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Medical Devices Enter the Information Age

Despite increasing competitive and regulatory pressures, medical device manufacturers have an opportunity to seize a significantly growing market. Streamlining operations through automation will be key.

Operators use the HMI’s visual displays in Progea’s Movicon SCADA system to interact with processes, accessing real-time or historical data on each phase in the operation.
Operators use the HMI’s visual displays in Progea’s Movicon SCADA system to interact with processes, accessing real-time or historical data on each phase in the operation.

Medical device and pharmaceutical manufacturers face many of the same challenges, from shrinking patent pipelines and greater competition to growing regulatory pressures and the persistent problem of diversion/gray marketing (directing regulated goods from a legal source to an unauthorized marketplace or channel).

On the opportunity side, says Dave Sharpe, Industry Director, Consumer Packaged Goods for Rockwell Automation, are predictions that market size will increase significantly over the next 10 to 20 years due to a growing—and aging—global middle class. “Automation technologies can address both the challenges and the opportunities in this market.”

Better manufacturing quality

Medical device manufacturers often complain that it takes longer in the U.S. than in Europe for new devices to win regulatory approval, delaying time to market.

“One reason is that Europe has more standardized quality manufacturing procedures, which makes it easier and faster for new companies to learn and then enter the market,” says Greg Crouch, director of engineering services business development at Circuit Check Inc.

“GAMP (Good Automated Manufacturing Practice), a set of guidelines targeted at the manufacturing stage and issued by the International Society for Pharmaceutical Engineering (ISPE), applies well to medical device companies,” he explains. “Medical device startups come and go. Employees moving between companies are already well versed on a manufacturing development lifecycle.”

Circuit Check, a member of the Control System Integrators Assn. (CSIA), is the largest supplier of automated test fixtures in North America. “We’re involved in the manufacturing test of a wide range of medical devices—everything from implantables to disposables,” Crouch says. “The more mission-critical the device, the more important testing and traceability of test through the design-to-production cycle becomes. Young companies trying to get to market faster often put the cart before the horse, trying to document test methods after the fact, which gets them into trouble during the submission process.”

Although the FDA is trying to streamline the guidelines, many medical device manufacturers are slow to change, sticking with paper processes rather than leveraging software tools to integrate test data results back into the design and verification process, Crouch contends. “You can find many companies just beginning to adopt electronic recordkeeping and electronic signatures for production monitoring, [the directives for] which were laid out by the FDA’s CFR 21 Part 11 guideline many years ago,” he says. Part 11 defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable and equivalent to paper records.

Does it work? Is it safe?

Other experts point to the litigious nature of American society, where lawsuits breed like rabbits, for the more cautious approach U.S. regulators take to new product approvals.

“We’re focused on the safety and effectiveness of medical devices; are they safe for humans to use and do they perform as the manufacturers claim,” explains Dr. Herbert Lerner, Deputy Director of the FDA’s Division of Reproductive, Gastro-Renal and Urological Devices.

“Over the last few years, our relationship with the industry has become more cooperative and less adversarial,” Lerner says. “Business wants everything yesterday, but our job is to make sure that what gets to market is safe and does what it’s intended to do.”

To achieve that, the FDA puts out a large number of guidance documents and holds seminars and webinars for device designers and manufacturers every year. Despite these efforts, it still receives hundreds of thousands of consumer complaints every year about faulty devices.

“If manufacturers work closely with us, their path to market will be easier and there will be fewer regulatory hurdles,” Lerner says. His office is currently focused on issues such as biocompatibility—which determines if the materials used in a device will cause an adverse reaction with the human body—and the reprocessing of reusable devices through sterilization.

Path forward

Joe Whyte, Global Serialization Lead for Rockwell Automation, sees the convergence of mechanical, electronic and software technologies as an essential path forward. “The industry is entering the information age, and the new FDA requirement for unique device identification (UDI) for every device manufactured lays the foundation,” he says.

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