The regulatory roller coaster of clinical research has always gone through
changes — ups and downs, twists and turns. However, these changes are undeniably more substantive and frequent in recent years. Recently, the European Medicines Agency (EMA) released a work plan for accelerating trials in the European Union (EU), and the more lenient requirements of the Medical Device Directive (MDD) transitioned to the stringent demands of the Medical Device Regulation (MDR), sending a wave of uncertainty rippling through every ongoing and upcoming clinical trial across Europe. Additionally, the Food and Drug Administration (FDA) announced its draft guidance for improving diversity in clinical research, increasing the challenge of enrolling a wider demographic of subjects.
What do these changes mean? Creators of innovative medical products now require even more innovative strategies to obtain regulatory clearance and maintain compliance in an increasingly complex global market. To build these robust regulatory strategies, like those tested and proven by our pre- and post-approval specialists, we suggest an examination of the three W’s of regulatory success: what to do, when to do it, and why It Takes Avania.
What to Do
There are no step-by-step instructions that ensure regulatory success. Shepherding medical products to market is an involved and lengthy process, and what to do might not remain the same from start to finish, whether due to a development in the trial itself or a shift in the regulatory landscape. This uncertainty can slow research progress to a halt, which is why most successful product developers seek out a strategic partner with specialized knowledge and the proven ability to predict and mitigate unexpected challenges.
Developing a comprehensive, empowering regulatory program starts with a list of broader considerations:
- What is the appropriate regulatory path to market?
- What is the product’s classification?
- What are the pre-clinical test requirements?
- What are the quality system requirements?
- Will this product need a clinical study?
- If so, how many and what do they need to demonstrate?
- How can existing data or predicate devices be utilized?
- What post-market follow-up is necessary?
- Will a reimbursement process be needed?
In the midst of such uncertainty — in the moments that will define the success of your medical product approval — it is imperative to answer these questions carefully and confidently. These answers will inform your regulatory strategy from the very beginning, providing a clear guiding light to the finish line of submission and approval. Whether you are navigating the currently tumultuous pre-market journey of MDR regulations in the EU or attempting to collect clinical evidence for post-market submissions, it is essential to know the what behind your regulatory strategies: what data you need, what requirements you must satisfy, and what information will keep your product viable over time. Such insight requires expertise and demands a history of success.
When to Do It
While it is critical to know what to do when building and deploying successful regulatory strategies, it is equally important that you understand when these strategies need to be planned, modified, and executed. At the start of your product’s journey to market, there are a host of pre-market requirements that must be met as well as a wealth of considerations when proactively positioning your product for success:
- How can your study benefit from early clinical program development?
- Which regulatory pathway offers the clearest route to market?
- How can you prepare for the rigorous Premarket Approval (PMA) pathway for Class III devices?
- How can timelines differ between 501(k) and de novo clearance?
- Are you capitalizing on preemptive evaluation opportunities, such as the Q-Sub program from the FDA?
At the same time, there are a number of post-market considerations that are essential to maintaining market compliance and nurturing continued product success.
- What post-market surveillance is required for your device?
- Are your corrective and preventive actions (CAPAs) comprehensive and effective?
- How will your regulatory pathway affect future market entries?
In confronting these considerations, timing and proactive planning mean everything. Preparing the right regulatory strategies at the right time — or choosing the right pathway and taking the right steps — requires experienced, knowledgeable foresight. The best strategic guidance will give you a leg up from the beginning, utilizing pre-market data and proven preparation to speed up every step of the process. This guidance can also instill confidence in your product’s progress over the long term, using robust post-market clinical follow-up (PMCF) and post-market surveillance (PMS) protocols to maintain compliance and manage risk. This level of regulatory confidence saves time, money, and ultimately, lives.
Why It Takes Avania
Knowing what to do and when to do it are not the same thing, yet you cannot hope to achieve prolonged regulatory success without both skill sets. You might know the precise definitions behind every component of the new MDR in Europe, but that knowledge counts for nothing if you lack the insight or experience needed to collect the required data in advance or to prepare inspection-ready documentation. You might have the foresight to recognize that your CAPAs lack consistency, but that foresight could be wasted on team members who don’t have the specialized expertise to proactively respond to those shortcomings and restructure plans appropriately.
These gaps in capability represent risks you cannot afford to take. Each day lost in your product’s regulatory journey can cost you millions of dollars. Avania’s experts will set you in perfect harmony with what to do and when to do it. Whether you’re looking to enter a new market, stay compliant with post-market requirements, evaluate transition plans from MDD to MDR, or expand on a product’s indications, we have efficient and effective strategies to support your journey from early development to post-market follow-up and beyond.
Advance Your Regulatory Strategies
Your MedTech innovation has a protracted journey ahead, from approval to long-term commercialization. Each stage of development is defined by its own requirements and processes, and Avania’s strategic direction will help you pair together the what and when of each regulatory milestone. We provide world-class assistance from start to finish, shortening timelines, instilling confidence, and fast-tracking your product’s approvals. To move your product forward, It Takes Avania.