Why medical innovation is so hard

BIOMEDevice Boston conference will happen between April 13-14 and one of the speakers is Bill Betten, director of business solutions at Devicix (Eden Prairie, MN). He recently gave an interview for Qmed about the reasons why medical innovation is so hard to fullfil. “You build around what has been done before. When people hear that statement, they sometimes say things like: ‘what about the implantable pacemaker? Surely that was not incremental?’ But you could argue that the pacemaker certainly built on what came before,” says Betten.

Here are some reasons why leapfrog innovation rarely happens in the medical industry, according to him:

- Financial Constraints: makes it difficult for companies to create breakthrough products or create devices that are less expensive but functionally equivalent to older technology. Due to increasingly cost-conscious hospitals, companies are being forced to reduce costs of their products. “In the past, it was commonplace for device makers to charge substantially more money for new products that only had minor improvements over the previous-generation product. That isn’t the case anymore: many hospitals are now hesitant to invest in new devices that are not demonstrably better than established technologies.”

            Another important point is the vital role of medical device start-ups in developing revolutionary medical technology: one has to add the struggle they go through to obtain venture capital funding for their projects.

- Regulatory Challenges: in a highly regulated industry like the medical sector, product development costs can skyrocket. “Regulatory costs run in the tens of millions of dollars for most 510(k) products, according to a report on AdvaMed’s website. For PMA products, marketing a medical device in the United States can take close to $100 million on average.”

These obstacles are faced by medical start-ups all over the world and Biokyra is no exception. The Brazilian-based company is currently developing medical devices in the vascular area, going through regulatory processes and filing Brazilian and international patents.