Medical, Lab & IT Equipment Benchmarking & Analytics

Medical, Lab & IT Equipment Benchmarking & Analytics

March 01, 2024

Market Alerts

FDA Identifies Increase in Fraudulent Data from Third-Party Device Performance Testing

A recent communication from the FDA has reported a trend of an increasing amount of fraudulent data related to medical device testing from third-party labs. The FDA’s communication not only reiterated the responsibility of equipment manufacturers to validate third-party test data, but also highlighted the potential risk to hospitals that equipment they are using or planning to purchase may become unavailable for these reasons.

Relevant highlights from the FDA’s announcement:
– A growing volume of unreliable and fraudulent data is being used by third-party labs that provide performance testing for medical device manufacturers, specifically in China and India.

– This could have an impact on hospitals and patient care and reduce availability of new medical devices, further disrupting hospital supply chain needs for critical technology. Devices awaiting approval might not get approval, and others already approved risk being recalled if the FDA finds questionable data were used as a basis for approval.

– The FDA is asking device firms to be proactive and heavily scrutinize third-party test labs, as well as any research and data that is not directly overseen or generated themselves.

To see the full FDA communication, click here.

This is another example of how critical having the best information is for hospitals. Miga will continue to monitor and share information on this topic as it becomes available. If you have questions or would like to learn more about how you can continue to get the best information about the medical equipment lifecycle, please reach out. We look forward to hearing from you.

 

Know the right price.

And get it.

Having the right information saves hospitals time and money on medical equipment lifecycle costs.

Scott Bosch

Manager of Clinical Engineering

Park Nicollet Health Services

“The groups responsible for managing technology in our healthcare organization need data and analysis to manage costs and make informed decisions. Miga’s EVMS platform is an important and valuable resource that helps us make the right decisions for both our clinical priorities and budget.”

Matt Werder

Chief Technology Officer

Hennepin County Medical Center

“Miga’s data is key to helping us be good financial stewards and validates we are using our resources wisely. The market intelligence provided by Miga’s EVMS platform has allowed us to save substantial amounts of money.”

"Miga’s ability to match equipment donated by their customers with the needs of our medical projects has been a most valuable and welcomed resource."

Jim Tierney

CEO

Suburban Radiology

“Miga’s data, analysis and expertise – in particular related to the fair market value of clinical equipment – is a critical resource we need to support strategic acquisitions, divestitures and joint ventures.”

Eric Hoag

Director, Corporate Strategy & Development

Allina Hospitals and Clinics

“Miga’s proprietary data and expertise was critical to our ability to close an acquisition deal quickly and with a high level of confidence in our valuation.”

Bill Barta

Corporate Director, System Imaging

Fairview Health Systems

“Miga’s objective information-based approach and understanding of the needs of hospitals makes them a valuable resource and helps us make the most cost effective spending decisions.”

Matt Blashill

Enterprise Director of Supply Chain

Lake Region Healthcare

"There’s a personal touch that sets Miga apart from their competitors. They don’t just offer great insights. They always take the time to provide additional analysis that is meaningful and actionable."

Dan Bazinet

Director of Clinical Engineering

Southcoast Health

“In all my years in health care, I’ve used a lot of benchmarking tools. Most simply repeat information passed along from others; Miga’s information tells me what’s really happening.”

COO

Community Hospital

"Miga's negotiating skills save us time and money. And their unique understanding of the market means we’re always playing from a position of strength."

Supply Chain Director

Regional Healthcare System

“All suppliers claim to have excellent customer service. Miga actually walks the talk and always has our best interest at heart. We love working with them."