Continuum has decades of experience with medical device design—and this work has informed, and deepened, our work in consumer health. As the two disciplines blend, we’ve found that people on both sides of the fence have many questions. Below, Mike Dunkley, SVP of Advanced Systems (left), speaks with Kevin Young, SVP of Product Experience (right), about what medical device expertise can offer consumer companies entering the health and wellness market. It’s the second installment of a two-series. Read part one here.
Kevin Young: It’s no surprise that consumer companies looking to create a medical device need to be prepared to enter the rigorous world of regulatory approvals. However, they may not be aware of the impact these safety and regulator needs have on their speed-to-market and marketing strategies. Can you share your thoughts on this?
Mike Dunkley: To enter regulated markets or not to enter regulated markets: that is the question. It is, in fact, one of the biggest issues facing consumer companies that are contemplating health and wellness markets. Regulations can certainly slow you down, since companies must demonstrate a level of rigor in their development process and back up any clinical claims they make. Depending on the intended use and associated claims, companies may also need to conduct clinical trials in support of such claims.
Being regulated also restricts your marketing activities, since all messaging must adhere to the claims being made. This results in a much less nimble marketing strategy. So marketing in regulated markets ends up looking quite different for consumer companies, who typically live without such constraints. On the positive side, being regulated can establish credibility for the resulting product and place barriers-to-entry for companies that might otherwise follow quickly. When Glooko initially launched its app for glucose tracking in the U.S., the company deliberately chose to avoid regulation by simply collecting data in the form of an electronic logbook, rather than extending their functionality to include glucose trending. This allowed them to get to market quickly and build a user base, while still enjoying the flexibility of “living in beta” as they refined their product. Later on, Glooko decided to opt for 510(k) clearance and extended the functionality to allow for trending in order to provide more value to its users. Interestingly, from day one, the same trending functionality was available for Glooko’s users in Europe, where the regulatory framework is more permissive.
Now, what works for one market may not for another. When MC10 launched its Checklight skullcap with Reebok, it deliberately avoided claiming any form of diagnostic application. According to MC10 developers, the cap’s green/yellow/red traffic light acts as an indicator that a significant impact may have occurred, rather than as a diagnostic for any resulting trauma. This placed the product firmly in the consumer space, while allowing it to address a known cause of significant injuries.
KY: Unlike the consumer products industry, where end users are almost always the buyers, buyers and users in the health and medical device market are often different people. For example, if a healthcare provider purchases fitness trackers and distributes them to their partner companies, the employees of these companies become the end users of a product they never elected to purchase. It’s important to consider the business implications of this new distribution and B2B approach. What do you see as the major challenges here?
MD: I think the separation of payers and users adds significant complexity to the business for consumer companies entering the B2B space. Historically, medical device companies have largely figured this out, although many end up focusing the majority of their efforts on payers and other clinical stakeholders at the expense of end users or patients. The category of durable medical equipment (commodes, wheelchairs, walkers, etc.) has been driven by a focus on payers (typically Medicare and Medicaid) and their desire for low cost above all else, rather than the needs and desires of the patients or caregivers. As a result, the level of design of such products is often poor. Functional products often message sickness. Just drive by any downtown DME distributor outlet and you can see this through the window….
This is where consumer companies can prove really valuable. They can enable product experiences that truly resonate with the users, and therefore drive greater adoption and adherence.
Let’s return to your example of fitness trackers within an employee wellness program. The significant challenge for consumer device companies will be the often-conflicting needs of users and payers. Employers are not readily going to pay $99 a pop for fitness trackers to distribute to their employees; $20 may be a more likely price. And these devices may need to be more rugged to survive use by folks who haven’t had to spend their own money. (Who pays when one is lost or dropped in the toilet?)
In addition to the complexity of dealing with additional stakeholders, there’s also a greater need for consumer companies to demonstrate ROI on their devices. Businesses are not looking to merely buy cool tech; they want a return. These factors amount to a sales process that can be long and complex. Not surprisingly, Fitbit is eyeing corporate wellness as part of its growth strategy. They will need to learn how to deliver delightful products at a much lower cost point, and how to navigate a more complex sales process.
KY: As consumer products and medical devices grow more and more alike, these systems become increasingly dependent upon each other. Companies entering the consumer health/medical space from the consumer side need to be aware of this interdependency and how that might influence the lifecycle of the product. Can you share your thoughts on this?
MD: One of the results of operating in regulated markets is the lengthening of the product development lifecycle. Material changes in the product design specification or manufacturing process need to be verified and validated and may even result in the need to repeat clinical trials. One impact of this: regulated products come to market later than their non-regulated counterparts, and can begin to look out-of-date on launch day! A quick tour of the ADA conference—where companies tout their new-to-the-market insulin infusion pumps—is a tangible, and sobering, reminder of this.
A recent example of how lifecycle extension can complicate regulated products is Sanofi's iBGstar, a strip-reading glucose meter originally designed to plug directly into the port of the iPhone 4S. As a side note, the iBGStar was deliberately designed with its own battery and display so it could act as a standalone device and be regulated as such. Connectivity to the iPhone simply allowed for use of a secondary display and a means of storing and communicating data. However, the device’s design and method of connection was intended for integration with the iPhone 4S. As we know, the iPhone has since gone through various hardware incarnations including iPhone 5, 5C, 5S, 6, 6 Plus. As a result, the iBGStar requires “an authentic Apple Lightning to 30-pin adapter” to integrate with newer iPhones, and therefore loses some of the product design intent from its original incarnation. Of course, Sanofi could have attempted to upgrade the iBGStar hardware in step with the iPhone lifecycle, but this is neither practical nor possible given the secrecy with which Apple launches its new phones.