From Passing the Test to Driving Safely: A Journey of Quality Management in MedTech
When my daughter recently passed her driving test, it was a day of pride and achievement. After weeks of careful training with a great instructor, everything came down to one final test. But then, a little hiccup, her instructor couldn’t make it due to personal reasons. With the test looming and only a day to prepare, I rented a dual control car to give her one last practice session. We went out on the roads, and I couldn’t help but notice something: she was a good and safe driver, except for a couple of manoeuvres that I was a bit concerned about.
Despite my gut feeling, I decided to take a step back and not push too hard on those small concerns. The next day, she drove to the test centre with focus and determination, and by the end of the test, she returned with a big smile and her driving certificate. It was a proud moment, but I also knew that this was just the beginning of her driving journey.
Five days later, when she started driving her own car, she said, “Oh my God... I have to start again... new car... new control... new environment!”
It hit me like a ton of bricks. This wasn’t the end. Passing the test was just the first step. She had learned the basics, the rules of the road, and how to pass the test. But now, with her own car and the responsibility of driving independently, she had to focus on driving safely and enjoying the ride. It was time to shift her mindset from “testing” to safe driving in real-world conditions.
The Test Route and the Real Road Ahead
During her driving lessons, the instructor would often take her down routes that might be part of her test route. This strategy was designed to boost her confidence; she was already familiar with the roads and knew exactly what to expect when it came time for the test.
But once she passed the test, the real world was a different story. The test route was just a tiny fraction of the vast and unpredictable world of driving. After all, the roads ahead were full of risk, unfamiliar streets, unpredictable traffic, weather changes, and surprises around every corner. The test route was safe, but driving beyond it meant navigating new challenges.
The Shift from Test to Practice: A Metaphor for Quality Management in MedTech
This experience made me realise a striking parallel with Quality Management in MedTech.
In MedTech, we often focus on passing the test, getting products through regulatory hurdles, checking off compliance boxes, and ensuring everything is up to par for FDA approval. Like my daughter’s driving test, the process is crucial, but it is only the beginning of the journey. Once a product is on the market, it faces a new environment, like my daughter’s transition from the driving test to actually navigating real-world traffic. That is where the real work begins.
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Just like my daughter had to adjust to the new car, MedTech teams need to adapt to new challenges once their product is out in the market. They need to shift from passive compliance to proactive safety.
From Certification to Safety: The Real Journey
In my daughter’s case, the test was a checkpoint, but her true driving journey was about daily practice, adapting to new conditions, and most importantly, safe driving. Similarly, once a device is certified and launched, the work doesn’t stop there. The real journey begins when the device is used in real-world conditions by patients and healthcare professionals. That is when continuous monitoring, post-market surveillance, and ongoing quality management are critical to ensure the product performs as expected.
Just like my daughter had to adjust to the new car, MedTech teams need to adapt to new challenges once their product is out in the market. They need to shift from passive compliance to proactive safety.
Quality Management Lessons from the Road
- Testing is Only the Start: Passing the driving test doesn’t mean you are a perfect driver, just like passing FDA approval doesn’t mean a device is 100% risk-free or effective. Real-world performance is key.
- Continuous Monitoring is Essential: As my daughter adapted to her new car, she had to monitor her driving constantly, checking mirrors, adjusting speed, reacting to road conditions. Similarly, MedTech companies need to continuously monitor the performance of their devices through post-market surveillance, ensuring they don’t face any unforeseen issues after approval.
- Quality Management is About Adaptation: My daughter quickly realised that driving her new car wasn’t just about following the rules; it was about adapting to the environment. For MedTech, this means staying flexible and adapting to new challenges such as changing regulations, evolving patient needs, and emerging risks. Quality management isn’t static, it is dynamic.
- Risk Management is Key: One of my main concerns during my daughter’s test preparation was her ability to manoeuvre safely. The same goes for MedTech: you can’t just pass the test and forget about risk management. Ongoing risk assessments, particularly through FMEA (Failure Modes and Effects Analysis) and continuous clinical evaluation, are essential to ensure products remain safe throughout their lifecycle.
- Start with a Safety Mindset: When my daughter said, “I have to start again”, it was a reminder that even after passing the test, she had to learn to drive safely and confidently. In MedTech, this translates into a mindset where safety and quality are prioritised at every stage, from design to post-market. Quality isn’t just about checking boxes; it is about a culture of care and continuous improvement.
“Quality management is a lot like driving a car. You can pass the test, but it is how you handle the road that counts.”
In the end, whether you are behind the wheel of a car or managing quality in MedTech, the test is only the beginning. The real work happens when the product is out in the world, interacting with real challenges and real users. So, let us not just focus on passing the test; let us focus on driving safely, consistently, and with confidence, knowing that the journey ahead is all about continuous learning and improvement.
Ready to start driving safe? Let us talk about how we can make the road ahead smoother in MedTech quality.
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Excellent metaphor for the ongoing challenges of quality management at a medical device company! It reminds me of something I told my kids when they were learning to drive: "It's bad to get a traffic ticket but it's much, much worse to be in an accident." (product safety should be the ultimate concern, way beyond any audit findings)