Why Your Medical Device Start-Up Needs a Lean eQMS

In this blog, Shaun Knights, Head of Quality at period care company Callaly, tells us why his start-up needed an eQMS - and why yours does too.

Callaly is an award-winning British period care start-up and the inventor of the revolutionary tampliner. 

When I joined Callaly in 2019 I was one of only a few employees who had been drawn specifically from a medical device and quality background.

As a result, it became one of my objectives to build an eQMS for the company. I wanted to create the right support for what I knew could be a challenging journey from innovative start up to international challenger brand, in a sector that had seen little disruption in 70 years.

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Given the perceived complexity involved, it was quite unusual for a startup to want to build an eQMS so early on in its journey. Many entrepreneurial companies believe that a focus on quality systems strangles their creativity and kneecaps their agility. I don’t agree. Done properly, I knew it would be vital for our global ambition to focus on quality early and power future growth.

FDA compliance and ISO certification were vital for our growth

In the US, menstrual products are classed as medical devices, while in Europe they are not. We needed FDA 510k clearances to trade in the US, so getting a QMS in place would be a necessity for future compliance. Regulation in the UK, however, meant that we didn’t need ISO 13485, but I still wanted to gain ISO 9001 to ensure that our focus on quality and our customers would be ‘built in’ to the way we worked.

From my experience in innovation and development I had seen what could happen if you didn’t bring your process and documentation under control early on - and it wasn’t pretty.

5 reasons every medical device start-up should build their QMS at the start of their journey:

1. You need structure from the word go

When I arrived at Callaly I understood that we needed to get organised and take a structured approach to quality from the outset.  

In my career, working with big corporates developing new products, I’d seen how a piecemeal approach to quality could result in documentation that was an absolute mess. I’d seen companies battling with vast and complicated Quality Management Systems, which had grown out of control over time. Anyone who has been part of an organisation that’s not controlled its documents knows the struggle involved in retrospectively trying to ‘make it compliant’. It can slow up your progress and waste precious time, resource and money. At Callaly there was an opportunity for a company with global potential to get things structured correctly from the word go - and we took it.

2. You’ll want to scale

Any ambitious company needs a plan to scale. In this sector that means having properly documented processes (revision controlled) that could help us share information and train our people effectively.

It would ensure knowledge wasn’t lost and quality compromised as we grew to meet our goals. With an eQMS in place we now have the ability to create, approve and distribute everything electronically which means we can operate while staff are literally located in countries on different continents.

3. You’ll need sound data to demonstrate your products are safe for the market

A Quality Management System that will comply with FDA regulations needs to contain and control a huge amount of data to demonstrate its safety and performance before it can get its clearances.

As part of the FDA's review, we needed to submit data collected from different sources including the results of tests for the absorbency, strength, and integrity of materials; as well as the presence of preclinical microbiology.

We needed the digital tools to help us demonstrate the way we validated the product’s performance against these requirements.

There were 30 or 40 tests that had to be conducted, producing thousands of records. These results had to be summarised in separate reports, shared with and approved for distribution by key stakeholders. The use of ‘document holders’ in the Cognidox eQMS helped us marshall and control all the evidence that we needed to gather and present to support our application in a way that would be challenging with ordinary file sharing software.

A 21 CFR Part 11 checklist: 7 key FDA e-signature requirements

4. You need to be customer-centric

At Callaly, customer satisfaction is key to our mission - an ambition shared by a lot of disruptors in our sector.

We needed to be led not only by customer safety but by customer satisfaction. Because of a historic culture of shame built up around period care products, it seemed tampon design had barely changed in the last 70 years. We wanted to have a way of listening to our customers and creating an improvement process that was built around their requirements and feedback. As we say on our website, we wanted to listen to those voices because:

“With no frank conversations shedding light on how common problems [with these products] really are, from the outside it looks like there’s no problem at all. But in private bathrooms the exasperated faces of people the world over tell a different story”

Our production team needed to understand which product characteristics (including our packaging) were important to our customers’ satisfaction. In line with ISO 9001 standard, we needed the quality mechanisms to control the way we were collecting feedback and responding to these needs as an integral part of our development work. Our eQMS helped us achieve this.

5. You want to send a clear message to workers about the importance of quality in your organisation

With an eQMS in place through which we define and control all our processes and documentation, quality has become the ‘way we do things’. The framework of the eQMS structures the way we work day-in, day-out; from the way we manage change control to our validation processes. It builds the quality culture, baking in a compliance mindset to our operations. That’s an objective that any medical device development company would want to achieve

Why we chose Cognidox

The risk with many off-the-shelf Quality Management Systems is that they are over complicated and difficult to customise. This can force developers to work in particular ways that sometimes aren’t even demanded by the regulation.

As I’ve said before, by having procedures which require well beyond the given regulation, you are not only ‘over-processing’ and doing more work than is necessary, but you have given yourself a higher risk of non-compliance due to the size of your documented process.

In Cognidox we found a system that was as Lean as we needed it to be. It came with all the controls we needed, for example phase gating for design controls  and electronic signatures compliant with FDA CFR Part 11. But it was also flexible. It was a digital framework for an FDA/ISO compliant eQMS that we could configure to reflect the way we wanted to work.

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The result was 3 FDA clearances for three products, and a clean sheet from our ISO audit with zero non-conformances. With our documentation controlled and structured in a dedicated platform it was easy for our auditors to retrieve required information, and they could see how easy it was for our staff to use, too.

When we were building our quality system I was very conscious that we shouldn’t get overburdened with unnecessary process and administration. This is why my advice to any medical device developer is that they set up an eQMS early on in their lifecycle, but choose a system that they actually have the resource to maintain. We’re living proof that you can create a system that can been Lean without compromising compliance.

Shaun Knights is Head of Quality and Continual Improvement at Callaly - follow him on LinkedIn