Everyone, from new device entrepreneurs to engineers at mega medtech companies, runs into regulatory hurdles during the innovation process. Here's how each type of innovator can tackle these challenges.
We have seen the variety of challenges that non-pharmaceutical healthcare innovators face. They are all presented with unique difficulties and opportunities based on their type of business. By and large, they are segmented into three broad tiers:
- The large scale medical device innovators and manufacturers—the folks building the next medical scanners or cardiac surgery devices.
- The new device innovators—ranging from the surgeon with a good idea and a business card to the existing medical device company with a product line of a few products.
- The software technology innovators—everyone from the fitness tracking applications to wearables that predict a seizure or diagnose a disease.
While these parties all face some shared challenges, each of their primary challenges has to do with their particular role in this complex market. They all can and must learn from each other. The common thread here is the volume and complexity of the data facing innovators in the healthcare innovation field.
As a provider of a ClearRoadmap™ through the regulatory forest of the US market, we talk with and offer services to each of these innovator segments. This gives us insights into what are shared problems and what problems are unique to each tier of innovator. Here are three of the biggest challenges we see from clients:
1. The cost and complexity of analytics to improve and optimize innovation. The large scale innovators have a broad view of both science and regulatory challenges and opportunities in the marketplace. But the sheer breadth of this view can be stymying. Identifying the most fertile R&D opportunities is not always easy. Big data analytics, such as those powered by the biggest artificial intelligence/big data solutions, are expensive and complex to implement and deploy. More importantly as of yet they are not fully proven. We recommend leading with iterative data analytics solutions rather than large projects. In our team's experience, the more incremental the deployment of any new technology can be made, the more likely you are to achieve final success. This may be because the incremental perspective provides a quicker path to profitability, gives you a better idea of what features matter most, or pinpoints what will become your big problems.
2. The time and volume of follow-up and tracking data from FDA. Despite FDA providing better interfaces to some of its data sets, new device innovators face a mountain of data to sort through. One existing business with a product line of about half a dozen products each in multiple configurations told us they spend roughly one-half man-day per week sorting through FDA notices just to stay on top of competitors, recalls, and regulatory changes. As far as smaller practitioners with promising ideas, we’ve spoken with innovators who are—or are considering—avoiding the US marketplace entirely, simply because of the sheer complexity of information that comes out of FDA. Of course, having advice from an experienced medical device consultant is critical to understanding the information coming from FDA, but the cost can be very high. Of course, the consultants are also dependent on manual data sorting. Technology now allows you to both take optimal advantage of the level of effort required and increase the quality of the results for you by automating the access to the data.
3. Getting blindsided by regulatory issues is probably the most common complaint from software innovators. From the disabled pulse-oximeter in the Apple Watch to the much publicized travails of 23andMe—even well-funded organizations can miss relevant regulatory directives. Furthermore, as Fitbit found out with its sleep measurement claims, not all of them come from FDA, but FTC and state level regulations can apply as well. Having access to flowcharts that link FDA guidance, regulations, and industry best practices can help innovators avoid problems and headaches that may seem unavoidable to those without time and experience in the regulatory minefield.
Vizma Carver is founder and CEO of ClearRoadmap, a solutions platform providing regulatory, clinical, and reimbursement information for the medical device, biotechnology, mHealth, and wellness fields. Carver, who recently completed an appointment as FDA Entrepreneur-in-Residence, has more than 25 years of experience working for small, mid-size, and Fortune 500 companies, government agencies, academic, and nonprofit organizations. Reach her at email@example.com.
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