3. Regulatory burdens on OEMs
Regulatory issues continue to challenge medical device companies of all sizes. The findings of a survey conducted in 2017 by the Emergo Group, a medtech regulatory consulting firm, reveal that regulatory issues are keeping medical device executives awake at night. When asked to identify the biggest business challenge they face, nearly 70% of the more than 500 senior managers of medical device companies surveyed cited changing regulatory environments as their top issue. But depending on the size of the respondent’s firm, other challenges such as product development, profitability and funding were also identified, according to Emergo’s analysts. Managers at smaller firms reported greater concern for funding and capital issues, while larger firms are more challenged by pricing and competitive pressures.
In all of this is an opportunity for contract manufacturers to provide OEMs with robust systems that help to streamline their regulatory compliance process. The FDA, for example, continues to request additional clinical and manufacturing data for product clearance and approvals, which can lead to additional research and development costs, among others. (In fact, the FDA recently released details of the agency’s Medical Device Safety Action Plan, which could mean new approval, review, compliance and post-market processes and requirements for manufacturers.) On top of domestic considerations, international regulations such as CE mark come with their own nuances and challenges.
Contract manufacturers can alleviate the stress by maintaining the proper FDA and international manufacturing registrations and OEM-level quality systems and personnel, as well as providing extensive documentation management and verification and validation services. Managing the regulatory “paper trail” and working closely with the OEMs’ in-house regulatory personnel is part of contract manufacturers’ growing value offering.