Health tech is seen by many to be the “next big thing” in entrepreneurship and investment. Between Obamacare, big data, and diagnostic apps, the field is ripe with big possibilities and big payouts. Unfortunately, health has been the next big thing for some time now. New startups crop up and then die away, VC firms are created solely for these investments and then go eerily quiet. What is going on here that is preventing startups and even established players from bringing new innovations to the public? You can blame the high cost of entry, the need for highly specialized equipment and talent, or a medical patent system that is beyond arcane. Despite all these reasons, for many the answer is clear – the FDA is a massive roadblock that is stiffing innovation.
FDA innovation is largely seen as an oxymoron, from both inside the entrepreneurial ecosystem and in the public at large. From companies that have attempted to bring some new technology to the market there are complaints about the agency’s byzantine rules, their imposing of large financial burdens, and their general lack of communication or transparency. Red tape and seemingly arbitrary decisions abound. The FDA has been fighting back against these claims by bringing on tech industry advisers and instituting an Entrepreneur In Residence (EIR) program. In fact, the agency is currently closing the second EIR program with the results of the initiative coming soon.
Despite what comes from the EIR program, or any other push for innovation, can the FDA really afford to innovate? The FDA has been put in place to protect consumers from potentially harmful drugs and medical equipment. Anything that strips away those safety nets is potentially quite dangerous. Bureaucracy and red tape are never efficient or enjoyable, but in this case they might be saving our lives. Yes, people are flocking to Europe for procedures and drugs that are seen as unsafe here. Yes, lives are lost waiting for approvals and clinic trials. But look what happens when something makes it all the way through the approval process and then makes us sick with side-effects or defects. Look at the recalls and huge class-action suits for medications or devices that have hurt more than they healed. This country has an extremely low tolerance for medical risks or mistakes. We expect anything given to us by a doctor to work the right way the first time. We expect this and sue when it doesn’t happen because the FDA allowed us those expectations in the first place. By all means innovate and change and cut red tape, but keep us safe while you do it.