Will the sun shine translucently?

As manufacturers prepare to submit the first Open Payments (Physician Payments Sunshine Act) report to CMS on March 31, 2014, the question at hand is how will this affect and influence medical device research, education, and clinical decision-making.

The act is intended to stop dishonest influence that can harm patients by bringing transparency to the relationship between physicians and industry. Yet, there are well intended and beneficial reasons for industry payments to physicians, which at a quick glance may be shadowed by the focus to reveal ill unethical physicians. 

We can all agree that shining the light on the blatant influence of large payments for the purpose of corrupting physicians' judgment is in the best interest of patients.  But we don't want to throw the baby out with the bathwater.

There are three cases where the relationship between industry and physicians, which includes the exchange of funds, benefits patients.

First, medical devices are constantly changing with innovations in material and technology. Consider the innovation life cycle of pacemakers.  Early versions of pacemakers were large and made with heavy material.  Modern pacemakers are sleek and lightweight.  Pacemaker innovation, in part, is a result of the interactive relationship between physicians and medical device companies.  These interactions occur as a result of funded studies and subsidized training, ultimately benefiting patients. 

Though the speed of innovation for medical devices differ between device types, what is consistent is the catalysts for innovation.  For medical devices, innovation occurs during two stages; 1) prior to submitting the medical device to FDA for approval, and 2) post FDA approval.  It is the post FDA approval feedback from physicians treating patients under real world situations that enable medical device companies to make quality improvements to their next generation device. This feedback loop is invaluable.

Second, implantable medical devices require extensive training for the physician and surgical teams.  To remain proficient and safe in implanting a device type, physicians typically focus on a few manufacturers' medical devices, rather than learning all manufactured devices.  Since medical device training can be subsidized by a company to off-set the cost to the physician and hospital, the perception may be an inaccurate deduction that medical device companies are influencing clinical decisions. Removing the training subsidies or requiring physicians to learn to implant all manufactured devices does not benefit patients, if anything it increases risk to quality health care.

Third, the difference between Class I, Class II and Class III medical device classification impacts the ability for companies to obtain feedback on their products performance in the real-world setting.  Class III and some Class II medical devices are typically implants.  Under specific circumstances, FDA can require a Post-Approval Study (PAS) to further monitor devices for safety and effectiveness, and answer long-term performance questions.  But, these studies are very expensive, often tens of millions of dollars and are typically only requested for a subset of Class III devices.  Yet, a benefit of these studies is to provide industry formal access to patients' clinical data.

Since most devices are not part of the formal FDA PAS process, industry solicits research studies to further their understanding of device performance for the development of the next generation.  Again, the relationship between industry and physicians compensated for their time to collect study data can be perceived as influencing research and clinical decisions, yet benefits patients with the next generation device. 

How the medical device manufacturers' dollars to physicians will be presented by CMS to the public this September is yet to be seen.  We can hope that the data collected and compiled will be the right data for intelligent decisions(SM).  

-- Vizma Carver, Founder and CEO, Carver Global Health Group

vizma.carver@cg-hg.com