Navigating regulatory hurdles in MedTech adoption

Successful adoption of MedTech devices relies on innovation – meeting an unmet clinical need and providing solutions that offer quicker and more cost-effective care – as well as collaboration and communication behind the scenes between critical business functions.

Building a case for adoption

MedTech devices cannot be implemented into healthcare systems without real-world clinical and economic evidence of success. This requires proof that a device can improve the current standard of care – speeding up recovery times, reducing treatment costs or making treatment better for patients. In an ideal world, a device or technology would be able to achieve all of this; the key objective for MedTech innovation is to improve patient outcomes.

One of the initial challenges with MedTech adoption is gaining the clinical and economic data required to prove the device works and will enhance healthcare systems. However, this is complicated and time consuming, and relies on a variety of conditions. For instance, companies should demonstrate the validity of a medical concept, identify key clinicians that are likely to become early adopters of the technology, and work with them to arrange studies that demonstrate the impact of the device on real-life patients. Only then will a device have the potential to achieve regulatory approval.
 

Read the full article in DPA's December issue