Compliance has completely overrun Ortho companies who now focus only on “risk avoidance” |

Compliance has completely overrun Ortho companies who now focus only on “risk avoidance”

Compliance Gone Wild (OrthoSpineNews)

While Federal Investigators have the Brinks trucks lined up delivering penalty revenues in the billions, today’s pharmaceutical and medical device companies are forced to take extreme actions to safeguard themselves from scrutiny. No longer is it enough to do things in a compliant manner, in this environment companies find themselves working to prove that they are NOT violating off-label marketing, anti-Kickback, of FCPA guidelines. Proving a negative is almost impossible, so in efforts to thwart personnel from violating these laws companies are implementing and empowering Compliance teams like never before.

With the impossible task of proving the negative squarely on their shoulders, Compliance leaders are forced to do the next best thing, which is prove that everything has been done to prevent the negative. This takes the form of instituting myriad policies to document SOPs, extensive training, oversight, and disciplinary actions. With so much at stake (think hungry Brinks trucks standing by) Compliance teams naturally implement every conceivable measure and business leaders risk peril when they challenge or overrule compliance suggestions or directives.

In many companies the compliance team is not familiar with how products get designed, built, sold, shipped, etc. Instead, their knowledge is based on what must be avoided. Since ensuring the people are NOT doing things is far more challenging than the opposite, teams must look harder at everything, and   implement check points, inspections, or oversight into every process. While important, these mean extra work, more time, and delays to the business at hand.

Remember those drivers-ed training cars equipped with a brake pedal for the passenger seat? We now have Compliance teams perpetually riding shotgun with foot poised above this proverbial brake. They checking our speed against the posted limit, ask not where we are going but why, and request documentation that the chosen route is best, safe, and shortest. So will this ever change?

This can change, yes. However until every driver effortlessly follows the rules of the road, that brake pedal will stay  there, right at the feet of the Compliance team. Once compliant practices are fully understood and accepted by all personnel, and the new processes become as second nature as those required to requested a check or approve an expense report, two things will happen. First, Compliance will naturally revert to intermittent  checks instead of system-wide involvement. Also, once more people in the organization  understand the rules as well as the Compliance team, business leaders will be equipped to push back on excessively restrictive Compliance decisions. Remember that Compliance is tasked with proving the negative, so it’s natural to build in a margin of safety which often translates into additional hurdles to accomplishing key objectives.  Leaders who understand the laws and guidelines can  differentiate between the absolute requirements and this safety margin, and will be empowered to push back.

I remember in drivers ed there was an odd intersection where I had the right of way, yet I would always slow down anyway. The driving instructor would slide his foot behind his brake pedal and pull back to prevent me from braking at all. It never occurred to me that I might be able to put my foot behind the brake pedal on my side and do this back to him later on down the road….

POSTED BY

With over 15 years of experience in the medical device industry, Scott Barnard brings extensive experience and relationships with top executives and surgeons around the globe. After a tremendously successful career carrying a bag for Orthofix, a leader in electrical stimulation and orthopedic devices, Scott was promoted to Sales Management in 2002. Shortly thereafter, Scott was made Regional Sale Director of the 15 Western States. In 2007, Scott was promoted into the senior management team and played a key role in the merger and integration of Blackstone Medical after its acquisition by Orthofix. Working closely with the C-Level executives from both organizations, Scott’s efforts were rewarded and he was promoted again to the position of Vice President of Consultant Relations. In this role, Scott was responsible for leading the integration of Compliance best practices relating to paid interactions with healthcare providers across a steadily increasing number of global divisions for a highly visible, publically traded (OFIX) medical device company. Scott’s most recent role has made him one of the industry’s first and most-established professionals in this segment of the industry. Realization of the incredible need for expertise in this ever-changing area and his desire to educate and help many companies rather than just one, led Scott to the consultancy path where he is the Founder of Pathfinder Consulting. Pathfinder Consulting LLC serves to bridge the gap between industry and healthcare professionals by offering third party solutions to meet ever-stringent regulatory compliance requirements for the protection of the company and its employees’ liability.

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