Ee Bin Liew the healthcare industry certainly have learnt about providing 'solutions' by now, but not yet fully learnt how to create, or collaborate symbiotically to form 'ecosystems', which is what customers need (or will need).

Cheers,
Ee Bin

My realm of expertise is reimbursement and like it or not, obtaining reimbursement for the use of a product is critical to its success in the marketplace, even if it improves healthcare and saves lives.

I'm continually surprised by the afterthought many companies give reimbursement. If what you say is true that they are selling meaningful solutions to healthcare problems, it is important to recognize who the buyer is in the equation, the payer.

Medical device companies need to engage payers during the development phase of their products to both capture their interest and gain insight into what the payers really need to support a new product. At a minimum, the design of clinical trials should include payer input.

The key tenets for reimbursement are coverage, coding and payment. All three are necessary for successful reimbursement and medical device sales.

As the AMA continues to restrict the issuance of CPT Category I codes and not develop RVUs for CPT Category III codes for emerging technologies, new medical devices are going to struggle gaining use and acceptance without a comprehensive plan for reimbursement starting at the development stage.

I think that some companies are so proud about their innovations that they highlight thechnology, that is product-thinking, rather than the use, which is the Need.
That often happens with start-ups.
But when Technology meets Needs, the best product takes birth, which is a medical application.
Let's think applicaiton, not boxes.
KInd regards,
Giovanni

Moshe Engelberg You make a strong case for Joe. Med device companies do need to think of payers as a critical target audience, like FDA is a regulatory target audience, and engage them early on. Your comment reminds me of a favorite quote I first heard from my friend Steve Osinski: "The answer's money, now what's the question."

Moshe Engelberg You make a strong case Joe. Med device companies do need to think of payers as a critical target audience, like FDA is a regulatory target audience, and engage them early on. Your comment reminds me of a favorite quote I first heard from my friend Steve Osinski: "The answer's money, now what's the question."

Moshe Engelberg Good point Ee Bin. As the industry embraces the idea of co-creation, I think a greater appreciation of ecosystems will emerge. More her on a behavior change ecosystem FYI: http://www.researchworks.com/YMM_2013/ResearchWorks_YourMarketingMinute_HowToChangeYourEndUsersBehavior_BehaviorChangeModel.html

Boxes and internal politics...Introspection

Wim van Hoogdalem For me it has always been; patient first!

Karen Boyd, ASQ CQA I agree, Wim. It should always be what's in the best interests and well-being of the customer first.

Wim van Hoogdalem Karen, patients are customers in a way, but I still refer to them as patients. Most of them have no clue what we are doing to them and are thus vulnerable. The term customers reduces patients to consumers and that's not right (my personal opinion).

Interesting that the two choices are boxes or patients. I am no expert but I encounter a significant number of companies and managers that say the challenge if really the reimbursement and not the treatment. In other words, the patient is not empowered to make a choice regardless of the benefit. I think there are many great technologies that have never seen the light of day because there isn't a direct path to hospitals and doctors getting paid for the treatment. Further, this raises the whole question of treatment value. Should the patient establish the value for a treatment for cancer, the doctor, or the payer? Until you answer that question, I am not sure how you can answer a question of patient focus or product focus (my opinion).

I think that Louis has summed it up quite correctly.

Karen Boyd, ASQ CQA Here's a link with respect to the US FDA initiating more proactive approaches to involve patient input ---http://www.raps.org/Regulatory-Focus/News/2015/09/18/23237/FDA%E2%80%99s-CDRH-Unveils-First-Ever-Patient-Engagement-Advisory-Committee/?utm_source=social&utm_medium=post&utm_campaign=RFnews.

I agree that product-centric thinking still seems dominant. As Dave Gray writes in The Connected Company: "A product is a service avatar. The first step to a service orientation is to change the way we think about products. Instead of thinking about products as ends in themselves, we need to think of them as just one component in an overall service, the point of which is to deliver a stellar customer experience."

In the med device context, the customer may be defined as a payer, a patient, or a provider -- but the point is the same: to orient the business away from "boxes" as you say, and toward a sustained experience that meets customer desires and preferences. In this case, for better health care, for intuitive therapies, for responsive relationships that support behavior change.

Jerrold Shapiro Karen, we usually think of the customer as the person who makes the purchase, pays for it and uses the product, but in the healthcare industry those could be three different organizations, none of which include the patient. Medical economics is only one of the many ways our industry differs from most others. While the "selling boxes" attitude may be short sighted, the bigger danger comes from people turning off their brains with expressions like "that's above my pay grade." The immense complexity of the human body and the pathogens that sometimes attach to and live in it is one of the fascinations of designing medical devices to treat disease and relieve suffering. As much as we know, there is so much more to learn that bioengineers never reach the point of doing the same thing every day - always a new challenge, always new problems to solve. Even in the far less complex, human-designed worlds of regulatory affairs and reimbursement, changes in the law and in third-party-payers keep you on your toes.

Karen Boyd, ASQ CQA I certainly understand your point, Jerrold. However the end-consumer should be considered in all circumstances, whether they are the purchaser or just "blind" recipient.
In cases of devices, such as contact lenses, the customer, end-user, purchaser, or patient is direct. They do have and should utilize their own decision-making capabilities of what product is best.

Luigi Torre We do not buy drills, we buy holes. This is more valid in a consumer market rather than in the MD business. Despite what Karen says (and I agree with her) my 15 years experience in selling MD to hospitals and doctors tells me that the patient is something very far from the goals of my counterparts (Surgeons, Nurses, Hospital buyers, etc.). Of course, is a MD is directly purchased by the patient (as contact lenses) he can make the difference (but I am not so sure that the doctor and the optical technician are secondary figures). In the hospital, everybody is keen on his safety, advantage or goal. For example, a surgical glove is seen as the protection of the surgeon and the nurse and not something which protects the patient. So the attitude of MD companies is somehow justified.

A lot of devices aren't as simple as contact lenses and can take a quite knowledgeable person to understand the solution it may offer. Physicians, clinicians, c-level, and patients should all be considered "end user" and have a stake in what's clinically superior offering the best outcomes. It will require data tracking and studies

Karen Boyd, ASQ CQA Agree, Patrick. Best summary.

Wim van Hoogdalem Experts, data tracking, studies? It's time that healthcare PROVIDERS come down from their ivory towers and put the patients first.

William Hannon You could not be more right. Sadly after all these years too many firms are Box oriented. They are not alone. I have been trying for over a year to convince a university in Boston to establish a Center for Healthcare Design. It would be multidisciplinary and include.Nursing,Industrial Design,Architecture and Graphic Designers to address issues from devices to environments. It would be "Patient Centered". Boston is in many ways America's medical center with dozens of world class hospitals and three medical schools.

I have presented this idea to there university and received a resounding HO HUM.

If this is the attitude of such institutions why should we expect companies to be more perceptive.

William J Hannon
Professor Emeritus,Industrial Design
The Massachusetts College of Art and Design

PS;Children's Hospital recently built a new wing which allowed mothers to stay over night with their kids.

The press releases bragged about the reduction in patient anxiety and staff time. DAH!

Antonin Cuc Dear friends, we should respect "perfect behavioure in through Transformal processing of Channe, since th Begin of Developement medical Devices including well predicted efficiency safety usage", there are allways typical structures in timing and parameters for Project Designing, innovative technological realisation, implementing in Mass producttion, perfect Planning Marketing, distribution, and high quality of education of users, the are defined priorities to hierarchical targets and minimize of patient risks by perfect long safety usage, the other aspects are important planning rentability and horizon of economic Life each innovation, predicted summary economic efficiency, disponsable costs from insurance organisation for practical usge Medical Devices in medical praxis, long being stability in common Market with respect to concurency competition in Market. Practical allways there are in todays Medical products many mistakes in respects to minimize patient risks - for example with bad interfaces between Technical information realised in material Desaign of Medical Devices - and lack of practical knowledges of technical knowledges of Physicians...many patients are injured frequently on beginning of new Medical Devices by beginning Physisians first 5 month after implementing in medical workflow on workplaces with the same Mass of medical user mistakes. It schould be stopped by inforced testing of quality medical praxis with samplings and opf course independent namely inforced Technical supervising! There are dying in USA about 380 thousands of patient yearly - mostly as consequents of repeated similar technical medical mistakes! We should take innovative strategic thinking about Medical Devices - full out of Boxes thinking - cybernetic coumputer Design, computer processing Planning, so as computer processing testing so as perfect regulation of safety usage Medical Devices in medical Praxes! .

We stand out in the market because we create value and are a trusted advisor.

very true!

William Hannon In the mid 60s Dr Karl Walter (Who had a degree from MIT in Electronics and was a multi millionaire from a mechanism used in bomb sights in WWII then went back to get a medical degree)warned the world about the over use of ant-biotics. He said the "bugs" as he called them would mutate and out run the drugs aimed to kill them. The only answer was to fight them with technique. To bring an operating room sensibility to every procedure. history has more and more shown his predictions to be right on the money.

As someone who has been part of design teams from everything from urinary drainage systems to intraaortic balloon pumps I say "To hell with the CUSTOMER". The Patient should be the prime focus of any design effort.

If done right the money will follow. Remember "First of all do no harm?"

Antonin Cuc I agree with Wiliam Hannon - we are able to project "Closed Integrated Standard Health Care" with minimize increases entropy, with all disponsable sufficient information - material, energy, automatic Planning, perfect detect adequated patients on Inputs, perfect detect indiviual Health status, skeletal conditions, family anamnesy...to diagnostics, individual treatments, individuaul automatic surgery Planning with usage 3D, minimize sum of radiation risk, perfect testing surgeons, automatic videorecording all surgery processing, automatic detect comparation with optimal Planning by best similar last processing, perfect choiced individual fitted implants, integrated supervised Unit of postoperational intensive care, perfect informing patient about typical and individual risks with full explanation to gain patient agreement with surgery to respect adequated informal backround and individual patient preliminary education, individual explaining postoperational physioterapeutic Health care with motivated cooperation of patient, explaining Life style for postoparational time, self-rehabilitation at home, postopeational supervising of Patient Health statut in Out door Ambulance of surgery.....Yes, dear friends - we are able to keep extremal low level of postoperational complication, we are able to have lower Health costs and less days off from patient working acitivites...with more better postoperational locomotion ability, we can supervised the Health Status of patients till 5 years after complicated surgery similar orthopaedic THA...there were perfect coordination with nurses, staff in surgery hall, computer supporting by archiving all Health documents of all patients in Cluster with deep continuously Statistic evaluating each surgeon, each patient, each types of used orthopaedic implants, each Crash of implants, reason of Crash implants, cooperation with Suppliers of Implants, etc. All probable Crash situation on surgery hall must be educated for staff in time and before with deep analyses by Criminal computer simulating real archived causes, prevences of real causes,....similar ways defined results like as by Crash of Airplaines in Airspace State Surveillance in Canada....there no Chance to repeat mortality injuries of patients without personal responsibilites of Physicians, Suppliers, Designers, Computer IT support...We can namely working as Technician with extremal minimize patient Risks! It will be new destribution of work duties for all Persons in "Closed Integrated System of Stanadardized Health care"! I have patented such system as a Method "S_T_A_R_S-Statistical Retrieval and search of information to reuse for strategic repeated decision making with risk and computer support", Utility model 21532 Czech Republic. Would you take it?

Stuart Sundem The device is all but 1 element in the entire end to end customer experience. Albeit important, today's customers expect all sales and or service engagements with a company meet their needs, be easy and be enjoyable. The med device space does struggle with being holistically innovative throughout the entire customer journey.

William Hannon Stuart, I could not agree with you more. We need to look at the patient experience from beginning to end. That includes environments. We should all imagine our own five year old as the patient.!!

Stuart Sundem Siegfried, I think you missed the point of my initial comment. It doesn't matter if you are a surgeon, lab tech, hall nurse, hospital planner or a patient, the common thread is they are all customers. In today's customer centered world companies who pay attention to more than just the device will be the long term winners. The idea is to intentionally plan your entire sales engagement process which includes pre-sale, sales processing, on boarding and training, technical support and probably the most forgotten element customer retention. Like it or not, products and in this case med devices alone are not enough to wow customers. Customers these days equally look at the entire end to end experience they have with the supplier.

Stuart Sundem Prof. Hannon,
You are correct, a human factor approach to med device development is essential. The days of engineers creating devices in a vacuum needs to be abandoned. And I agree, while developing a device, imagine your child using it or it being used on your child.

William Hannon Alright. I get it. There are numerous stake holders,etc,etc,etc. But in the end someone is lying in a hospital bed scared and feeling out of control. Some years ago as a young Industrial Designer I went to check out a intensive care unit in one of the World's most famous teaching hospitals. Lying in a bed was a guy in his mid 50's who had been brought in after collapsing on the street. Next to him was an EKG unit beeping away. The only on watching that display was him. He had seen Marcus Welby and the other medical shows on TV. He was waiting in horror for that line to go flat. There was no need for that display to be on. If he went into arrest an alarm loud enough to wake up the dead (sorry) would have gone off. When I asked the resident on duty why didn't close the cover (A printer was making a record of his heart that his heart doctor needed).The resident's answer was "Oh don't worry. We are managing the patient's anxiety with drug therapy" In other words he was pumped fool of tranquilizers. The argument about the customer v the patient is a false dichotomy. No medical device is designed by one person. I am saying from an ethical point of view at least one person should be an advocate for the patient EG; My hypothetical frightened five year old.

William Hannon Please excuse all the typos.

Stuart Sundem Great discussion, I believe we are all on the same page. In the end med devices are designed to save and or maintain life. Customers will always be multiple and varied. The goal should aim to understand every customer in the chain and then use those insights to develop the best products and services possible.

Wim van Hoogdalem In Healthcare we should stop talking about customers. We're talking about patients and anybody thinking differently is in the wrong business.

Mike Robinson Couldn't agree more. It's absolutely all about the patient. Yes there are considerations in terms of how you make it market accessible, economically viable and user friendly however all of these are 'nice to haves' when compared to the possible clinical benefits. That said, you cannot have one without any of the others and no two patients or customers are the same. The winners are those that can address all of the above, and convincingly.

Jerrold Shapiro At the Health Care Investors Summit this morning in Boston, opening keynote speaker Michael Weissel (Executive Vice President and CEO of Consumer Solutions, Optum) said that "patient" and "member" are incorrect terms because they apply only in the short term - while the consumer is sick or in one company's health plan. While there are many stakeholders, there is only one consumer and that consumer may move from company to company and insurance plan to insurance plan. Whatever you call them, I think we all agree that the focus should be on those who are ill, on finding ways to prevent their illness, and failing that, to treat them. On the prevention side, we learned last Wednesday at the Medical Development Group's deep dive into diabetes mellitus that pre-diabetics can return to normal by losing just seven percent of their body weight. Since diabetes cost the US healthcare system 245 billion dollars in 2012, preventing it by preventing obesity can save a huge amount of money in addition to preventing diabetes sequellae like heart disease, peripheral neuropathy, diabetic retinopathy, etc etc.

Wim van Hoogdalem @Siegfried, as you have been on the buying side, you know that only the purchase cost and c.o.l. counts. At the purchasing departments there is no concern (or expertise) about patient's best care.

William Hannon I am now at an age when I have been on the patient side more than enough. In my experience the American healthcare system is dysfunctional. If I get 15 minutes with my primary that is a surprise. I have had two marvelous docs both from Germany. One has gone back because of frustration with the system. We have the most expensive healthcare in the world and it is only going to go up as the baby boomers start to retire. The device industry is caught up in this morass that places on patient turn over rather than care. I am not alone,sadly in this cynical assessment.

Wim van Hoogdalem The American healthcare system is dysfunctional indeed, but so it is in most other countries. As long as healthcare is treated as a business instead of a service, nothing will change. I can only hope that the decision makers start realizing what it would mean if they come to rely on healthcare themselves.

William Hannon Once more Wim. A hearty AMEN!

Mike Robinson I believe the savvy device manufacturers are those that strike a balance. They get the patient care focus, but understand that they have a business to run. No company should rest on its laurels and to succeed in delivering patent care, not with just one solution, but with subsequent solutions, they must also survive a competitive marketplace and have profits to reinvest in development. I may be naive, but for many of my colleagues and ex-colleagues, a big part of why they are in the devices industry is because they get to help those in need with the skills and knowledge they have developed - despite having to make tough business decisions from time to time. It certainly helped me get job satisfaction.

William Hannon Mike, Right On, I may be naive but I believe that Medical Device design teams can and should lead in creating products that advance healthcare and that will also produce profits. I think the Either Or approach is counter productive nor can we stand still. New advances in science,materials,etc,et. require constant reevaluations of our products. As a designer I am never content with anything I have done. It can always get better. And I know I am not alone.

Moshe Engelberg Wim, I agree. We need a new term - not patient, not customer, not consumer, but something that speaks to the realities of patients needing to rely on the expertise of providers, and of also being empowered to make (some) decisions.

Suggestions anyone?

Moshe Engelberg Jerrold, thanks for sharing the points made at the Health Care Investors Summit and in the Medical Development Group's deep dive. We do need better labels (see prior comment). And it seems the prevention/lifestyle change/ROI argument is finally catching fire through it's been around for 30+ years in public health circles. Yes!

Moshe Engelberg As many of you have stated in various ways - it should ultimately be all about the patient. But that's a challenging business reality to make happen. In my view, the "old" FFS paradigm lost sight of that by making "more" the MO for healthcare with providers in charge... more procedures, more services, more devices, more days in hospitals, etc. Then the "managed care" shift swung the pendulum the other way toward minimizing utilization and putting payers in the drivers seat.

Can patients lead the way? That's tough, by virtue of patients needing the expertise of the providers and system, and coverage by payers. I see the shared accountability models of the payer/provider Kaisers of the world being our best bet.

In my last company we consciously added value using the product packaging, the box if you like. We moved from boring white or grey featureless packaging to a coloured version which helped healthcare professionals and patients identify the product clearly. We also use the inside and outside to give enhanced information about the product, the conditions it was used for and also how to access further help from patient groups and charities. This helped us build partnerships with clinician and patient groups and helped to build our brand into something where we were seen as much more than "box" movers.

Moshe Engelberg MARCUS- great example of how to add value and strengthen partnerships by simply changing the product packaging. To me, it's all about putting the customer first. Here's a brand new post about other simple ways to go from selling boxes to connecting with customers. It's about... butterflies:

https://www.linkedin.com/pulse/med-devices-butterflies-increasing-sales-little-things-engelberg?trk=hp-feed-article-title-publish

Wim van Hoogdalem Moshe, I don't think we can capture it in one term or word. What about 'people in need'. That covers more than just the medical profession.
The medical industry is too often acting as second-hand car salesmen. Every slick person can sell a car once!
Question is: what care would you like to receive.

Antonin Cuc Dear Wim, Dear Moshe! You are working very hard and mostly common with Physicians for finished Medical Devices...but despite the Clinic testing with a few Patients...your material Design of Medical Devices with product instructions for user....this is extremaly shorten information in Technician Speach...this is absurd, when such complicated Machinary and Electronic Product are taking as unadequated interface....lonely users - Physicians, which are mostly don´t time enough to read Your Product instruction...because they are undertaken the real responsibility to prevency patient risk...and nobody from Designers could analyses the practical medical workflow....The human practical skills has the same exrtremal frequency of medical mistakes in the first 5 month from beginning the usage of perfect Medical Devices....thatsfor on this phases there are many injured or dying patients. It is similar when you are producer of cars with instructions and regulations forn safety cars transport - but the drivers have got NO SURRVEILLANCE of Street transport Policy...there are great interaptions in interfaces in the being Transformal Shannon´s Channel. The Physicians have a general pardon to injure their patients...each medical mistakes are covered by collegues Physicians in often false Medical Court Message in Civic Jouristic cases...and there are no chance to stop Mass repeated technical medical mistakes by illegal usage of the modern complicated, very sofisticated technical Medical Devices. We should refused this todays ways of usage "Based Evidenced Medicine" but we should ask next time: and with independent technical controlling including "Based Evidence Science Transformal processsing", because we should integrate multilateral medical so as multilateral technical Knowledges fro guaranted safety usage of Medical Devices! .This is keys to minimize increases entropy in the Whole Transformal processing Channel...including perfect by Users! I have patented such decision making method "S_T_A_R_S-Statistical Retrieval and Search of information to reuse for repeated strategic similar decision making with risk and computer support", Utility model 21532 Czech Republic. We should guaranted perfect technical quality of medical activities in workflow by independent industrial ways! Just there are meedless dying in USA about 380 thousands of patients yearly - mostly as consequents of repeated trivial technical illegal medical mistakes! I have been heavy injured and dying on illegal medical work too! There were absency mandatory tochnical activities Processing Planning, preliminary patient testing actual skeletal conditions before THA surgery, false interpretation RTG in 3 D of stem THA imaging, bad controlling functional testing of set THA on surgery hall, etc., etc. Nothing was declared as fatal illegal mistakes in false Court medical Message...this is namely typical situation with monitoring the technical medical mistakes in Orthopaedy in Czech Republic!.As a patient we are quiet on the prosecture hall regularly..Personally I have been harmonised EU/CZ Law with Directive 93/42/EEC Medical Devices including - but the Judge prefered the False Court Medical Message only.

Ee Bin Liew With all the numerous examples already cited (and need no more), sometimes I wish there was more focus on the 'care' in "Healthcare"

William Hannon As an Industrial Designer and a teacher of young designers I believe we should first of all be an advocate for the patiet. I would rather listen to nurses than many doctors who seem too oftent to forget that that piece of flesh lying in the bed feels out of control,has a wife or husband our kids at home or elderly parents that rely on him or her is scared,etc,etc,etc. There is no reason for the design of medical device not to try to mitigate as much as possible those fears and concerns. I also beleie that done right it will produce products that increase PROFITS. Several years ago Children's Hospital in Boston built a new wing. They bragged in the press that the patient rooms allowed mothers to stay over night. The noted that patient anxiety was greatly reduced resulting in fewer problems for staff. I may be naive but I believe that properly designed taking into account the PATIENT's experience that similiar results could be achieved-even if tiny. First of ALL Do No Harm-that includes to the non physical "feelings"