Startups are besieged by demands on their time and resources, both of which are in short supply. That’s why they may be tempted to postpone developing and establishing a quality management system, in order to focus on what might be considered more pressing needs.
But that would be a mistake. First, of course, it is required by regulatory bodies. But besides that, it’s smart business to do it correctly. Failure to establish these systems at the start can prove to be extremely expensive down the line, hampering eventual success if the device ends up not meeting the user’s need or doesn’t perform as expected.
It’s not a question of “if” the company should create a quality system, but rather how to best to develop an effective system.
The Institute’s fourth lecture series covered this topic from a wide range of angles, moderated by Fogarty Institute chief technical officer Denise Zarins and featuring input from seasoned professionals that included Scott Wilson, vice president of regulatory affairs and quality assurance for Cala Health; Windi Hary, vice president of clinical, quality and regulatory for HeartFlow; and Maureen Bensing, an experienced consultant for medical device startups in Silicon Valley.
The startups and entrepreneurs in attendance learned the nuances of quality systems from a big-picture view of their importance down to an in-depth look at how to create one and why design controls are crucial for startups. In addition, Healyx, one of the Institute’s startups, shared an insider’s look at its recent journey into creating a quality management system, sharing best practices and lessons learned.
The Ins and Outs of Quality Management Systems
The first step may seem obvious, but can be easily overlooked. Before a company does anything, it has to start with a basic question: Is my device a medical device?
This is important because the answer helps determine regulatory pathways and the United States and European Union have different tools that determine classifications. Domestically, a good place to start is the FDA’s website, which offers insights into everything from the definition of a medical device to post-market requirements.
The European Union has a comparable process with a clear-cut classification system that defines medical devices.
And then, everything flows from that:
- How you approach the depth of your quality system
- The type of technical files or design dossier you need to put together
- Necessary proof to outline and solve the potential risk of your medical device
Why should you care about your quality system?
Well, first off, it’s the law. In California, for example, you need to have a manufacturing license in place even to ship devices for clinical studies.
But meeting regulatory requirements is just the first reason that a quality system is key. Its most value-added purpose is to provide a business advantage: A simple, easy-to-understand system can provide a common understanding and structure that your company will coalesce around – and later, that strategic partners will appreciate when they value your efforts.
Given the rapid pace of development and the myriad individuals who are working on your innovation, from different team members to consultants, a quality system provides a consistent common language for elements from user needs to evaluating risks to labeling to distribution across multiple markets.
It provides a mechanism to make sure that team members can work interchangeably as needed, but also establishes cross-functional approval, ensuring that that no one single person can make a significant change unless the remainder of the team buys in.
A quality system can complement and strengthen your intellectual property strategy, and can help outside entities evaluate your company through the insight it provides. A quality system:
- Serves as an outside indicator that you are simultaneously being deliberate and creative.
- Demonstrates how transferable your work is and if your efforts are repeatable.
- Creates a common understanding with vendors, who have quality systems of their own, thus improving your interaction.
- Reduces business liability and risk.
While there is a common expectation for quality systems, that doesn’t mean that one size fits all. “Plug and play” doesn’t work: The system needs to be appropriate to your company, customized for scalability and evolution in a way that makes sense for your company specifically.
In whichever way you approach your quality system, the most important principle is: Your team is going to go create value through its precise, creative and unique efforts – use your quality system to capture that important work in a systematic and efficient way, so that you and others know what you have done.
Transitioning into your quality systems – When and how to implement
There is no substitute for implementing a simple quality system early on. Creating that structure forces companies to get the documents in place that will be later required for submissions, and it also helps create a common culture where everyone is on the same page and understands the road map, so you are not changing how you do business on a whim.
Your system will evolve as your company does; implementing a quality system is a process where you tackle the parts that are pertinent to your current stage.
For example, in the research phase a quality plan will help you:
- Understand the unmet need.
- Give insight into your cost structure.
- Identify your end user.
- Detail your competitive advantage.
- Determine the market size.
- Formalize your need for initial filings, patentability and regulatory and clinical requirements.
- Ensure design verification, validation and risk analysis.
In other words, it will be a living document that states your intentions and implementation timeline.
Then to phase in the rest of your system, work backward from your regulatory milestones, considering the size of your company and the risk of your medical devices. The higher risk the device, the sooner the quality system should be implemented.
Current trends are pointing towards implementing quality systems early in the process. In Europe for example, you need to have a quality system qualified before you receive your CE marking. The FDA also is now assessing which quality indicators should be in place in earlier phases as they aim to reduce recalls and adverse events.
A Focus on Design Control
While just one aspect of the quality system, design control deserves special attention because of its import.
While the product idea is the first step, it is just as important to envision the end product and how it will be used. Design controls are required for medical device companies: Regulatory bodies emphasize the need for knowing your device so you can understand and control any potential risk.
The time spent developing it upfront is paramount and will pay off in the long term. That’s because an effective design control will:
- Create a repeatable and hopefully predictable process for developing your product.
- Show you are in control of your product development.
- Provide a means for supporting risk assessment/risk control of your product.
- Establish appropriate identification and traceability of the product.
- Demonstrate the product is effective, which can save a lot of work in the long term. After all, you don’t want to get too far and realize the design is not meeting user needs.
- And ultimately, it will ensure you receive regulatory approvals to allow you to get your product to market
Healyx Labs Case Study
As Fogarty startup Healyx develops its device for wound care, it is currently in the process of implementing its quality system evolution.
Healyx had already completed some of the foundation for establishing a quality system. They had conducted extensive research in Bangladesh to determine the need and built out their prototypes to guide the understanding of how the device would fit the users’ need. They were very sophisticated in their documentation with users from the start, which eased their process.
When they joined the Institute, they developed a quality system that enabled them to advance their device. While their initial documentation was helpful in starting the process because it was so detailed, it lacked compliance requirements, as well as cross-functional review, which is a critical component of the process.
Healyx developed a basic system in a lean, cost-effective manner. Thanks to the system now in place, the product development milestones seem more approachable in terms of design control phases. While it forced them to make design decisions earlier, it gives them leeway to change things later if needed without being penalized and gives them confidence they are designing the right product for the end user.