For the past few years, healthcare has experienced a lot of disruption: new regulations and requirements, new contexts for use, shorter market timelines, emerging competition from startups, and new expectations from consumers. The pressure has never been higher for companies to come up with the next great breakthrough in the medical device world.
We have seen that leveraging design has given medical device companies the ability to gain the upper hand and ultimately develop the next big breakthrough in medical devices.
The Genesis of Successful Medical Devices
If you define success as “acceptance” or “adoption,” our experience suggests that all successes have started with addressing the unmet needs of patients, caregivers, and clinicians. Start with a holistic evaluation of healthcare consumers and their entire ecosystem—we call this approach “Voice of the Ecosystem.”
The second critical element to success is to validate early to ensure stakeholders understand and accept the hypothetical “transaction.” Before one of our recent projects, Vessix Renal Denervation System, had a name, a logo, or a prototype, we worked as a team to distill the benefit of the system to a simple premise: Vessix will deliver a proven therapy that previously required 30 minutes in 30 seconds with a minimum of user interaction needed. This benefit was concisely captured and validated by stakeholders and informed the development of the entire device.
Ways to Overcome Challenges
Most likely, there will come times in device development when two objectives come into conflict. For example, patients prefer body-worn devices that are small and discreet, but they also expect that batteries will last for two weeks without a charge. Sometimes, there are dozens of these “tensions” to work through.
Unfortunately, both time and money are in short supply in the product development life cycle, and the biggest challenge can lie in making smart tradeoffs. Experience has taught us that stakeholders understand these realities—they make tradeoffs every day in their lives and can be trusted to help determine which potential benefits are of highest priority to them. “Failing forward fast” and “iterative prototyping” are terms for involving stakeholders early and often in the development process and letting their voices guide which challenges warrant the most time and money and which will have a lesser effect on success.
Moving an Idea Forward to Commercialization
Due to the duration, size of the team, budgets, and disciplines involved, it’s often hard to maintain focus on the intended premise, stakeholder needs, and priorities of a medical device project. One of the most powerful tools we have used is the “Appearance Model.” An exciting model builds internal alignment and confidence in the project, which helps budget, resources, and morale. These models can uncover new opportunities and can serve as a benchmark for future development teams that may not have the benefit of understanding why maintaining design intent is critical to success.