The FDA, as part of the transparency initiative, has developed a Total Product Life Cycle (TPLC) report capability on their website (www.fda.gov). The intention behind this new report is to provide existing data to medical device manufacturers that will enable them to proactively address quality related issues as early as possible. The TPLC database allows users to search by type of device (product code) and provides a report that identifies the related 510(k) clearances for that particular product code, recall reports, and medical device reporting (MDR) information for the product code selected. What does that mean? Ultimately, companies should have quality systems that incorporate TPLC information into all aspects of their system; such as supplier qualification/monitoring, risk management, design controls, corrective and preventive action, and complaint handling. Incorporating this information throughout the entire life cycle of the device will bring devices to market more efficiently and with less issues post-launch.
Even though Risk Management and Usability Engineering are clearly two separate processes with unique requirements, they are interdependent and must communicate with each other during the entire product lifecycle. Risk Management identifies the risk of a medical device’s potential hazards and provides input to the design requirements. The process determines the likelihood and severity of those potential hazards, analyzing the device’s design, function and manufacture. Usability Engineering identifies and assesses risks associated with using the device. Controls used to develop product and usability specifications are established to mitigate the associated risks. The user interface, operation manual and/or instructions for use play key roles in Usability. Together, they help to ensure safe and effective medical devices are brought to the market. Their implementation takes time and effort, but is well worth the investment if field issues are mitigated.
The process of submitting a 510(k), demonstrating that your device is substantially equivalent to a device that is already cleared, can be daunting. Typically designed to be a 90-day review by the FDA, the entire process could take several months if adequate information is not supplied to the FDA. Their requests for additional information need to be met satisfactorily and in full, or you risk delaying your release schedule and going into a total of three rounds of questioning. If you have not adequately addressed the FDA’s concerns after three rounds of questions, your device will be found not substantially equivalent (NSE) to the predicate device(s). Ideally, you’ll avoid rejection and an NSE letter, and your device will gain clearance into the market, keeping your release on schedule and your investors happy.
Having a documented regulatory strategy developed early during a new product’s development life cycle and updated periodically is critical for a new product’s market success. An inaccurate or lack of regulatory strategy can lead to the product not being cleared for market in the desired countries, not being released to market on time because of regulatory hiccups that were not anticipated, and/or being released to the market with inadequate claims such that the product does not fulfill the need of the target market, thereby not selling. Many times during development there are disconnects between marketing expectations and engineering development plans. A thorough regulatory strategy will not only document the regulatory pathways, but also align the new product development team on critical product requirements (intended use, claims, indications, release countries, etc.) and tracks risk items for the selected regulatory pathways. A regulatory strategy is one location where these items can be aligned on at least at the highest product requirement level to ensure a smooth start for development. Periodic updates are very important. When changes are proposed in design, intended use, or claims or changes occur in the regulatory environment, an update to the strategy and proactive communication to the product development team will maintain alignment of the regulatory activities and business strategies, creating an efficient pathway to market.
Healthy CAPAs = Competitive Advantage
In the medical device arena, recalls are a fact of life and competitors love to find out that you’ve had one. Regardless of recall classification (Class I, II, or III), a recall procedure is instrumental in working in concert with a company’s post-market surveillance and agreements with suppliers. Companies should not assume there is never going to be an issue with a product and not have these procedures in place up front.
Each year, the FDA issues hundreds of warning letters to medical device companies for reasons ranging from manufacturing practice violations to breaches in labeling and misbranding. Companies responding well to the FDA’s demand for prompt compliance will ultimately return to the agency’s good graces and through the experience develop processes that result in better business both culturally and financially. But getting to that point may be a slippery slope if the issues in the letter are not addressed effectively and expediently.
On February 18, the FDA issued the final guidance document for the Pre-Submission Program and Meetings with FDA Staff. The Pre-Submission process is a way for industry to get feedback from the FDA prior to the submission of a premarket application (PMA, 510(k), HDE, IDE, de novo, etc.). The sponsor may submit a pre-submission application to the FDA requesting answers to various questions about the marketing application or clinical trial design of their device. The sponsor may request a written response, teleconference, or meeting. The FDA has committed respond to the sponsor within 75 to 90 days.
Innovative ideas for medical devices are often costly for manufacturers to make and for patients to own. However, not all innovative medical devices will cost you an arm and a leg.