New Regs Tighten Compliance for Medical Devices Manufacturers

By AMY HORGAN | Published: NOVEMBER 16, 2011

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 theSustainability 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:

• RoHS2 Compliance: Is Your Company Ready?
• Best Practices for Collecting Product Material and Compliance Data

Ideas on the Cheap: Outsourcing Innovation in the Medical Devices Industry

By NANCY PARDO | Published: JULY 25, 2011

The medical devices industry in the United States has long created top-notch lifesaving equipment built to work across the board in every possible scenario. The American market demands über devices with all the latest bells and whistles (whether necessary or not). But this ultra-expensive bigger-is-better model is turning off a global market. Emerging economies such as India and Africa just can’t afford to buy super-fancy medical devices designed for the American market.

The India Biodesign initiative at Stanford University is a powerful example of how a lower-cost product, stripped down to it’s bare nuts and bolts function, and designed to fit the needs of a specific demographic, can be much more effective in less affluent countries.

As part of the Stanford program, fellows from India spend time at Stanford studying the biodesign process. They then return to India to see how this process can be applied to real-world medicine in their country. Thanks to this initiative a new bone drill has been developed for the India market, similar to the US version in some respects, but very different in other ways, the bone drill can be manufactured cheaply with few parts and it’s easy to assemble and use. The bone drill works manually rather than using costly batteries.

It makes sense for the medical devices industry to embrace emerging economies as both consumers and a potential source of labor and innovation. According to an article published by theThe Economist back in January, companies such as Medtronic—a major manufacturer of medical devices—are investing heavily in China and India, “setting up research centers, hiring local talent and developing frugal inventions of their own.”

Medtronic recently partnered with a Chinese company and has already launched six innovative and inexpensive products inspired by its Chinese counterpart, according to The Economist report.

Perhaps, in light of skyrocketing healthcare costs in the US, investment in emerging markets will provide some cheaper medical alternatives. Yet foreign-made medical devices have yet to flood the American market, in part because safety regulations in India and elsewhere are not as robust as FDA regulations in the US.

There’s no doubt however that we’ll be seeing more and more innovation from and investment in emerging markets, with more attention paid to lining up compliance requirements across continents. And the next time you visit the hospital and get reusable sutures, you can thank Chinese innovation.

Medical Equipment Manufacturers Accommodate Supersized Population

By NANCY PARDO | Published: JULY 12, 2011

It’s no secret that the American waistline has been expanding for quite some time. In the past 20 years, according to the United Health Foundation, the average American male has gained 17.1 pounds and the average American female has added 15.4 pounds. A recentNational Health and Nutrition Examination Survey by the CDC shows that 68% of the US population is considered either overweight or obese.

In turn, the obese are thought at greater risk for certain types of cancers, coronary heart disease, type II diabetes, gallbladder disease, osteoarthritis, hypertension and stroke, so it stands to reason that this population would have more contact with healthcare professionals and emergency workers.

It takes five people to lift an unconscious 180-pound man, and the average weight of a patient today might be double that or more. It’s unrealistic to send 10-plus emergency workers to an incident, so medical equipment such as ambulance stretchers need to be smarter in design, allowing for easy lift and mobility. Automated stretchers hold more weight but are easier to move. Ramps to roll the stretcher onto ambulances and winches to haul the patient up the ramp are also in use today.

For the patient, comfort and dignity is important. The Obesity Society—a scientific body advancing research into obesity and keeping the medical community and public informed of new developments in this area—recommends that in order to help obese patients feel more comfortable and less stigmatized, medical facilities should “create a supportive health care environment with large, armless chairs in waiting rooms and appropriately-sized medical equipment.”

Medical equipment manufacturers such as Stryker are now supplying newly designed hydraulic stretchers to meet the needs of medical professionals and patients alike. “Five or six years ago our cots were rated for 500 pounds, and now they are increased to 700 pounds, “says Kurosh Nahavandi, a design engineer with Stryker. “The average patient is about 500 pounds being transferred in ambulances.”

The stretcher (or “cot”) of today has many requirements, says Nahavandi. “It has to roll well, it’s got to be small enough to go through apartment buildings, and in addition to that it has to be able to hold the largest of patients as well.”

Stryker has also designed a smooth no-pinch side rail for its cots. The new side rail offers more comfort for patients, and the controls—located on the outside of the rail—allow EMTs ease of use.

It stands a good chance that your nearest hospital has been grappling with obesity for many years, and it looks like medical equipment manufacturers are catching on to the new requirements and demands of an over-sized population. And it’s probably safe to say that as the demand for surgeries like gastric bypass increases in the US, so, in all likelihood, will the need for operating tables that can hold up to 1,000 pounds of human.