Devices & Diagnostics

Spinal rod maker decides to provide lifetime warranties. What?!!

Medicrea is offering lifetime warranties for its custom rods used in posterior spinal fusions, a move that the French company describes as an industry-first.

Spinal rods from Medicrea now have lifetime warranty

Spinal rods from Medicrea now have lifetime warranty

It’s not every day that the term lifetime warranty is used in the same sentence as a medical device.

So French spinal product maker Medicrea is likely to turn heads as its announcement Wednesday about providing a lifetime warranty for its spinal rods becomes more widely known.

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” I had not been tracking that company specifically, but it is noteworthy,” said Venkat Rajan, industry manager, medical devices at Frost & Sullivan, in a response to questions in an email.

Based in Lyon, Medicrea makes thoracolumbar and cervical rods among other implants made using the company’s UnID technology that allows for customization according to a patient’s anatomy. The warranty goes into effect Nov. 1 in the U.S. The news release claimed that Medicrea is the only company to offer a lifetime warranty on spinal implants used in posterior spinal fusions.

It adds that “The UNiD lifetime warranty program is offered as an affiliated benefit of the UNiD Lab Premier service through which biomechanical engineers offer real-time support for all pre-operative planning and post-operative analytical services.

“Because of the overwhelmingly positive results obtained in all of the 950 plus UNiD  patient-specific cases performed to date and our confidence in the science behind UNiD technology, Medicrea is taking the extra step to warranty each patient-specific implanted construct for the duration of the patient’s life,” said Denys Sournac, president and CEO, in a statement. “This is a true testament to our belief that, by offering surgical planning services with a patient-specific device, Medicrea is eliminating the inherent risks and associated costs to the healthcare system that are created by manually bending a rod during surgery.”

The company plans to extend the warranty program to other countries too.

The idea of a lifetime warranty may appeal to hospitals and surgery centers in the U.S. at a time when costs of many implants, including hips, knees, and cardiac devices, are being scrutinized. And as the value-based model in healthcare becomes further entrenched.

“I think moving forward as we move more towards value-based compensation models, we could see more of these types of deals,”Rajan, the Frost & Sullivan analyst noted. “Whether it is called a warranty or not, we will see medical device manufacturers take on greater risk associated with product failures, readmissions, or other complications associated with their technology.”

The announcement also begs the question of what the warranty landscape looks like in the devices world. Rajan said he has seen warranties in breast implants and partial knees.

Cardiac companies like Boston Scientific provide limited warranties for certain implanted pulse generators and leads and they are not available in all geographies. Medtronic also provides limited warranties for a variety of products including its cardiac leads and diabetes products such as insulin pumops.

To Rajan’s point, Zimmer-Biomet offers what the Indiana company calls the “industry’s only lifetime knee replacement warranty program” although it’s only for the Oxford partial knee.

Back in 2014, activists from the Safe Patient Project, part of Consumers Union, the policy and action unit of Consumer Reports, went to the annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) demanding that hip and knee implant makers provide some level of warranty for their implants.

“You get warranties for flashlights, toasters and cars, for almost everything in the U.S.,” Lisa McGiffert, director of Consumers Union’s Safe Patient Project, told MD+DI. “I know they are less complicated, but this is something that is going inside people’s bodies. We think they ought to stand behind their products for a certain number of years. They can decide how long.”

A medical device industry believes that product warranties are not uncommon but those that are tied to specific outcomes are fewer and far between, though that will change.

 

“Basic product warranties commonly exist for medical devices to protect against product defects, but warranties on how a medical device leads to a clinical outcome is highly unusual today,” said Jonas Funk, managing director, L.E.K. Consulting, in an email forwarded by a representative. “Some innovative companies, like Medtronic, have begun offering warranties on outcomes for a limited number of products, such as its Tyrx absorbable antibacterial envelope.  We expect these examples to expand going forward, particularly as hospitals become more enabled to accommodate these novel pricing models.”

Photo: Medicrea

This post has been updated with comment from L.E.K. Consulting.