US policy aims to speed up approval of medical devices

What if our ability to quickly deliver innovative medical devices from the lab to patients determines the direction of healthcare? Will medical device policy become a reality if we focus on the U.S., a market that is expected to grow at a compound annual growth rate (CAGR) of 6.1 percent, from $184.61 billion in 2022 to $291.04 billion by 2030?

The medical devices sector, which includes everything from basic bandages to advanced imaging systems and robotic surgical instruments, faces leaps and bounds like any other sector. Historically, the path from innovation to market has been fraught with regulatory hurdles, lengthy approval processes, and significant financial investments. These challenges often stifle innovation and delay the availability of life-saving technologies for patients.

In recent years, efforts have focused on speeding up the regulatory process without sacrificing patient safety. The U.S. FDA has launched several programs to speed up the approval process for medical devices. Initiatives such as Breakthrough Devices Program are designed to accelerate the development, evaluation, and approval of medical devices that offer improved diagnostics or treatments for serious or fatal diseases. So far, these measures have yielded promising results. Devices that qualify under the Breakthrough Devices Program receive priority consideration and increased interaction with FDA officials. This reduces the likelihood of costly delays by giving manufacturers critical input early in the development cycle and speeding the approval process.

Several important actions and policies have impacted and will impact the medical device development scene in 2024. A new era of rapid innovation, especially in AI-enabled devices and advanced imaging technologies, has been ushered in by streamlined regulatory processes, aided by FDA’s accelerated approval processes and the Medical Device program Development Tools (MDDT). For example, the FDA’s Medical Device Development Tools (MDDT) program marked a significant milestone, including Apple Watch atrial fibrillation (AFib) history function. Thanks to this qualification, a first-of-its-kind “digital health technology”, Apple Watch can provide invaluable data for clinical trials.

Political program AdvaMed Continues to emphasize the importance of a solid supply chain and legislative support such as Art The Act is IMPORTANTguaranteeing precise diagnostic tests. Additionally, AdvaMed promotes startups and small enterprises by donating money for research and favorable tax regulations, which promotes innovation in the industry. The United States, China and Japan lead the industry in growth despite macroeconomic challenges. This growth is reinforced by initiatives to ensure equitable access to innovative health technologies and promote diversity in clinical trials.

In addition to regulatory reforms, new policies strengthen innovation through increased financing and public-private collaboration. The U.S. government has provided significant funding and grants to support research and development in the medical device industry. Early-stage innovation is greatly aided by initiatives such as the Biomedical Advanced Research and Development Authority (BARDA) and the National Institutes of Health (NIH).

In addition, collaboration between government agencies, academic institutions, and private companies is becoming increasingly common. The medical device market is expected to grow even more, indicating that flexible policies are desperately needed in an ever-changing healthcare environment. There are several compelling reasons for this, including the growing number of people with chronic diseases, an aging population, and the growing need for minimally invasive surgery.

The COVID-19 pandemic has shown that with the right policies in place, the healthcare sector can thrive, providing grim proof of the importance of strong healthcare systems.

As lawmakers strive to create flexible regulatory structures, the United States is becoming a leader in medical innovation, prioritizing improving patient outcomes while lowering health care costs. The industry’s projected growth depends on continued legislative support, emphasizing its critical role in shaping the future of healthcare.

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

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