If it were simply about the engineering or the science, this job would be so much easier. Effective med device R&D leadership is not just about the black and white of the data. It is also about bridging the communication gap between what needs to be done and why it matters to the company. Sometimes the path is clear, but medium to large companies with broad portfolios often find themselves with many small fires burning at once. Left unmanaged, those fires can converge into a full-blown burning platform, and it is your job as the R&D leader to prevent that from happening.
Communication to the executive team and the R&D team needs to be clear, convincing, and simultaneous. Executives need to understand why investment is important. The R&D team needs to feel heard and understand the strategy driving the company. Easier said than done when it takes 18 to 24 months to bring any new idea to the medtech marketplace.
Over the past several decades, I have spent my entire career participating in and leading R&D teams across many geographies and company profiles. What I know for certain: success depends entirely on communication and teamwork. It doesn’t matter how difficult the engineering or science is. The team needs to coalesce to make it happen.
As a Generation X engineer, I feel privileged to have gone to school before the internet handed you answers. My contemporaries and I spent a great deal of time trying new ideas and failing. At the time, I didn’t appreciate that I was learning from each failure and finding my own path forward. Now, in an age where most questions are answered almost as fast as you think of them, something has been lost. The creativity and judgment required to stare down a tough problem and grind toward a solution is a shorter, easier process today. There are countless tools that accelerate innovation, and I am genuinely excited to use them. But I have also seen a growing tendency to give up too quickly when the answer doesn’t come fast.
The thing about AI and other problem-solving tools is that they are trained on existing data. Engineering and science, at their best, are about new ideas standing on the shoulders of giants. Those ideas are not found in the mix. They are found at the interface, in the outliers, in the changepoints in the data. You have to build something, test it in the real world, and create a new outcome. That cannot come from existing data. It comes from generating new data, new experiences, new results.
I watched a gradual shift in engineering skillsets over the years, and COVID accelerated it dramatically. Now I see the fallout, and I have been actively looking for ways to address it as an R&D leader. Every single company I speak with says some version of the same thing: we have aging devices that have been neglected (the chip crisis of 2021 and 2022 shares some of the blame); we need a next-generation product in the field quickly and it needs to be connected, but nothing in our portfolio meets current standards; when we submitted to FDA, significant data was missing and now we are remediating. And then the one that is hardest to hear: my R&D team does not understand how the product is actually used.
That last one is not entirely their fault. They were never trained to go to hospitals. And why would they be? Nobody was allowed in for a while, and travel budgets were slashed for years. An entire generation of R&D engineers was stuck at home searching for answers online, but never generating new ideas or actually building anything new.
We are now in a different phase. R&D teams are largely back in the office, and most are getting back in front of customers. The tools available are genuinely accelerating problem-solving. But have you noticed a hesitation to draw outside the lines? I have sat with engineers who cannot meet the specs but have no real understanding of what those specifications were written for, or how to set the right ones in the first place. That is a problem-solving gap, not a technical one.
Newer engineers often lack the mentorship needed to push boundaries or reach across to a colleague for a new perspective. Some of them want to push and are ready to. Others are comfortable searching documents, pulling test data, and stopping there if the answer does not come clearly from the tool. And some are simply waiting for R&D leadership to hand them the answer.
So where do you start? How does a leader shift behavior and get the team back to solving problems creatively? I use a framework I call the 4 Ps: Planning (strategy), People, Process, and Programs.
It starts with planning. A clear strategic vision, aligned with executive leadership, lets you focus your engineering team on the skillsets you want to cultivate internally and what you need to source externally. From there, you reflect that vision back to your team so they understand what you are trying to build over the long term. With that foundation in place, you can assess your people: their skillsets, their gaps, and whether you have a deep enough bench to execute.
Next is process. If requirements management is the problem, invest in a tool and train on it. These solutions can be turnkey and give your staff something concrete to learn from. Finally, programs: the heart of the growth strategy. Your teams need clear goals, realistic timelines, and defined spending parameters. Solid project management is not optional here. If you do not deliver on time, executive patience erodes quickly, and the long-term change you are trying to make becomes that much harder to sustain.
In the next installment, we will talk about motivation: how to identify it in your staff and how to cultivate it for long-term gain.
Terri Kapur is a seasoned R&D executive with more than 20 years of experience driving innovation in the medical device industry. She has led global, multidisciplinary teams across the full product lifecycle, from early research through development, commercialization, and post-market support.
