Overcoming the Roadblocks to Medical Device Innovation

In September 1952, American surgeon Charles Hufnagel implanted the first aortic “assist” valve into a 33-year old woman with rheumatic heart disease.  Although the rudimentary ball valve clicked loudly enough to be heard by others, the woman – on the brink of death prior to the operation – was able to live a normal life for almost a decade.

Eight years later, in 1960, the Starr-Edwards Silastic ball valve, an artificial valve of almost identical design, was brought to market, and was sold by Edwards Lifesciences as recently as 2007.  

This 8-year gap between conception and full-fledged use of the artificial heart valve would now be considered remarkable.  Today, the development of surgical devices is far less expedient. According to a 2011 study, the average time lag in the medical research translational process – from idea to clinical implementation – is 17 years.  

There are a host of factors contributing to these prolonged delays in innovation.  Some of them are good.  There is an inherent conservatism in medicine that favors the status quo and, thankfully, views new devices with skepticism until controlled studies have proven their safety and efficacy.  It was this concern for public safety that led to the development of the United States’ FDA and Europe’s Notified Bodies, which only approve those devices that have been shown, in large scale clinical trials, to be safe.  But many have accused the FDA of overstepping its role: it not only demands that innovators establish the safety of a new product, but also its efficacy.  The added pressure to prove efficacy compounds the already long and resource-intensive process by which a device goes from an idea to clinically usable.  Thus, R&D and marketing of new medical devices is an enterprise of high financial risk.  The hope of financial benefit, however, is often slim.  Even if a device is able to establish itself as both safe and efficacious in large-scale clinical trials, it may not be eligible for reimbursement in the real world.  In systems where payments are made based on diagnosis-related grouping, for instance, a bundled payment rarely covers the price of an innovative device.  

It’s no wonder that a new surgical device takes 17 years to become clinically usable.  But while some of medicine’s resistance to innovation must be preserved for obvious ethical reasons, we can and should do more to accelerate the innovative process.

One of the more promising methods of achieving this goal is the collaboration between basic science, clinical science, and industry. A famous 2003 study found that the greatest predictor of successful clinical experimentation was industry involvement in basic science research.  In fact, when industry was involved in early phase experimentation, there was an eightfold acceleration in the translational process.  On the other hand, a more recent study published this year in the Annals of Surgery found that the most important factor in accelerating the leap from laboratory experimentation to trials in humans was clinical involvement in the early basic science phase.  
In reality, both studies likely point to truths that intuitively make sense. Successful bench scientists are reliant on clinical researchers to provide relevant direction and guide first-in-human trials.  Likewise, early industry involvement is often essential in navigating the complex and costly federal approval pathway and in marketing devices to a wider clinical community. Improved collaboration between these fields could overcome several of the current roadblocks to innovation and facilitate translation of novel devices from the laboratory to the operating room.



By Nicole Van Groningen