Medtech Maturity: Assessing Regulatory Readiness

June 04, 2024

Nathan Downing presented on ways to assess regulatory readiness for medical products at a recent CLE program that Gardner Law hosted in Austin, Texas. If you did not have time to attend or watch live, please read below for some highlights and view the presentation online.

It takes a lot to bring a medical product to market in the United States. You need impactful technology and proper resources to develop a product for years without the assurance it will ever see a patient. Understanding your regulatory maturity will go a long way in burning down risks and increasing efficiency.

Gauging Maturity

Below are five high-level considerations that should be assessed throughout the life-cycle of your medical product. Having a strategy in place to properly address each can save time and money and ultimately provide a predictable FDA pathway.

  1. Classification: Failing to properly identify your medical product’s classification can have disastrous impacts. It can cause you to lose years and could ultimately sink your project. Have you vetted the classification with experts? Have you timely engaged FDA if further clarification is needed? Classification should be a focus throughout the lifecycle of your product.
  2. Quality Management System: The quality system should not be an afterthought. This will produce the evidence to successfully guide development for a commercial-ready product, navigate audits, and ultimately prove to regulatory authorities that your product can be marketed. It is imperative that companies adopt a compliant quality system, the longer you wait, the harder it is to properly put together.
  3. Submission: The submission seeking market authorization is a crucial step in any company’s history and should be treated as such. Do your homework to understand what your medical product will require and then deliver. Submission reviews can take as long as development itself and assessing submission readiness is not a final-hour task. Be detailed to limit deficiencies and take a proactive communication approach with FDA.
  4. FDA Communication: Engaging with FDA directly correlates with company maturity. Do you have a communication plan with FDA? If so, execute according to plan. If not, draft one and treat FDA with the seriousness required. Partner with FDA and educate them on your product and never miss an opportunity to provide value. The work done to communicate will pay off.
  5. Post-Market: Receiving authorization to market your product is a time to celebrate and then quickly start executing your post-market strategy. Do you have a plan to generate additional data? What is your change control strategy and how will it limit stress on your business? Taking a proactive approach, long before the submission has been sent in, will maximize the long-term success of your medical product.

If you are developing a medical product, you should constantly be gauging your regulatory readiness. Being engaged early and often on the five topics above will be a key to your success. If you need assistance with assessing your maturity, the team at Gardner Law can help.

Learn more about this topic by watching Nathan Downing’s session at Gardner Law’s Austin, Texas event.