Brian Baum Chris - interesting article.

I have a post pending with this group that relates directly to this discussion. I'll repost it here, because I am very interested in what this group thinks. The crux of the discussion - how to better integrate device data into the overall delivery of care.

Brian Baum Data generating medical devices – the future – comments welcome!

While not a medical device expert, it seems obvious from trends and research that we are entering an era of dramatic growth in “data-generating” medical devices. Everything from implantables, wearables, in-home, embedded, etc. Giga has projected that by 2017 more than 170,000,000 personal health monitoring “gadgets” will be in use. For discussion, I’m focused on any medical device that monitors a health indicator, generates data and stores/transfers that data. In my discussions, I refer to this category as “single purpose” devices. The monitoring device is either prescribed or a consumer direct purchase. Depending on the application, data may either flow back to the prescribing physician/clinician or be presented directly back to the consumer using the device.

In many cases data coming from these devices could have multiple applications. With the CONSUMER’S AUTHORIZATION, data could also feed into sponsored health management programs – linked into health interventions and coaching. It might be linked to other applications that a consumer is using or has purchased to provide a broader picture of health status/changes. It may be helpful to a broader care team – other physicians, etc.

My questions for discussion are twofold: 1. within the med device community, do you agree with the concept of primary and secondary device data applications and 2. If a platform were available that allowed the device provider to connect their data stream to a hub, have the “consumer/data owner” intermediate with secondary application providers and authorize (in a documented way) the passage of their data to a secondary party, for which the secondary party would pay a fee for the data and a portion of that fee would flow back to the device provider – would this be of interest?

The net of the transaction, the consumer gets something they want – perhaps an enhanced application they’ve purchased, the secondary party gets what they need – data to enhance their product/service and the device provider is able to monetize data being generated from their device in a way that previously was not possible.

As you consider this – there are numerous issues that flag the concept – however, think in terms of enabling the future of healthcare – mobilizing data, managing costs, enhancing the consumer experience and potentially extending access to care.

Paul M. Stein Monstrous hype. MONSTROUS HYPE! For those of us who have worked or do work for wonderful companies that build actual medical devices, there is a major difference between those real things and the miniboxes that the drones of the world stare at hour after hour flipping their thumbs on. The former save or extend lives and relieve pain and suffering, while the latter…………………..don't. Just because something comes out of Apple doesn't mean anything for certain except that it will create a lot of buzz. Frankly, and I've seen this many times before, here is a case for one speaker trying to make a name for himself at a major conference with his opinions of the future. Will any of this techy junk have any sort of role in "healthcare"? Sure, generating lots of temporary jobs and assisting with billing and communications, but beyond that? Let's just say I don't see anything that should be called a medical device.

Russell James An Apple a day may keep the doctor away but what about Google?
Apple and Google are not the only giants after this lunch.
Keep an eye on Comcast, Verizon, Qualcom, and Cisco, they are hungry too...
Remember, if you can't beat em, join em! :-)

I think this is one of the best threads in recent weeks. There are some very interesting questions/considerations to be raised around current medical device industry practices, the regulatory environment, and the business ecosystem. Any Class 1 and Class 2 device manufacturer that doesn't consider the mobile devices/"silicon valley" disruption in its long-term planning is doing itself a dis-service.

But there are some very significant barriers for these customers, especially with regard to regulatory compliance and quality systems requirements that could give them pause. Of the top of my head, I would consider their complaint handling infrastructures and their approach to the user in the field. Managing the quality of a global supply chain is another consideration. Plastics with bio-compatibility requirements are completely different to manage compared to just another plastic/composite part.

Plus, the high-tech consumer device mfg'rs have not dealt with an agency like the FDA. Just look at the way the 23andme confrontation played out. There is a cultural arrogance to the high tech sector (with it's relatively light regulatory regime) that could end up nixing many, many products.

In the end, there is always the possibility for disruption from this sector. Ignoring it is not really an option.

Brian Baum http://blogs.computerworld.com/healthcare-it/23517/7-billion-reasons-apple-gets-health - a related article.

In 1997 Barnes and Noble sued Amazon challenging its claim that Amazon was the world's largest bookstore. The point - most of the brick and mortar bookstores of that "era" did not take Amazon seriously because buying a book was an experience. Times have changed. One of a number of things Amazon accomplished was dramatically increasing the market for books. Bookstores still do exist, but certainly not to the extent they did - pre-Amazon.

Apple coming in to the med device space - will likely expand the market for med devices - and I think that is a good thing. I doubt Apple will task their iPod experts to develop medical devices. Rather, they will likely hire med device industry talent to move them in this direction. So "hype" - certainly a degree of that; but this is probably not a time to dismiss this trend, but rather assess the impact of dramatically increasing the global market for medical devices.

Brian Baum AT&T Eyes Future of MedTech by Tapping mHealth Visionary - Eric Topol to AT&T

http://www.qmed.com/news/att-eyes-future-medtech-tapping-mhealth-visionary

I don't think medical mobile devices will make half of current medical devices obsolete, but I do think they will create new functionality that will revolutionize much of healthcare. A large % (around 96%) of mobile health apps currently available are NOT medical devices. Only about 4% of them are. I think it is the 4% that will be the disrupters.

There was a time many, many years ago when medical devices were pure custom hardware products. Thirty plus years ago embedded processors and software started to play a role in medical product development with user interfaces starting to get more sophisticated. The next step in the evolution was the integration of board level or complete PC's, enabling even more sophisticated GUI's and data processing capabilities. Mobile devices provide a great platform for developing contemporary medical devices, especially devices focused on point of care applications. However, the specialized knowledge associated with sensor technology, real time signal processing, etc. is still as important as it was when medical devices were hardware only products. I find it unlikely that Apple, Google or other similar companies will develop competences in the sensors and specialized signal processing reguired for the development of medical devices used for diagnosis, monitoring and therapy. Large distributed information management system such as Electronic Medical Records are another story.

Brian Baum Good discussion. (I should qualify that I am "Apple neutral"). Use a PC and an Android phone - so no stake in what Apple does. However, they are grappling with a challenge these days - sitting on a $150 billion war chest. As they sit there and look at a $3 Trillion industry in need of some innovation, it is likely an appealing target. A reasonable possibility would be to rollup a few companies that are legitimate med device entities. In just a few acquisitions they could pick up much of the talent and expertise they need to enter the space.

With that said, I also think a lot of the focus of will be on devices that are not considered true medical devices - things like activity monitors, etc. Mainstream devices that could sell in high volumes to the mass market. This is an area that could lead to the expansion of the "real" medical device market. Think of them as a filtering mechanism to sort the market between those that are managing "health" vs. chronic conditions vs. those that are unaware that they have a chronic condition or are on a path that will lead them there. (The latter two being segments requiring more specialized health monitoring devices.)

Much of the next gen healthcare system will increasingly gravitate toward getting ahead of the condition curve - intervening before full blown care is necessary.

Of course then there is Google's glucose monitoring contact lens - http://www.forbes.com/sites/ptc/2014/02/12/google-contacts-will-help-diabetics-monitor-blood-sugar-via-tears/

The problem/opportunity - there is just so much money out there that is beginning to focus on the challenge of healthcare.

Mark J. Kania, MBA. There are Telemedicine Apps that work on Apple mobile devices that are beginning to get some attention, but much room for growth as adoption is proceeding slowly. Apple may make a dent in the device market, but that market is too broad, complex and clinically oriented. Glucose monitoring would be a great use for mobile devices, and Diabetics are already using mobile insulin pumps with great success. There are many more market opportunities for mobility.

Paul Laurence Sweeney Who moved my cheese? OF COURSE the tendency is and will continue to be towards software and away from hardware and anything digital is up for grabs. 4 out of 5 health industry jobs will disappear or be changed beyond recognition in the next few years - I mean 5 years or less.This is absolutely obvious to me.

Mark J. Kania, MBA. Mobile apps are being used and will continue to grow in addressing chronic disease management and wellness programs. There are mobile apps for certain acute care situations, and those applications will supplement the use of more fixed technologies. The use of mobile devices to monitor post-surgical patients will grow as well.

Chris Newmarker Thanks everyone! I think this is a great discussion because it hits on an actual debate taking place inside the industry. Maybe it's hype that Apple or Google or AT&T, with their minimal experience navigating the FDA, engaging in quality controls, etc. would really become device companies. But from this discussion, I'm also hearing that the mobile health applications being suggested really aren't that invasive, are more about collecting information and empowering health providers and average people to use it. The impact on traditional device companies might be more indirect: People develop less serious health conditions and then don't need as many traditional medical devices (a good problem to have overall as a society, but still a problem for device companies). Am I capturing the contours of this discussion well?

Brian Baum Chris - I think that is a good assessment. Perhaps the bottom line is the device market of the future will be markedly different than the past. I would still be quite bullish on the industry both "real" med devices and "casual" med devices - if I can coin a term. The reality is we have a physician shortage, we are bringing more people into the health system, demographics are creating a larger population of high health demand consumers, a shortage of facilities to accommodate the aging population and cost of care that is simply not sustainable. So, the demands on the individual are likely to ramp up relative to health monitoring so that limited clinical resources can be more effectively deployed. Many trends that should create a robust med device market for some time to come.

Paul Laurence Sweeney Through the use of "Apps" or suchlike , Apple, Google & Co. will complete the missing link in their database of every individual on the planet. As if they did not have enough info. about us already , they will monitor each heartbeat in real time. In turn, this will be used to prescribe untold amounts of medication without supervision by independent medical practitioners. What physician would be foolhardy enough to countermand the recommended medication protocols based on real-time monitoring in the form of billions of lines of code? What kind of professional indemnity insurance would that imply? That court case would be fun to observe! It is the dream of every multinational - to finally break the last frontier of independent professional decisions and for the companies to directly prescribe on the basis of the data compiled. The lobbying capacity of these groups in not to be underestimated and believe me this is going down! Or do you think they will continue to depend on the inefficiency of sales reps remembering the names of doctors´children and the birthdays of their secretaries?

Brian Baum Thanks for sharing the link Chris.

I live in Maryland and just came from a meeting with the Montgomery County Economic Development group. The County has targeted life sciences – med device, biotech, health IT as areas for development. Given they’ve got NIH, NIST, Bethesda Naval and a cadre of other health institutions it is an obvious target. We discussed this very topic – the future of healthcare and the role of medical devices.

With all of the pressures on healthcare – a fifth of the economy, demographics, physician shortages, and overall cost of care – medical devices can play a key role in cultivating the consumer/patient health experience going forward. The potential to extend access, convenience, support in-home care, better utilize clinical resources, the list goes on. However, the key to capturing the opportunity will be how adaptable the industry is to the needs of the emerging health industry.

Apple, Google, AT&T, Verizon are only threats if the industry views them through that lens. I think we can all agree one pillar of “future health” is “connectivity/connected health”. The better devices are able to integrate to the overall “care system”, the more relevant and critical they become/will remain.

Chris Newmarker Never underestimate the ability of huge corporations to be inefficient. :)

Brian, I like your comment that this is about the creation of a "markedly different" device industry.

That also seems to be the picture that George Samaras of Samaras & Associates Inc. painted in a recent email about the subject to MPMN. We posted it up: http://www.qmed.com/mpmn/medtechpulse/could-digital-health-make-most-medical-devices-obsolete

Samaras is arguing that most medical devices could potentially become obsolete. Here are some of his points (These are Samaras' words below.):
* Principal value added by most Class 2 and 3 medical devices, which are not mechanical things like structural prosthetics (e.g., knee replacement) or physical accessories (e.g., laser hand piece), is increasingly contained in the algorithms.

* Critical electro-mechanical infrastructure for algorithms, which used to be quite dear, has now become nearly a commodity with the proliferation of embedded systems for consumer use. There just never was sufficient volume for this to happen with just military and industrial use. The exact same thing is happening with sensors and sensor fusion techniques that permit extracting greater value from the sensed signals.

* Software tools, while still quite dear, for creating high reliability software systems are also coming down in price (sometimes to the price of almost free—check out www.sourceforge.com) and soon will be within reach of sole practitioners like myself.

* Ability to inexpensively create complex electro-mechanical parts (including 3-D printed circuit boards) using such techniques such as additive manufacturing, and within the decade self-organizing nanoscopic entities, will shift the real intellectual property values to algorithmic creations and innovations (including those algorithms driving the printers and nanobots). Math, physics, and high-quality software engineering will gain high perceived value!

* Forthcoming crop of healthcare professionals (physicians, nurses, pharmacists, etc.) grew up tech-savvy prior to choosing their profession–they will expect sophisticated HIT and will be greatly dissatisfied when they do not have it or have to struggle with it (e.g., HF/UX issues).

* Economic and competitive pressures in healthcare delivery, combined with the parallel new crop of tech-savvy managers and an emphasis on collective purchasing, will put downward pressure on medical device prices—meaning, at least from my perspective, that the cost of goods sold needs to decrease – which brings us back to the earlier point that the marginal cost of duplicating software is very low and the fixed cost, if distributed over a very large number of copies, can be made quite low as well.

Kiran C Shetty I have a feeling the recording and RFID and/or NFC transmission of clinical performance data, patient compliance data, and other pieces of information is coming.

There are devices currently in which clinical data, which can translate to patient compliance, is recordable and downloadable.

In my opinion, the tipping point will be when insurance companies require this information on a large scale. There are costs associated with these technologies, which the market will currently not sustain for many products. Once more largely accepted and reimbursed, those manufacturing costs may be incorporated into the product, and passed on to the customers. In time and as manufacturing efficiencies increase, those increased costs will decrease. The market will justify the product cost increase by decreased patient readmission costs through better disease management and patient compliance.

These technologies will never replace 50% of devices, but they certainly will augment many, and obsolete a few.

Hardware needs software...software needs hardware.

I think that Apple will only enhance the opportunities for Medical Device makers. They will not likely replace the diagnostic devices that are used in hospitals and at the point of care by physicians and practitioners. Rather, Apple and it's band of developers might make apps that either run off the sensors that are already in the iPhone and iPad (currently not really medical sensors, are they?) or develop external sensors to be attached to them. Then coupled with an app of some kind they could make some kind of cursory measurement that would have to be verified and confirmed on real medical equipment.

So what if Apple or some third party comes up with a method for consumers to measure; say blood sugars or blood pressure or body temperature in real time. I don't think that hurts the medical device business a bit. After all, this testing would require that consumers to get their results confirmed and verified. And anything that informs the general public about what should and can be monitored has to be good for healthcare in general.

I cannot imagine that an MD or a staff member at a hospital will use anything like an iPhone or an iPad with a peripheral hanging off it when they could rather use a real piece of tested and professional looking medical equipment. And after all, even if Apple could get a device to work, for that device or capability to be used, it will have to get through the 510(k) or even PMA process before being marketed. Now if by some stretch of the imagination, an Apple based device or peripheral with associated software were to be allowed to be used without a 510(k) or PMA, then I would also guess that the intended use would have to be based on follow up on a fully approved device. How else would such a device demonstrate safety and efficacy?

Apple can only help the medical device industry.

The fundamental impact of wireless technology and mobile devices alike is enabling information/data availability (accessibility) and connectivity almost anywhere and anytime. With it, more advanced (therefore more complicated) medical applications can be developed. This should not necessarily have negative impact to medical device companies as long as they timely leverage these new technologies and continue focus on their own competency and strength in medical applications including how to meet associated safety/regulatory requirements. Having said that, there will definitely be new challenges (e.g. device interoperability, cyber security and safety) that that medical device companies need overcome.

Rob Posthumus As stated earlier in the discussion the number of patients is rising steeply, mostly so in the number of chronically ill, the budgets won't be amended accordingly and the number of potential health care professionals (at least in Europe) will be falling. This will lead to demand pull and failing supply in the traditional health care offering.
Thus the demand for medical devices will prosper, but will seek for tools monitoring patients at distance or allowing patients to monitor themselves.
The self monitoring, communication, data collection and ’feedback' needed in a situation where the professional will no longer be driving these medical devices will offer major opportunities for new parties entering the market.
Interesting times ahead...

Even if the number is 10%, one can only hope the regulatory bodies are agile enough to respond in a timely fashion...

Great thread! I agree with above comments that negotiating in the regulated device world with the FDA and even HIPPA is not the consumer space. Having direct R & D, as well as clinical research experience with all classes of implantable and freestanding devices, there are see great efficiencies to be gained with partnering. Additionally, home and remote monitoring has been around for years, it has been the reimbursement for the use of those technologies that has failed the marketplace.

In all good, strong organizations data, not emotion, should drive decision making. Data collection, transmission, storage, and evaluation should ultimately lead to better patient outcomes and improved health care for the patient. Certainly and ultimately major organizations will benefit as they venture into this arena and hopefully long term - patient care is improved and costs contained.

I think this may be the best discussion I've seen yet on the future of medical devices. What hasn't yet beed said (it is alluded to in the article), is the primary changes to medical devices will come from changing an outdated and inefficient business model. Historically med devices have been developed as proprietary, (generally) expensive, stand alone hardware platforms with software that is specific to the one application it's designed for. In the future devices will become commoditized just as consumer PC's tablets and smart phones have been, with software being the "service" that is charged monthly or annually. I think we're also likely to see integration across devices in all areas of medicine from the OR to the ER to critical care and nursing. There's already significant benefits being realized from Big Data approaches to record keeping and integration of patient data that will also continue. And the barriers to clinical applications are coming down as Health Care Providers realize that observational development and improvements are more effective that the a priori development so many companies and entrepreneurs engage in. As the hardware becomes more commoditized and software becomes more flexible I think we will see a deeper and more profound engagement from the bedside to development rather than the traditional bench to bedside approaches.

Paul Laurence Sweeney We are seeing the last of the glory days of the medical technology sector as we know it. Within a few short years we will see the prevalence of ubiquitous cheap Chinese hardware supporting "Apps" and all of this will be done far away from the FDA or any equivalent.Take it or leave it. There will be no slices of cake for everyone & no crumbs either.The cake will just be divided in two - half for the Chinese & half for the software companies. And if you have a lawsuit as a patient, take it up with Beijing & see how that works out for you.Bye-bye to all the value-added , high markup stuff - thanks to an impoverished middle class , Obamacare & austerity measures worldwide , that tasty market is absolutely going to disappear.Many of us need to be keeping our options open & staying flexible enough to reconfigure for other markets.I would not recommend any job candidates or investors either for that matter to view healthcare tech as an attractive market.Rather it is an absolutely over-inflated bubble perilously close to the sharpest pin you can imagine.

Paul M. Stein Paul, I'm sorry, but I couldn't disagree more with everything you said. Chinese crap is Chinese crap. Even the Chinese want American made when it comes to medical devices. The Medtronic's, St. Jude Medical's, Boston Scientific's, and Stryker's of the world are doing just fine, no, insanely fine, in the face of all the non-issues you cite. Would I advise budding engineers to go into the glorious world of medical devices? Hell yeah! Saving the world is fun. I'd just tell them to be very smart with both their education and to head for start-ups once out, where the real excitement is going on now.

Paul M. Stein Hype, still hype.

Throughout all this discussion stream, I've seen nothing of substance regarding apps-etc. beyond better data communication. The basic reason why this will always be the way-of-the-world is simple. Medical device companies don't share with each other…on anything, any time. Simple example…pacemakers. To the uninitiated, one would think that a pacemaker is a pacemaker, and that there might be a universal controller (programmer) for all of them in the hospital if an emergency arose. Sorry, no. The pacemakers are all different from manufacturer to manufacturer, in design, features, and software, and only the individual manufacturer's programmer works with its own pacemakers. Hence, there need to be half a dozen desktop computer-sized programmers sitting around on the side taking up space.

It's called intellectual property. If there is absolutely no cooperation between just a single, small set of companies on one little product type, how can outside, non-medical device companies make any significant inroads into that world beyond what they only know what to do? So, Apple, Samsung, Verizon, AT&T, etc., data stream away on your little rectangular thumb-driven stareboxes. Have fun with that. Unless you acquire a Medtronic or a St. Jude Medical, leave the therapeutic medical devices to the professionals. Oh, and hypesters, go home.

Paul Laurence Sweeney There will indeed be innovation , Paul & lots of it. With all of the nano-technologies & ultra-thin materials coming on stream, there will be massive developments. However, the Chinese, South Koreans etc will be able to do this just fine & Indian programmers will do the rest. My argument is that Western companies will be completely left behind, because the old model of endless trials , FDA approvals and so on has had its day as far as tech devices are concerned. Tech, as opposed to medical tech companies just do not operate that way.Most medical devices are actually not that high-tech. Any smartphone or laptop is hugely more sophisticated than the immense majority of med devices. My argument is that the market will come to be dominated by a new breed of companies used to speed of light product development & whole operations will be off-shored to more company-friendly jurisdictions where massive compensation settlement packages for patients are unknown. The "medical" will be taken out of "medical technology" and they will be one more consumer-type item.These new companies will do a spectacular job of making equivalent devices for one- tenth or one- hundredth part the cost of the previous items. And this is just what a huge part of the world needs. Just as western consumers are increasingly ditching quality or perceived quality in favor of price when it comes to daily purchases , they are waking up to the fact that our industry has often been characterized by scandalous mark-ups and unjustifiable inefficiencies.People are waking up and they know that there is a reasonable quality/price ratio to be had from Asian manufacturers - as always, it is a matter of separating the wheat from the chaff. Decades of offshoring manufacture have had this result - people believe that if everything is made in Asia in any case, they may as well buy direct. Most sales of small devices to hospitals in Spain right now are direct from China to the hospital via EBay, at wholesaler prices.These smaller devices are just purchased as commodities and you are probably aware that Spain was specifically ordered to encourage this policy as part of European Union imposed austerity measures.The genie is not going back in the bottle anytime soon.

Paul Teitelbaum Mobile/home based diagnostic and monitoring devices? Some of them perhaps - it will be interesting to see if Apple, Google and Samsung end up physically incorporating sensors for vital signs, glucose testing, CGM, HbA1C, body fat%, heart monitoring/ECG, etc into their devices or they just choose to communicate with them via Bluetooth (and then the device makers still need to make them) and have their programmers or let other programmers just write the apps to communicate with them. Chips are getting awfully small, so I would imagine that the glucose monitoring contact lens that Google is developing would be able to send data to your Droid via Bluetooth and Google would just supply an app to display and transmit the readings. Is Google actually going to manufacture the lens or outsource it to a med device manufacturer? At the end of the day, someone with FDA/CE regulatory skills, ISO 13485 clean rooms and cGMP manufacturing capabilities has to make many of the devices that actually test you (maybe not for basic vital signs, but for things like glucose, etc). And then there are all the devices to treat you - unlikely the large PDA companies get into that any time soon.

Chris Newmarker This was a really excellent discussion, I think. It provided enough fodder for what I hope is another informative MPMN blog post:
http://www.qmed.com/mpmn/medtechpulse/how-mobile-health-changing-medtech%E2%80%94or-not

Thank you to everyone! And if this discussion was to have a soundtrack, maybe it would be this? :) http://www.youtube.com/watch?v=gbO2_077ixs&feature=kp

Ken Micciche Thanks for all of the input and ideas. I too feel an outdated delivery model will be improved through the availability and use of data to drive down costs and improve outcomes through the ability of practitioners and patients to use current, relevant, patient-specific data to drive behavior. I also see benefits and penalties being levied by insurers on patients for good and poor behavior and related clinical data. I hope manufacturers continue to innovate and accelerate the convergence of technologies to create the availability of meaningful data and information to drive behavior.

Michael McCarthy, MBA, BS, RRT-NPS As a hands-on healthcare practitioner, I can tell you, this will not reduce costs. It will probably improve care but you still need people to take care of patients. Data is only as good as the quality and interpretation of that data. I can put a pulse oximeter in a watch and broadcast it to China but if someone qualified is not there to make sure there is no aritifact to disrupt the signal then the data is useless and possibly harmful if misapplied. And this is only one very small, routine application in the healthcare arena. Thanks for the gadgets. They're real nice.

Mark J. Kania, MBA. Its great to have the input of a healthcare professional in this discussion.

Bruce Grayson I think this is probably the most exciting era in medicine. New tools, that we can barely dream of are being crafted today for use in the surgery, point of care, and home environments, Not as some have implied cobbled by gangs in China or faceless IT shops in India, but by some very bright people working together globally to ask the questions "what if? and "why not?".
Medical device companies that exist today make extraordinary revenues and this will continue into the near future. What they rely upon to protect their investment are barriers to entry. Regulatory costs, Quality costs R&D costs and Clinical Trials cost are all significant barriers just to name a few. IP and proprietary software helps to limit use or obscure the workings and helps keep those barriers up. Google and Apple have been reported in meetings with the FDA over the last month. One thing they both have is a significant pile of cash. Cost means nothing to them and when you own the technology the remaining limiting restraint is people. This is a good time to be in the business.
I read posturing in the posts, some opinion, and, frankly, a bit of arrogance, in the status quo of the medical business. We must move on.
In my meetings with FDA regulators, they have stated privately and publicly that the medical industry is trailing behind aeronautics and automotive in both risk management and safety, especially as it pertains to software development ie. APPs and embedded software. They are strained and see only an escalation in submissions. We need to help them.
When we need to put quotation marks and differentiate "real" and "casual" medical devices we miss the bigger picture that many of these new devices are medical devices today and have been for a while.When the first pacemaker plugged into a telephone socket years ago, that adapter became a medical device. Just ask the manufacture providing the radio shack style line splitter.
Look back over the last decade and try to imagine the changes you have seen in the use of technology. and even your own personal budget spend. How has it grown? Now imagine twice the change in just the next few years.
Buckle up and enjoy the ride! This will prove to be the best decade of your lives!

Paul Laurence Sweeney The patience demonstrated by the traditional medtech companies with respect to FDA requirements is admirable. I doubt that the software giants will have that patience and therefore I foresee following strategies being pursued:- (1) basing operations in Asia & well away from FDA supervision. (2) Making their products such killer apps that healthcare providers will insist on having them & pressure the FDA into granting approvals.(3) Using their considerable cash piles do do any remaining lobbying that the healthcare providers have not already done on their behalf.(4) Absolutely changing all known business models by tying up insurance data, prescribing & healthcare provision in one unique application in "the Cloud" & conveniently legally registered in legislations not known for generous compensation settlements for patients, decent privacy legislation or other business unfriendly practices.And I am most probably being exceedingly conservative.

Brian Baum Bruce - couldn't have said it better! These are exciting times and times of significant change. All that we know for sure is that the current model of healthcare is not sustainable. Beyond that - ?

Smart phones and data, whether Apple or Andriod are here to stay and will be used more and more. Departing from the data side, I believe the control functionality is a much more powerful use of the Smart Phones. As a medical device design and build contract manufacturer, we are seeing the increased demand for us to design in and add both the hardware and apps to products. This allows the smart phone to act as a remote controller, and in the end reduce the cost of redundant switches, dials and displays that were once one the device.

Kiran C Shetty Bruce/Brian - I agree, exciting times. I'm thrilled to see how the medical device industry can and will expand, grow and innovate with “tech space" cooperation in the coming years. I think we’re on the same page, but let me elaborate; With. Not because of. I have often had discussions about electronic health records, HIPAA, medical device companies, manufacturers, insurance companies, and others, and the interaction between them all with friends, family and colleagues.

No offense to age, as my father has been practicing medicine for nearly 50 years and I consider him one of the most moral, ethical and intelligent men I’ve ever known, but there is some distrust of apps, electronic data transfers, and cloud record keeping, when I speak with seasoned experts with his experience, and even many his junior. Security and accuracy is paramount, when reporting, tracking, and transmitting the type of data I think we're discussing is involved.

This paradigm will inevitably change as those up and rising stars come to influence and power, and don’t remember when doctors carried pagers and a pocket full of quarters for the pay phone call to the hospital when on call. Wait. What’s a pay phone…?

The success for what will only be enhanced subsets of each industry, medical device and tech, is cooperation. I really think combined, these industries can complement each other’s skill sets to develop and deliver cutting edge, safe technologically advanced devices which will serve humanity.

I would love to see some manufacturing come back to the US based upon some input, cooperation, and reliance on Silicon Valley. Not sure that’s realistic, but a thought.

Great comments, insights and opinions by everyone – glad I caught this thread.

Kiran C Shetty Obsolete is a very strong word Robert. I think augment and innovate is more accurate. I said earlier, hardware needs software and software needs hardware, and I feel that's the key.

Cooperation.

Neither industry is able to jump into the other and dominate.

We'll work together and it'll work, eventually.

I concede that in the last 40 years computing power has increased more than we would have ever comprehended, but if that continues, which is probably will, it will only help hardware, not eliminate it.

Rob Posthumus More than can be expected from the current medical devices producers and developers companies like Apple will seek for customer/patient demands and try to create disruptive/niche devices and cross overs.
In a period in which demand will be growing steeply and the health care budgets and staffing won't cope with that these new kids on the block have a large potential to steer this business into a new direction.

In this I think self management by patients, supported by customer oriented technology, will prove to be a way forward.
This will however need a shift from data collection (now threatening to drown the professionals by showering these with data in abundance) to information gathering and feedback. Therefor evaluation and judgment of individual data and then relaying these as feedback and advice to the layman users will be a challenge, or am I wrong on this in the perception of the other readers...?

Johan Goris Lets face some facts about 3 most common and basic medical parameter measurements:
- reliable SpO2 is still measured at the fingertip, toe or ear ...
- reliable NIBP is still measured with a limb cuff and ...
- reliable ECG is still measured with electrodes at > 3 limb extremities (or chest positions).
As long as we don't get alternate wearable biosensors or measuring methods, I think small "integrated" mobile health measurement applications will hardly grow above the actual fuzz level of nice to have gadgets.
I do strongly believe in added value trough communication of mobile device applications with "real" medical devices and other user, tracker or sensor input and see the future in
combinatory parameter analysis, data sharing, remote diagnostic interpretation and feedback ...

Michael McCarthy, MBA, BS, RRT-NPS I see nanotechnology with a better future in healthcare than silicon chips.

Anthony Antonuccio Hype. That's like asking if a transistor, a processor, a memory chip, a computer, a network, the Internet are useful. Apple, Google, and many others in the IT & consumer industries produce platforms and opportunities to leverage, extend, enhance, and embrace, helping those across all industries. It's goodness.

Tom Coss Companies who fail to appreciate the distinction between data that represents what I think and clinical data that represents who I am, are badly missing a critical point. Capturing even benign clinical data such as one's weight is quite different than a tweet, or music preference, a distinction HeartCloud takes very very seriously.

Brian Baum This really has been a great discussion.

I think Tom makes a key point in the discussion that is very relevant and in my opinion core to the evolution of care delivery. That is - there is a distinction between "island" data and what I might call "interpreted data". Island data being data that goes nowhere. This could be generated by any device that is solely used by the individual consumer - an activity monitor, a heart rate monitor, a glucose monitor, bp monitor, etc.

"Interpreted data" is where things will get very interesting. First, the data must be transmitted - this is certainly a device trend. Second, the data must be received by an interpreting party and probably integrated with other data sources. As Michael noted above - without someone to interpret the data its value is limited. The question is – must there be a one to one relationship? “One practitioner interpreting one consumer’s data?”

As an example, in my work I have the opportunity to meet with many different organizations in different health sectors. In a discussion last year with several people at Johns Hopkins I suggested the following – what if – Johns Hopkins were to create a consumer health application where “subscribers”, (yes, this could be a revenue generating private pay service), - arranged to have data being generated from their health monitoring devices transmitted to Hopkins. Twice a year an alert could be triggered for the consumer to go to a Walgreen’s, etc., for a blood draw/lab test. Results also transmitted to Hopkins.

Hopkins would receive the data, utilize a Hopkins developed algorithm to analyze the raw data and issue health reports back to the consumer. The “reports” could provide an initial assessment, trended results, recommendations for health improvement – could be emails, texts, etc. If significant deviations occurred in trends an alert to “schedule an appointment with a Hopkins clinician”. This could be bundled and perhaps sold at $29.95/month. (Whatever the right number.) Take it a step further and bundle with a health insurance offering that could be discounted because the individual is obviously very actively monitoring their health.

What does this accomplish? First, I as a consumer take some comfort in having the institution of Johns Hopkins – actively monitoring my health. Hopkins creates a long term relationship with the consumer and is able to monitor thousands, tens of thousands… For any consumers that “flag”, they’re likely to come directly into the Hopkins system for follow up. Since someone referenced that the device data could go to China…well, the data could also come from China and be interpreted by the “world renown” Johns Hopkins Hospital.

Of course this model could be replicated by providers around the world. Are there issues – absolutely, but what portion of the world is currently receiving no routine medical consult? (In the U.S. and beyond.) Is it better to be “algorithmically” monitored using steady streams of device generated data, or have no medical oversight until the first event?

I try to avoid absolutes – other than we absolutely know the current model of care is unsustainable. If we assimilate various emerging capabilities – device innovation, data analytics, a connected society, we just might develop the next generation care model.

Johan Goris After some feedback I reviewed some parts of my former message and this is the hopefully better result:

Looking back at the scope of our discussion, I would like to introduce the term:
Mobile Medical Measuring Devices (MMMD) and define them as personal mobile devices with the intended use of measurement, interpretation and representation of physiologic parameters.

The question was if these MMMD’s could beat the existing market of the classical active Medical Devices that we actually use in hospitals, doctors practices and also in the homecare environment. To enumerate some of them, devices to determine blood pressure, blood saturation, temperature, heart rate and rithm, core temperature, glucose level, etc ...


I believe in the near future mobile devices will become personal health devices serving as our "medical wallet".

At home we might all have modular multiparameter monitoring devices that connect to our personal mobile device, serving as a human interface and acting as our “private” medical data storage and sharing device. (trust me, I won’t share my medical records easily, unless via my own physician).
We might also use wearable devices, like fabrics, and invasive nano technology with wireless data transmission to our “medical wallet”.

Certain data may also be exchanged (trough standardised communication protocols) between our mobile “medical wallet” and doctors, hospitals, diagnostic centres, insurance companies, authorities, relatives, friends, fitness centres … I we decide to!
Though it may appear that the medical market keyrole players are not yet ready to agree on how to exchange or store patient data, though many initiatives exist. Many agree that interoperability will be a big challenge in order to make things succeed for all stakeholders. (Some key words : HL7, CDA clinical document architecture / MDDS medical device data system / PHMR Personal Healthcare Monitoring Report / etc …)


BUT in the mean time let’s not disagree on a concern that is globally accepted, namely PATIENT SAFETY (electrical safety / measurement accuracy / data consistency / privacy / biocompatibility / …)


To the new kids in town, a warm welcome … let’s play together, but:
If you want to develop medical devices, start to understand the definition and study the safety standards ... if you don't, leave it to the professionals or cooperate with them.

If you are only interested in the medical bussiness because there is a lot of money going around, please stay away and redefine your developments as “nice to have gadgets", that wil not make false promises, neither deceive or harm anyone that is already a patient.

Remember : FAST, GOOD, CHEAP … you can only pick two!

Edward Bukstel FDA approved medical devices will certainly change the medical device landscape. With FDA approval and positive outcomes there will be insurance reimbursement which will make certain mobile medical devices mandatory for treatment of chronic diseases.

John Douglas The artificial pancreas projects for people with type1 diabetes is a great indicator for how the future of medical device development may occur. It involves co operation and discussion between many parties including device & other companies, FDA, JDRF, clinicians and end users etc.

This evolving technology requires diagnosis, treatment and communication, Apple and Google etc will no doubt also play their part.

John Douglas By the way the one group I am not sure are actively involved in the Artificial Pancreas project are the health insurers!

John Douglas http://www.inc.com/christina-desmarais/3-hot-opportunities-in-health-for-tech-startups.html?cid=sf01001

We are marketing company. one of our company deals in consumer health care products and another is in distribution of mobile phones. India is our market. Our company is also planning to add new health care products for distribution/ marketing which have attachments for mobile / bluetooth connections, application to download on mobile and save data online, we are looking for companies, who are dealing in regular health care products with modern mobile technology.
Deepak Agarwal
Advay Consumer Care P Ltd.
Info@advay.co

Good article - Thanks for sharing !

Bruce Flora Medical devices are regulated and that is a significant investment. Apple might partner with a medical company and enter a market in that manner.

Jagu Barot I watched a video of a doctor in San Diego using iPhone for all kinds of diagnostic procedures. He ideas are converted to Apps by some nerds like me. He has made iphone a vital tool to help patients avoid clinic visits. Amazing. Illumina, inc has now made the table top DNA analysis machine that docs can have for 10k. Combine it with the power of iPhone. The future of medicine is shaping up, it is being invented, it is being transformed, and it is becoming more user friendly, where docs will lose their monopolistic powers. The future is always bright when Apple defines it.

Karen Lunde Will mobile health end up making half of medical devices obsolete? Not the ones that we work with!

At CERES, we run clinical studies on medical devices, mostly in Europe.

There is no amount of "mobile health" that would render obsolete the great majority of medical devices that we work with.

"Brick and mortar" medical devices won't be threated by mobile health. No mobile health system can put a stent in your heart, your head, or your leg; or occlude a hole in your heart.

If the mobile health system would be good at keeping people healthy, so healthy that they would not accumulate fat in their arteries, develop hypertension, become obese, or accrue adult-onset diabetes - that would be really great! These fine specimens of humankind would likely need some medical device in their future, and CERES will be here to run clinical studies on it!

My company (Peridot) is working with a number of startups that will measure various bodily activities and interface with an APP to collect and analyze data. Insurance companies will LOVE this as in many cases it will eliminate the need for a doctor visit. Apple and Google will be sure to be players in this area.

Dave Sheppard, CMAA I love the future application possibilities involving telemedicine and webmedicine. Apple will certainly be a player. Hopefully, they will provide some "game changing" moments as they did with the I-phone and the I-pad. Regardless, they will never "dominate" medtech but they can have a nice impact on innovation and applications.

Mark J. Kania, MBA. Mobile devices and sensor technology will help gather ongoing information about the nature patient procedural outcomes and chronic disease management. These outcomes are now of increasing importance since they're tied to reimbursement levels for hospitals.

Henoc Paulicin Jr There is no way that this apple device will make medical devices "obsolete". Medical devices used to monitor vital signs may begin to struggle (aside from the face that this market is over saturated anyway), but surgical equipment, implantable devices, esentially class II and III devices will go unharmed. Based on the article, it seems as though this Healthcare IT product with some diagnostics components to it. I see this more as a device to check vital signs which are continually communicating to an EHR platform. Does this hurt the Medical Device market? No. Medtronic, Stryker, Carefusion, Johnson and Johnson, GE, etc. they are not worried about this. However, the HIT market may benefit from this, if they play their cards right.

Edward Bukstel There is a difference between surgically implanted medical devices and medical devices that are designed to monitor or utilize sensors at this time. Although the stents, hips, knees, etc ... will have monitors and sensors attached as well to monitor real time functionality.

Certainly a CRO such as Covance, Quntiles or others will be useful in certain studies when gathering data and protocol design for use in a submission to the FDA or other appropriate health organizations.worldwide.

There are multiple examples of insurance companies investing in Health Technology, and this will occur in the medical industry in the near future. See URL below for one of many examples.

http://www.prnewswire.com/news-releases/highmark-blue-cross-blue-shield-launches-personal-health-record-58531847.html

Edward Bukstel I respectfully disagree. I don't care if you are Medtronic, St Jude, Stryker, or Blackberry. You are a dinosaur in this market if you don't realize the tectonic change that is occurring. No one thought Blackberry, Motorola or LG, would be be destroyed for essentially the value of their intellectual property, until Steve Jobs introduced the iPhone and Android devices came to be as a solid competitor. The stents, hips, and surgically implanted systems of today will have sensor technology that track motion, oxygen, BP, etc... to evaluate outcomes in a quantitative manner that does not exist today. It will be less important that you have trained a surgeon to utilize a device ... Instead the measurable outcomes will be there in numbers that don't exist today. This is way beyond readmission rates and productivity measures for back to work. The good news for the Medical Device industry will be patient accountability. The sensors will not lie and patients that smoke and lie to their doctors and insurance carriers will be caught. Diabetics that lie about their diet will be caught by smart glucose monitors for Type 1 and 2. We know GE and Radiologists are not happy about the recent studies on mammograms (they are worthless as currently prescribed) No one saw a camera contained in a pill to view the digestive track coming 5 years ago. Of course the video image is communicated via smartphone. 2 hours ago I listened to the CEO of Dartmouth Hitchcock discuss cutting 33% of costs because of the decline of fee for service. Everything in this industry will be about measurable outcomes via FDA approved sensors and monitors and they will communicate via mobile technology. Everyone else will be a Motorola Startec or a Blackberry.... Innovate and Communicate!

Having lived through the tsunami that was Apple in the consumer electronics industry, I wouldn't count them out of leveling and rebuilding the medical device industry. When the iPod came out and grew meteorically there was this giant sucking sound in consumer electronics in which an enormous shift of dollars in the industry aligned behind Apple's ecosystem, mostly into Apple's pockets. Whole categories of products disappeared and companies and retailers disappeared like a Black Hole. By the same token, many consumer electronics companies aligned themselves with the iPod, iPhone and iPad and now have nice businesses. Until we see exactly what Apple has up there sleeves, its just speculation, but if they introduce something disruptive and convergent that operates like a swiss army knife, heaven help the companies that make single purpose devices. People argued against the iPhone concept before it was revealed. Don't they feel silly, now. The question is does Apple have another paradigm shift left in them, or are they just a big, slow moving giant cash cow.

Henoc Paulicin Jr Edward: You make very solid points on the ability for newer medical devices to give off readings via a sensor thus giving more accurate patient data. This would be detrimental to the medical device industry. I agree that the market eventually will shift towards in that direction. However, we are a long ways from this. There are many studies being done at major institutions on using the body (muscle contractions, nerve impulse, etc.) to power medical devices however nothing has come to fruition yet (to the best of my knowledge). Also, the compliance and ethical battles that will have to be fought for a device like that to get approved is almost unbearable. According to the article, apple has been interacting with the FDA's medical device division, and is rumored to be a class I device. I'm sure you know that class I devices are not implantable. So, a stent, hip, and other surgical implantable systems. are out the question. Also, the product that they are currently working on is trying to use sound of blood flow to predict heart attacks; clearly a class I device. In addition, if a device you are referring to were to be made, i'm sure it would be a joint project between a major medical device company and a service provider, I.e. Stryker and Verizon. I'm sure you know Verizon has been looking to get into healthcare for quite sometime now, so I wouldn't be surprised if that does happens. However, Apple by themselves simply does not have enough resources and knowledge to enter the medical device market. The regulation for this market is way too strict for them to dominate by themselves.

Respectfully,
Henoc

Paul M. Stein Edward, I must respectfully disagree with you. Most medical devices are already technological marvels, but they do very, very simple things when it gets right down to it…pace, defibrillate, move, don't move, stay open, flap…you get it. Making them much more complicated or having a myriad of sensors won't, in my view, make them any better at their jobs. A lot of the current sensor information is really of dubious worth for normal, healthy people.

The medical industrial complex is currently stretched to its limits, and will only get worse in the future. Paradoxically, when they should be seeking more help, doctors will never let their reins go when it comes to being in total charge of the medical treatment game, and if anyone else tries it, and there are all those pesky practicing-medicine-without-a-license things. Hence, there won't be any real time for anyone to look at streaming information. All that extra "wellness" data will either be 1) lost or 2) relegated to those who are a) ignorant, b) incompetent, c) should really be handing it over to physicians, or d) looking to only make a buck.

Now, certainly, indwelling cardiac pressure monitoring technologies for heart failure patients (Medtronic, St. Jude Medical) have shown their utility, so, pointed, disease monitors will definitely prove themselves, and that's where efforts for improved communications should be placed. And, I absolutely thought that the PillCam was fantastic when it came out.

no

John Gilhooly Great question and some fascinating debate!

My perspective is that we are going to see a rapid acceleration and transition to innovation everywhere with coincidence and convergence of new, exciting and disruptive technologies, commercial platforms and business models emerging. It seems pretty clear that the future looks very different to the past!

Johan Goris I read that Apple only recently contacted FDA
(pretty late to me, and what about EU: CE-certification, ...)

They might however seek for cooperation with some key players to rapidly fill the gap.
I suggest them to catch up with their competitors fast
... and have a look at what is possible : https://www.openit.co.kr/en/product/healthup

Existing active Medical Device manufaturers will (have to) add mobile functionality to their existing range of "certified" products through wired or wireless communication (Bluetooth, Near Field or other) and cooperate with "certified" Management and Gateway Providers to serve us all. That is more people, everywhere, better, cheaper, safer, ...

PS.
Don't get me wrong ...
I'm a long term, happy and satisfied Apple (MAC, iPhone, iPod, iPad) and Windows user !

Dave Sheppard, CMAA And let's not forget Qualcomm! They are making significant investments in medical technologies and wireless infrastructure already. They have several companies 'incubating' -giving them a head start.

Paul M. Stein Dave, Joe Hage added a new discussion on the Qualcomm XPRIZE. Based on the extensive rules to diagnose various disease states, the thing is a joke, and will remain unclaimed for a very long time. If that is the "leadership" of these sorts of companies, then we have nothing to worry about.

Bernard Farrell I think Shahid is being premature. Personally I believe that mobile devices have pushed the envelope and it's up to device makers to catch up with them.

They (medical device makers) need to cooperate with each other, and inform mobile device makers of their needs so they can better integrate their devices and have the phones/tablets be the location for device control interfaces.

Given the primitive state of the user experience and user interfaces for many medical devices, they've got a lot of catching up to do. This pressure can only help.

John Gilhooly It is not hype and does not need to be a threat, it is a ground-breaking opportunity! As with all technology inflection points it is those who 'get it' that will win.

Dream it - believe it - achieve it!

Edward Bukstel I want to thank everyone on this thread. Great comments! I have been contacted and agreed to work with an industry leading device manufacturer. My thoughts and opinions may have struck a nerve. I cannot say anything more except thank you for your thoughtful insight!

Jagu Barot Henoc, You are very certain of what future holds. Be prepared for reforms, revisions, rapid changes, and revolution in the medical field. The future is not what it used to be. Ask MP3, Sony, Blackberry and Nokia. The future is being invented in thousands of garages, labs and companies around the world. We don't know all the changes occurring everywhere. But when they start converging, synergy is inevitable. The field of medicine will be run more by many professionals than by doctors only. The treatments we know today may be confined to the history books. The novel treatments that overwhelm the medical field with propaganda and hype may not yield the same return. The future patient will be better educated than now, as the current patients are better educated than they were in the past.

Brian Baum While this issue will never go away, at some point I suspect this thread will end!

But since it seems to generate such discussion, I thought I’d drop another incendiary topic into the conversation.

I attended a very small discussion group in the board room of Duke Medical Center back in 2005. Dr. Ralph Synderman was then Chancellor and presided over the discussion. Probably 25 – 30 people almost totally comprised of physicians. The proposition on the table was “the practice of medicine is 90% science and 10% art.” The “discussion” was further fueled with a stat that had been presented by Dr. Michael Leavitt then Secretary of HHS - statistically, an individual presenting at any facility in the country – urban/rural, AMC or community medical center had “coin toss odds” of being correctly diagnosed and the most effective treatment protocol prescribed. The discussion was further fueled by a study that indicated 95+% accuracy of the correct diagnosis and treatment when condition data was algorithmically processed by computer.

You can only imagine the discussion that ensued.

My point would be, while there is no substitute for one on one – patient/physician care, there is room for that care to be augmented with and through technology. An episodic annual or once every five year physical can be dramatically enhanced through device based health monitoring that provides trends in individual health statistics vs. a snapshot observation. The cost of care today is unsustainable across the total population. The future of care, will look different than the past. No one today can fully anticipate what shape it will take, the impact on consumers, physicians, the payment for care. The best we can all do is maintain an open mind and do our best to facilitate the future.

Henoc Paulicin Jr Jagu: I agree with you that there will be a revolution in the medical field. However, I think it's an unreasonable to make the comparison between the medical device and the electronics market. Even if we were to only consider the regulation atmospheres, it is significantly more difficult to bring a product to market in the medical device market. We're not talking about devices that can be created tested for 2 years then put out into the market. This is human lives we're speaking of. Medical devices go through a much more rigorous process than an Ipod or or HDTV. Why haven't the implantable RFID tags been released? The body rejects them, they can't find a source of power to continuously charge the device etc. Then lets consider the customer base that needs to be developed for a product like this. The issue you're going to have is that physicians are the most skeptical individuals to walk this earth. If you are new to the industry with an implantable product that has telecommunication capabilities, you need to have clinical trials to prove safety and efficacy. This is an investment that technology companies are not use to having to deal with. 30 million for a clinical trial that could possibly be rejected? This is more complicated then you considering. In my previous statement I agreed a change is coming. But that change isn't coming right now. It's too hard of a regulation atmosphere. Also, if you are referring to class I devices that apple is pursuing then yes there is revolution in that field. Most of those devices aren't subject to pre-market notifications or gmp so this may be a feasible route for apple and a lot of technology companies. However, as stated before this market is over saturated anyway.

Regards,
Henoc

Tom Coss So riddle me this: What's the one "app" nearly every one uses but few open?

We've taken the approach that the utility of remote clinical data lies in its being seen under conditions of context by people who want and need to know. Absent this critical, highly human exchange, remote clinical data produces all the joy of one hand clapping.

In order to complete the job completely, one needs to produce the data (remote devices), send that data to a safe place where it is given patient specific context, and forward important data to other people over a consumption medium of their choosing. We can make this more complicated, and I'm confident some will, but we've been doing this for nearly 2 years and this about sums things up.

The answer to the riddle is SMS, its simple, private and for us, bi-directional we even ask simple questions. //Tom

John Gilhooly All medical professionals know that quick and accurate diagnostics can have profoundly beneficial impact on patient outcomes. We certainly know that in Cancer Care! Thus, there is tremendous customer/patient value to be derived from quick, efficient, accurate and clearly presented access to information on health.

I think there is an opprtunity to 'think big' by thinking really small! I believe we are on the cusp of an unprecedented wave of new and radical nano-scale and micro-scale technologies and innovations. We will see the advent of a wide array of bio-sensing laboratories on chips and even the prospect of a hospital clinics on chips! Companies that know how to radically and rapidly innovate, and drive micro-miniaturization of packaged devices have great opportunity to leverage these advancements.

And at the same time, there is an opportunity to 'think big' by thinking really big! Clearly the continued acceleration in imaging technologies and data acquisition, and rapidly lowering costs and ready access to affordable super computer capability gives rise to the era of big data in medical. This will enable faster and more accurate diagnosis, prognosis and treatment planning. As such, companies that understand how to acquire, analyze and present mass data through intuitive and easy to understand information interfaces will have a key competitive advantage and role to play. As will companies with Strong understand of data integrity and security.

Clearly, companies like Apple, Samsung, Sony, etc., have great strengths in these areas and with their considerable resources at disposal positions them well to play in this space. In addition, the exponential rise of applications and platform developers is continuing to accelerate innovation and challenge the conventional wisdom and perceptions on value propositions! Check out the reference on Ted talk on 'start with the why'.

As for the current incumbents, well there is always a prescient need and imperative to reduce technology and product development times, and to accelerate the delivery of new incremental and radical medical devices and solutions. But, they could learn much from the Lifecycle pace and end user focus that exists in consumer electronics, semiconductor, and Web 2.0 industries!

Edward Bukstel Excellent comment, John, I think we will have silos of specific information that will come from FDA approved monitors and sensors. I would not discount Medical Device Companies at this stage. But, the market especially in the US is going to change over the next five years. The US market has a $399 per capita spending on Medical Devices, by far the highest in the world. The aggregation of data and subsequent integrated outcomes will be a critical factor in the success of Medical Devices as well as the delivery of medical care in general.

Bruce Grayson John G. I like the way you think. If we look to automotive, another highly regulated and safety conscious industry,how have they co-opted mobile technology? We now have touch screens, RFID keys, GPS, and sensors in all components ( even your tires). It takes over 100 different processors and 100 million lines of software to drive most modern vehicles off the lot. Premium vehicles have heads up displays and night vision as well as inter vehicle communications and perimeter sensing. Oh yes, and you can dock your Iphone as well. The autonomous car that will drive itself is on the campus of Google. Will this make the automobile obsolete? Not at all... And per your comment on lifecycle pace - it seems they come out with new models and features every year, fancy that! Buckle up... it will be a fun decade!

Really interesting topic chris..!

John Strupat The initial wedge for Apple and others to open the door to join what some here call "real medical devices" is in wellness apps combined with innovative sensors and hardware. Will be fascinating to watch how regulators chase the moving target as these products become more and more sophisticated, yet not quite in the realm of the traditional medical device.
For the old school folks with confidence that the ways we capture biophysical signals from the body now are the only way to accomplish this, check out the Qualcomm Tricorder X Prize.

Paul M. Stein John, the ancient Greeks felt that anything that can be imagined in the mind of men could be so. Hence, sea monsters and crazy-by-today's-standards ideas of physiology were relegated as fact for 1,500 years until science finally set in. This X-Prize is one of these. I'm sorry, but Qualcomm has created an impossible wish list, based on today's technology, and the X-Prize won't be claimed for a very, very long time. Plus, anything truly "tricorder"-like won't be possible until 2050+.

Edward Bukstel Paul, I couldn't disagree more. It is tough to have a window on what's going to happen in the next week let alone 36 years from now. I'm still trying to wrap my head around the "pill-camera" and all of the areas that are going to be affected especially with other ancillary devices. I don't think anyone saw the pill camera as being a FDA approved device 5 yrs ago. If you are a Class I device manufacturer, I would follow MakerBot and other similar technologies over the next 5-10 years. Using your "Star Trek" reference, the replicator is not far away. NASA is looking at recipes that involve ingredients that could last 50+ years until mixed in a 3D printer. Think recipes for custom implantable Class I devices. I agree that the core set guidelines on page 73 of the Qualcomm is a significant area for a single device to address "in total" today. But there are companies with significant demonstrated capabilities that could address individual or at least 2-3 of the core areas.. The fact that this challenge has to occur shows a lack of innovation in the medical device industry. The algorithms that could be placed on a simple iPhone stethoscope (of course with FDA approval or other regulatory body) could easily address 3 of the core items. This of course is a simple example, now think about the existing technology that would allow for EKG's... that could be completed with a tight-fitting shirt and appropriate sensors. We will be faced with Billions of peta-bytes of bio-sensing data... It is all happening now... I don't think it will take 36 years.
http://www.qualcommtricorderxprize.org/files/qtxp.org/QTXP_Guidelines_20130701_v18.pdf

John Douglas I repeat my previous comments - look at the JDRF artificial pancreas project to see what the future may hold regarding collaborations of stakeholders.

Chris Newmarker Thanks for sharing the link, John. Thanks to everyone for the great comments! I definitely think mobile health is one of the major—if not "the" major—topic of discussion in the medical device space right now.

Matthew Romey Johan: Great post! I especially agree with your emphasis on PATIENT SAFETY. If mobile health is to achieve the goal of democratizing medicine and empowering the patient, it must do so carefully so as to protect the consumer from incorrect application and interpretation of the technology.

I believe the Apples, Googles and Qualcomms of the world want to do what’s right. That’s why they should work closely with the medical device industry on this. While they may understand how DESIGN and FASHION work to sell products, the medical device industry knows how SAFETY and EFFICACY work to protect public health. In collaboration, it’s should be a win-win situation.

Johan Goris Thank you Matthew, see also another discussion in our group named "FDA Helpdesk" where I will leave another comment on the importance of PATIENT SAFETY and the need to rely on STANDARDS reflecting the STATE OF THE ART.
Some stakeholders feel like CE-certification or FDA-approval are a burden, while there is so much to win for a company when managing it's assets through a certified Quality System approach (unless it's "paper only" or "badly applied"). It's vital to apply "documented common sense" (what else is a Quality System) right from the start, to avoid unforeseen delays and costs, after a working prototype is hyped.
Multidisciplinar collaboration is the way.

Edward Bukstel Agree, devices must pass Regulatory standards, but must also, in this cost conscious environment, demonstrate efficacy, cost effectiveness, and quality outcomes. All should be measurable.

Matthew Romey Edward: I agree that cost is important. but, following a Quality System, as Johan recommends, *IS* cost effective. It is the best way to guarantee efficacy and quality, as required by law, while minimizing the costly mistakes that inevitably happen during the development process. It's always more cost effective to do it right the first time then to keep fixing mistakes.

From one consumer's perspective (mine), it seems to me that Apple does it the opposite way. Get the product out early, warts and all, and people will still buy it and happily wait in line to buy the next generation with the warts removed. That's not the way to design medical devices because peoples' health and safety are at stake.

Johan Goris I Agree that cost effectiveness, usability and the efficiency to solve real problems in healthcare is often denied in start-up development. Many will try, few will succeed.

Knowing the figures, we may reasonably assume that Apple is interested in Medical applications, as they also have been hiring field experts.
Some suggest that Apple only recently talked to FDA ... all the rest is buzz
and we'll have to wait for the real thing

My guess: they will buy what they need, when available, with the knowledge they hired.

Paul Teitelbaum Are we STILL talking about this?!?! It's been over a week! I'm still getting emails on this conversation! Next topic: Is Google going to end up owning our entire planet?

Paul Teitelbaum I think we're ready for next topic: is Google going to end up owning our entire planet?

Johan Goris Hello Paul, next topic is fine, this topic is HOT.
I guess one can simply "unfollow" a discussion to avoid any further distraction
or untick the case "send me an e-mail for every comment" below.

Paul Teitelbaum Thanks. I know. I'm partly kidding - not really bothered by the emails. Just amazed that discussion has been going on for 19 days. Wow.

Edward Bukstel Don't be amazed! Intellectual Property is a serious issue for innovative companies and individuals. I am actually surprised that there has been a dearth of comments given the size of the group. Paul, you should applaud the active interest of innovative people wanting to protect their ideas, concepts, and legal patents and copyrights!

Edward Bukstel Paul, with all due respects, if you've ever built a product and taken it to market and had doctors tell you that the product helped save lives of patients... than maybe you would understand the passion that people in this group have to helping people. Thank you for your thoughtful comments!

Anyone who uses term"medical devices" means that he/she is still out of world of medical devices.
Talking about different categories within "medical devices", below is my thought
-Imaging systems: Apple is not good at, big game change for them as well
-implants: dental, ortho,vascular: not sure if Apple got the key competences
-low value consumables: injection needles, condoms, gloves...Apple condoms??good idea.
-smaller devices: might be Apple's sweet spot
-softwares: Apple may stand a chance
-IVD: I don't know either

John Strupat The strength that Apple and Google bring is obviously in the mastery of wireless technology, human interfaces and packaging to meet the needs of their customers to communicate and be entertained. I suspect that their initial target for this new market will be their existing base customers with interest in monitoring their personal health and wellness.
I foresee the acquisition of personal biophysical data such as ECG, blood pressure, respiration, movement, position, temp, blood glucose, blood alcohol, and so much more. Will be exciting to see how such data will be stored, processed and displayed for the customer?
The transformational aspect is that a package like this and the data acquired could be considered educational or just for entertainment. No prescription needed for purchase. No restriction for use by qualified medical personnel. No legal requirement to report results to insurers, a medical practitioner or anyone else.
As the user of such a product and service, the data is "MY" data and "MY" property.
I can put it in the Cloud for analysis or interpretation by man or machine anywhere in the world.
Such an exciting time ahead for regulators, legal types and the medical community to keep up with innovation in this area of "medical devices" for use outside hospitals and diagnostic services.
Not so sure how this will effect the use of equipment and services inside brick and mortar institutions, other than the potential for a "customer" to arrive with their own memory stick of historical data. Won't that be interesting?

Edward Bukstel Peta-Bytes+ of constant exponentially growing bio-sensor data that has never been seen before. The aggregation, integration, and analysis will be monumental task and opportunity for the right entities.

Johan Goris I agree with John Strupat, and launched a new discussion on the ownership and asset value of MY data as an empowered patient.
Exciting times and loads of work to be done, for all stakeholders ... but where is the guidance and who will defend MY asset?

Bruce Grayson Great insights John. Paul, we keep talking about this because it is a combination of wake-up call to industry insiders and game changer that excites the innovators. I would have expected that thoughtful dialogue on future states would be interesting to a finance specialist!
What I like about this dialogue is that different perspectives are being put forward. I would rather expand my view and avoid confirmation bias, than follow other topics that are thrown out there to discuss the next mobile health conference.

Paul M. Stein Edward, you are quite correct about how the analysis of "data that has never been seen before" is a tremendous opportunity. It will also change science as we know it, examining how the variation in measures change over the 24-hour cycle. It's a movie versus occasional snapshots. Back in the late '90's, when Medtronic was doing their first clinical research with the Chronicle implantable right ventricular pressure monitor, the data fascinated employees and physicians alike. Upon looking at the very first patient's data, I knew this sort of device would be a medical game-changer. Unfortunately, the FDA then came along...

Paul M. Stein Johan, regarding ownership and asset value of my own data, frankly, I don't give a damn. I don't care if it is freely distributed around the World to anyone and everyone as long as I can get better treatment out of it. The more eyes the better, I say. If that were the case, there would be more oversight or at least more watching each others' backs, leading to less errors and more lives saved that might occur and thus fewer lawsuits, resulting in lower costs. Again, I'm only talking me, mind you.

Chris Newmarker On an interesting aside, no one can even agree on what to call all of this. Qmed/MPMN had an informal survey. Here are the results from the first 100 answers:

Mobile Health: 41
Connected Health: 34
Telehealth: 15
Self Health: 5
Other: 5

Answers in the “other” category included digital health, dangerous risk to personal property (some dark humor, it seems), MyData, iCare (Apple’s newest service option?), and health logging.
http://www.qmed.com/news/whatchumacallit-medtech-industry

Matthew Romey Chris: Don't forget "Wireless Health".

Johan Goris Thank you Paul,
I think it's about ROI and the collateral profit that can be generated from our data ...
I only wanted to express my concern that it should be a free, well informed choice to share private medical data and that, just like for pharmaceuticals, misleading publicity for fake mobile medical devices is to be avoided (and maybe should be regulated too)
I sometimes have a Telsell feeling when watching some flashy websites promoting and selling their mobile medical measuring devices to the lay people.

Johan Goris Chris,
I'd like to add eHealth, HealthIT, ... and there are also a lot of abbreviations going around ...
Maybe it's time to define the terminology?
Who can help find resources and synthesize?
I'm in, but do we have a kind of cooperation platform on Linkedin?
If not, this is my e-mail: goris.j@skynet.be
Input is welcome.

Chris Newmarker This is pretty funny. It's hard to even find agreement on what to call this, let alone reach a consensus on what it means.

John Douglas Will the G20 meeting in November change the Country tax obligations for companies like Apple? Bet a few "medical device" companies would like that problem!

Chris Newmarker Perhaps.. if the G20 has a place to meet.. :)

I just started another discussion about how there's a trend to use super-tough synthetic sapphire for all these mobile devices that seem to be turning into medical devices. I'm wondering why they don't just up the ante and go to diamonds. It would be great to get a few opinions. Here's a link to the discussion: http://linkd.in/MUZ1hU

Paul M. Stein Adam, you're a little late to the game, so because over a hundred other comments are on the wall, you'll need to state exactly what you think "This is untrue." is in regards to.

Burrell (Bo) Clawson Apple is not a medical device company. They might connect a % of electronic devices, but that is mostly it.

Apple as an actual device maker would face the same innovation, FDA clearance, delay, competition & market niche issues every other medical device company faces.

Andrew Kyle I think Bo summed it up well. Apple is not registered with the FDA and pays no ACA taxes, has no CAPA or complaint handling system and is clearly not a medical device company as the FDA defines one. Use its applications with an eye to the risks. If you read a PACS on an Apply iPad, I believe the reader is supposed to have an FDA 510(k) class 2 clearance under 892.2050 and be viewed on a DICOM compliant display. Does Apple's iPAD/iPhone have a DICOM compliant setting for its display?

Ultimately, the decision is up to the physician on what is used and how they use it. The vendors of PACS readers have to follow the FDA rules before they can market the "device" and have GMP controls in place.

The courts would decide, in case of patient injury, based on facts and using an apple application for a medical decision might not be the strongest legal position in my opinion.

Edward Bukstel Apple appears to be acting as a Medical Device Platform. 3D Imaging is on a chip, Theranos has over 200 Lab Tests on a chip (disrupting a $10 billion Clinical lab industry). The FDA has recently expedited various technologies for remote patient use, Ultrasounds are currently on a chip. The Medical Device Industry is due for a shake-up, and those companies with their heads in the sand or lack of understanding of the big picture will no longer exist or morph into something different.

A few companies that pose a threat to legacy Medical Device Companies are listed below.
http://medcitynews.com/2014/11/eric-topols-view-of-democratized-healthcare-includes-shoutouts-to-healthcare-startups/

Andrew Kyle So the PC is a Medical Device Platform too. I don't see HP, Levino, or Dell running into the regulated industries like Medical Devices quickly. The mindset is totally different having worked in both industries.

I believe that Andrew Kyle's comment "Ultimately, the decision is up to the physician on what is used and how they use it" is especially relevant. Physicians currently use drugs for "off label" use although drug reps cannot market drugs for off label use. Nevertheless, there may develop a substantial amount of published experience involving off label use. There have been instances where the literature is so supportive that drug companies do not invest the time and money in subsequently obtaining FDA approval for a use that has become "clinically" accepted and perhaps widespread.

I expect that cautious unapproved use of digital devices may develop. Just a thought.

Andrew Kyle Hi Donald
I believe that will be the case. An application, cardioo, is subject of a current Scientific American article. It is quite amazing and works quite well.

I use it routinely now. Biofeedback can have a very positive effect on an individual's health and that is the ultimate point. Take care of your health and thus avoid as many medical interventions as possible.

Edward Bukstel Pharmaceutical companies have recognized the importance of direct to consumer marketing. Medical Device manufacturers are late and require a considerable amount of catch up. The paradigm has already shifted and MedDev companies are behind the curve. Even the FDA is accelerating approval to proven disruptive technologies.

Burrell (Bo) Clawson Edward has it right. Home healthcare products are behind the times and projected to do double digit % increases in sales.

Consumers, with higher healthcare costs across the board, are accelerating their uptake with proactive steps at home. Just like cars emphasizing gas mileage when oil prices went up, citizens are starting to see the real price of the ACA healthcare and deciding to be more proactive along with their providers.

This includes everything from email with their doctors, apps for smartphones for tracking and home testing and monitoring.

Devices of all types for home use are coming to market, but it takes years to get a typical med dev product to the point of FDA OTC clearance. I read on MobiHealthNews.com the FDA gave about 31 digital health "app" clearances in 2014 and that is out of hundreds underway. There are obviously a lot more OTC clearances that are not "digital health."

Jouni Erkkila Chris,
APPLE, a new comer in healthcare business...

==> Both hype and true.

Fact: The healthcare monitoring in hospital wil not change dramatically. The specific areas - especially acute care- such as anesthesia, critical care and cardiac care require "big" equipment and lot of parameters to provide physiological data to care givers. The bed side monitoring is necessary.

New: The baby boomers are now out there and growing population needing home halthcare - this is area that has been in focus of several companies during tha last two decades! The technology is now available to develop this area - being an excellent oppotunity to make good business. The entire infra structure to manage the home healthcare is flat zero. The technology is easy to put in the package and some solutions are available. Yet, the lack of infra will make this business as "self care follow-up" and simple applications for consumers - tha dta is "simple physiologic data" sush as pulse rate, SpO2. The responsibility on the actions of the "physiologic data" of those simple applications will remain on the consumers fulfilling the curiousity. The care givers will not take responsibility of the "simple physiologic data" without seeing the real time signals and that the quality of the data is verified as IEC/ISO standards require.

New: Hospitalized patients. There is also room for "i-Monitors" among the acute care. The faster the patients are removed from the high-cost beds the better profit is to the hospitlas. Still - the low number of "simple parameters" prevents the development of this business.

... and after all - consumers are interested in knowing their pulse rate, SpO2 and that sort of suff as part of their other interest in the health. This is new business - not replacing the conventional business in acute care. The new business will be remarkable in volume and money.

Regards, JoE