Medtech Maturity: Regulatory Readiness Assessment | Gardner’s law

Nathan Downing presented on how to assess the regulatory readiness of medical products during a recent CLE program hosted by Gardner Law in Austin, Texas. If you didn’t have time to attend or watch live, read some highlights below and watch the presentation online.

It takes a lot of effort to bring a medical product to market in the United States. You need effective technology and adequate resources to develop a product for years without knowing it will ever reach a patient. Understanding regulatory maturity will greatly help reduce risk and increase efficiency.

Maturity measurement

Below are five general issues that should be considered throughout the lifecycle of a medical product. Having a strategy to properly address each of these can save time and money, and ultimately provide a predictable FDA path.

1. Classification: Incorrectly determining the classification of a medical product can have disastrous consequences. This can waste many years and ultimately sink the project. Have you checked the classification with experts? Have you contacted the FDA in a timely manner if further clarification is needed? Classification should be a concern throughout the product’s life cycle.
2. Quality management system: The quality system should not be a secondary issue. This will provide you with evidence that will allow you to successfully guide the development of a market-ready product, pass audits, and ultimately prove to regulators that your product can be brought to market. It is essential for companies to adopt a compliant quality system. The longer you wait, the more difficult it is to prepare it properly.
3. Submitted work: Submitting an application for marketing authorization is a key step in the history of any company and should be treated as such. Do your homework to understand what your medical product will require and then deliver it. Reviewing submissions may take this much time, unless developing and assessing the readiness of the submission itself is a last-minute task. Provide detailed information to reduce deficiencies and take a proactive approach to communicating with FDA.
4. FDA announcement: Cooperation with the FDA directly correlates with the company’s maturity. Do you have a communication plan with the FDA? If so, follow the plan. If not, draft and treat the FDA with the seriousness it requires. Collaborate with the FDA and educate them about your product and never miss an opportunity to provide value. The work you put into communication will pay off.
5. Post-launch: Receiving approval to bring your product to market is a time to celebrate and then quickly begin executing your post-launch strategy. Do you have a plan to generate additional data? What is your change control strategy and how will it reduce stress in your company? Taking a proactive approach well before submitting your report will maximize the long-term success of your medical product.

If you are developing a medical product, you should constantly review your regulatory readiness. The key to your success will be engaging early and often in the five topics above.