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When Should Medtech Startups Implement a Quality Management System?
“Too Late. These two words summarize the reason for the failure of most med tech startups” (Kamen).
Medical device development is a game of time. Every critical decision either preserves momentum or quietly erodes it. And one of the earliest – and most misunderstood – critical decisions every medtech startup must make is choosing when to implement a Quality Management System (QMS).
What follows is a three-step framework to help you implement a QMS when it creates leverage – without sacrificing early momentum.
What a QMS Actually Does
A Quality Management System is a formal framework that allows you to control your design documentation: design drawings, requirements, test methods, plans, SOPs, and more. At the heart of a QMS is controlled documentation, a critical aspect of medical device development, one that is invaluable to understand as early as possible. Here’s a quick breakdown.
When a document becomes controlled, its current state is locked, and any future changes will require a formal rationale, review, and approval before implementation.
Imagine you’re the Chef of a Michelin – star restaurant.
You release your summer menu built around seasonal ingredients—sweet corn, tomatoes, zucchini. Once June arrives, the menu is locked. For the next three months, your guests enjoy consistency – same recipes, flavor profiles and presentation. Additionally, your suppliers rely on predictable demand.
But seasons change.
When fall arrives, the menu must evolve—pumpkin, squash, mushrooms, apples. That transition requires coordination, approvals, and new sourcing decisions.
The Rule of Thumb
Similarly to a Michelin restaurant’s menu adjustment, controlled medical device documentation becomes rigid, requiring rigorous assessment and consent prior to integration. Depending on your startup’s status and position, this rigidity may be appropriate. However, most professionals will encourage you to invest in a Quality Management System as early as possible.
I disagree.
A QMS is powerful only when your system is ready to be controlled. Until then, it will not drive quality – just add inopportune complexity.
Who Does This Advice Apply To?
To provide effective guidance, the first question that must be answered is “who does this advice apply to”?
Out of the four phases of the medical device development lifecycle,
- Concept
- Development
- Validation
- Commercialization
this conversation is most applicable to teams in the concept phase. If you are still shaping your idea, outlining your end user’s needs, and just starting to build momentum through prototypes, you are at risk of premature QMS adoption.
To QMS or Not To QMS
If you’ve reached this part of the article, you are probably in the concept phase of development and this is precisely the area of development where new medtech founders have a massive advantage.
You’re fast, resourceful, audacious, agile, and you need to maintain this mentality for as long as you can. But here’s the challenge
- Implementing a QMS too early will smother your fire and derail your productivity.
- Waiting too long may lead to delays in FDA approval, accrued cost, and painful retrospective documentation.
So where’s the sweet spot?
The rule of thumb I want you to follow is simple; Refrain from a Quality Management System until:
- Your user needs are complete and translated into engineering specifications. You’ve extracted as much information from your end user as possible. You understand their expectations, their pains, their circumstances. And you’ve taken each of those needs and refined them into engineering specifications, aka design inputs. For a comprehensive breakdown of this process, check out my recent article “Biggest Mistake MedTech Founders Make… and How to Avoid It“.
- You’ve developed a comprehensive list of system level requirements. This activity is particularly hard. The good news is that you’re already on your way since you have a comprehensive list of design inputs based on your user needs.
The unfortunate news is that you will need to complete a rigorous risk analysis of your device, outlining potential failure modes, their severity, occurrence rate, detection rate, and controls for mitigating them.
Also, you need to identify the appropriate regulatory standards that apply to your technology, extract all of the critical considerations, then addressed them through your design.
This is a topic which deserves its own article, so stay tuned for that. It will transform your project from a semester-long exercise into a formal business; A business that will serve as your mission for the foreseeable future; A business that will improve the lives of countless patients. - You’ve developed a functional prototype. This prototype should clearly showcase the functionality of the technology, and it should be approved by your stakeholders. The design should encapsulate a majority of your user needs and the work necessary to address the remaining system level requirements should be planned out.
Final Thoughts on QMS Implementation
Before closing, I want to make one point crystal clear: not using a formal QMS does not mean you should stop documenting.
In fact, the opposite is true.
Early-stage teams should document everything – design decisions, assumptions, results, failures – early, often, and in detail.
Quality management systems are a critical part of any medical device development venture. However, rash adoption converts efficiency into bureaucracy. It promotes rigidity when you need agility.
Remember, medical device development punishes poor timing. So, use the framework we discussed today to implement your QMS not too early, not too late – but right on time.
