Every technology and product sold in the US and any of the major markets around the world requires regulatory clearance by the respective government agency. The regulatory requirements are constantly changing and becoming more complex. With decades of experience working both on the sponsor side and for the FDA (at different time periods), we understand how to navigate this environment. We also understand the implications of the regulatory requirements on product design, marketing plans, reimbursement, competitiveness and market acceptance.
Understanding the intricacies of such issues and developing appropriate plans can spell the difference between success and failure for projects and investments. Selecting less than optimal strategy can be prohibitively expensive, extend time-to-market and slow down sales for otherwise, promising products.
Boston MedTech Advisors can assist medical technology companies, inventors and investors in addressing these critical issues by:
- Reviewing FDA and other pertinent regulatory guidelines to develop rational regulatory strategies and plans, addressing short and long term corporate objectives
- Incorporating the regulatory and clinical testing requirements into the product development process
- Preparing regulatory filing plans, Pre-Submissions, 510(k), De Novo, PMA and IDE applications
- Conducting meetings with the FDA and other regulatory agencies
- Evaluating the regulatory impact on marketing campaigns
- Developing plans and conducting audits for compliance with FDA and CE quality systems requirements
- Representing companies in discussions with regulatory agencies concerning compliance with QSR requirements and providing training on compliance with QSR and internal company procedures
- Negotiating with regulatory agencies and formulating corrective actions to adverse regulatory actions
- Assisting management in developing comprehensive plans for emerging from operations under consent decree
Case Studies: Regulatory Affairs and QA
Over the years, we have submitted numerous applications for 510(k) Pre-Market Notifications and Pre-Market Approvals (PMA) for diagnostic and therapeutic products, including complex electromechanical systems, computer-controlled devices, disposables and single-use devices, implantable devices, combination devices, etc.
A company developing revolutionary new technology required a regulatory clearance prior to marketing.
To reduce costs and allow faster product introduction, we have identified a unique patient group that could immediately benefit from the device. Communications with the FDA led to the qualification of the device as a Humanitarian Use Device, allowing early submission of the device for marketing clearance, under the Humanitarian Device Exemption statute.
A company developing a new surgical instrument required an approval from the FDA to conduct clinical studies within a limited timeline.
We formulated and presented to the FDA the scientific, clinical and regulatory evidence of the technology, and obtained approval for a clinical protocol that significantly shortened the trial duration and allowed meeting the clinical end points with a smaller number of patients. This resulted in significant savings in trial costs and acceleration of the time to market.