It’s no longer sales as usual for medical device firms when Patients shop in the Apple Store for devices that are better & less expensive than what Hospitals are prescribing…

screen-shot-2017-03-06-at-11-04-40

I originally shared this as an update on Linkedin and it generated some interesting discussion but as discovery and retention of content on Linkedin is a bit hit and miss since Microsoft  acquired the company in June, I thought it might be worth cutting and pasting the comments thread in a blog post for posterity and to share with those who don’t use Linkedin:

Joel Selanikio: And this is just getting started.

David Doherty: oh yes but the fear of becoming little more than an iPhone accessory brand is real even in the boards of the biggest global Medical Imaging firms:

https://mhealthinsight.com/2017/01/11/medicaldevicemakersbecomeiphoneaccessorybrands/

Johan Goris: think again https://theskepticalcardiologist.com/2017/02/15/sustained-atrial-fibrillation-or-not-the-vagaries-and-inaccuracies-of-alivecorkardia-and-computer-interpretation-of-ecg-rhythm/ also

David Doherty: Think again? There’s nothing stopping Kaiser Permanente San Diego having their own Cardiologists reading the ECGs that their own Patients record/share. You know you don’t have to use Alivecors read services?

Johan Goris:It was a generalistic reply on a generalistic statement.

Johan Gorisnot to mention the many “put your finger on the camera” Afib detection apps. PPG based Afib actualy only sustainable for follow-up of AFib diagnosed patients, not for screening and only when clinically validated …

David DohertyI think you know it’s unfair to compare either the medicomp or alivecor to these unreliable apps that lack evidence of their effectiveness despite the claims. Perhaps you’re inventing a problem that doesn’t exist in the hope that we’ll stay distracted and keep the life support going for the broken medical device sales model in which the Patient never knows the price and never has a choice. The real threat isn’t cookie cutter me too apps that promise a lot and offer very little but it is that medical device companies need to turn around their business model if they’re going to survive being redesigned by mHealth. The question we should be trying to answer is how would the Born Mobile Generation sell that medical device? https://mhealthinsight.com/2015/09/22/bornmobile/

Johan Goris: Just like it’s unfair to compare validated ECG machines offering extended arrithmia detection with Kardia from Alivecor… The link you included refers a.o. to the Aura Activity Monitoring Ring ( I guess they mean the OURA ring) … clearly an unvalidated device for sleep monitoring, as they themselves conclude in their pre-compliance study : https://support.ouraring.com/helpdesk/attachments/6027900621 … “the variability in individual accuracy in some parameters informed the ŌURA team of clear opportunities for improvements” There is no technological chicken & egg situation with mobile biomonitoring, it’s the just the chicken often reluctant to deliver the real egg (not just empty shell). Some mHealth devices manufacturers (± 15% in my +3000 # database) do perform and will probably make it, if only they keep their claims realistic. Its a funding/adoption chicken & egg situation suffering from hyperbolic inflation/distrust from people with skin in the game.

Johan Goris: But I disagree … the system is not broken … it was built this way … and needs a restore (but not without a clever backup)

Denis KhitrovI would agree with almost the whole statement if the word “better” is skipped. While quality/value of professional medical devices in comparison them with consumer products is overrated, these are still different worlds that can’t be compared directly. If patient could really switch from using of continious monitoring Holter system to another simpler solution it’s not about “better” in terms of medical data collection. It’s about usability and real needs of the patient.
Johan GorisUnfortunately there is no trade-off possible between better usability and minimal accuracy performance in function of the health or medical data purpose. The citizen-patient needs sufficiently accurate measurements to get correct actionable feedback information, whether for prevention, (early) diagnosis or monitoring health. The same applies to data used for clinical decision support, clinical research, payers risk evaluation or regulatory evidence …
Denis Khitrov: I agree with you. What I meant is that there many basic but meaningful things that could be done with much simplier (and cheaper) devices. For example in some cases patient don’t need to have a multi lead Holter monitor, but can collect data with a simple one lead ECG by applying fingers or using a smartwatch with HR/RR sensor. All that doesnt mean that one lead ECG or HR Monitor is “better” than a Holter, but could bring a lot of value for Healthcare and surely a lot of speculations too =)
Johan Goris: OK, I fully agree that there is more grey between the single black and white claims from both sides of the spectrum, so according to the application (intended use) we will have to fix the expected accuracy and exclude what does not comply for it. Today only 10-15% in my evaluated database of +3000 mHealth devices and associated apps shows (validated) specifications to backup their claims.
Denis Khitrov: I do not wonder. There are many Software Vendors that even have no idea of the “Intended Use” meaning. No culture of Risk Analysis at all. And to be honest even regulatory bodies are still not experienced enought with mobile software clearing and seems to loosing controling position in general. That’s why stories like “Theranos” or “PIP” are happening … But from other side overregulation would simply kill the industry or terribly slow it down. I think your point is correct – new simplier devices should be very cureful with Intended Use claims.
Johan Goris: Today disruptive industry is slowing itself down (killing itself) by regulatory avoidance … sometimes one just can’t be ‘carefull’with claims, as some parameters are regulated by default (and that’s a good thing for their expected accuracy !) I believe we might need an extra ‘lighter’ regulatory level for health devices & software, to bridge between existing “medical” and “consumer” whilst product & manufacturer registration remains essential towards market vigilance

 

Denis Khitrov: Surely it’s still a sign of changes. RPM and personal health tracking solutions bringing a lot of disruption and gives more freedom to the end users. A lot of shifts will happen in direction to simplier consumer devices, because regular dynamic changes monitoring may be more valuable than precision of measurement. But that would hardly replace “what doctor is prescribing”

Emmanuele Angione: “90% of strokes can be prevented” is a big – BIG statement. Where will clinical liability fall if things go wrong for the patient? On the patient using that device? On the clinician interpreting the data from that device? On the developer of the algorithm? On the ISP?

David Doherty: Emmanuele Angione Correct, read up on the BIG opportunity to prevent strokes:

https://www.ncbi.nlm.nih.gov/pubmedhealth/behindtheheadlines/news/2016-07-18-nine-out-of-10-strokes-preventable-claims-study/

Alivecor is also doing great work to support researchers (including colleagues of mine using their tech in leading European Medical Institutions) and publish evidence on their technology:

https://www.alivecor.com/en/research/

Also check out this brilliant interview with Alivecor’s CEO Vic Gundotra to get a feel for how the tech is enable machine learning that is transforming how we practice medicine:

http://www.recode.net/2016/12/5/13837908/machine-learning-doctors-vic-gundotra-recode-podcast

Seamus Flood: Promotes owning your health not leaving to the medical professionals to wave magic wands

About 3G Doctor

The Corporate Blog of 3G Doctor
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