Cautious Medical Device Manufacturing

When it comes to medical device manufacturing, Europe is faster about getting regulatory approval for new devices than the United States. This is due to several factors. The first of these being that Europe has a more standardized quality manufacturing procedure. This makes it easier for new companies to learn and enter the market.

In the U.S., the guidelines aren’t as standardized. In the rush to bring new products to market, new companies often neglect these guidelines, quickly getting them into trouble and causing delays. Testing and traceability is very important, but often these companies try to document test methods after the fact, instead of beforehand.

As the FDA continues to streamline the guidelines, many companies are slow to adapt. For example, numerous companies are just now adopting electronic recordkeeping and electronic signatures for production monitoring, concepts that were laid out many years ago.

On the other side, a more cautious approach could be due to the prevalence of lawsuits in the U.S. Because of this, companies are under even more pressure to ensure product safety and proper performance.

When manufacturers work with the FDA, paying special attention to their guidance documents, seminars and webinars, their path to market is generally much easier. They are more likely to successfully maneuver the regulatory hurdles and produce a quality, safe product in a timely manner.

Now, the FDA is requiring unique device identification (UDI) for every device manufactured. While this was originally required to prevent counterfeiting, it is also being used for supply chain efficiency and fault identification. The new requirement could actually benefit manufacturers. With UDI, they will be able to optimize production processes, reduce over-manufacturing, have faster turnover rates and less discounting at wholesale or retail levels.