Automotive Manufacturers: Overcoming the Challenges of Medical Device Regulation and Compliance
At a time when the news is dominated with uncertainty and distress, it is uplifting to see automotive manufacturers join in collaboration with the medical device industry to overcome the current shortage of badly needed medical devices needed to respond to the unprecedented public health crisis.
Collaboration between the automotive and medical device manufacturing industries is novel. It will necessarily come with significant supply chain and quality control challenges as the two industries seek to blend their capabilities to meet today’s needs. To their credit, automotive leaders have been undaunted by these challenges and are determined to play their part in helping the United States recover. Yet overcoming these challenges will be crucial to our ability to rebound and resume normal lives in the near term.
The quality standards and complexities of the regulatory and compliance frameworks for medical devices are different than automotive. Complicating matters further is the fact that automotive companies will now need to engage with new political and regulatory stakeholders. Successfully navigating these complexities in the necessary expedited fashion increases the need to develop a pragmatic lens from which to evaluate them and then to work through them.
Three Key Challenges
Manufacturing Quality
While leaders in the automotive space have deep and stable relationships with regulators at agencies such as the National Highway Safety Administration (NHTSA), other agencies will have growing importance to support the shift to manufacturing medical devices. These include agencies such as the Environmental Protection Agency (EPA) and the California Air Resources Board (CARB). Members and staff of Congressional committees will also need to be considered, including the House Energy and Commerce Committee and Senate Commerce and the Environment and Public Works Committee, among others.
Commercial Compliance
Automotive companies must understand and address the key differences in manufacturing quality standards between automotive and medical devices. Although the Food and Drug Administration (FDA) is providing as much regulatory flexibility as possible, automotive manufacturers must still follow specific guidelines to manufacture and deliver a safe and effective medical device. Additionally, manufacturers should plan for possible legal scrutiny from plaintiff attorneys who have built a practice around medical device liability.
Navigating a New Political and Regulatory World
While leaders in the automotive space have deep and stable relationships with regulators at agencies such as the National Highway Safety Administration (NHTSA), other agencies will have growing importance to support the shift to manufacturing medical devices. These include agencies such as the Environmental Protection Agency (EPA) and the California Air Resources Board (CARB). Members and staff of Congressional committees will also need to be considered, including the House Energy and Commerce Committee and Senate Commerce and the Environment and Public Works Committee, among others.
Automotive manufacturers need to consider the various medical-device related quality and compliance risks and mitigate the potential of significant legal, political, and reputational problems. Regulatory and compliance frameworks that may be acceptable in the motor vehicle industry do not include the unique requirements, and special application of the various medical device codes, anti-trust laws, anti-kickback laws, and anti-corruption laws within the medical technology sector. These challenges underscore the need for clarity and focus on these risks and enable automotive manufacturers to properly harness the spirit and energy of collaboration and successfully deliver on their commitments to society.
