Medtech lessons from the Trenches: Arnaud's story on QA Engineers in Medical Device Companies
When Arnaud started his career, freshly out of university, he applied for a job as a QA Engineer at a Medical Device company. The company was at the stage where the clinical study was soon to begin on the innovative prototype. A device that would help thousands of men, by helping urologists detect prostate cancer based on ultrasound data.
Some of the early tasks he encountered:
Needed to structure and organize all the tests for the device, all in printable Word documents, and manually manage the complete V&V traceability in a single Excel file.
Prepare the office room, building some shelves to file and store all the printed documents in binders.
Choose a good ticketing system to track bugs and development tasks.
Some of the biggest memories from that time was the difficulty of printing documents for tests. Arnaud also remembered how difficult it was to keep the Excel traceability matrix up to date; after each test cycle, it had to be reviewed, and manual errors were so frequent that it was really frustrating.
Ticketing Journey and Risk Management
The ticketing system, Jira, was very useful in structuring the work of the development team, and they were very happy at the time to have implemented it, even though it was one of the only scans they had.
However, remembering the first risk management review meeting was not something he wished to hold in his memory bank. The main previous file was a big Excel file. After that, with each version, the team needed to go through everything again, with no link between this sheet and the test results or other design elements, which was very time-consuming. He also described this in a previous blog: Pursuing Paperless in an Medical Device Landscape - Part 3.
Time to set up a QMS
At the same time, the business also had to set up the QMS. This is essential when you want to start a clinical study. As there wasn't much in-house knowledge, the team worked with an external consultant who worked at the time on a set of documents, adaptable to fit our own device and company. Arnaud helped him set up the whole quality management system, maintain documentation, define document and design control. Another area where he remembers it was difficult to introduce Quality in a start-up company, most people see this job as a hassle, wasting their time, and they see Quality managers as a real police agent. The time spent on approval workflows and making sure people had access to the latest version of relevant procedures, work instructions, etc. was enormous. He also shared his experience in another article: Pursuing Paperless in an Medical Device Landscape - Part 4.
Today, although it still exists, he thinks fewer companies are in this all-paper system, but in fact, the paper-based approach, saving documents in word/excel, updating them manually in a shared drive doesn't make things any more efficient. It's just a matter of saving a few trees.
Arnaud moved into different roles later on, as an applications specialist, mastering the device to conduct clinical studies and train urologists in the use of our certified device throughout Europe. He then took on the role of Product Manager to shape and evolve the product according to the needs of users.
For Arnaud, working in a rigorous, structured and controlled environment is a default choice and he was surprised to find that in the less regulated industry of his career, there were no written procedures for some of the things he wanted to do.
5 Years getting Medical Devices to market faster.
Arnaud has now been working with former colleagues at Matrix Requirements for 5 years, and being in contact with many of our users, constantly hears quotes such as "I wish I'd started sooner". And seeing some startups walking the same path, he can only agree with them. If there had been a tool like such as Matrix Requirements back then, they'd have been much more efficient.
In any case, the team at Matrix Requirements realized that there was a huge need, and that need is still there today. When you focus on your innovative idea, quality and control seems like a waste of time, but in the end, you'll gain a lot. "I'm very happy that my two former colleagues, the two founders of Matrix Requirements, have built this tool which is now helping a large number of innovative ideas to see the light of day more efficiently."
It's very gratifying to contribute to making things change, and that's what Matrix Requirements is here to do, for all our customers, our partners and all the stakeholders in our network.