The Quality Management System (QMS) Pitfalls of Medical Device Entrepreneurship

Eric Fish, MS, MBA, Operations Director, NDA Partners LLC and Roberta Druyor-Sanchez, MS, Partner, NDA Partners LLC

Experienced medical device developers and manufacturers are well aware of the need and value of a robust Quality Management System (QMS) to ensure proper documentation and quality. Following the relevant standards improves the consistency of product quality and mitigates risks to the company by maintaining compliance with FDA and international regulatory standards, such as ISO 13485 and US FDA 21CFR 820. Building a robust QMS requires discipline and time that many emerging medical device or diagnostic companies may not have or fully understand how to implement. Ultimately, it is critical that these companies dedicate early resources toward QMS compliance and, in essence, “getting it right.”

What Are the Key Elements of a QMS?

There will always be various nuances depending upon the specifics of a given medical device product. However, any QMS will need to include standard operating procedures (SOPs), work instructions, and quality records to address elements such as:

• Documentation/Record Controls
• Design Controls including Product Realization and Risk Management
• Production and Process Controls
• Measurement, Analysis, and Improvement

​When Should a Company Implement a QMS?

The sooner a QMS is implemented, the better. As a medical device product is being designed and developed, whether it is software as a medical device (SaMD), an in vitro diagnostic (IVD), combination product, or a straightforward medical device, applicable design control documentation will be required based on the type of device and the regulatory agency’s requirements. For FDA, this may be a 510(k), de novo, or PMA submission whereas in the European Union it would be a Technical File. In an ideal world, these components are being tracked in a systematic way as soon as development work is completed. This required documentation becomes critical during the initial interactions with the regulatory agency, since it is not likely to have a successful FDA interaction without the documentation required in a robust quality environment.

Potential Pitfalls

Poor quality management systems can result in lengthy inspections from regulatory agencies, which cause FDA 483s (or warning letters), delayed product launches, and even failed mergers or acquisitions. When quality systems are complete and well organized, companies can bounce back from these setbacks. However, delays in establishing a quality system will add unnecessary costs, increase time delays, and strain normal operations. Failing to implement a QMS early is fairly common, especially when a product is spun out of an academic setting. During the early stages of developing a product, companies may not even realize they are creating a medical device, let alone the implications of approaching the FDA for marketing clearance/approval.

The Case Study

One of NDA Partners’ clients is a start-up company with less than a handful of people and is considered a “virtual company.” The company’s CEO is a highly experienced entrepreneur in the medical device field. When approaching NDA Partners, he described a previous company that he founded where the due diligence of a potential acquisition fell apart because of a poor quality system. The company had made faulty assumptions: 1) it was too early to invest in a robust QMS, and 2) the potential acquiring larger company could set up a quality system with their greater resources. In this case, he was wrong. He thought he had a deal in place, but the acquiring company was scared away when product and process changes had not been properly documented. They realized that the investment needed to improve the QMS was significant and lengthy and it negatively impacted the valuation of the company.

The CEO has since moved on to start a new medical device company developing an ophthalmic product. Learning from past mistakes, he engaged NDA Partners early in the development process (earlier than most companies would) in order to implement a full and custom-built QMS. NDA Partners Expert Consultants created customized SOPs and record-keeping forms for all aspects of a QMS, including design controls, risk management, purchasing controls including supplier audits of their contract manufacturer, and production controls, which are all properly designed to be easily transferable to a potential partner or buyer. NDA Partners experts then trained the company employees on the quality system to ensure they not only had the tools they needed, but that they could successfully execute their day-to-day responsibilities using it. Although the CEO’s expertise is in identifying emerging markets and corresponding products, providing the right resources for initial development, and then executing the transition of this new product to an acquiring company, he gained the knowledge through NDA Partners that in order to be successful, you also need to have a stellar regulatory and quality team as an additional resource for full execution of the process.

Experts at NDA Partners have collectively worked with hundreds of companies implementing, auditing, and improving quality systems by evaluating the needs of the company and then offering tailored QMS for usability within a variety of industries. They are available to support companies as they navigate the regulatory pathways including implementing a strong quality system and are experienced in many of the common QMS commercially available software applications, including Greenlight Guru, Master Control, and Grand Avenue.