A presentation at MD&M Minneapolis aims to help medical device manufacturers and newcomers alike overcome the challenges of designing digital devices.

“Scale and cost and prevalence of consumer-oriented technology like Wi fi and Bluetooth and cell phones have made possible a whole new category of health-related devices,” Bill Betten, president of Betten Systems Solutions LLC, told MD+DI. He will discuss digital health products in a talk on November 1 at MD&M Minneapolis, “Case Study: Overcoming Digital Health Product Development.” The session will feature a case study that shows the development of a device that uses commercial sensor technology, from design to a practical therapy, describing the challenges along the way.

MD+DI spoke with Betten to get his thoughts on these emerging technologies.

MD+DI: Please explain what products fall into the digital health category.

Betten: Digital health products include wireless medical devices, mobile medical apps that are regulated by FDA, health IT, medical device data systems, and software.

Since this definition kind of came from FDA, there’s a heavy emphasis on regulated medical devices that are used to diagnose or treat medical conditions. But general wellness devices such as fitness trackers can be part of this environment as well. So, it’s a broad category that spills over into wellness, as well as traditional medical devices with connectivity.

MD+DI: What are some of biggest challenges faced during the development of digital health products?

Betten: The biggest challenge is not so much the technology, unless you’re really doing something innovative and creative like identifying cancer from a blood sample or a breast sample. It is much more about the regulatory environment, the reimbursement environment, and just the way we practice medicine. The challenge the industry is facing is the organizational inertia.

I like to say that there are corporate antibodies that resist change. Change is sometimes viewed as infection, and there’s a lot of pushback on that. The good news is that there are signs of change in the movement to value-based healthcare, in reimbursement changes, and regulatory flexibility.

MD+DI: Are some less challenging than others?

Betten: Class I medical devices such as thermometers and fitness and wellness apps can be. But even with Class I devices, you have to be very careful about what you say is the product’s intended use.

MD+DI: What types of mistakes have been made in the past when developing digital health products?

Betten: I think you have to be very specific about the intended use. For example, there was a class action lawsuit filed in 2016 (and still ongoing) against Fit Bit, claiming that it had deceptive and misleading representation about its heart rate monitor. You have to be very careful about what you say the product will do. If it’s a regulated medical device, the instructions for use, the intended use, will be very clear. That’s one thing the medical device companies are trained to do is be very specific about its intended use. That same rigor does not apply to consumer-oriented devices. Apple’s new watch, for example, has a heart-monitoring and ECG capability that they submitted to FDA for clearance, hence making it a medical device suitable for the uses that they claim.

MD+DI: How big a part of the entire medical device industry is the digital health products category?

Betten: The problem is how you define it. For example, are fitness trackers part of that? But it’s very clear the growth rate in that space is very high. It’s certainly in the 10%+ range of the overall healthcare space and it’s growing rather dramatically and rapidly and will continue to do so.

MD+DI: Who should attend your session, and why?

Betten: I think it’s good for the traditional medical device development folks to help make them aware of some of things that are bleeding over from the consumer space.

Also, people in the consumer space should attend. People who want to develop an app, to know and understand, particularly the closer to they get to the FDA line, to being regulated, the clearer they must be about what they’re doing. It’s a good high-level introduction to the medical device industry.

MD+DI: What do you hope they learn from your session?

Betten: A better understanding and appreciation of the promise of digital health technology and the challenges that you face when bringing a product into that space. This will not be a focused talk on regulatory, reimbursement, or even cyber security, but it will be an overview of digital health with a specific case study of a product that has been brought to market. We hope there’ll be enough in there for everybody.

Betten’s presentation, “Case Study: Overcoming Digital Health Product Development Challenges,” will be held at MD&M Minneapolis on Thursday, November 1, from 11:00 to 11:45 a.m.