FDA And The Case For Quality For Medical Device Manufacturers

Manufacturing medical devices comes with risk. Mitigating that risk through good practices is better for your customers and keeps you from spilling red ink. If you don’t focus on quality and compliance, you’re out of business. So what do you need to know and do before your next device hits the market?

Know the risks

Of course taking care of your customers with safe, effective, high quality products is the goal. The complexity and pace of technology, plus global markets and regulations, make it more challenging every day. There is no room for mistakes. Nobody wants to be the next viral internet news story because of a costly recall.
These events are more common than you might realize:

  • The number of product recalls grew nearly 100% between 2003 and 2012.
  • Major recalls can cost hundreds of millions of dollars each.
  • Routine quality events - observations, letters, warranties, lawsuits - cost the industry $2.5-5 billion per year. Plus losses from stock price drops and tarnished brands.

Know the standards

The FDA launched The Case For Quality in 2011, following a period of feedback and reviews. It’s a recognition that investing in quality pays dividends for both the manufacturer and customer. It also concedes regulatory oversight can impact costs for manufacturers, product quality, and availability in the market.

But there are steep consequences if you don’t stick to the standards. The FDA already sent 35 warning letters in 2016. These letters point out the flaws in the product or processes the business has failed to follow. Halting production or shipping due to regulatory fouls can be detrimental to a business. And if you look at the root causes for product recalls, the patterns are clear.

Biggest reasons for product recalls:

  • Design flaws (31%)
  • Manufacturing (24%)
  • Suppliers (14%)
  • Post-production (12%)

Hardware was most affected by the recalls (29%), then processes (24%), and finally software (15%).

The FDA’s recommendation to reduce the number of recalls suggests implementing:

  • Design Control
  • Quality Systems
  • Inspection and Global Harmonization
  • Unique Device Identification
  • Process Control
  • Documentation Control Procedures

That’s a lot to take in at once. Fortunately, the FDA Case for Quality also uses quality practices to guide its own oversight and audit process. This transparency and predictability keeps you informed and prepared before and during inspections.