Cambashi, a U.K. research and consulting firm for production industries, revealed today it’s running a study on regulated medical device manufacturing, according to a company press release.  

The study, “Improving Quality and Agility in Highly Regulated Medical Device Manufacturing,” will be conducted by the Industry Council, a team of experienced executives and managers from a variety of medical device and component manufacturers, including those from operations, IT, quality, customer service, program and project management, and supply chain management.

Reports of failed devices have filled the news recently. Anne Trafton wrote that in about 17 percent of patients who receive either a knee or hip replacement, the implant eventually has to be replaced. The Medicines and Healthcare products Regulatory Agency (MHRA) has noted that around 49,000 U.K. patients, out of 65,000 with all-metal hips, must now be closely watched because of a high risk of failure. And those in the US have been made very aware of hip implant failures.

“I think people make the assumption that when their doctor implants a device, whether it be an artificial joint or a pacemaker, that it’s undergone very rigorous testing,” Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, told CBS News. “That assumption isn’t always true.”

Even heart implants are at risk of failing.  A recent New York Times story detailed implants that could cause death because the electrical wires inside the lead connecting the defibrillator to the heart had worked their way out through the lead’s coating, knocking patients out or possibly killing them.

The NYT goes on to say the problem with leads “is the third highly visible safety episode in the last seven years,” raising questions about whether the medical device industry “is adequately scrutinizing the safety of heart devices.”

"Many companies appear to lack a detailed awareness of what the regulations require. With the uncertainty of what needs to be done, companies often layer in far more checks and balances than they need, which drives up costs,” said Larry Dube, a veteran executive of the medical device industry. “Companies that can streamline their compliance needs are more competitive and flexible. I am supporting this survey to help the industry understand what we can do to gain agility and profitability yet still be in compliance."

A quick look at the findings will take place at the Medical Device and Manufacturing East show May 21-24 in Philadelphia.

Edited by Braden Becker