How the Medical Device Sector Can Support Innovation Methods for Developing Digital Health Products

Overview

The global demand for medical devices far outpaces the rate of production. There are two driving forces behind this trend. The first is that patients are becoming more accustomed to technologies that enable at-home monitoring for conditions. The second is that, despite market demand, monetization structures have not evolved to support straightforward paths to reimbursement. Innovation programs within medical device companies  need to address these goals while incrementally building upon core product development capabilities. This resource provides insight into how.

In the healthcare sector, the term innovation can be a charged word or a controversial concept. While there is a need to bring new solutions to the market, there isn’t an option to take risks, cut corners, or learn through failure. Every decision a company makes has ripple effects that can impact a person’s well-being in the long term. The notion of hypergrowth — scaling quickly — has the potential to create danger and understandable regulatory risks.


But the need for innovation — improving efficiencies and expediting the deployment of new products — has never been more pressing. One way to improve efficiencies is to increase the range of options that consumers have, at their disposal, to monitor and self-manage their own conditions more effectively.


Why the Medical Device Sector Needs to Think Bigger


The medical device industry, consisting of an interesting mix of large companies and startups alike, are well-situated to address market needs related to digital health management. At the same time, barriers continue to stand in the way related to provider and patient education, reimbursement protocols, and the navigation of regulatory standards.


Put bluntly, there’s no choice but to innovate.


Addressing these challenges requires a level of creativity that has been difficult to achieve, historically, in the healthcare sector in which financial and operational barriers stand in the way of the device development. At the same time, over the last several years, more tools have evolved to help digital health product leaders walk the tightrope walk of deploying solutions expediently while ensuring patient safety. 


Resources to Help Guide Your  Innovation Strategy


One of the biggest misconceptions about innovation is that the term describes leaps forward with respect to technology, operations and processes. But there’s more to the equation — innovation involves the small steps forward that people within your organization takes every day. There may be an opportunity to change a process, even subtly, in a way that yields an amplified impact.


An example of this idea in action is Lief Therapeutics, an Enzyme customer and small startup that built a device that makes it possible for clinicians to monitor and treat mental health patients with a reimbursable and FDA Class II Exempt device. First launching as a consumer product, Lief used Kickstarter to meet fundraising goals and created a very basic device. Over time, the company continued to invest in user experience — by the time that Lief needed to work with the FDA and insurers, minimal device retrofitting was necessary.


So how can larger companies and fellow startups adopt similar processes, driven by experimentation and iteration — without taking on the risk of adopting methods from the consumer products landscape? Moreover, how can organizations of all types keep up with teams like Lief that are successful in deploying products, without operational overhead?


Here are a few resources and frameworks that product management leaders at medical device companies may want to consider and adapt to their unique workflows.


1. The National Security Agency (NSA) Cyber Threat Intelligence Sharing Experiment

Recommendation: Offer definitions, guidance, and education from the leadership-level, down.


As with the healthcare sector, the need for cybersecurity products and services is growing to the increased risk exposure levels that companies face every day. For several years, the United States Department of Defense has been using a system called the I-Corps methodology to study and understand processes for building optimal products in high-stakes scenarios.


One of the most surprising findings to the team, in a recent NSF funded study, was that the DoD’s internal innovation teams needed more time than anticipated related to pre-planning for initiatives. Where NSA thought that pre-planning would take several days, defining the scope for projects took about two weeks. Teams then devoted additional time to assembling diverse teams in terms of skills and personal background.


NSA also found that teams needed a higher degree of interpersonal attention with respect to ongoing training and supervisor support. When team members did not receive this level of support, they were less inclined to spend time, even when pre-allocated, related to innovation projects.


The key lesson for medical device companies to take away from these findings is a need for discussion, at the organizational level, regarding what innovation means for each particular organization. Leaders at companies would benefit from receiving training and then establish structured programs with the support of management. Ongoing internal education is necessary for all team members who show an aptitude and desire for participation.  A lengthy pre-planning or brainstorming process will be important and effective, especially when operating in conjunction with an early customer feedback strategy. 


These methods, as they have been helpful for the Department of Defense, can help complex, matrix organizations generate more ideas, deploy more solutions, and reduce potential friction.


2. Google’s Story of Scaling Up

Recommendation: Build repurposable libraries that support the human sides of engineering.


As with many of today’s medical device companies, Google’s growth took place during a time when the role of the system administrator was going through transformation. Just as today’s healthcare product managers are thinking about ways to weave together technologies, effectively, Google needed to build structure around processes that were yet-to-be defined.


One of Google’s earliest observations was that system administration “was a form of human-computer engineering,” according to a book from Mark Burgess, technologist, professor, and author of  In Search of Certainty


The book recounts, in details, how modern IT best practices emerged from a very human foundation of trial and error. 


One resource to pay particular attention to is the discussion around  ensuring reproducible and reliable launch processes. 


“In a large organization, engineers may not be aware of available infrastructure for common tasks (such as rate limiting),” write Rhandeev Singh, Sebastian Kirsch, and Vivek Rao.


“Lacking proper guidance, they’re likely to re-implement existing solutions. Converging on a set of common infrastructure libraries avoids this scenario, and provides obvious benefits to the company: it cuts down on duplicate effort, makes knowledge more easily transferable between services, and results in a higher level of engineering and service quality due to the concentrated attention given to infrastructure.”


Build libraries of reproducible processes to ensure that you’re always moving forward — even across different device launches, then backwards. It’s this thinking that led to the creation of modern design and engineering standards, programming libraries, and open source frameworks. Tidepool, a leading diabetes technology startup (that also happens to be a 501(c)3 nonprofit) expresses their mission focus by Open Sourcing and sharing their learnings. 


Internally, Enzyme relies on reusable workflows built into GitHub projects, Asana or documented in wikis for manual implementation.


3. Adobe Kickbox

Recommendation: Give employees a structured pathway to brainstorm and validate ideas.


In 2014, Adobe released an open source framework called Kickbox, which helps individuals within companies run experiments on their ideas. Thousands of organizations and innovation practitioners have used Kickbox over the years to curate best practices. 


“Adobe Kickbox is a new innovation process that Adobe developed for its own use and then open-sourced so everyone can use it,” explains the website. “It is both a process for individuals and a system for deploying that process across an organization at scale. It’s designed to increase innovator effectiveness, accelerate innovation velocity, and measurably improve innovation outcomes. It can also optimize innovation investments by reducing costs compared to traditional approaches.”


Kickbox, as a framework, is not directly translatable from the consumer products to the healthcare sector. For instance, the program encourages employees at companies to test out ideas as experiments in the field — by building landing pages that gauge consumer interest, for instance.


Medical device companies will need to put more stringent parameters around the ideation and testing process due to . One simple step?


Encourage employees to go back to the drawing board in researching potential ideas that are relevant to your existing lines of business.


“The research world tends to be far ahead of the medical standards of treatment, explains Billy Freese in an interview with Enzyme. “Our team at Lief, for instance, discovered a huge body of research on heart rate variability, the autonomic nervous system, the immune system, the brain, and how all of these systems connect to influence every aspect of human health. Think of what should be part of medical standards of care but isn’t right now.”


The bottom line is that employees of all functions need to devote time to exploring. In this regard, employees medical device companies can build their own research Kickboxes.


The outcome of each micro R&D initiative could be a presentation or low-fidelity prototype, along with customer and provider interviews, to share with insurers and clinical stakeholders to discuss potential reimbursement. Bring  tangible, minimum product prototypes to discussions with insurers, sooner rather than later. Begin addressing regulatory considerations shortly thereafter using the FDA submission program when appropriate. The combination of the two will ultimately be what needs to be proven through the experimentation and design process.


Authorship

This blog post was a collaboration between the Enzyme team. Jacob Graham, Ryan Stellar, and Manasi Shukla contributed to this piece. Ritika Puri was the storyteller and writer.


Disclosure
The opinions expressed are those of the authors. This material has been prepared for educational and storytelling purposes only. It is not intended to provide, and should not be relied upon for, legal, compliance, product development, financial or regulatory advice. 

We’d Love to Hear from You

Enzyme is on a mission to increase  knowledge-sharing and collaboration in the digital health sector. Have a question about building a medical device? Want to recommend a story for the blog? Reach out to Ryan Stellar via info@enzyme.com, any time. You can also join our mailing list, here. Every week, we’ll send you an interesting article to help inform your product development strategy.



Additional Reading & References

https://www.brookings.edu/research/the-global-burden-of-medical-innovation/


https://www.ncbi.nlm.nih.gov/books/NBK218279/


https://www.cato.org/publications/policy-analysis/bending-productivity-curve-why-america-leads-world-medical-innovation


https://www.rand.org/pubs/periodicals/health-quarterly/issues/v4/n1/03.html


https://hbr.org/2006/05/why-innovation-in-health-care-is-so-hard


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