The FDA outlines very specific requirements for developing a medical device. These requirements necessitate a product development process that is conducted in a series of stages, where one stage must be completed before proceeding to the next. This rigor ensures that the assessment of risk and device effectiveness is reviewed and documented at all stages.
For example, the FDA requires that a clinical validation be performed “on initial production units, lots, or batches, or their equivalent”. The clinical validation tests that the device performs as intended, based on the user and patient needs, in a simulated environment. The design and product development should be completed in such a way that production units can be used for clinical validation. If the results of your clinical validation lead to a design change, you must go back and reassess design control and production control before clinical validation can be repeated. Almost all project stages will need to be reviewed and evaluated, even if the design changes have minimal or no impact on risk
A Quality Management System (QMS) is as a set of documented processes that demonstrate how your company complies with the FDA’s regulatory requirements, such as clinical validation outlined above. The international standard for QMS is outlined by ISO 13485 and we’ll discuss the differences between these a little later.
If your company develops and manufactures medical devices for sale in the United States, your company and its Quality Management System will be investigated by the FDA. Additionally, if your company is going to design and/or sell a medical device in the US market, you will likely need to prepare and submit a 510(k) or Premarket Approval to the FDA for device clearance or approval. Regardless of which path you take, your Quality Management System will be essential as you navigate this process. Here are just some ways a well-managed QMS can enhance your medical device design.
1. It keeps your medical device design FDA compliant
Why is FDA compliance so important? To answer that, let’s take this real-world example where a leading medical device manufacturer was found to be out of compliance:
From 2005 to 2007, a leading medical device manufacturer, produced and sold an Electro-Surgical Pencil, a medical device that used high-frequency electric current to cut, cauterize and destroy tissue.
Though the company sterilized their device, they had poor manufacturing practices that did not comply with the FDA’s documentation and process control requirements. Federal investigators determined that the owner of the company falsified sterilization records and tried to mislead the FDA. As a result, the owner was sent to prison for 4 months.
Facing jail time, heavy fines, and/or recalls are just some of the consequences of not complying with the FDA. More serious consequences include patient injury or death. The FDA’s role as a regulatory agency is to prevent harm to patients and ensure that medical devices are safe and effective.
By complying with FDA regulations, you’re not only following the law, but you are demonstrating that your company’s medical devices are safe and effective for use.
2. A QMS makes the 510(k) or Premarket Approval process easier
A 510(k) submission is s formal process for providing documentation to the FDA that your medical device is safe and effective. The FDA will then “clear” your medical device for commercial distribution. A PMA or Premarket Approval is a similar application process but for more stringent Class III devices which require FDA approval, not just clearance.
The FDA will investigate your company within 2 years of you marketing your medical device product, usually within 2-4 month after registering. If you’re just starting to develop and manufacture a medical device, our recommendation is to first establish a QMS. Then, as you develop your device, in parallel you should also be preparing your 510(k)/PMA submission.
If done properly, your 510(k)/PMA submission will be ready as your device nears the end of development, and the QMS that you’ve had in place since the beginning of your project will document your compliance when the FDA comes to investigate. Many companies run into trouble when they start developing their medical device without establishing a proper QMS. This can lead to not having the right documents for submission or when the FDA comes to investigate.
3. The Quality Management System keeps your medical device design project on track
As mentioned previously, it is important to implement a QMS in your company as early as possible, ideally before the development of your medical device. This helps ensure that all the required documents needed for 510(k) or Premarket Approval submission and FDA investigations are prepared in a logical order. It’s very difficult to retroactively fill in missing documents.
A common mistake companies make is not applying proper “Design Control” during the development of their medical device. While medical device companies can use whatever design process they want, the FDA requires that the design process follow the requirements of the FDA for Design Control (outlined in 21CFR820.30).
When a company prepares their 510(k) submission, it can be misleading because you are only required to submit the device’s performance testing and not the entire DHF (Design History File). The Design History File is documented proof that your design and development process followed the FDA requirements for Design Control. Performance testing is only one part of the DHF.
If you took a shortcut, and only did the performance testing, there is a chance that your 510(k) submission will clear but you may be in trouble later when the FDA investigates your company.
4. It adheres your medical device design to ISO 13485 standards
If a company is ISO 13485 certified, it means that they have a Quality Management System that meets the International Standard for Medical Device Manufacturing. While ISO 13485 certification is not required to comply with FDA regulations there is a lot of overlap between FDA and ISO 13485 requirement. This makes ISO 13485 certification advantageous for complying with the FDA and with various international regulations such as Canada or the European Union.
One major difference between ISO 13485 and FDA compliance is that ISO 13485 certification is done through a 3rd party company, known as a notified body. This self-certification means that you can schedule when the notified body will first audit your company. Instead of waiting for the FDA to come and investigate your company, you can become ISO 13485 certified before you ever release a medical device. This is a good way to actively show that your company complies with medical device requirements long before the FDA investigates your company.
5. A well-established Quality Management System helps mitigate risk
The FDA and ISO 13485 requirement have one overarching goal: to make sure that medical devices being sold are safe and effective. Mitigating any risk is one of the many advantages to using a product development company that has a well-established Quality Management System, is used to developing regulated medical devices, and is ISO 13485 certified.
Almost all products are human-centric. However, many product development companies disregard potential harm that their products can have on the human body. By following proper Design Control, a product development company can meticulously ensure all products, regardless of if they are medical or not, can meet all the user and intended use requirements. At Synectic, our experience developing medical devices leads us to use materials safe for human contact. We also perform biocompatibility testing, which checks that all parts of your product touching human skin will not cause irritation.
In conclusion, complying with FDA regulation is a formal process that demonstrates your medical device design is safe and effective. Before developing a medical device, we strongly recommend that you have a Quality Management System in place that complies with the FDA. If you are unsure where to start or how to go about establishing such a system, partnering with a product development company that is experienced working in medical device is a great place to start. This ensures that your medical or non-medical product is designed using a robust system that minimizes user harm and maximizes intended use. When choosing such a company, find one with an ISO 13485 certificate that had demonstrated that their processes meets the international standards for medical device design, development and manufacturing.
About Synectic Product Development: Synectic Product Development is an ISO 13485 compliant, full-scale product development company. Vertically integrated within the Mack Group, our capabilities allow us to take your design from concept all the way to full scale production. With over 40 years of experience in medical device design and manufacturing, we strive for ingenuity, cost-effectiveness, and aesthetics in our designs. Learn more about our medical device design services and see how we can help your next project.