Medical devices are an important part of healthcare. The advances within this market help to continually improve patient care. The minds behind these innovations must balance new ideas with federal rules and regulations put in place to keep patients safe. In many cases this burden falls, at least in part, on the shoulders of the CEO.
What could go wrong?
In a recent example, the United States Attorney for the Southern District of New York announced a guilty verdict after the trial of a CEO of a medical device company. The jury found Laura Perryman guilty of healthcare fraud charges related to her company’s creation and sale of a non-functional medical device component. Perryman faces substantial penalties, including a maximum of 10 years in prison for healthcare fraud and up to 20 years for conspiracy to commit healthcare fraud and wire fraud.
The presiding judge has yet to move forward with sentencing for the conviction and will take various factors and guidelines into account during the decision.
How can I avoid similar allegations of wrongdoing?
CEOs must adopt a proactive approach to avoid similar allegations. It is important to have compliance programs in place that include comprehensive policies that adhere to healthcare regulations and conduct regular training sessions to educate employees about legal standards. Use of regular internal audits to better ensure all within the organization are in compliance can also help mitigate the risk of wrongdoing.
Medical device CEOs play a critical role in ensuring ethical and legal operations. By establishing strong compliance measures, they can protect their companies from the legal and reputational damages associated with healthcare fraud. Remaining vigilant and informed about legal requirements is not optional; it is a fundamental aspect of leadership in the medical device sector.
