Medtech compliance — not regulation — is stifling innovation

This article originally appeared in STAT News on July 26, 2024.

"Regulation is stifling innovation" seems to be a prevailing opinion among medtech leaders who believe the FDA's rules are slowing medical device advancements — especially when it comes to software. I couldn't disagree more.

As someone who has led artificial intelligence (AI) and machine learning (ML) efforts at Amgen, I've seen firsthand how vital these regulations are for keeping patients safe. Looking across the industry, I believe the real culprits behind slow innovation in medtech are outdated compliance practices.

Modern software companies are known for moving fast. That certainly isn't the case for medtech companies. Manufacturers' antiquated processes and tools hinder productivity and time to market, making compliance programs more expensive and less efficient over time. By modernizing compliance toward a developer-first approach, medtech businesses can move fast and keep patients safe , which in turn improves patient services and care.

Thinking critically about compliance practices

To understand the problem, it's important to make the distinction between regulations and compliance. Regulations are the rulebook, while compliance is how an organization chooses to play within those rules.

The FDA requires manufacturers to prove, or validate, that their medical devices, including software, function as intended and have undergone rigorous assurance, testing and risk management. These requirements are good: they keep patients safe by ensuring that medtech products fit their intended purposes.

Compliance, on the other hand, is how companies prove that they've followed the regulations. Because medical device manufacturing was historically centered around hardware, many companies today still take a 20th-century approach to compliance and product development featuring arduous, time-consuming documentation and long release cycles. They are sacrificing speed and innovation for the comfort of the way things have always been done.

Companies that believe their compliance efforts are adequate don't understand how much better their processes and outcomes could be with a more agile approach that still ensures patient safety and follows FDA guidance. I've spoken with countless executives who theoretically understand that finding a smarter way to operate within the rulebook would result in a faster time to market, but aren't sure what that looks like in practice, especially within their existing IT infrastructure.

How manual compliance efforts inhibit innovation

Most medtech companies tackle compliance with a manual, resource-intensive process that is loosely connected from the software development process or disconnected from it. This lengthens development cycles, makes it difficult to respond quickly to the market, and slows innovation. Here are some of the top obstacles that are hindering teams.