As a medtech startup, you have an idea that could perhaps change lives. But how do you ensure your innovation works and is safe, effective, and scalable?
This is where Quality by Design (QbD) comes in. It's a mindset that can guide your journey from prototype to final product. Let's walk through how we incorporated QbD at Enhatch and some lessons we learned along the way.
Quality by Design is a systematic approach to product development in which quality considerations are proactively incorporated throughout the product's lifecycle.
For medtech status, this means embedding quality into every decision, from initial sketches to clinical validation and beyond.
One of the first lessons we learned at Enhatch was to define our goals clearly.
Document these answers. They will act as your compass throughout development.
In medtech, it's about translating an idea into a product that works in real life.
This starts with defining design inputs (design requirements, what the product must do). Design inputs are the starting point for product design.
Design inputs should be linked to design outputs (how the product will achieve this). Design outputs involve everything that goes into making the medical device.
For example:
At Enhatch, each input-output pair was tracked and tested. This traceability ensured we stayed aligned with our goals.
Testing isn't just for the final product. We tested at every stage.
This consideration of quality throughout each phase allowed us to catch issues early and drive toward a reliable product with consistent outputs. Testing revealed any gaps and gave us time to pivot.
Risk management isn't just a checkbox for compliance. It's a way to protect your innovation.
We created a detailed risk management plan early. Every risk—technical, clinical, or operational—was identified, assessed, and mitigated.
One lesson we learned? Risks evolve.
In such a fast-paced development field, we were noticing increased cybersecurity concerns arising and flushed out a comprehensive security approach to address these risks and maintain operational effectiveness with controls and mitigations Staying proactive kept us ahead.
An advantage of being a medtech startup is transparency, open communication, the ability to wear many hats, and, thus, the shared ownership of embedded quality.
QbD isn't just for your quality team; it's everyone's responsibility.
At Enhatch, we have focused on creating a quality-first culture right from the outset.
We held regular cross-functional meetings. R&D, quality, clinicians, data scientists, and marketing contributed to shaping the product. This collaboration helped us see blind spots and align on the bigger picture.
Tip: Encourage open communication. Some of our best ideas came from unexpected sources.
Documentation can feel like a chore, especially when you're moving fast, but it's non-negotiable in medtech.
From our design history file to our risk management reports, documentation created a solid foundation. It also made audits and regulatory submissions smoother.
The key? Make it a habit.
We right-sized a regulatory-compliant QMS for the applicable procedures and policies to adopt and enforce. Additionally, we used tools to automate where possible, reducing the burden on our team.
The medtech journey rarely goes as planned. Regulations change, market needs shift, and your product will evolve.
For us, early feedback from customers highlighted features we hadn't considered. Instead of adhering rigidly to our original plan, we adapted. This agility allowed us to create a product that truly met user needs.
As a startup with an AI-powered product, we faced unique challenges. Ensuring the algorithms were transparent, explainable, and reliable required extra attention.
We incorporated QbD into our AI workflows by:
This approach not only built trust with users but also aligned with regulatory expectations.
Regulators aren't your adversaries; they're your allies.
Our perspective of the FDA changed drastically after the opportunity for three Submission Issue Request (SIR) Q-Submissions. The FDA is very amenable to collaboration and discussion about your device and the sooner you initiate the better off you are.
Engage with the FDA early, seeking feedback during pre-submission meetings. This helped us align our QbD practices with regulatory expectations.
Tip: Don't wait until the review period clock is ticking to start these conversations. Early engagement saves time and reduces risk.
Building a medtech product is hard work. QbD doesn't happen overnight. Celebrate milestones along the way.
For us, every completed prototype, successful test, or positive user review was a reason to cheer. These moments kept us motivated through the tough times.
Incorporating Quality by Design isn't just about compliance; it's about building a product you're proud of. It ensures your innovation delivers on its promise and improves lives.
As you embark on your medtech journey, remember to stay patient, stay focused, and keep learning. And if you're using AI, embrace the unique challenges and opportunities it brings.