forward.

Beth Killion The original question I believe was - does the med device industry "need"
physicians or are they just customers? And I wholeheartedly agree with many of the comments above... although the physician's influence in the final purchase decision may have changed over the past several years - there is much more to the collaboration between physicians and industry than just the purchase.
Successful medtech firms know that early input to product development, clinical trial design, clinical trial execution and post market education of other physicians is critical to a device's long term successful adoption. While companies must consider the economic buyer and ensure their product can also meet the needs of these other stakeholders - they must start with a product that has a positive health outcome for the patient and that meets the needs of the clinicians that use it.
However, collaboration with physicians has certainly become more difficult as greater regulation of those collaborations has been put in place and other economic factors such as cost of travel and more limited staffing have stressed the conventional meeting approach.
New digital platforms are allowing companies to augment their valuable face-to-face relationships with continued collaboration. Private, topic specific communities can extend beyond an advisory meeting to continue conversations and offer unprecedented capabilities to share medical images, manuscripts, publication links, PPT presentations, etc... all in support of continued knowledge sharing. These approaches not only make collaboration among physicians and industry more efficient - but they actually increase the quality of the collaboration by enabling the sharing of relevant content (all file types) and enabling a broader group to "discuss" vs. 1-1 conversations that fail to elevate the ideas through discourse and debate.
However I will say - physician participation in a broad interest group such as this - is valuable on some topics - but won't be on all. The interests of this group are widespread and the topics won't appeal to all community members all the time.
We encourage specific companies to build digital communities with their key constituents around a shared focused interest - something that all members are equally vested in - such as a group of clinical trial investigators for a specific device, or a group of experts focused on a new indication for a device... this way conversation is specific and all members benefit routinely from the conversation.
It might be interesting to have sub-groups from this community that have more focused common interests.. such as clinical trial designs, or specific disease states... that would enable physicians to find more discussions of interest to them and provide more specific input to a target group of manufacturers.
Regards,
Beth L. Killion, Founder Socius Medical

Mervi Hamalainen I have been in med device industry rather short time (less than 2 years) and I have been really wondering how in many cases the end-users (physicians/clinicians) are not involved in med device R&D process. I come from IT/Telecom industry and the companies coming from that field spend huge amounts of money to produce products/services suitable for those who are actual end-users. E.g. the mobile industry make great research work for designing products (both sw and hw) that are easy to use.

In addition all the more physicians and clinicians are requiring "evidence-based" products, so I would see that physicians role is vital in R&D functions.

Neda Al-Saadi Hi Zeljko,
I believe that physicians and medical clinicians are key players in the medical industry. When developing a new product, the first question that should be asked is "How does this product help the doctor help the patient?".

With a decrease in physicians, increases in patients and rapid changes in technology, there are many opportunities for physicians here. Stick around.

The problem is that funding is an issue. The big device companies have grown by acquisition of small innovators. They then jettison the experienced engineers and pHDs in R&D to cut costs. They take advantage of the growth in the product life cycle, but have killed the sources of innovation and development. When the big company is willing to reinvest in that product area, the expertise is gone.

So, the innovators and physicians must work together to keep the industry current.
- Neda Al-Saadi

Zeljko Roncevic I realized that my original question was one of the topics at today's Digital Marketing for Medical Devices Conference in Minneapolis. Pretty good for a physician from Bosnia and Herzegovina.

Chris Dahm I guess it depends on how "intimately" the physician is involved with the product. I can see how a surgeon would want a voice for things like instruments - there is a lot of good and a lot of junk out there. But, although its not a call point for me, I can see where another specialty might not have as much clout and/or be involved with such critical and costly decisions. I have several nurse friends who have to switch to products of lesser quality because the GPO chose it. And the irony is they tell me often more product is used because the "new' product doesn't last as long, breaks right out of the package and such.

Zeljko, I fully agree with you being an European, in France, where Med Devices are of the responsability of the Hospital Pharmacist working closely with surgeons and physicians. Even if we now have GPO like groups for getting better prices, you cannot sell Devices they don't like to surgeons and they are the primary prescribers. We do not buy anything they have not tested (and that is why it takes time for the bid to tender cycle)

The best work the MD industry is doing is being present in the operating room, presenting the products and their use to the new interns every 6 months. They so well know the hospital that we recruited an engineer from an Implant manufacturer to be our operating theater manager 2 years ago and he has done a tremendous work, with the surgeons, physicians and nurses improving their work environment and helping what is important : TAKING CARE OF THE PATIENT, what nobody in this field of work should ignore

Companies in this forum seems always to think of the US market and US events (their biggest market) but do not forget Europe and for example at the size of the German market !,,

Zeljko - We work with medical device inventors and entrepreneurs. Sometimes these are physicians. Many times they are not. Physicians and having close connections to them are critical to my business. I need to have resources who can tell me if the new product idea has any clinical utility.

Zeljko Roncevic Maybe it is naive but I think that the very first idea about a new med device must be innocent. It must be idea how to help the patient with this device and it is usually physician's idea.The first idea must be free of thinking how to get money. Later will come inventive people from med devices industry to turn the dream into reality.

I understand your point of view and agree. However, I've been part of
medical device product developments where ideas did not come from
physicians. In several cases, patients have come up with ideas. One case in
particular, a patient had a terrible clinical experience with the current
technologies available to treat his condition. It was bad enough to inspire
him to develop a better way.

Elena Buran Dear colleagues!
let me point out the importance and urgency of this debate. I'm on the side of the living and their responsibility for life, health and full life of other living people. I would like to note the criticality of today's date - it turning. Yes, dear colleagues. Will the treatment of a simple technical procedure where a doctor - a walking machine for the application, he withdrew from the responsibility. or the medical device - the continuation of the doctor's hands, and treatment is ethically justified set of activities for the benefit of interacting living.
You all know that the technique thought up by people, that they are very talented and able to ... but the technique still is not perfect is always the case. it depends on many things - food, quality of raw materials, .. executive mood, ... even the humidity. can not be held responsible for the life of a living person on the device - it could not understand the essence of things, it aid.
However, the money interests of producers and sales are now lobbying to make a simple - You, dear doctors, will be strongly suggested that, ... which requires a payback at any cost. because it is produced and released.
In this case, the script is known: to be found some experts who agree to "push" produced by the equipment, regardless of its actual use for the treatment and use. connect marketers and traders ... and there will be a lot on the head of every doctor who ... confined attention only to the patient's pain empathy.
This means that doctors, most capable, talented, best doctors are obliged to distribute their attention between the patient's suffering and the proposed methods of treatment using the apparatus. a new era ..professionalism and human competencies for physicians.
Just save your talent, you will save patients from death in the hands of a dead machine.

Duh! Physicians are the customers, really, as the patient has little control over what device/implant his physician chooses to use. As such, they should be the center of the focus on what's working and what's not, not only for manufacturers but for regulators as well. Fortunately there are a few physicians in Congress. Unfortunately, they are quite often ignored by the bureaucrats.

John Townsend Gradient is in the pain managment device business. Staistics indicate that 50% of the reasons why patients contact primary care physicians if becasue of pain. Do we need physicians. YES

John Strupat You have asked questions in the Medical Devices Group which really covers a very broad spectrum of products from implantable electronics, surgical tools and multi-million dollar imaging systems down to ECG electrodes and glucose meters.

In this light, my view is, as follows:

Does meddevices industry need physicians? Maybe- depends on product area. Do you need a physician to specify and order a new ECG electrode?

Or we are just a kind of customers? Maybe- depends on product area. Perhaps the real users of the product are other health professionals like nurses, EMS, PT's,RT's etc..

Is cooperation with physicians so difficult? YES!

And at the end: how to improve cooperation?
Perhaps physicians and other health care professionals have interest from the opposite side of the table but I think that many companies would appreciate answers to these questions:

1. How does a company actually find a physician and get access to them to discuss the company's new product idea or to ask the physician about their product idea?

2. Is a specific physician an entrepreneur, a scientist, a teacher, a healer or some combination?

3. What does a physician want (or demand) from a company for their idea, their advice on the company's idea, writing articles in medical journals or their public promotion of the new product idea?

4. What does the physician's "employer" at the university or hospital group want (or demand) from collaboration with industry.

5. ***Most critical to small companies**** . How does a small company get the interest of a physician or hospital or medical group when the same people are already targeted by professionals from huge companies with deep pockets and unlimited expense accounts?

Elena Buran but if I found these doctors, in what way could be to organize an exchange, international exchange?

Dan Levendowski I've had the good fortune of collaborating with a physician thought leader in the sleep medicine field and we've developed several medical devices together. When we first started, I don't think this physician necessarily thought of himself as an entrepreneur, he just saw a product/market need and wanted to help improve his specialty. His role was critical in obtaining NIH funding, assisting in collecting and publishing outcomes, representing the product to insurer technology review boards, developing protocols/ practices for the product that could be used by the sales force and making introductions to his thought-leader peers. I simply do not see how our products could have gotten to market without a physician who was closely involved.

John Strupat @Dan. Certainly seems like a critical resource for you.
Not clear here if the physician generated the product idea or it came from your company?
Could you describe in general terms what the physician was looking for, what your company was looking for or offered, and then what you both received.
Is the physician now part owner of your company or a major shareholder?
How would you start again with a new product where you needed a different physician?
Any advice for small companies in this situation?
Collaboration means very different things to different people!

Mark Driscoll, P.Eng., Ph.D. Indeed a very interesting topic of discussion. Being a Medical Device Engineer I recognize that the identification of an unmet clinical need or possible device/instrument improvements are often brought to my attention by surgeons with first hand experience. This, in my opinion, is a critical first step to any worthy product development journey. The further involvement of the surgeon in the subsequent brainstorming sessions will be dictated by their inventiveness and familiarity of navigating the IP landscape when presented with relevant prior art. I have had the pleasure of collaborating with some distinguished surgeons that I consider to be both though leaders in their fields and very inventive - which definitely facilitates this process. And yes, I agree with Mr. Roncevic's comment to the innocence of this stage of product development; however, as appropriately echoed throughout this discussion, the next decision gates of the product development process require some important business input which may extend outside the physician`s expertise.

John Townsend Dan is spot on. From concept through science to technology, prototype, trial, IP, FDA and reimbursement the guiding hand of a practicing physician is key to acceptance and usage. This is really a cooperative effort amongst the believers.

John Strupat @Mark & John.
Would be so helpful to understand how to find one and what the cost is to obtain the collaboration and cooperation of a physician?
Do some become officers of the company?
Do physicians want to become part of a company? Shareholders? Consultants?

If a medical device company has the guiding hand of a physician for every aspect of a new product ONCE, do they really need the same on the next products?

Mark Driscoll, P.Eng., Ph.D. Dear John: the involvement and respective remunerations/agreements of physicians can take many different forms. As alluded to in my previous comment, I prefer an agreement that stretched the length of the product development cycle. From experience, if the physician believes strongly in the proposed technology they are enthusiastic to see the project through. Now, evidently several legal implications need to be ironed out before collaborating on such a large scale project.
Personally, I believe that every new project will benefit from the guidance and experience of a physician over the course of its development as it enables your team to be agile, from a clinical perspective, in response to the challenges you are sure to encounter while working your way through the many hurdles of the medical device environment.

Dan Levendowski John: The physician started as an adviser, he provided input for positioning one of our existing product as to what he and his peers needed. He then came to us with an idea that he believed was necessary to create more cost effective delivery of sleep medicine. He came to us because we had an existing relationship and he felt our small company could help him implement his idea. He had some options as an adviser and then become both an employee and a shareholder.

In our collaboration he taught me the specialty (visual interpretation of physiological signal patterns), I turned his teachings into algorithms that our software engineers implemented. Together we tested and fine tuned. We designed the product for his physician peers however we severely underestimated how much resistance his physician peers would put up because it was extremely disruptive to their existing financial interest. Because he was a thought leader he was invited to testify to CMS and eventually we helped change reimbursement patterns for home sleep testing.

I have since collaborated with a dentist on another medical device in the sleep disorder therapy space, and this collaboration included the physician since he is our CMO and remains a thought-leader in this space. As long as our products are sleep/respiratory related he will be involved.

My advice to a fellow small company - make sure you choose to collaborate with a physician who is a doer not a dreamer....providing a novel ideas is not enough, the physician collaboration requires discipline on their part to be a champion and that requires carving out the time your product will need to bring it to market. And in today's regulatory and reimbursement environment that can be a long haul..... hope this was helpful.

John Townsend I actually went on the (adjunct) faculty at a major University to in part become imbued with the communication/conversion process. This challenge is not casual in this changing time. Each party in this symbiotic triumvirate has a has a risk as well as an opportunity.

John Strupat This is just excellent to get real world experiences on the subject. Thank you all!

Any physicians in the group care to contribute?

Zeljko asked the original questions. I would really appreciate comments from the clinical side on their experiences working with the medical device industry, wherever the product idea originated.
How did they find you?
How did they get past the gatekeepers at most hospitals and research institutions?
What are physicians looking for from a collaboration with industry?
Do you see changes coming for future collaboration?
Will that stifle innovation or improve it?

Jac Higgins, CHFP In my consulting practice, I am guided by one goal: is the change I recommend measurable (either financially or clinically)? I can compute the financial advantage of any change, but improvements in outcomes are best communicated by a clinician. The physician I work with has a stellar track record of engaging physicians in the change we recommend and I wouldn't have it any other way.

BTW: I'm curious about all the comments regarding GPOs "forcing" change -- in my experience no GPO can compete on price compared to the price which an individual hospital or IDN negotiates with commitment. Where are these powerful and marvelous GPOs?

Hans-Peter Steiner As a physician in IVF and inventor and producer of devices for Egg Collection in
hum. and vet. IVF, I have the advantage to create perfect devices by improving
them after testing in my own IVF-Unit.
This is the reason, why my products reached final prototyping within few months.
I would be thankful for a comment, if you would be in a similar situation
and tips how to sell the devices via website (with optimal prices for end users).
Perhaps you are a Distributor in this field? My STEINER Flush/Valve
is the only flushing pump for flushing follicles currently on the market.

Hans-Peter Steiner, Graz, Austria

www.ivfetflex.com
http://www.youtube.com/watch?v=YgupW5DWP4g
http://www.youtube.com/watch?v=5jtAcZi_AWk

IVFETFLEX.COM
Dr. Hans-Peter Steiner
IVF Technique in 21st Century
Rechbauerstr. 49
1. Graz, Austria

office@ivfetflex.com

Zeljko Roncevic Thank you for your interesting comments. It seems that the medical devices industry still needs physicians.

John Strupat Many comments from the medical device industry but almost nothing from physicians?
This matches my experience.
Their interests and viewpoint remain a mystery.

Perhaps a more accurate conclusion is that the medical device industry needs feedback and collaboration from end users?
Obviously that is the physician/surgeon for surgical instruments,etc.
May very well be other health care providers for many, many other medical devices.

Dan Levendowski John: I wouldn't be so jaded, this forum simply may not include the mix of physicians with time available to provide the comments you are seeking. From the feedback that others provided, its clear that physician interests and viewpoints are accessible, albeit requiring a bit of luck and hard work on your part to develop the network in the specialty you wish to target.

John Strupat @Dan - I'm still not clear at all on the "how" aspect of accessing physicians?

Since Zeljko is a physician who posed the original question, perhaps he could speculate with some general comments on what industry could do that would be positive and negative in trying to make contact with him to potentially collaborate on a product idea?

Some ideas for a book that would be a best seller in this sector:

"How to involve a physician in your medical device development 101"

Chapter 1. How to find the right physician for your product concept?

Chapter 2 What can you expect the physician to do for your company?

Chapter 3. What are you expected to do for the physician?

Chapter 4. What will the cost be over the life of the product?

Dan Levendowski My suggestions - don't assume there is a formula that one could write into a book because in reality it's about personalities and experience. If both parties have been through the process, they each know what to ask and what is expected.

Chapter 1 and 4 issues - Physicians who write peer reviewed journal articles related to the topic or who present at scientific conferences that physicians go to for CE credits are the thought leaders, they are influential and they will cost more. If they are the ones who have the product idea - consider that a opportunity. I've worked with physicians who are happy to obtain initial compensation to have a piece of the action - how much you have to give up depends on how successful you could be with or without the physician (really no different than any other key person).

Chapter 2 issues - You need to be knowledgeable enough to define for the physician what your company needs from him, not the other way around. If you haven't been through the development cycle yet and can't define this criteria, they you'll need to either first gain that experience or find another consultant/key person who has been through the process or you may make bad decisions (giving up too much for too little) or both party's expectations won't match up and the relationship will go sour. Once you have what you need defined, then it becomes clear whether the physician is a match for what you need (all or part). If yes, then it rolls to how much to pay....

Chapter 4 issues - What you expect to do for the physician depends on whether you're assisting him commercialize his idea or you're asking him to help commercialize your idea. Each impacts the "cost". How much time are you asking, of him/her. Your offer should consider how he values his time (i.e., consider opportunity costs).

Conflict of interest is an important consideration to manage as well. Consider who the 3rd parties are who would be concerned about a financial conflict (peers, institutions where they work etc), may consider a paid consultant (assuming you have cash to do so) less of a conflict than if they have an equity stake.

Elena Buran Dear colleagues! Practitioners certainly will not stretch their minds to deal with new devices ... Among doctors there are many differences in the chain ... among members of the supply chain in the air space. Those who wrote many articles in prestigious journals - are physicians with a touch of PR-specialists, they can be expensive in queries, but not very disciplined in the execution. In my opinion should be sought in the laboratories at schools, maybe it's even a post-graduate students, or it may be in the hospital laboratory, with research divisions. Typically, researchers have division in labor: a writer, the other considers the data table. At the same time and write the article and read the data - it is extremely difficult. Hence, we need to seek out those who fill the table of research. They tend to, and supply material for the articles, and have ideas, or they are directly connected with the authors of the idea. And they are not expensive, it's workers are not spoiled by the attention, keep a low profile cabinet. And they have relationships with those physicians who practice and have provided data. And as an article published will be a person - after .. Good luck in your search for contacts!

Clifford Thornton I think we're seeing a common-thread here....physicians in the equation is not only helpful but mandatory from a regulatory, features & design, practicality, and marketing standpoints. The physician, I believe can be very helpful in the positioning of the product as he/she knows their patients better than anyone else. Think of the relationship between a pacemaker patient and their electrophysiologist -- that patient is literally putting their life in that doctor's hands -- so in turn by trusting the physician they are trusting them to make the best decision when it comes to selecting the right pacemaker/defibrillator from the right manufacturer. So, if you're going to develop a new device to compete with Medtronic, you better have some seasoned cardiologists/electrophysiologists on-board to craft your strategy, figure out where there is an unfulfilled need and then how to get that down the pipe/communicate it to patients and develop a following of physicians who are trusting of and committed to your product. Of course this can be a windy, dangerous road -- both for your company and the physicians involved.

Product positioning involves a lot of psychology and like I said who better to understand the patient's psychology then their physician. I believe they even have some training on these aspects in medical school. If you're going to rely solely on engineers/R&D, operations, finance, and career marketers -- you're taking a big gamble and can get it wrong without a key stakeholder. It's like engineering a hydro-electric dam and not consulting with the city who needs the dam as to what their needs are.

What I would recommend for a company is to have a panel of physicians who have some experience in some facet in medical devices in specialties that relate to the functionality of your product. Get this panel involved in not only the product development and regulatory process but also get them on the product launch team. I've worked as a product manager and conducted "product launch team meetings" and it would help to get them in on as many of these calls/conferences as possible. They should be a part of your "core product launch team". Of course this is easier said then done, which is why you have to find the right physicians. They've got to have an entrepreneurial itch and perhaps they have flirted with engineering. I once worked for an ER doctor turned Emergency Room Information System (EDIS) develop and company founder (i.e. Wellsoft). So, you need someone like that to get involved. Of course you have the risk of them jumping ship to a competitor or starting their own outfit to compete with you, but I guess that's where "non-compete" clauses come in for some reasonable period.

My point here is we should not look at the physician as this 3rd party outside "consultant". Bring them onto your team, invite them in, get them involved, let them be one of the parents of your baby. Teams win when everyone is committed and focused on a common goal.

John Strupat @Zeljko . Dan has described his pragmatic experience in collaborating with physicians.
Difficult now for anyone to remain naive after reading this.

Is the following statement correct?
"The medical device industry needs to collaborate with physicians and other health care professions to survive. In contrast, physicians and other health care professionals do not need the medical device industry to survive"

If true, it seems to me that this is the core issue that makes cooperation or collaboration so difficult.

Can this situation be improved?

Dan Levendowski John: To respond I would argue that human nature must be factored in. Physicians are no different than any other professional, some will have curious and creative minds and are ambitious and willing to take risks. The difference between an engineer and a physician is the engineer's training is to identify and solve a technical problem. A practicing physician's is to treat a patient. Within the construct of this discussion, we're asking the physician to cross over and help identify and solve a technical problem. Bottom line there are simply fewer physicians who can do this because its a deviation from their primary training and mentality. But they are out there and many are probably already associated with a company doing what you're asking about because its in their DNA.

As Elena suggested, it's sometimes better to find the diamond in the rough, however the value will only be extracted if you have the experience to transform what the more novice physician doesn't know. Having a physician partner who's done it before adds credibility to the project and helps raise $$, if that is a consideration.

Good luck to you and Zeljko great question!

John Strupat I must confess that my particular interest in the topic comes out of a recent event where Government was announcing new funding for the medical device industry. The presenter then polled the group for their issues in growing the industry. He was stunned when a representative from the largest manufacturer in my area stated that contacting and working with physicians was their top concern. Everyone else in the group agreed except a rep from a multi-national.

I took away 2 general conclusions from this event:

- Multinationals have all the resources needed to attract and work with clinical physicians and researchers anywhere in the world. They hire recent PhD's and set them up in local research parks as contacts, plus attend every research conference and trade show. That makes them the target and the preferred collaborator of every private and Government funded research institution, technology transfer office and hospital.

- the rest of the medical device industry is primarily made up of very small companies.
The majority are NOT involved with surgical instruments, implantable orthopedics, implantable electronics, drug delivery devices or medical imaging. The majority do not have interest, or the resources, in developing a device that requires a PMA. They are rarely contacted by research institutions as potential collaborators. They have great difficulty in making any contact with individual physicians and other health care professionals.
Their typical regulatory process with a 510K often does not specifically require formal collaboration with a physician, but may benefit from that contact or use others instead.

Keep asking those questions Zeljko in as many different ways as possible!

Zeljko Roncevic John,

you are right when you say that there is a big difference between multinational and small companies in cooperation with physicians.

I can't talk much about USA situation because I live in Europe where the situation is a little beat different. In South East Europe physicians have a small salaries so they are interested for extra money but there is a small number of companies with potential to made the new medical devices. So we have to think how to connect inventive physicians with companies ready for cooperation with them.

Generally speaking, the physician may be of great help in identifying unmeet clinical needs that comes up as an opportunity for developing new products that can be marketable and to streamlining the product in the clinical need requirements. In this regards the physician plays a critical role in the design input and design output of the devices as well as in regulatory issues and clinical monitoring.

Robert Trinka, MBA Zeljko, I hope that we can make physicians be comfortable in this group. Although most of us may be business people, physicians, directly or indirectly are our customers. Anyone who ignores the needs or opinions of their customers will not be in business very long. In trying to improve patient outcomes, physicians identify many tools that they need. It is important that business people work with physicians and healthcare organizations so we can provide the tools (products) needed. In my work, I do not find physicians difficult to cooperate with (I attend meetings with physicians who describe the new tools that they need). For improved cooperation, is to respect each other. Thank you for your post.

Zeljko Roncevic Thanks to all from the group who think that this is a great question, and once again thanks for your contribution and support.

Pat Ridgely, MD Lots of interesting and useful comments so far here! Not sure I can add all that much in the way of real insights, but here are some thoughts based on my experience over the decades, mostly (but not exclusively) in the US.

I think it important to consider physicians as an important part of a broader group: namely, clinicians. At least in the US, non-physician clinicians are an important constituency, and teams are becoming more and more a factor in therapy/device adoption and use. (By the way, as an MD I welcome these developments, though many regard them as unfortunate and even threatening trends.)

More and more we see the value of addressing not just the physician using the device, but other physicians involved in patient-identification/referral and ongoing-management. Similarly for parties involved in formally assessing a new technology/device, including those addressing the key issue of incremental cost-benefit. I know this has been regarded as a truism for some time now, but I am amazed how often I still see it ignored in product reasearch, design, development, and marketing/sales.

I have consulted for a variety of multi-national companies, from small to quite large. Even the small ones have generally been able to identify physicians with whom to work. The physicians I have seen work effectively in a corporate setting (as either employees or consultants) have typically shared a common set of traits. They recognize the following: (1) they are a member of a team, and thus being a great clinician or researcher does not mean they can ignore alternate points of view or the input of non-clinicians, (2) technical (or even clinical) excellence is not by itself sufficient, and (3) business/financial considerations may outweigh nearly everything else.

I think it crucial to have a strong sense of context when working with physicians, especially in a start-up situation. I have more than once seen a famous physician have such influence early on that it is ultimately stifling to the success of the endeavor. One way in which this occurs is to not have a good sense of what practice-patterns exist; this can lead to being wedded to one physician's vision.

The best physicians know they bring a ton of value to the table, but they also recognize they don't bring EVERYTHING to the table.

Yuri Iserlis I see many evidences of the high-tech revolution in the medical practice in different countries around the world. First of all here are computers, iphone and so on in the any medical office, second here are devices for diagnosis without x-ray, ultrasound and even CT, third here are devices for treatment serious diseases without medications, fourth here are robots for surgery and nursing. I don't speak about medical expert systems, because many doctors don't know what is it. Therefore main question for this discussion is rhetorical. If physicians will not participate in this revolution process, in the future patients will be treated by ignorant people armed by new medical devices.

Zeljko Roncevic Yuri,
main question is rhetorical but essential. Will physicians be inside or outside this "revolution process" it's very important. There is still many medical devices that can't be made without cooperation with physicians. Simply, how people from medical devices industry know what we (physicians) need if we don't tell them.

Yuri Iserlis At all times, no one new medical devices could not be created without testing, and without testing on patients and without cooperation with their doctors. Here is another problem how doctors relate to many existed and new devices. It is not ease without special education in field of electronic, computer science, especially in field of artificial intelligence. On other side, a new modern integrative medicine demands using such types of devices, because the background of many physicians based on classical medical theories doesn't allow them understand a new trends in informatic and energetic (mostly oriental) medicine.

Zeljko Roncevic Yuri,
you underestimate doctors and their education and even their intelligence. Believe me many of them are very smart and very good in high-technologies. Do not forget that many of them are well-known scientific researchers whose findings enabled the production of many drugs, medical devices, and laboratory tests. I do not know how you can connect a high-tech medicine with alternative medicine (energy medicine).

Neda Al-Saadi Technology has changed medicine. Most patients look up their symptoms on the computer. They may even self diagnose before they see the Doctor. The Doctor is strongly influenced by the pharmaceutical industry to use the newest treatment. Often, there are older
methods that are more established and safer. The patient, by educating themselves as to the advantages and disadvantages of a course of treatment, can help choose the best course collaboratively with their physician.

Natural therapies, as opposed to man-made pharmaceuticals, are often an option for early intervention. The Internet puts all of this information at the patients fingertips. They seek a better understanding of the options and consequences with their physician. There must be tremendous trust and confidence, in addition to a required quick decision, for a patient to say "Whatever you say, Doc." as opposed to
"What do you think about this, Doc?"

Yuri Iserlis ZeIjko, I don't underestimate doctors and their education. I respect this profession very much. During my life I knew, and work together with many wonderful doctors, medical scientists and developers of medical equipments. At last decade I asked and discussed with several doctors new methods of treatments. I don't know whats going on in other states , but in Bay area (California), where I live, physicians, on one hand, don't know last innovations in medicine like Clinical Decision Support Systems , EAV devices, Metatrons from Russia ,Chinese devices of Tiens Corp, etc., on other hand ,don't have a right for using these innovations without permit from FDA . Unfortunately crisis in traditional (western) medicine and problems of American healthcare reform are items which are out of item of our discussion.

Elena Buran Dear Neda, all cases when a person experiences a painful shock, he loses control of the situation, has damage ... it is difficult to find on the internet description of the pain pills. His hormones, neurotransmitters of the brain background quite different in response to a painful process, the perception of information is distorted. What to read with pain during the illness is perceived quite differently than if the same information reading a healthy person.
In addition, there is an aspect of human living energy, of course. Long ago, more than 20 years ago I helped a little bit during the dressings. Patients suffering from gangrene, festering wounds. This is a very heavy dressings. There were various accessories ... but I remember that many patients able to remain calm when I held their hands as if they were small children. I touched his temples, and it gave them energy, with which they coped with the pain during dressing. Never internet or medical device can not replace a live person.

All that had made man - only his instruments, which make some things more convenient for storage and analysis. and nothing more.

with respect

Mervi Hamalainen Now I am not sure how big medical device industry is globally, but I assume the numbers are high. I think MD industry should bench mark other industries and learn from them how R&D and Product development is done e.g in car or sw industry. To learn best practices from other industries, MD manufactures could improve their performance and save big amount of money for not developing products that are not end-user driven. I think those who are investing money for MD companies should start to demand right processes etc. for Product/ R&D development. I think in every sector, those who make their "home-works" well and are end-user driven will collect the greatest awards.

Antonin Cuc At least ten years of intense longing for direct cooperation with orthopaedists on security issues orthopedic safety procedures. Of course there are many industry-meets disciplines from biomedicine, technical materials and their safety in prolonged contact of metal surfaces and bone tissue destruction in solving solid implant anchorage components, etc. I am educated as a mechanical engineer and I have 30 years experience in the field of product safety life testing of products, the design of secure processes with applications approaches Evidence Based Medicine. I also have ten years of experience in the management of state supervision of work Health and Safety, thus also providing services to patients in the field of Health Care. It is for me a matter of course technical interpret three-dimensional X-ray images and test success and timeliness of the radiological interpretations to the diagnosis by support of computer. Now I'm after a failed orthopedic hip surgery, crippled, and I prove surgeons that when "fousse route" with uncoaxialities between the femor and the stem, by critical 14 degrees it could never operate the product properly at the mandatory test before the operation completes. Immediately I could write "Standard Safe orthopedic surgery total hip" with details down to individual detailed tasks, "the control shaft position measurements before pushing", "Safety pushing of stem", then "on after stumbling stem", compared on X-ray with the conditions compared with mask of stem position on X-ray with support of computer by controlling the correct position: "in the right depth of the shaft", so as by radial position to a large trochanter .... but no me as retired researcher engages in very practical research: And my trial for life destroying nerve function ischiadicu to all doctors act like they do understand no word the scientic arguments at the level of the correct application of the Pythagorean theorem - that is not accpeted the bad position of stem with argumentation to take only virtual picture of axis of the stem ..... image that is being seemingly shortened 3 % depending on the COSINUS of angle misalignment 14 degrees. It is absurd by the fact that doctors could only "visually interpretation X-ray image", without paralell X-ray, without radiological mask of stem, without mesurement the right long of the stem - It's so hard to understand to doctors? It's so hard to change their very bad habits in medical interpreting radiographs? I am able to build with Medical Devices Group: a trenager as computing and testing workplaces for the knowledges of the medical students so as for the professsor, you could be able with me to solve simulating crash situation on orthopaedic surgery room! Utility Model 21532 Czech Republic,

Pat Ridgely, MD Are people under the impression that physicians are currently NOT involved in product research, design, development, and implementation? My long experience is quite the opposite, but perhaps others' experiences are different.

In respectful response to some of the more recent comments here: I think it important to not treat physicians as gods and goddesses, even if some of them seem to regard themselves that way. But neither is it useful to treat them as idiots or narrow-minded, even though some of them are indeed the latter. I know any number of physicians who are quite tied into new technologies, health informatics, use of social media, and alternative/integrative medicine. (And they are not all in their twenties or thirties, I might add.)

John Strupat @Pat - Great that you have entered this discussion.

Perhaps you could comment on one of the original questions; how do physicians and the medical device industry co-operate?

The two situations that cover most opportunities to collaborate are when the physician has a novel idea or when industry has a novel idea.

How do physicians and companies find each other?

Would be excellent if you could comment on approaches that worked for you and those that didn't.
Is just everything a straight financial negotiation, or is this often considered an insult?
How can industry tell when they are asking for too much from a physician?

So many places to go wrong in the early negotiations!

Antonin Cuc Sometimes an impulse to innovate is creating of medical devices industry, sometimes new design of new Medical devices is authorized of specialized doctor - and a resulted reason to change is comming to the management of patients, with new regards to risk. Many of patients are able to bear joint responsibility of "finding the right diagnosis" and "finding of the right kind of treatment" with doctors - but now communication between the patient and physicians - and with providers of Health care services (such as the hospitals) - working together is not enough well and safety, efficiency. Especially patients suffer from the poor of the physician and their low level of the right praxis with use of new technical devices - as telemedicine, surgical procedures too complex with more special risks for the elderly patients, suffer from the difficulty of mutual contraindications medication paralell prescribed of medicaments by different specialists physicians in various ambulancy, etc. All services will bring much more expensive costs and to much complicated risks and typical weaknesses among multilateral medical brunches in one patient case. Often many patients begin their doctors be worry because the medical mistakes just shrugs doctor - but the patient is often crippled for rest their life. Therefore, I believe in forced major advance and speedly forced progress in the management of risks pacients. We haven´t got in States of OECD such enough money to support the all increases of mistakes and medical errors! I prefere Health and Safety in medical care on the same level statistical relibility as in computer and airplanes industries: 1 mistakes to 1 milion right medical decisions and acitivities! We need computerized education and controlling of medical knowledges and skills, tested systematical on the simulators - like as in the trenager with pilot cabine! I recommend you build new informal systems "to decision making" by Utility model 21532 Czech republic,

Sean O'Reilly I believe physicians need more of a say in the device development process, and are sometimes left out of the loop. In a recent article I wrote for "MedicalDesign.com" magazine I included an interview with Dr. Arlen Meyers, Founder of SOPE (Society of Physician Entrepreneurs), which is trying to bring physicians "in the trenches" with device ideas back into the loop. The article can be found here: http://medicaldesign.com/Medical-Manufacturing-Technology-3D-printing-medical-device-development/

Yuri Iserlis We need to discuss problems cooperation of doctors with developers of medical devices only in existing environment.
These days, we don’t see anything unusual or special when:
• A radiologist interprets medical images from a clinic across the state;
• A nurse takes the blood pressure of a homebound patient without ever leaving her office;
• A cardiologist sees and checks up on a heart transplant patient while away from the patient on a business trip;
• A patient and a medical expert have a two-way video consultation;
• A patient’s medical data is captured from monitoring devices and sent directly into electronic medical records.
• Some doctors or workers in special departments in clinics use automatic and advanced devices for different goals of medical practice

Everything from above mentioned is examples of realization of Medical Artificial Intelligence systems appearing at last decades in the medical industry. About some of these systems you can read in my book “Artificial Intelligence around Us.”

Antonin Cuc I agree with you Yuri till to each word. I cannot understand, why we haven´t systematical monitoring of medical mistakes and why we don´t prepare "The New optimal transformal Channel for standards typical activities" without new personal education all staff, without new perfect medical devices and without a successful communication among the patients, physicians, hospitals, developers of new technologies and computerization experts. All processing must be rational, with minimal increases of entropy in informal system with high resulting Health for long time for all citizens, with minimum costs and conflicts to multilateral medical knowledges by World Health Organization! It is bad to prefer only more profits for producers of medicaments or medical devices before Health and Safety of patients with requirements to more quality of personal Life in the States OECD, there is trendy for democracy in the world and there is a best idea for next new popolutation of doctors, producers and patients. There is ground for my Utility model 21532 Czech Republic to build a new informal systems for repeated strategic decision making about a new stream of innovations and predictions of the superinnovations - often with the similar strategic tasks and similar risks with minimazing statistical risk of accepting some bad decisions! We need find cooperation among multilateral balance of interests, knowleges and skills of patients, so as doctors, hospitals, providers of Health care, producers Medical devices, computer experts, State Health policy, insurence experts, etc. We are able to solve it, wenn we are going to solve it!

Zeljko Roncevic I want to remind you that we are discussing about the role of physicians in the medical devices industry. The topic is not about the relationship between doctors and patients, nor the role of doctors in the health system. At the moment it will be the best to discuss how to improve cooperation between physicians and medical devices industry.

Pat Ridgely, MD Thanks for the kind words, John. There are lots of different ways that these situations can begin and play out, and the increased use of networking and social-media tools is expanding it even further. One avenue that is often overlooked is the role of ongoing advisory boards made up of clinicians; large device companies typically have many of these, often (but not always) with a very specific focus. This can be a great way to establish and maintain ties between clinicians and industry.

Something else that is often overlooked is simply keeping your ear to the ground by talking to people in the field, contacting authors of papers, attending conferences and seeking out speakers there (and working the exhibit halls), leveraging industry forums and professional associations, and checking out universities which have relationships with industry. Some venture-capital firms specialize in medical-device investements, of course, and I have seen clinicians go directly to them with ideas. I have also seen clinicians simply contact device companies (either directly or via a field rep) and ask to speak to groups involved in product-ideas, new-therapy development, and the like. It helps if clinicians who are new to this can have access to other clinicians who are veterans of the process and can get some mentoring.

There are MANY ways in which things can get off-track, of course. One of them is greed. It's important to have realistic, stated/documented expectations. Intellectual-property protection is essential.

We are blessed here in Minnesota to have a large base of companies that are a visible player in the state's economy, and an active trade association (LifeScience Alley).

Elena Buran Dear colleagues, I have a small collection (several dozen) summary of doctors, engineers, computer scientists, who either participated in the development of medical devices and equipment, or participate in research, database, useful for building and testing devices. They're people who live in Moscow, Russia, who speak English and are open to international cooperation in the companies. I invite those who are interested, to establish contact with me or send a private message directly ElenaBuran@yandex.ru
I can send you the content of the summary, no personal information. If you would be interested, I'll be glad to help to contact and negotiate with a resume writer for you for a small fee.

regards

John Strupat @Pat - your perspective is very valuable to this discussion.

I'm hoping that we can get advice on how the smaller device company can make contact and obtain collaboration with a physician?

Realistically, small device companies are often direct competitors with the large multinational device companies that dominate the institutional research and hospital environment. These have vast resources committed to the direct and indirect support of physicians and the professional teams of "technology transfer facilitators" that are now in place at every institution.

My experience from the clinical side matches your comment in that the first point of contact is always the easiest point of contact; the sales rep from the multinational company.

How can the small company, especially the start-up, get a chance to even be noticed?

I see this situation as a major roadblock to medical device advancement. The groups at institutions who now sift through employees device ideas do not want to work with those pesky and demanding small companies. So much easier to negotiate with one's colleagues at the multinationals.

What can be done to improve this?

Elena Buran I think there are two important points
1. correct, competent, well-described task - for the group as a whole and specifically to the physician. This jewelry work with words.
2. very important work of the mediator, agent - he will inform and describe the task so that it looks complicated, interesting, and ... feasible for the benefit, including the material aspect. see and engage the personal motivation for each participant - is very important

Harish Kapoor We always invite physicians feedback from concept to product development and market launch. They work with these devices everyday, and can provide valuable ideas.

Mark Lutvak You Physaicians have to finnaly realize that you are RUNNING A BUSINESS and not just exercising your oath! You cannot give any healthcare unless you are making money, because if you do not make money, you will not STAY IN BUSINESS - pretty basic, right? As a businessman (or woman), you have to continually bring NEW REVENUE into YOUR BUSINESS. Please comment on how you will do that? More Hours? How about bringing into your practices - services you now OUTSOURCE (for example blood draws/tests). I challange all on this Blog to answer - especially after the changes you WILL HAVE TO MAKE under Obama Care!

Pat Ridgely, MD John, you raise a good point. My experience with smaller/startup companies is that some clinicians actually prefer to work with them rather than with the huge multinationals. I think small companies just need to work the conferences, associations, and networks and try to interact directly with the clinicians rather than be at the mercy of university technology-transfer groups. It can take a lot of plugging away.

Elena mentioned the use of mediator/agents. I have not seen the need for this all that much in the US and other developed markets, but I can see it having value in some markets. And even in the US I have known startups who simply retained a consultant who knows the specific area and can help them build their base of consulting clinicians.

Elena: I agree very much with you on the value of well-described tasks and expectations!

Mark: I am not sure your questions are relevant to this discussion, and I confess to finding your tone unacceptably hectoring. But I will say that if you think American physicians in private practice are as a group unaware of these issues, then I think you are very unfamilar with what has been going on the last few years. My experience is that even most academic physicians in the US have been aware of them for some time.

Elena Buran Thank you Pat, I also think that the doctor is much more convenient to work in a small company for a number of reasons: it is psychologically comfortable, reduced risk of error and the consequences can be more flexible to build cooperation. and they removed some of the questions Mark, because the doctor who wants to practice and keep it at the same time to do research, develop, developing technology, need more flexibility in daily routines and communications that large companies are not always able to give because of their size. In a small company, you can communicate directly with those who influence the decision and make the adjustment quickly. great company - great circle involved in the coordination and the risk of error. and there does not need intermediaries in, yes. - Only at the stage of dating and attraction.

Antonin Cuc Elena, I'm a researcher and designer, mechanical engineer. I am "furious" when the technology orthopedic operation must either large hospitals have expensive Medical equipment "Ortho-pilot" - but where even in a small hospital we haven´t to take enough small mechanical universal equipment "for coaxiality making" for cementless total hip stems. Would you buy patent of mine? Also, you can paralell imagine how the postoperative X-ray imaging after total hip with a simple software - automatically could be checking the right position of the stem in the correct depth of the femur and so as "profile" - include in the correct angle to the great trochanter. Nevertheless, orthopedic poorly trained "how to safely detect" when the shaft with malposition is with uncoaxialities to axis of the femur - just in the plane of projection X-ray imaging! Then, many patients with bad diagnostic uncoaxiality needlessly die for interoperational complications in surgery room or they are maimed for rest their life - as I have been unfortunately experienced too. Many of the suppliers of medical devices generally do not force enough attention to detailed user training - then it is lack of cooperation between the manufacturer and the doctor, as a primary user - but often the bad consequences will take Health of final user - patient. Well we begin with the firstly formulation aims to solve design of Medical devices, but the final result of advantages of introducing new innovations - we have to tested, including the statistical sampling effects by of final users - patients! I cannot understand on common markt of EU there are implants with long life only about 8 years, so as with 19 years - and the patient must accept only one type of set of TH-A by recommending their insurance and his doctor!

Elena Buran Yes, of course, feedback is very important, both for large companies, and small. importance the task and complementarity. worked out in detail medical devices in the small companies should be replicated in larger ones. big companies do not have to replicate the mistakes and weaknesses model, they have to take the best and proven capacity and include them in accordance with the market needs.

The interaction between small and large companies, or the presence of a large company pilot independent laboratories - a separate complex topic.

Well, on that and there is a community to talking, we're all better understand our tasks and optimize our activity.

Christina Cherrill Antonin - unfortunately amazing medical devices do not necessarily equal amazing results in the hands of suboptimal perioperative medical understanding. Even so you must remain proactive as you consider ways to impact these situations from a medical device design point of view. I like to think we always have options, and with this situation I envision lots of room for innovation - mostly it sounds like you are in desperate need of knowledge management infrastructure and the right approach to get everyone involved. Can you locate an ortho surgeon who can empathize with this situation and be your advocate? You need someone who can help determine how to get the best results that will work for all parties involved.

Pat Ridgely, MD I second Christina's point about finding a physician champion. Idelaly, you'd like to work with an institution to demonstrate that not only is the device/process technically innovative (perhaps even amazing) from an engineering viewpoint, but it also can be implemented realistically in the clinical and economic world that the clinicians and institutions face and can bring about the desired outcomes. This includes an effective program for redesigning processes where necessary, training all involved, and tracking the outcomes.

(A side-comment: at least in the world of implantable programmable devices in the US, we have seen extensive training programs for many years, including the use of simulations. In fact, the literature on use of medical simulations goes back to the late 1960's. This doesn't mean we are (or should be) satisfied with where we are at, of course.)

I urge everyone who is trying to get innovations introduced into medicine to consider the value of the classic segmentation of clinicians and institutions/systems into "early adopters", "late adopters", etc.

Antonin Cuc Thank you all for the sincere attempt to discuss and think about optimization. I found in 2010, the 2 scientists - as heads of orthopedics from Orthopaedic Clinic Medical Fakulties two teaching hospitals - in the town Olomouc and Brno in Czech Republic, who both wanted with me to start working on - a standard "preparation and orthopedic surgery, TH-A" with minimal risk patient for all activities. So it was a repetition of standard orthopedic sequences of strategic decisions - in selecting sets of total hip arthroplasty for individual patient, the preoperative examination Health standard of the individual patient, ensuring the input of written duty information for the patient to provide informed consent with the legal agreement to operations - including to optimize the selection of the type of anesthesia, the selection of surgical technological approaches to hip, for preoperative planning orthopedic surgery according to the preoperative radiographic image and with regards to the individual characteristics qualities of dimensions and bone structure, etc., etc. After about 3 months of our discussions, both orthopedic researchers found that would eventually result was a process that would work any elementary orthopedic testing based on Evidence based Medicine, so as with adequate the level of the new solution would be using with Telemedicine and computer support, the more "clever small databases" using archiving of similar best experiences from abroad, then we coud predict a next highest national level Orthopaedic Knowledges Centrum EU - that of Medicine in Olomouc and Brno take the leading role in the orthopedic field and overtaken by scientific results Prague faculties. Probably both scientists have lost the courage to use such challenge and possibly damage the existing relations between scientists among all orthopaedists in the Czech Republic. Therefore they withdrew from cooperation and I immediately to give my private patent Utility model 21532 "How to build faster, cheeper and "more clever" the informal distributed databases for the repeated similar strategic decisions with support of computers". Now I am seeking entrepreneurs around the world who have the problem strategic decision with new way with minimum increases entropy in informal system. It could be not only in the area of patient safety in orthopedic - but it is the same interesting practical thema for industry too. The same way I can take my patent for industrial productions systems, I am experienced "How to design the new machines in machinary", "How to find with best efficiency by statistical reliabil prediction for a best speeder and rational choice a innovation from group of variant in stream of innovations", etc. I would like to cooperate with you and I would sell my licence to my patent in time - to worldwide disemination by a experienced and strong designing firm.

John Strupat @Elizabeth. Not sure of your definition of clinician?

Medical devices are used by a wide range of people, from individual patients to specialist physicians.

Sometimes a physician may be the decision maker and end user of a product, such as a surgical instrument or a pacemaker.

In far greater proportion, the end user's of most medical devices will be nurses, paramedics, respiratory therapists, nursing home attendants and the patients themselves. Much more challenging here to uncover who the decision makers are and how they make that choice?

I agree with your comment on the importance of getting early input to educate the company/inventor. There is similar immense value in educating the physician/clinician on what the market needs, rather than what they personally feel they need or are convinced their specific institution needs. Collaboration has benefits for both parties.

Very sobering to see the end results of expensive and time consuming development of a new medical device at an institution that is then discovered to already be available on the market or even replaced by newer technology.
Seems to be a trend worldwide to fund institutions to develop medical devices that they hope to profit from, but will never take part in the manufacturing or sales and marketing.
What could go wrong with that scenario?

As a consultant who works with a number of PE and VC firms specializing in medical devices, my work includes extensive discussions with physicians and physician assistants. Subjects discussed include not only product claims, but pricing expectations, communication, claims and messaging prioritization as well as how and what types of data should be presented which has actually influenced the type of information obtained from clinicals. However, it should also be noted that my clients also had me conduct research among potential patients as physicians aren't always aligned with their patients along these same parameters.

Antonin Cuc I feel bad - as a scientist and government expert in the field of Health and Safety of Czech Republic - I am very sorry that the entire medical field of orthopedics does not openly investigate the current state of true effectiveness of the treatment in some standard orthopedic surgery. Try with me to ask common for some large teaching hospital orthopedics necessary when the annual number of total hip arthroplasty performed primary operation is 950 performances, how many of operated patients after 1 year (after surgery) have relative frequency distribution: - How much patient % can play sports, - How much % other could go well, How many other patients % must wear "a stick or French stick" still after 1 year, how many % in the first year experienced dislocation implants and they have got a new reoperation, How many patients are unable to walk independently. how many patients died or are hard injuried from complications of the orthopedic room or within first 1 year (due to anesthesia complications, brain strokes, heart attacks, embollie, indoor hip fracture afylactic shock, etc.) .... and what % of patient adverse outcomes could be a good prevention of patient health risks affect well - better technical equipment room, better improved education orthopedists, better and higher quality tutorials for implantation, better skills and training of physicians in dealing with mainframe complications, more careful individual preoperative estimation of personal risk in individual orthopedic surgery, manytimes a absence of taking non-surgical treatment of early reversible changes in articular cartilage, treatment of necrotic surfaces sliding surfaces joints tomoskopic and artroscopid methods, etc. All manufacturers of orthopedic implants and so as orthopaeds keep face, as if to implement the operation THR was some trivial matter, which always results in happy ending for you. Orthopedist for the performance of total hip arthroplasty receive 8x more money than non-surgically cured joint and manufacturer of implnats provide a bonus to the hospital stay of 4 doctors at the World Conference on "Computer-controlled operation THR". When total hip surgery did not at all objective for medical reasons to take place, so I am naturally furious when I was at such a concatenation medical errors by operation unnecessarily crippled on orthopaedic hall! I admire new technical Medical devices and I can design it to, but next medical policy and Medical Devices must be more oriented for human services and for more patient with sure safety.

Pat Ridgely, MD "Seems to be a trend worldwide to fund institutions to develop medical devices that they hope to profit from, but will never take part in the manufacturing or sales and marketing." John, can you share any examples of this?

Frank, you make an excellent point. Individual docs are often not that informed on what the broader communities (other clinicians, pateints, instituions, or healthcare system) want or would value.

Antonin, I was just in Prague a few months ago. Wish we could have had a chat over some fine Czech beer! Keep the faith.

Antonin Cuc Hi Pat! We could sit down together and talk without censorship by the Czech beer about World and World of patients. The fact is that, according to research by the OECD (2010) there are error medical decisions in individual cases large probability sample of visits patients in hospitals so as in ambulancy - in around 10% important errors of all visits. The reasons are obvious: they are now much more complex surgery technology, new technology for diagnostic and variant of treatment, etc. Now there are much more complex equipments and variable medical devices, and sure: much more available space summary of all knowledges in multilateral medicine in WHO. It means not to continue into maintain the outdated style of work of physicians, who nobody have such " a big head and, such experiences and knowledges in just moment in one workplace and taking by one doctor." It must be completely changed computer support, involvement and responsibility of patients and new ways of communication and regards to manage risk of patients. That's hard to decide only by a financial profit of some partners on the market of Medical Devices. He wants to find another purpose, goal and motivation of physicians, and new respect for other patients and their knowledges and human rights, new tasks for other health policy of the state. It is no big reason to discuss only about relationship between 2 entities "Physicians" and "Medical Devices Industry" in the functional system Health care.

Lynn Kellen We also listen to all physicians in our specialty and design according to their needs if it is possible and goes over with more than one. We could not have got to market either without 'our' Docs.

Zeljko, What is the background to your initial comment? I mean it is so general, it is hard to grasp. Are you a clinician? A med rep? Are you employed by a company selling medical devices? Or are you just frustrated at something or somebody. The short answer is, in my opinion, what can the physician do or what does he do? If he treats patients, then yes, we need him so he can buy from us after making a considered judgement (we hope) . We also need to employ physicians to handle medical relations or act as ambassador to the customer base. Make speeches, presentations, take complaints by phone, etc. .Doctors like that. If a physician has technical skills or design skills, then, yes, the industry needs him or her too but not because he is a physician, Because he has ideas.and skills. We do not need physicians to sell the products, make the products or run the company.We need specialists with enough background knowledge. Physicians may do it but they do not have to have a MD degree.

Oh, by the way, the comments and deeply held views posted here about listening to customers,i.e. physicians, about new product ideas is sadly no longer the truism it used to be. The gurus du jour say we have to lead the customers like Steve Jobs did with the Ipad.or Iphone. Customers will only give you tweaks on what they know. Little bit like asking coachmen about what can be done to improve the stagecoach. Get it? Visionaries like many of the members here will understand that shift in strategy separates the men from the proverbial boys in the new world order of medical device makers. Good Fortune to all.

Zeljko Roncevic Thomas, yes I'm clinician and researcher and I'm not employed by a company selling medical devices. I like to put a small dose of emotions just to brake monotony. Discussion is general but from time to time it's good to discuss even that kind of questions. The number of comments (touristic as you think) shows that this discussion was interesting for members and even for you. Thanks for your comment and of course good Fortune to you.

Antonin Cuc Thanks, Zeljko, it was good! I have a good sense of multilateral space of these realised discussions. Just I have a paar rest questions - but I would like to discuss practically and completely separately, with a hope to gain some advise from you. I'm also a scientist for decision making and Health and Safety, and I welcome the views across the problem from more a very respectable experienced partners angaged in Medical Devices. We need to understand each other, to have a best technical equipments so as a best way to use it and to innovate it. So as a bilateral discussion could change our personal behavior and opinions.

John Strupat Hi Elizabeth. I was hoping that you define clinicians this way.

Your process matches what my experience has been in collaborating with clinicians. The idea of having an evaluation of a medical "product" before commercial launch is the elephant in the room.
When (in the development of a new product) will a clinician be able to provide useful information to the inventor?
When will the clinician be able to write papers and technical articles and attend meeting with colleagues without damaging the business opportunity for the inventor or their IP?

Most lay people and most clinicians are not capable of looking at concept drawings, renderings and even the best computer simulations, to "see" the end product envisioned by the inventor.

So we go down this typical path:
The inventor will now spend money to make physical prototypes that look like the end product but may not be totally functional.

The inventor then spends more money to make functional prototypes that work properly but may not look like the desired end product, or perhaps not be made of the actual materials that the end product should be made with.

The inventor now spends much, much more money to make prototypes that are totally functional and look like the desired end product and are made from the desired materials. The inventor can now begin to pay for initial testing required by medical device regulatory agencies.

The inventor can now spend exponentially more money to fully develop a pre-production "product" that should be identical to that expected for full production runs.

Everyone benefits from having clinicians involved from the early stages of new product development but this is extremely difficult for inventors outside institutions.

Reljko's original question was on how to improve collaboration.
More ideas and comments from clinicians, inventors and small businesses would be valuable here!

Physicians need to define the medical problem that needs to be solved - whether it be a new start-up or an ongoing entity. With a clear definition of the unmet need, solving the problem becomes meaningful. That is, the company builds a product that actually has a use. It is very difficult for a business person to understand the nuances of the challenges being faced by the caregiver. So the challenge for the physician is to keep his (her) mind open to recognize what can be improved in treating patients.

Pat Ridgely, MD John, my experience with prototyping has not been as you describe, though I am not really a product-inventor. I think some clinicians CAN provide useful feedback even at the simulation level. And inventors who form a connection with one or more companies (or clinicians) can increase their odds of success, though I realize there is a price to that.

Mark, I agree with you about the need to consider the business side of things as well as improving the clinical treatment (as Paulo rightly noted). But at least in the US, physicians are more and more selling their practices to hospitals and hospital systems, where the business discussion can be significantly different (though still essential). I fully expect to see more emphasis on efforts of the type that Elizabeth describes from an NHS perspective.

The silos are breaking down, though too slowly and painfully...

Mark Lutvak Paulo: Yes the Physician must keep his mind open to improving treatment BUT ... The Physician is ALSO running a BUSINESS that must be profitable, or the Physician does not stay in Business! With that in mind, the Device Crreator, not only must provide Technology that improves Treatment, but also answers the need to Improve The Physicians Revenue and Profit. I good example is the trend by Physicians to brind treatments and testing into The Physician's Practice, rather that outsourcing them - called POINT OF CARE Procedures and Technology.

Mark Lutvak - Synergistic Marketing www.synergistic-marketing.com

Most Med Dev companies are already working closely with physicians, most of whom play consultant or advisory roles. Getting physician input is fairly easy. Unfortunately, as physicians we often don’t understand our value add to the team, or worse, we overestimate it. Unless you are a founder or inventor or have some other reason to be permanently connected to the core team your services are best outsourced and often obtainable for much less money (often free) then hiring you as an employee. Whether it is opinion, hands on testing, or writing a manuscript, it is really best outsourced as long as possible. This means the company can and will use you when needed but not really want you hanging around otherwise. This is hard for physicians to grasp because most have never worked in a company yet they often think they know better. Med Dev is a very big undertaking that takes full-time commitments, which most physicians don’t have to offer. Hence, this is also why most business people will tell you not to quit your day job. Unless you bring some other unique value to the table, your biggest value add is as a clinician.

Antonin Cuc Until you deal only with a doctor discussion over a cup of coffee, you will be honest and communicative together, doctors are usual very friendly. When you will explain to one doctor, that it is necessary, together with other doctors and with experienced educated patients to create a very well working common team "to monitor the most statistic important technical and medical errors in any real medical surgeon room or clinic - ie instantly you will have a rather fierce opponent of scientific methods of recognizing complex complicated systems. Doctor maybe wants - to alter the new technology and organization of hospital work, but he does not want to change his private ways of thinking and private habits and duties and he do not want to know exactly - that just it is a main reason because many patients a day die or there are maimed. In the Czech Republic it is said - "It is more better to be rather healthy and rich as to need some doctor! - But doctors there are the best friends to walk with you common at the annual ball of their university.

Hans-Peter Steiner As I am the inventor, and producer of an new Egg Collection System in hum. and vet. IVF, the big advantage for me was the short time between the first innovative idea to the final product.
My problem is to explain colleagues advantages of my STEINER-TAN Needle 17gauge for flushing follicles, which has the same outer and inner lumen as single lumen needles on the market, but can be flushed from outside needle (link to computer animation at www.ivfetflex.com), because it is quasi double lumen.
In comparison with non flushing one can increase percentage of eggs/follicle from 40% towards 80%.
I would be thankful for any advise, given from IVF colleagues or experts in marketing, how it is possible to change a paradigm in the field of IVF in brains of colleagues, who were used not to flush follicles for decades. Also a marketing expert working in this field would be welcome.

As consultants to start up companies in the medical device industry and their investors, we often assess the market potential of a new device by interviewing the physician who would be the ones to recommend/prescribe them. All too often, we find that they are satisfied with the current standard of care and do not see a need to change. A major device company may be able to educate the market to a better way to do things, but a start up company never has the resources to do that. If they don't start by learning what physicians believe they need, the products they develop will not be successful.

Antonin Cuc I think that the media space is completely exhausted the information from manufacturers, retailers and physicians, while patients often end up on the dissecting-room or maimed, they have neither the power to enforce in court, or at the microphone or in professional journals. Trivial problem of damage to health by "fausse route during total hip stem " in the surgeon hall discussing vain in court in the Czech Republic for three years, whether it is "a technical error in activites of hospital with responsibilities for the legal consequences" or "if this is a common error in the Lege artis without duties pay for the patient the next consequences" and "whether the law was violated when the radiologist checks the alignment of the stem for a mandatory X-ray - only visually - or whether he had an obligation to attach the slide radiological firm template or accuracy measurement on computer screen with SW till 3 days after TH-R." Suddenly find almost none of the experts manufacturers of implants, who stood up for me and suddenly culprit doctor and so as the Court expert orthopedics lying together and the judge's face it is not obligated to understand "what is the apparent alignment only" and "what is the actual scientific control shaft alignment with the femur." Now, who would then of orthopedic surgeons interested in my simple invention "positional Instrument" of a safe and technologically safe anchorage in the femur and shaft coaxially?! Who would want to calculate the probability that only the Czech Republic and comes to death unnecessarily in surgeon Hall of dozens of patients and more hunderds are injuried bad with astronomical economic Loss? I hope in your support.

Andrew K. Palmer, MD Ben,
I agree with you. In the orthopedic industry , the big companies may be able to change patient or physician opinion regarding the need for a new product. Both physicans and sometimes patients listen to them but a start up is in a very different position. Although not impossible to introduce a game changing idea or product, it is far easier and less costly to improve upon something already marketed. And when we do decide to develope a product that is an improvement on products already marked/accepted, I think it is important to know the predicate device ( if a Class II product) before spending much time and money on developement.
Thanks. Andy Palmer

Zeljko Roncevic Although I will begin this comment with I have a dream, I'll be more specific than the rhetorical and generalized. I have a dream to be a part of the team that will make the best electronic stethoscope so far. As experienced end user who works with electronic stethoscopes for years and has made some studies and researches with them, and who has written several articles on auscultation and stethoscopes I know how this stethoscope must look like. Stethoscope should have all the latest technology with some so far unused features. I do not know much about electronics, the software, marketing but I have a feeling for acoustics, aesthetics and ergonomics, and I know how a stethoscope must look like (to be the best) and of course I’m in position to test the prototype on patients. Some marketing slogans in its marketing presentation I have already in my mind. So, this can be my contribution to the collaboration between physicians and medical devices industry.

Hello, I reassure you the medical devices needs physicians and experts in reason of the regulatory and clinical evaluation requirements. A practical example is the request from the agencies regarding the clinical evaluation of the devices, the process will be the same then the drug, probably less complex but the companies must to show some new data and follow the devices by registers. The safety also will be reinforced by the law. All this evolution need the medical and scientifical expertise.

As a physician inventor who has licensed a medical device it seems obvious that physicians are integral to the development of medical devices. As Dr. Roncevic notes the kernal should be "how can I help the patient?" I have always looked at how I could improve the existing surgical procedure or treatment for the benefit of the patient. When I get an idea and find a solution for a problem that I have noted as a physician (surgeon), then that is the beginning. Getting others to help develop the idea or patent into a viable product or device is the challenge that all physician inventors have.

Zeljko Roncevic Arnold, you are quite right the challenge is how to get others to help in developing the idea. Is Linkedin group the good place for entertainment of those who would participate in the development of ideas? or maybe better: can Linkedin group be a good place for it?

John Strupat @Arnold & Zeljko - help is expensive.

Your industry partner needs to discover if your idea has any merit outside of your practice or your institution, before any development can be funded. That includes thoroughly investigating how the FDA and other Regulatory bodies view the product class. So much needs to be completed ahead of even the first prototypes.

In my experience a touchy subject related to early development is that physician's are very reluctant to make an actual financial investment. Perhaps this is key to get industry to show some early interest?

Antonin Cuc I am an inventor - an experienced patient - a mechanical ingeneer. But from the construct idea technical design to first prototype - for example to be surgical orthopaedic new instrumentation and then to its practical testing in clinical trials in orthopedics is infinitely far away and it takes so as a lot of firm money, it is full out of my private possibilities to realize. In the best case with patent in your hand, you could explain it with fun with someone who should have some potential interest in it. But when the cheef of construct firm office will be able to understand it in detail, so there is no problem with inspiration of your patent go on "bypass". The historical success of Edison, in addition to his invention also had a workshop, some co-workers and enough money to invest in prototype testing. Many firm has focus is now more on innovation in the field of Medical Devices there are products still the same big industrial companies - but an individual author and his own patent will not be as interesting partner to cooperate generally. But inspite of it - I offer you my cheap patent "How to centre best way" how to keep coaxialities between the stem and the femur for non cemented sets with a assembly tolerance about angle 0,5 degree", have you some interest to help yours orthopaedic patients in their hope to keep more better Health and Safety?.

Brian K. Buntz This article on the topic of physician collaboration with engineers may be of interest. I included quotes from Zeljko as well as Elizabeth Muir from Trustech (who also posted in this thread) in it:

http://www.emdt.co.uk/article/developing-devices-are-just-what-doctor-ordered

Brian K. Buntz Thanks, Jac. I received that same piece of information in conversations I had with physicians in the CRM space. I was curious about the story you shared about physicians who identify sales relationships as more important in product selection than differences in outcomes. How common do you think this issue is?

Pat Ridgely, MD I think the sales relationship is still important to many US physicians, especially if they see little difference in outcomes between different products. And familiarity with a product still plays a role, and may outweigh outcome differences that are based on data across users. But the importance of such relationships is in general declining, at least in terms of relationships with true sales reps. My sense is that relationships that are based more on clinical support provided by technical service reps still seem to be important.

Jac Higgins, CHFP Brian,

To understand the importance of the physician/sales relationship and how it effects product selection, you need to understand how product decisions are normally made in a hospital. Traditionally, the supply chain (in a genuine desire to lower costs) will work with its GPO, or on their own through an RFP, to find a reasonable benchmark of what savings are available. At this point the savings opportunities are presented to the clinical staff, essentially asking the staff if they would change products in order that the hospital could implement the savings. This is all wrong, and seldom (never, in my observation, but I want to be fair) successful, and never gets all parties what the desire. As soon as the supply chain sends out an RFP, the manufacturer sales staff contacts the docs to find out "why the hospital is changing manufacturers" which leads to its own problems.

Our approach differs in recognizing that each stakeholder has "what's in it for me?" questions which need to be addressed FIRST. We examine hospital financial and clinical outcome data to identify what is working right, and what can be improved, then sit down with administrative and financial leadership, the physicians (or private practices), the supply chain and affected device manufacturers to get those "WIIFM?" question out in the open, then work collaboratively towards a solution that makes financial sense for the hospital and manufacturer, and meets the physician's clinical (and often financial) needs. We don't ignore the physician/sales relationship, nor do we try to end-run it. We acknowledge it from the outset, and use this relationship in decision making.

Jac Higgins, CHFP As I mentioned in my group discussion (http://www.linkedin.com/groupItem?view=&gid=78665&type=member&item=169477391&qid=2abb5be8-e82e-4ebf-8d03-ee11f45b8eb9&trk=group_items_see_more-0-b-ttl) selecting implantable medical devices is a dance which requires physician input. One of my team members, a surgeon with over 20 years in the OR, acts to engage physicians in hospital decisions related to PPI. Could not make change happen without him.

John E. Hamm The role of doctors is critical to the product development process. The best medical device designer or marketing professional can't do his job without the input of doctors and medical professionals to clearly articulating the user needs and requirements for new designs. Without good input, projects often go awry and the resulting products suffer. Also who other than the experienced doctor or surgeon, can validate that the resulting new product fulfills those requirements and "user needs". I propose that your participation as a physician is critical to the product development process and to the medical device industry.

I am an entrepreneurial physician that spends a significant amount of time working with the medical device industry, in addition to maintaining a boutique private practice.

Physicians can help inventors, entrepreneurs, small companies, and large medical device companies in a number of ways, including:

-Identification of unmet clinical needs
-Concept development
-Clinical and technical assessment of device concepts, prototypes, and products
-Identification of product requirements and user specifications
-Development and execution of preclinical testing
-Development and execution of regulatory and reimbursement planning
-Development of KOLs and Advisory Boards
-Development and execution of clinical trials
-Development of clinical strategy
-Clinical support of marketing strategy
-Clinical support of market research
-DSMBs
-etc.

On a macro level, physicians can provide quick but valuable needs, concepts, device, clinical, marketing, reimbursement, and usability feedback that no other medical device personnel can provide without performing extensive market research.

All medical device developers, particularly early stage companies, would be wise to work closely with a trusted physician that can help provide clinical insight. Advisory boards can help a great deal in this regard, but many boards don't spend enough time together to prevent a company from going in the wrong direction. It's very important to find a physician(s) that is smart, intellectually honest, and understanding of the needs and practices of both business/industry and the practicing medical community.

Warmly,
Larry Fan, MD

Larry - Bravo! I agree 100%. A medical device product developer is only as good as the clinical resources working alongside.

Pat Defelice There's a new paradigm in action. As additive manufacturing built patient specific medical implants become more and more the norm, surgeons will necessarily become involved in the design and build of the implant. Joint collaboration will be the positive end result

John Strupat Interesting. Do physicians need to be involved in the other 99% of new medical devices that are used directly by a patient, or by a nurse or other health care provider?

Pat Defelice I think it behooves any and all medical device companies to be associated with several interested, smart and dedicated surgeons to advise them on their product line. Orthopedic advancement depends on collaboration.

Zeljko Roncevic John please mention a few medical devices from 99% where physicians not involved. I'm not sure that producers didn't ask physicians for their opinion before they were released to the market.

John Strupat Zeljko, I'm thinking of the high volume medical products that fill the supply rooms of hospitals around the world. Commodity items like bandages, dressings, needles, syringes, etc.. Standard devices like thermometers, weigh scales, heating blankets, cooling blankets, Oxygen flowmeters, humidifiers, suction regulators, tubing, nebulizer compressors plus even more sophisticated devices like IV pumps and automatic blood pressure units.

Have to agree that physicians were asked for their opinion when such products and devices were first introduced to the market long ago. Much less need now for a purchasing group making decisions for a different brand or model of a commodity product used by nursing, for example, to contact Dr. X, to make sure that he likes it.
Politically they might do that anyway, but that is not involvement.

Extend that to home care and assistive devices where most new ideas and concepts appear to come from physiotherapists and even the patients themselves.

Lynn Kellen Nurses come into play with many of the items you mentioned John.

John Strupat Lynn, I agree with you and will also include physiotherapists, respiratory techs, paramedics and other allied health workers to the list.

This is a serious dilemma for new medical product development.
How does a company get access to such people, since they are the real users?

I suspect that hospital based groups ,centered on the physician, are not willing to confront this situation, or have no comprehension of how to do anything about it?

Jac Higgins, CHFP If, as a device manufacturer, your primary consideration is to sell your product, any clinician will be viewed as a salesperson by your customers. If you can actually say that your primary goal is better patient outcomes, and helping hospitals be more profitable, you are halfway to using clinicians in a meaningful way.

Harish Kapoor Unfortunately - medicine and medical devices has been commercialized heavily.

The role of physicians these days is - how to exploit the industry, and how to press the button and bill medicare.

As an engineer and an entrepreneur, I have worked with doctors throughout my career to collaborate on many new products. I love to collaborate with physicians across the table and to bat ideas back and forth. The physicians are experts on the patient needs, usage and attitudes, and hospital environment where the product will be used. I bring to the table my experience in materials and manufacturing processes to be able to articulate what is possible and how to achieve design goals simply. This give and take process results in an elegant solution that is streamline from a cost perspective. This would be impossible without shoulder to shoulder collaboration with physicians.

Robert Houghland Anyone interested in contacting physicians should check the LinkedIn group "Society of Physician Entrepeneurs"

Hi Zeljko,
I totally agree with your comment that physicians should be more involved in the development of medical devices, as your profession represents the interests of patients and therefore has the expert knowledge required.No two disabled people's needs are the same.
Apart from my role with the UK based charity The Disabled Motorists Federation (see www.dmfed.org.uk)I am also soon launching another project which has already received pledges of support from the U.S.A.and will hopefully lead to building relationships with members of the medical profession and counting on the support of people like yourself.MASIS (Mobility and Sickness Information Service) will operate as a charity, but will address a wide range of issues designed to help improve the lifestyles of disabled people and those with long-term medical conditions as well as giving additional support to carers and families.
It is also my desire to want to establish relationships with hospitals,medical research projects and other appropriate organisations as well as manufacturers and providers of mobility equipment and medical devices.
MASIS's website will have an on-line forum and newsletter which will be free to use for both medical professionals and patients and families and they can post information on any topic required (it does not have to relate to medical conditions).
From a revenue generating point of view,which will allow for the opportunity of financially supporting needy cases (irrespective of where these may be located throughout the world), MASIS wants to establish trading and commercial relationships with appropriate companies in the future.
Please be assured, that the more communications received by professional medical experts such as yourself, the better.
Kind regards,

Peter Lyne.

Zeljko Roncevic Dear Peter, I really appreciate your work. I wish you success with the MASIS.

The physician-patient interview could be a significant opportunity for the conception of new medical devices: on one hand an individual (the physician) with thorough knowledge of a medical problem - along with current devices for treatment; and on the other hand a patient with a vested interest in the solution to the problem. If the patient is also an engineer, physicist or biochemist, there is an opportunity for invention - the very first step in new medical device development - if both share some simple thoughts on the current devices (or lack thereof) to deal with the problem.

Oddly, this has worked out for me (the patient) with dentists more successfully than it has with physicians - despite a greater frequency of visits with physicians. I don't know the answer, but I'm sure of the opportunity. Maybe the dentistry - by its nature - has more gadgets; or some medical specialists, like the ENT people, have more specialized equipment to talk about.

An interesting way to foster this opportunity might involve the patient questionaire: if the technical background of the patient is included in the personal data section, it could offer the physician an opportunity to engage a short discussion on the appropriate device. I believe it would increase the odds for invention - and more specifically its reduction to practice (because of the combination of 'problem articulation' and specialized technical expertise).

It may have been covered in the many responses to the original post but I can't help but think that medical device companies would be best served by hiring physicians directly rather than trying so hard to use them as outside "consultants". In many cases this is just a ploy to have that consultant use the product and drive sales. Obviously there have been many important physician/industry collaborations where the physician brings a new idea to the company and vice versa, but we have seen all types of abuses with both of these practices.

Industry will have to realize that in order to bring physicians, in particular, well paid surgeons, into the company, they will have to pay accordingly. Perhaps not as much as that surgeon would make in clinical practice but something close to it. I know of surgeons who would gladly give up clinical practice for the potential security of corporate work or to work on a more intellectual level with product development. I have seen this work and experienced some of this myself.

I would love to hear back from everyone about this concept. Happy New Year!!

Zeljko Roncevic Scott, your idea is interesting but it seems that for your concept physicians are more interesting than medical devices companies.

It's nice to see that my post is still active. My advantage is that I have no conflict of interest. I have no company, I don't work for others, so I'm completely independent. I work only with patients (children), medical students and sometimes I prepare short Internet multi medial courses for physicians. What is my disadvantage? It's that I live and work in Bosnia and Herzegovina a poor postwar country where I can't find audience for my ideas and that is one of the reasons why I'm on Linkedin. I'm happy that I live in Mostar a very beautiful town with beautiful green river and famous old bridge. My disadvantage is that I don't know well the situation in USA but I've learned a lot discussing on linkeding.
Thanks all for contribution in this discussion. Linkedin showed me that it's not so important where you live. English is not my native language, excuse me for possible mistakes.I wish a Happy New Year to all members of the group.

Pat Ridgely, MD Scott, I think a blend of MD-employees and MD-consultants is best. While I readily acknowledge the potential for (and actuality of) abuse in using consultants, my experience in the US has been that this is outweighed by ethical roles on, say, scientfic advisory boards maintained by companies. And some companies have long had MD-employees in a variety of roles.

Venture-capital firms may offer another avenue; I have seen some surgeons become very active with them.

Kurt Yockey Physicians are critical to the development of products for patient care. The Affordable Care Act will (has already) damaged or destroyed inquiry into future innovation in medical devices. If any money is invested in private (vs governmental) ideas that may help patient care, physicians will be critical as they provide know how beyond most engineers experience. In other words, it is a collaboration between engineers and physicians that leads to helpful devices. If the government will not permit payment for novel, or new devices, the potential market is destroyed. Without a market, there is no incentive to produce anything better than what is approved by non-physician government employees trying to work with their budget. It looks as if this discussion of physician involvment in medical device creation has been rendered meaningless since the government has decided that technology in 2020 need not be any better than what exists today, only cost reductions are favored, not quality improvements. You won't be able to have that expensive surgery, just take the pill to temporarily reduce symptoms.

As a consultant in the SRED area in Canada-I am wondering why physicians are not
more involved in the medical device development area.Certainly,funding is a large problem for hospitals,and research facilities in North America.Why are physicians and
research facilities not looking to these types of funding as there is ample funds for those technological developments that can qualify.Please contact me if you would
like more information on this topic.

Mark Lutvak Zeljko: Jeff Sugarman's comments ARE relivalent. My firm, Synergistic Marketing actively seeks "Ulminary" site status (at a leading USA Medical Center to Trial, get feedback, fine tune development, and finally try for Lumindary Site Endorsement) as a tool to seek vital Physician and Therapist feedback during development. If anyone out there wishes to learn about Our Luminary Site Process, Please E-Mail me at: mlutvak@sbcglobal.net

My experience after working for more than 30years in healthcare and now the Founder of Nextgen Solutions, an " Access to Success" healthcare solution company is that physicians will continue to play a important role in passing on the benefits of innovation in healthcare to the sufferers

A lot of excellent replies. I really have nothing to add, except, input from the end user can play a critical role. However, sometimes it is very important that the idea or actual prototype of the product be presented to the physician first. In some cases, I feel this is extremely important in order to change the way the physician would approach the problem the new device will solve. I also believe it needs to be a collaborative effort, with compromise to get the best product to market in the shortest time given the obstacles of budget, resources and regulatory issues.

I am working on organizing a national network of consulting clinicians, researchers and ancillary consultants. I am hoping to pull our resources together for a well rounded clinical and research support system from development to market. This is a new adventure for me but I am receiving tremendous support from those in sales and marketing. The Sunshine Act will likely impact involvement of practicing physicians.

Antonin Cuc Personally, I understand most dentist with - he is a friend who has also qualified so as an practitioner. He is very confident in understanding the technical conditions for the correct use of Medical Devices and vice versa can imagine very specifically, that even the best dental implant does not make sense to implant for a man who has a priori bad state of the jawbone and not at all prepared carefully every day to take care of your dental implant to worsen Liaison tissue and that even after 4 years dislodge. With it, you can discuss of monitoring errors in the use of health facilities, and he already knows in advance how I have a view of a inspector Health and Safety, he understand very well why doctors and lawyers hate me, and other times the manufacturers of Medical Devices - when I prepare the concept of objective project selection survey as testing their work and products. Under the guise of greatest interest to the patient so often happen fierce battle for crucial financial interests of the division of money on health care - between the interests of manufacturers in the world of health funds, insurance companies and health care providers, lawers, physicians and patients. My friend doesn´t treated me, but sometimes I need some a advice of the health situation and consult me on friendly points prior to the sometimes severe health risks of some medical tests and some treatments. For him It is gilty Aesculap´s oath and he doesn´t financial the bonuses of pharmaceutical companies and from manufacturers of implants consciously cough. This is the reason that it is a pleasure to sit together and discuss issues of healthy lifestyles and the use of "hard" and "soft" knowledges and methods to maintain a positive view of the world. Where it is a the prevailing influence of money and the market relations, there is often humanity and quality of life of patients, trueth, speedly to end.

As a physician and now as part of marketing within the medical device industry I feel both the customer (physician) and industry perspective are extremely important and I can't see how one can function independent of the other. The physician perspective is very important and if included from the earliest part i.e at the stage of product concept initiation and if channelized properly in light of industry inputs can ensure a brilliant product innovation. Even for products in market, the physician or the end user inputs go a long way in improving and upgrading products and solutions.
As the medical device industry is getting increasingly focused towards Solutions rather than plain product introductions we will see increasing synergy between physicians and industry.

I noticed a discussion regarding physicians as end users... however there is a need to recognize that it is the person with a disability or a senior who is indeed the end user. If principles of universal design are used... persons with various levels of strength and various disabilities will be able to use medical technology...
... often what happens is the individual is provided technology and then is unable to upgrade it.. unable to fix it if it becomes broken... unable to access repairs... unable to control it... or to obtain assistance when they have lost control... unable to replace parts or modify it as their needs change

... if they talk about problems with the technology that may be implanted in their own bodies... for example something about the sounds that pace-makers make when they are in a person's bodies... they are not heard... are thought of as mentally incapacitated or ungrateful.

I entered this group with a specific goal in mind... I wanted to discover what medical technology would assist a specific individual, my niece who has severe CP, who is totally incapacitated, unable to control her body, to feed, clothe, bathe, or toilet herself. Her parents are the one's who would have to provide her with access to technology and thus would have to use it... she can sometimes use toys that respond to movement... she does not have head control, she cannot use her voice... when her parents try to access technology... the difficulty of mastering it means that it often sits in a box...
in terms of medical technology... she is diabetic... she needs her blood drawn... her results interpreted... her insulin ... she has a feeding tube... she has a wheelchair... she has an electric toothbrush (but her teeth are very difficult to care for as she is resistant)...they have modified their home for the track used to lift her from her wheelchair to the bed or bath... but find it is often easier for her father to lift this adult sized woman ... because her body is spastic... she is resistant and the equipment doesn't work. There may be something that works better.. that can move with her from room to room... but how will they obtain access of it... knowledge of it.... pay for it...

I wonder if she will ever be provided access to technology that will enable her to make simple choices, to influence her environment... to go beyond being cared for like an infant to expressing herself as an adult woman. These are the issues I am grappling with... but I recognize that this is not the purpose of this group... but should anyone have any ideas or technologies that can assist this young woman... please tell me. We are in Calgary, Alberta, Canada. I have heard of many technologies which if I had access to could be helpful... but given no access they are not very helpful.

Pat Ridgely, MD Cynthia, I am sorry to hear of your niece's situation. I have had experience in working with people with severe CP, and have some thoughts. Will contact you privately.

Zeljko Roncevic This can be a kind of summary about the subject. Medial devices industry need physicians in many situations ( not all of course). It's good to include physicians from the start in producing the new device. Many devices where produced to be used by physicians as diagnostic tool or tools for medical interventions. Cooperation (according to the comments) with physicians is not always good ( various reasons). We have now many patients with implants as well as patients depended on medical devices with intention to improve their quality of life. Some of patients (human beings) have various problems related to malfunctions of medical devices or because of their poor quality. I wrote many times on Linkedin in various discussions that I like modern technologies and I'm sure they will change health care so much that it's maybe hard to imagine now. We have to accept digital technology revolution but always trying to avoid mechanical approach without empathy . Let's use emotional intelligence as much as possible. I know that many businessmen, engineers hate the word empathy (and what the word means) as something what is hard to incorporate in business. Women have better emotional intelligence than men so it's the way to improve things – more woman in business. Cyntia, I appreciate work of all people dealing with disabled people; their work is blessed , I'm sure. In my comments I am sometimes poetic, controversial, ironic or even cruel but believe my intentions are always good as in the song of the Animals "Don't let me be misunderstood".

Simon Sikorski, M.D. This is exactly why Healthcare Pioneers is forming - bringing doctors & device entrepreneurs together. We will also be bringing patient perspectives into this too. Let me know if you're available to help out with forming these events in San Francisco, Boston and other areas of the country - http://healthcarepioneers.eventbrite.com/

We'll need space & sponsors. We're already finalizing the space & speakers in NYC for the 26th. Let me know if you have a physician speaker or want to sponsor.

Great discussion!

OK,Ok I get it? I've yet to see the investors asking question.. Where is the money? Let's stop BS ourselves no one has stepped up to the plate to advance the cause.All we're doing is collaborating amongst each other. If you see it differently show me the money and let's deal.Clear

Simon Sikorski, M.D. Not with that attitude Abdullah.

I met plenty of folks who come to our Pioneer meetings with open minds leaving their past experience and failures at the door.

Sure, lots of investors come with an attitude of their own, but it's all about the environment where business is conducted.

Let me give you examples, if you go to an environment where the investors are they will control the outcome (and most technologies are shot down).

If you go to an environment where doctors are you'll meet skepticism.

If you go to an environment where technology geeks hang out, you will come away more confused than where you started.

But there's something cool that happens when all of them come together on equal terms and on neutral ground.

If you approach the meetings with "show me the money and let's deal" you will only get to see a cold shoulder.