Why the Device Landscape Continues to Face Significant Hurdles

17th April 2018 (Last Updated December 13th, 2018 10:13)

CTA’s Jisong Seo examines the biggest challenges facing small to large medical device companies

Why the Device Landscape Continues to Face Significant Hurdles

Over the last few years, FDA approvals have taken significantly longer than any other markets so it delayed new product launch in the U.S. Gradually, however, the FDA have improved timelines through new measures bringing about greater productivity. On the other hand, the European regulatory process has become more complex than ever.

Traditionally, the EU has been viewed as a faster way to get to market, however, the new product registry in Europe is expected to increase delays by 20-40 percent, greatly impacting EU-based companies. To reduce the unpredictability of timelines, it’s vital sponsors learn how to obtain a CE mark.

Medical Device Innovation

Additionally, emerging technologies are continuing to revolutionize the industry, but its ultimate impact on clinical trial processes are yet unknown. Medical device companies are adapting and modifying their behavior as seen in the way sponsors use electronic medical records to manage big data.

There is a wealth of tech-based software that doesn’t require approval as they do not enter the human body. Therefore it is much cheaper to develop and easier to bring to market. From this point of view, looking at the software regulation for the future is essential. While the extent to which wearable products are regulated is yet to be clarified, the industry will soon reach a crossroads as it decides how best to regulate them.

Funding Challenges

Another factor that remains a pertinent issue in the industry is acquiring funds. Funding has always been challenging for small medical device companies, in particular. With clinical trials becoming more and more expensive, the regulatory knock-on effect impacts sponsors greatly.

Furthermore, as clinical trials require more time, costs begin to mount placing undue pressure on a company’s resources. Therefore, streamlining costs in product development is always the issue for medical device companies.

If sponsors don’t have enough money for the development stage, they can’t produce proper data to bring the product to the market. Even though the global investment environment is difficult, the med device industry must take steps to ensure it can compete by adopting new approaches.

Spiraling Health Care Costs

Lastly, the clinical reimbursement of medical devices in the U.S. is becoming increasingly difficult year on year. According to experts, the U.S. has about 1150 private payers with rising health care costs showing no signs of abating.

As a result, insurance companies are far more hesitant to provide coverage, meaning obtaining reimbursement presents significant barriers to trial sponsors. The financial constraints this creates is reaching its tipping point, almost akin pouring water into a glass as it overflows.

However, as regulations governing reimbursement evolves, the hope among those within the industry is that there is light at the end of the tunnel.