Mitigating risks in medtech development

Developing a medical product is a complex process that requires a methodical approach to bring it to market. Unfortunately, most clinicians, researchers, and entrepreneurs lack a clear understanding of the product development process for medical products. This gap in knowledge can lead to significant risks, which investors consider important to remove before launch.

There are three key areas of risk that innovators must address to de-risk the launch of a medical product. These include technology risk, regulatory risk, and commercialization risk. By identifying and addressing these risks, innovators can secure the necessary funding to take their innovations to market launch.
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Technology risk focuses on the viability of the technology and whether it results in a product that is IP-protected, manufacturable, and scalable. Regulatory risk ensures that there is a clear pathway that has been validated by the FDA. And commercialization risk involves demonstrating the voice of the customer and validating the demand from multiple stakeholders, including a viable business model and execution plan.

One of the main challenges in the product development process is that technologists and clinicians often focus too much on the design and prototype of the product, without considering the manufacturing and regulatory challenges that must be overcome for market adoption. Therefore, it is crucial to ask these questions early on in the process to either assure a fast failure or get the product positioned well for funding.

To build a robust plan to ensure market acceptance, innovators must understand market adoption issues. In the past, connecting with Key Opinion Leaders (KOLs) was the main approach. However, with the shift from volume to value in healthcare, Value Analysis Councils have become more critical. Unfortunately, there is no standard approach to how these groups and committees’ function within a healthcare system, making market adoption more challenging.

To address this issue, innovators must determine the ROI of their product for these systems and provide a body of evidence to meet the higher bar set by these groups. It is crucial to reach out to healthcare economists, value analysis committees, supply chain, and salespeople to inform the go-to-market strategy and ensure market acceptance.
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In conclusion, developing a medical product requires a methodical approach that addresses the three key areas of risk, including technology risk, regulatory risk, and commercialization risk. To ensure market acceptance, innovators must understand the shift to value-based healthcare and the importance of Value Analysis Committees. By following this approach and seeking out the right expertise, innovators can increase their chances of securing funding and successfully bringing their innovations to market launch.