New Regs Tighten Compliance for Medical Devices Manufacturers

Photo from flickr.com/photos/fdaphotos/

There are amazing things going on in the medical devices industry today, as evidenced by stories of war vets returning from Afghanistan with prosthetic limbs, and the 50-year-old Englishman who last month become the world’s first patient to have a Smartphone built into an artificial arm.

But as these medical devices become more common and complex, so are demands from consumers and government agencies about product quality and environmental safety.

Just within the past few months, compliance to RoHS, the European Restriction of Hazardous Substances regulation, has become a serious challenge for medical device manufacturers. It’s a challenge that could have very expensive and damaging consequences for companies which fail to comply.

RoHS first went into effect in 2006. It mandates that producers of certain categories of electrical and electronic equipment are not allowed to place products on the European market if they contain six banned substances: lead, mercury, hexavalent chromium, cadmium, and polybrominated biphenyls and polybrominated diphenylethers flame retardants.

This past July the European Union revised RoHS to include previously-exempt medical devices manufacturers. Beginning in 2014 the new RoHS recast will apply to medical devices and monitoring and control instruments.

But RoHS isn’t the only new regulation targeting the medical devices industry. Another is the Sustainability Scorecard from the California-based Kaiser Permanente health care organization. This scorecard—similar to Walmart’s sustainability index—requires that medical suppliers provide environmental data for equipment and products used in Kaiser’s hospitals, medical offices and other facilities. Add to that the EU’s 2007 REACH (Registration, Evaluation, Authorisation and Restriction of Chemical substances) and the need for effective product data management for the medical devices industry has never been more critical, or challenging.

As Jim Brown, industry analyst with Tech Clarity, notes in Tech-Clarity Perspective: Making Product Development Trade-offs Designing Products for Compliance, Cost, and Sustainability, the number-one difficulty for device makers involves collecting timely and accurate data from suppliers. Brown says that these new standards have registered little improvement in comparison with previous benchmarks over the last two years.

On the upside, Brown says, some other top concerns—lack of awareness and lack of understanding of compliance requirements—seem to have eased. This shows that the industry is making progress. Other encouraging news, according to Brown, is that fewer companies are suffering from lack of resources to address environmental compliance.

Failing to comply with regulations is more than a slap on the wrist. At the very least companies can face recalls, brand damage, costly redesigns, and scrapped parts. The stakes are high, with potentially millions of dollars of revenue at risk.

In order to satisfy regulations, manufacturers must provide regulators with detailed reports demonstrating product compliance, while keeping up with frequent changes in product designs, parts, suppliers, and in the regulations themselves – an enormous data management challenge.

Manufacturers defining supplier data-collection needs have to factor in ever-changing environmental regulations. Just as environmental compliance is a process and not an event, the same is true for environmental data acquisition and management.  The data acquisition process is particularly important to get right, as the need for substance and material data from suppliers is growing.

Successful compliance programs require both a strategy and a process to improve data capture to attain the information needed and continually improve upon it without overburdening already scarce resources.

How is your company dealing with the challenge of regulatory compliance and data management?

Further Information:

Photo Credit: FDA on Flickr

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