John Walmsley

Digital Health & medical devices – advantages and motivations

Gastrointestinal sampling-pill Concept Image:

I have been moderating panels on Digital Health for the past few years and noticed that this term can mean different things to different people.
To our clients, Digital Health generally refers to connecting a medical device to a network to capture all of the advantages that such a connection brings.
For example, we’re working with Interface Therapeutics on a fully autonomous gastro-intestinal sampling pill. This capsule passes through the GI tract knowing its location and taking samples at appropriate moments. There are many valuable applications for this functionality. Interface amplifies the value of their solution by having the device transmit its known location with timestamp to a network for analysis in combination with post-sample omic data, enabling enhanced diagnostic and therapeutic actions.

Our internal conversations and client discussions generally revolve around the numerous advantages and motivations for engaging with Digital Health as well as the challenges to be overcome. The challenges can be both technical and, since we are in the world of medical devices, regulatory.

I‘d like to touch on these areas in a couple of blogs.  This week’s focus is advantages and motivations.  Next week, I’ll tackle the challenges.

Why would you connect your device to the network? (In addition to the desire to know and control everything that your customer is doing, of course!)

First, more and more, people are expecting their data to be available and portable rather than left stuck on a device. Clinicians welcome more information. (Provided the information is actionable and they are not simply left with a deluge of data and the uncomfortable feeling that they should be doing something more with it.)

Pharmacy practices are welcoming the opportunity to use patient data to build deeper and longer-lasting relationships with their customers. The Affordable Care Act brings with it the concept of the Accountable Care Organization. These organizations have challenges where they can be assisted by having more knowledge and control over what is happening within their facilities, no matter what regime they choose to supervise protocols and usage. To this end, connected devices can enable and support the checklist approach to medical care (as described by Atul Gawande in the Checklist Manifesto).

A perennial concern where Digital Health can provide a lot of value is in monitoring patient compliance with prescribed care. This can be clinicians checking on their patients, parents checking on their children, (grown) children checking on their parents  or patients being incentivized to ensure their own compliance.

By taking advantage of all of the distributed computing that patients and users already own, it is possible to be on a path to great scale with reduced investment. Many of our clients are finding that this provides access to interesting revenue models. When use of their application grows, there are many areas of potential for patient care – creating that actionable information as well as providing information for their own business needs. Of course, it is always worth considering how the data from a device can be brought to Big Data where novel analyses can bring new insights.

Summarizing, there are several compelling reasons to connect your device; to make it part of Digital Health. Prominent among them are: you can address some major problems involving compliance (whether in a clinic or within a family); you can access some interesting business models; and you can take advantage of pervasive computing power.

This brings us to the interesting question of the regulations associated with the collection and use of data. What extra regulatory hassles are there for Digital Health?  I explore those as well as technical challenges in my concluding blog next week.

John Walmsley is StarFish Medical’s Vice President of Product Development.  He leads a team of innovative medical device experts and speaks frequently on Digital Health & medical devices throughout North America.


2 responses to “Digital Health & medical devices – advantages and motivations”

  1. >>By taking advantage of all of the distributed computing that patients and users already own, it is possible to be on a path to great scale with reduced investment. <<

    it is possible. But there is a fairly steep challenge here. The FDA has indicated that it will not regulate Wellness apps like smoking cessation yet out of over 300 such apps reviewed by the American Cancer Society, not one of them actually provided the state of the art known best practices.

    Part of that is because the style of engineering that is not only common in the SaaS/Web/Mobile Device world – a style that includes "incremental updates", Continual Deployment, daily hotfixes – but which is actually "best practices" is almost completely the opposite of what you expect from a medical app.

    Medical apps cannot just drop data because you are switching from WiFi to 4G or from 4G to Edge – and similar sloppiness that you see.

    So while it is "possible" it is a very dangerous area currently

  2. Thanks, Karl. You make good points. They are very real and it seems very likely that the regulatory landscape will shift again at some point in the future. For now, the FDA has chosen to call some priorities. At StarFish, our focus is on regulated medical devices and we use the associated development methods and controls to address exactly the sort of concerns that you raise. There will be some standards identified in the next installment!

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