US policies aim to expedite approvals for medical devicesUS policies aim to expedite approvals for medical devices

What if our ability to get novel medical devices from the lab to patients swiftly determined the direction of healthcare? With the US in focus, will the policies on medical device development become a reality in a market expected to grow at a compound annual growth rate (CAGR) of 6.1 per cent from US$184.61 billion in 2022 to US$291.04 billion by 2030?

The medical device sector, which includes anything from basic bandages to sophisticated imaging systems and robotic surgical instruments, faces leaps and hurdles like every other sector. Historically, the path from innovation to market has been fraught with regulatory hurdles, lengthy approval processes, and significant financial investments. These challenges have often stifled innovation and delayed the availability of life-saving technologies to patients.

In recent years, concentrated efforts have been made to expedite the regulatory procedure without sacrificing patient safety. The FDA in the US has launched several programs to expedite approval procedures for medical devices. Initiatives such as the Breakthrough Devices Program aim to accelerate the creation, evaluation, and approval of medical devices that offer more efficient diagnosis or treatment for serious or terminal illnesses. Thus far, these measures have yielded encouraging outcomes. Devices eligible under the Breakthrough Devices Program receive priority consideration and increased interaction with FDA representatives. This reduces the possibility of expensive delays by giving manufacturers critical input early in the development cycle and accelerating the approval process.

Several important activities and policies have and will influence the medical device development scene in 2024. A new era of rapid innovation, notably in AI-enabled devices and advanced imaging technologies, has been ushered in with the streamlining of regulatory procedures, aided by the FDA's accelerated approval processes and the Medical Device Development Tools (MDDT) program. For instance, the FDA's Medical Device Development Tools (MDDT) program marked a significant milestone with the inclusion of Apple Watch's atrial fibrillation (AFib) history feature. This qualification, a first of its kind for "digital health technology’, enables the Apple Watch to contribute invaluable data to clinical studies. 

The policy agenda of AdvaMed continues to spotlight the significance of a robust supply chain and legislative support, like the VALID Act, in guaranteeing precise diagnostic tests. Additionally, AdvaMed promotes startups and small enterprises by providing money for research and advantageous tax laws, which advances industry innovation. The US, China, and Japan are leading the way in industry growth despite macroeconomic problems. This growth is strengthened by initiatives to ensure fair access to innovative medical technology and to promote diversity in clinical trials.

Beyond regulatory reforms, new policies are strengthening innovation through increased funding and public-private collaborations. The US government has allocated significant funds and grants to support research and development within the medical device industry. Early-stage innovation is greatly aided by initiatives like the Biomedical Advanced Research and Development Authority (BARDA) and the National Institutes of Health (NIH).

Moreover, collaborations between government agencies, academic institutions, and private companies are becoming increasingly common. The medical device market is expected to develop even more, which indicates that flexible rules are desperately needed in the ever-changing healthcare environment. This is backed by several compelling reasons, including the growing number of people with chronic conditions, the ageing population, and the growing need for minimally invasive operations.

The COVID-19 pandemic showed that, with the right rules in place, the healthcare industry can develop swiftly and serve as a grim reminder of the importance of strong healthcare systems.

While legislators try to create adaptable legal structures, the US becomes a leader in medical innovation by prioritising improving patient outcomes while reducing healthcare costs. The industry's anticipated growth is contingent upon continued legislative support, highlighting its critical role in shaping the future of healthcare.

Jennifer Orisakwe is a health researcher and data storyteller, who loves to explore the ways actions (and inactions) of healthcare stakeholders affect decision-making and outcomes.