Is There a Better Way To Approve Medical Devices?

Aug. 3, 2011
Industry group says 35-year old system needs to be overhauled.

The Institute of Medicine (IOF) would say yes. In a report issued last week, the group wants the FDA to replace the 35-year-old 510(k) clearance process for medical devices saying that process "lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk Class II devices and cannot be transformed into one."

The group advocates that a better investment would be a new framework that uses both premarket clearance and improved postmarket surveillance of device performance to provide reasonable assurance of the safety and effectiveness of Class II devices throughout the duration of their use.

The problem with the process, according the group, is that at the 510(k) clearance does not determine a device to be safe or effective.

Whether things will change as a result of this report or not is uncertain. "I think it builds towards the continuing narrative that the healthcare landscape, particularly for medical device companies, is changing and not for the better," explains Venkat Rajan, Industry Manger, Medical Devices for Frost & Sullivan. "Increasingly it will be harder for them to get products approved and paid for with changes to reimbursement and health care cost cutting measures."

IOM said the FDA should explore whether a modified version of its de novo process could replace the 510(k) process. The de novo process reduces the amount of information manufacturers must supply for devices deemed to be of low or moderate risk but that have no predicate devices against which to be compared. "Changes would be necessary to fix problems that make the de novo process time-consuming and difficult to navigate before FDA initiates a pilot program," the group concluded.

"Specific to the report, I don't think there was anything particularly completely revolutionary," Rajan added. "Their recommendations called for more transparency, and for a better process and set of metrics to evaluate the safety of new medical technologies regardless of their equivalency in function to existing products.

"The FDA has already come out and said while they are always looking for methods to improve their evaluation process, they do not have any current plans to scrap the FDA 510k process," said Rajan.

One of the issues particular to the U.S., Rajan, says, is that there is much simpler regulatory approval processes in Europe and abroad without major safety risks. "Companies are worried about further restrictions here which could hamper product launch cycles."

About the Author

Adrienne Selko | Senior Editor

Focus: Workforce, Talent 

Follow Me on Twitter: @ASelkoIW

Bio: Adrienne Selko has written about many topics over the 17 years she has been with the publication and currently focuses on workforce development strategies. Previously Adrienne was in corporate communications at a medical manufacturing company as well as a large regional bank. She is the author of Do I Have to Wear Garlic Around My Neck? which made the Cleveland Plain Dealer's best sellers list. She is also a senior editor at Material Handling & Logistics and EHS Today

Editorial mission statement: Manufacturing is the enviable position of creating products, processes and policies that solve the world’s problems. When the industry stepped up to manufacture what was necessary to combat the pandemic, it revealed its true nature. My goal is to showcase the sector’s ability to address a broad range of workforce issues including technology, training, diversity & inclusion, with a goal of enticing future generations to join this amazing sector.

Why I find manufacturing interesting: On my first day working for a company that made medical equipment such as MRIs, I toured the plant floor. On every wall was a photo of a person, mostly children. I asked my supervisor why this was the case and he said that the work we do at this company has saved these people’s lives. “We never forget how important our work is and everyone’s contribution to that.” From that moment on I was hooked on manufacturing.

I have talked with many people in this field who have transformed their own career development to assist others. For example, companies are hiring those with disabilities, those previously incarcerated and other talent pools that have been underutilized. I have talked with leaders who have brought out the best in their workforce, as well as employees doing their best work while doing good for the world. 

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