Anyone who works in the medtech industry knows that when it comes to developing new ideas and truly novel devices, moving quickly is critical. That can be particularly challenging for larger companies, where innovation and progress can often be slowed to a snail’s pace as more people contribute to the process.
Steve Geist is the director of research and development within the transcatheter mitral and tricuspid therapies division at Edwards Lifesciences. During his 12 year career at Edwards, Geist has worked across multiple business units and has played an integral role in helping the company move device ideas from a napkin-sketch, to iterative product development and preclinical evaluation, to formal qualification, and eventually clinical trials.
He recently spoke with MD+DI Qmed about the challenges of enabling and encouraging innovation in a large company setting and the lessons that can be learned for any company pursuing innovation at a faster pace.
Qmed: What do you think are some of the biggest challenges when it comes to inspiring innovation within a large company setting?
Geist: The challenge isn’t inspiring innovation, it’s unleashing it. Within companies, there are already a lot of talented engineers naturally inspired to innovate…but providing opportunities for these individuals and teams to truly innovate, and then provide them the nurturing environment necessary to develop, iterate, and refine their innovations into meaningful solutions is the real challenge. The unknown is really hard to budget around, to plan around, and to staff around. There are inherent ambiguity and lots of risk in real innovation that must be embraced and understood for it to have a chance to thrive.
Qmed: In your own experience, what have you seen work well that has helped your company establish an environment where innovative ideas won’t get lost in the crowd of a large corporate environment?
Geist: When innovation is made a true priority and not simply a buzzword, that’s step one. But you cannot commit to innovation without encouraging failure, or at the very least having a high tolerance for it. A mantra of “fail early and often” encourages risk-taking and enables the deep learning that comes from failure. I’ve always learned more from my own failures than I have from successes. In fact, I’d suggest the first question that should be asked in the face of a successful first attempt is “did we dream big enough?” For example, in my role I am not criticized for the failure of an innovative concept; instead, I am asked what I could have done to fail sooner so the learning could have happened earlier, and then how am I applying those learnings moving forward.
Qmed: Can you talk a little about the stakeholder quagmire, and the effect it can have on innovation? How can companies work to avoid this?
Geist: Teams can certainly be derailed addressing and responding to all of the stakeholders who at some point will inherit some aspect of a developed innovation, so to avoid this I think it’s important that during the early conceptual stage innovation teams should operate with a lot of independence from normal product development hierarchies. It’s not that the wider array of stakeholders don’t have important and legitimate concerns which must (eventually) be considered and satisfied, it’s really that the time and place for this is later. You don’t start a campfire with a pile of logs…you use a small amount of kindling, let the fire take hold, and then introduce the large logs to which the small fire is now ready to take on!
Qmed: When it comes to innovation within the realm of medical devices, time is always a critical factor. How can companies better streamline the process of innovation in a large company environment, where it’s difficult to bring ideas to fruition quickly?
Geist: Innovation involves risk, and the level to which a company requires that risk to be reduced before proceeding is directly proportional to overall development timelines. If success is an absolute hard requirement, then the process will be slow. If failure is unfortunate but not regarded as a catastrophe, the process can move more quickly. It is readily acknowledged and accepted that not all startups succeed; why then would a company expect their internal innovative programs to all succeed? I believe flexible quality systems that allow innovative ideas to proceed through processes and controls which tolerate a higher level of risk are important, so that these concepts can advance to the clinical environment sooner. Doing so prevents innovative ideas from being stifled within level after level of risk mitigation and also allows more shots on goal to be taken because they’ll move faster and be understood clinically much sooner.
Qmed: Once companies do eventually reach the stage of clinical introduction, what’s next? How would you chart a successful course from the birth of an idea, to the end product?
Geist: The transition to the clinic of a novel device is a vulnerable time for a new technology. Bench testing and preclinical in vivo evaluations can only tell you so much, and so it must be recognized that there remains a lot to be learned with the initial human experience. It is vital that during this time the right team of people is in place to support clinical cases so that each case can be thoroughly analyzed for important learnings and also identify opportunities to optimize and keep moving forward. Instead of a pure handoff approach, members of the development team should instead transition into roles to help support this clinical introduction. A second group, in close collaboration with the folks on the front lines of the clinical introduction, should begin the work to prepare for commercialization. However, with a deliberate decision to go to clinic sooner with more risk as yet unresolved, all teams must be prepared to pivot based on the clinical experience and adjust strategies accordingly, while always keeping patients in mind.
Qmed: For a company that is already large and established, what are some immediate steps that can be taken to help foster an environment that can begin to innovate at a startup pace?
Geist: To set the stage for innovative thinking, engineers can be provided with professional development opportunities beyond just those in the technical realm to mimic the “wear all hats” nature of a startup. This will help to develop a broad foundation from which clinical needs can be identified and better understood. Often we think that means just conversations with physicians but it goes deeper and broader; engineers in this field who are expected to innovate should also be exposed to the actual clinical environment in which their products are used, as well as regulatory negotiations, clinical trial design and endpoint definitions, manufacturing lines, audit reports, and just about anything else which delivers a perspective that can be leveraged to innovate. Breaking down knowledge silos so people have a good understanding across multiple areas of the industry enables unique connections to be made and innovative solutions to be conceived.
Qmed: Finally, what would you say is the most valuable lesson you’ve learned that could be applicable to a medtech company of any size that is pursuing innovation at more of a startup pace?
Geist: Assumptions about what will and won’t work are potentially detrimental if left unchecked. Rigorously and honestly testing assumptions is critical in the process of innovation and doing so can help increase the likelihood that the end result will ultimately be successful. Environments where title or role doesn’t factor into who can challenge ideas and propose new solutions creates synergy in a development team by fostering mutual respect and trust. In environments where the opposite is true, where design requirements are handed down from above and/or solutions themselves are pre-identified, the innovative spirit is stifled and the solutions may be at best satisfactory but uninspired. Innovation is a process, and giving teams a legitimate opportunity to go through that process is the only way to actually get it.