Regulatory Pathway Strategising
A sound Intellectual Property (IP) strategy is more than just filing a patent. Using IP as a commercial strategy requires a complete understanding of market drivers, other commercial entities in the space, and the changing nature of the market and technology landscape. Vestech Medical ensures you are well informed to enable you to employ the most secure and cost-effective IP Strategy in the development of your device.
Understanding patents as a business tool, not just a statement of invention, is essential to achieving the greatest possible commercial success with an innovation in any field, but particularly in medical devices. Patent jurisdictions and their differences, ways to extend patent life, and to capture the full aspects of any invention are key to our approach to IP strategy. Failure to consider freedom to operate aspects and the misapprehension that patents “protect” you not only expose the inventor to commercial risk but also make the project less likely to achieve government funding and other investment.
Planning of the development path and understanding the sequence and interdependency of tasks, key project milestones, and critical path is vital to meeting your business strategy and commercial success. Obtaining successful regulatory approval of your device is not only dependant on technical success but also creating the project outputs (i.e., documentation) needed to meet quality and regulatory requirements. A common cause of delays in product approval is inadequate product testing, due to missed requirements or insufficient sample size, leading to additional product testing. It then leads to delays in product approval and subsequent need for additional funding.
Vestech Medical will work with you in mapping out the development plan, and de-risk the project, by giving you clear view of timelines, required activities, and the likely expense of each stage. Following the early business planning stage, Vestech Medical will support you in developing and fulfilling your business strategy to achieve success.
To protect the patients and users of medical devices, every jurisdiction enforces regulatory requirements to ensure medical devices placed on their market are safe and effective. While the intent is shared, the details of each jurisdictions regulatory requirements can be meaningfully different.
A well-devised regulatory strategy leveraging the nuances of each jurisdiction’s regulatory requirements can save significant costs and time to market, but this requires intimate knowledge of the intricacies of these requirements. Vestech Medical has first-hand experience in composing regulatory strategies for a wide range of jurisdictions, including the United States, European Union, Canada, UK and Australia, and can help you plan your pathway to regulatory compliance.
The order within which you plan to enter jurisdictions can affect your project timeline. Vestech Medical can help you develop a regulatory strategy for efficiently entering multiple jurisdictions by leveraging the approvals from one jurisdiction to gain easier entry into another. Thus, entering the market sooner.
Vestech Medical in the regulatory strategy also considers the regulatory requirements that impact product design. Some requirements are common whilst others are jurisdiction specific. Obtaining clarity on these requirements early in the project will allow for a smoother path to market and prevent delays due to product redesign.