Image source: ESB Professional/Shutterstock
The potential of digital technology to transform healthcare is tremendous. Data-generating products, for instance, could arm patients and practitioners with information at unprecedented levels, enabling quicker, more-informed healthcare decisions.
To bring such products to market, digital health product development teams often draw from both medical device and information technology disciplines. But there can be challenges. During the BIOMEDevice San Jose 2017 panel discussion, “Building Better Cross-Functional Teams for the Digital Health Explosion,” panelists discussed some of the potential issues that could be faced when building such teams. The discussion was moderated by Gregg Jackson, principal consultant for Gershon Medtech; the panel included Charlie Dean, vice president, R&D and corporate development for Apollo Endosurgery; Marta Gaia Zanchi, vice president, digital health, Orbees Medical; and Dagmar Beyerlein, senior director of product development for director of product development for Drawbridge Health Inc.
In digital health, product development is “unlike traditional innovation processes in healthcare or IT,” Zanchi told BIOMEDevice attendees. “In digital health, technology is only a piece of the innovation.
"Companies embracing a service mindset, embedding tools into end-to-end process workflows, have greater chance of success," Zanchi later explained. "The sector needs service innovation—and a focus on evidence of outcomes generated by new services."
Team members from medtech and IT backgrounds may actually be accustomed to different regulatory environments.
"IT has very little in regulations, whereas medical devices have much more,” Jackson told the audience. "There’s no question that you want some oversight, but is there too much to get a product out?" He later told MD+DI that "it seems most start-ups do too little in terms of following the regs, and the larger/mega companies do too much, thus causing confusion for what's really needed to get a product safely to the marketplace."
When the panel was asked how conflict resolution should be handled, Zanchi told attendees that it’s important to "acknowledge the differences," particularly "in risk tolerances." For medical device companies, there is "regulatory risk," whereas for IT the risk is "not being innovative fast enough."
She later told MD+DI that "The historical apparatus is used to very long timelines and is inadequate for digital health. Yet, do not confuse fast-iterating, continuously learning innovation processes with short time to market: some solutions continue to take a long time to bloom."
Remembering consumers throughout the process is critical for success. "The product development process should be distributed with a warning sign—don’t forget the market needs,” Zanchi told the audience. Consequently, digital health companies must consider “how these core teams function as they relate to outside need experts."
And the basics cannot be overlooked, Jackson told MD+DI: "There seems to be a plethora of IT and or health-conscious people clamoring for a much-needed revolution in how medical technology is developed, and more importantly, how healthcare is thought of and delivered. Where they make the mistake is to not follow the basic aspects of quality, regulatory, and good clinical practices (QSR, cGMPs, GCPs, etc.). When I've seen this done successfully is when the senior management and senior staff of a company have a good balance of IT/consumer with Healthcare/Medical experts. AND... when they are able to effectively work together and find compromises."
Bottom line: "Digital health innovation teams need wide organizational support and leadership with skilled ecosystem management," Zanchi told MD+DI.
Don't miss the Product Development Best Practices conference track at MD&M West 2018 February 6-8 in Anaheim. Jordan Shlain, MD (Founder and Chairman, HealthLoop) will kick off the track with the Opening Plenary Session: "Let's Get Real About Consumering Healthcare."