Integrating Quality Management for Medtech Startups

Bringing innovative medical technology to market is a daunting yet exciting challenge, especially for startups. Often, these startups have brilliant ideas but face significant hurdles when it comes to implementing effective Quality Management Systems (QMS) required for FDA compliance. Many founders mistakenly view quality management as a separate function from product development, which can lead to costly delays and setbacks. To help medtech startups avoid these pitfalls, it is important to integrate QMS into product development, define marketing and product requirements, and streamline management controls.

The importance of early QMS integration

Graphic courtesy of John Leavitt

Medtech startups often lack the product development history and customer feedback needed to guide their progress. Agility is crucial, as these companies need to test assumptions and adjust course frequently. However, this same agility can make robust quality management seem like a hindrance rather than an asset. A common misconception among founders is that quality management can be deferred until FDA submission. Phrases like, “Can’t we wait until the 510(k) submission for that?” are frequently heard from those who are eager to push their product to market. However, by delaying quality management, startups may face unexpected costs and development roadblocks. Integrating a QMS from the outset ensures that product development runs smoothly, with quality controls that mature alongside the product.

Who and when: simplifying QMS integration

Establishing a QMS can feel overwhelming due to the myriad of components, acronyms, and procedures involved. To simplify the process, startups should consider two essential variables: who is responsible for each part of the QMS and when it needs to happen.

By aligning QMS components with product development milestones, you can create a phased approach that maintains the agility startups need while ensuring that the appropriate controls are implemented at the right time. Identifying the person or team responsible for each part of the system ensures accountability, while setting expectations for what artifacts (eg, records, processes) are required at each phase, helps prevent last-minute scrambling to meet FDA requirements. This approach not only supports developmental agility but also helps avoid playing catch-up at the end of phases. By setting clear expectations early, startups can integrate the necessary documentation practices throughout the process, preparing for regulatory submissions without compromising speed or innovation.

Defining your marketing and product requirements

Effective documentation is crucial for both FDA compliance and the successful development of a medical product. Just as you would write a business plan, it’s essential to define your marketing requirement document (MRD) and product requirements document (PRD) early in the process.

The MRD should outline key factors such as who your customers and users are, what problems your product solves, and how it stands out or improves upon existing solutions. This document serves as the design input against which the impact of an effective product will be validated. Not only is the MRD necessary for FDA premarket approval or 510(k) submissions, but it also acts as a guiding vision for your team and development partners. As the vision for the product evolves, the MRD should be updated to reflect those changes.

Graphic courtesy of John Leavitt.

Building an effective management control system

Beyond the MRD and PRD, management controls are critical for medtech startups. These controls document all standard operating procedures and control document numbers, forming the foundation of the device master record, for which the company is responsible. Your startup, as the medical device manufacturer of record, will need to maintain these controls to ensure smooth FDA submissions and adherence to regulatory requirements. A qualified product development partner or agency can help draft and establish compliant records, processes, and document controls, working alongside ISO 13485-certified manufacturers to provide production, process, equipment, and facility controls. These experts streamline the integration of quality management processes, helping startups avoid unnecessary costs and delays while adhering to regulatory requirements.

Leveraging expert partners to ensure success

The ultimate goal for a medtech startup is to bring an innovative product to market efficiently while ensuring that it meets all regulatory requirements. The product must undergo FDA clearance, with a sound development plan and strong quality control processes. Startups that are unprepared for the complexity of FDA compliance often experience escalating costs and delays as they rush to create the necessary documentation at the last minute. In the worst-case scenario, a poorly controlled product may reach the market, leading to significant risks for the company and its customers.

Building a new medical technology without strategic partners can result in millions of dollars in unnecessary infrastructure costs. That’s why collaborating with expert partners who can implement an agile, yet compliant quality control plan is a critical advantage for any startup looking to scale efficiently and get to market faster.

Summary of key takeaways:

About the author:

John Leavitt is a lead industrial designer with Intelligent Product Solutions (IPS), an award-winning product design firm. He designs a wide range of products, including medical devices, digital imagining, transportation, and fire safety.  Since joining IPS, Leavitt has contributed to the design and launch of three FDA-certified medical devices along with the design and clinical testing of products that are now in review for FDA clearance. During his career, he has focused on designing products that have a positive impact on people’s lives, with a focus on medical products.

Prior to joining IPS, Leavitt was lead industrial designer at Air Techniques where he designed Class I & II medical devices for the dental industry.  Before that, he worked for Pride Mobility: Quantum Rehab, designing and developing complex rehabilitation power wheelchairs and accessories. At Quantum Rehab, he worked on a low-cost seating system and a low-cost power base. Both products have been launched internationally reaching a wide customer group, who previously only had access to lower-quality products. While working on Class III medical devices, he developed a working knowledge of the documentation, certification requirements, and good practices for developing new and revising released medical products.

He holds a BFA in industrial design and a minor in psychology from Rochester Institute of Technology. Leavitt can be reached at [email protected].