Medtech companies are used to running into regulatory obstacles during their innovation processes. According to MDDI, these companies are divided into three type of business: large scale medical device innovators and manufacturers; new device innovators (ranging from the surgeon with a good idea to the existing medical device company with a product line of a few products); software technology innovators. It’s true that they all share common challenges, but their primary ones are different according to their role in this complex industry.
When talking with each segment; here are the three biggest challenges they all share:
1. Cost and complexity to improve and enhance innovation: large scale medical device innovators have a great overview of the marketplace and the regulatory system, but identifying the best R&D opportunities is not always easy. Big data analytics are expensive and complex to implement. “The more incremental the deployment of any new technology can be made, the more likely you are to achieve final success.”
2. Time and volume of follow-up and tracking data from FDA: it’s very time-consuming to go through FDA notices, recalls and regulatory changes. “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”. Having access to FDA guidance, regulations and industry best practices can help these innovators avoid this type of problem.