Allison Love knows medical devices.
A mechanical engineer by training, Allison has worked in product development for medical devices at a variety of companies including Genea Biomedx, Leica Biosystems, and Invetech. She loves engineering, and she chooses to work in the medical device field because she believes applying her engineering skills to a field that changes lives makes her work more meaningful.
In 2021, Fertilis came on her radar. Allison’s natural curiosity, experience in medical product engineering, and desire to make devices that change lives made her a perfect fit as our Chief Product Engineering Officer.
In this interview, Allison talks about the technical challenges of developing micro devices, the regulatory obstacles that come with designing medical devices, and what she loves about working at Fertilis.
The following interview has been edited for clarity and length.
Why medical devices?
It’s great to work in a field that has the capacity to change people’s lives. For instance, one of the more recent projects I worked on was updating a platform that improved tissue processing for cancer diagnostics. To be able to do something tangible and work on a device where you can say, “I know that work improved the way that tissues are handled, or I know that now somebody is getting the diagnosis that they need” is a pretty rewarding experience.
What attracted you to Fertilis?
I’d previously worked in the IVF space, and I think it’s a really interesting field.
The technology that Fertilis has developed, which we are continuing to develop, is incredible: it has the potential to create a huge change in the way that IVF is done and to improve results for people undergoing fertility treatment.
From a purely techie point of view, I have previously worked on instruments of a sizable scale. I’m still trying to get my head around the scale of this micro device. I work on it all the time, but on a screen where it always appears enlarged. Whenever I see the physical device, it’s really something– the size of it. It’s so tiny.
What is product development?
Overall, product development is trying to take an idea from concept to market. You have an idea and then you create a prototype of that idea, working out how feasible it is to develop it to a point where you’ve got a commercial product that you can manufacture, distribute, and maintain in the market.
When it comes to medical devices, it’s a very regulated field– for good reason. There are regulations that govern the process for developing a product which must be satisfied and demonstrated with documentation and evidence. In the medical device space, you can have an amazing product, but if you haven’t satisfied regulatory requirements in terms of the process used to develop it, then it won’t get regulatory clearance.
What’s the day-to-day life of the Chief Product Engineering Officer look like at Fertilis?
At the moment, I’m working across a variety of different things. We’ve got engineers in Adelaide that are working on the test bed, so I’m working with them to determine what experiments we need to run, how we go about developing the software for those experiments, and how to refine and troubleshoot the prototyping.
I’m also looking at our product strategy, so focusing on what we want to achieve with the product in the longer term, what direction we need to take to get there, and who we need to partner with to best develop this technology.
Then on the regulatory side, we’re setting up a quality management system which is part of the requirements of developing a medical device, so I’m looking at initiating some of those early design controls.
And since we’re a startup, I also get the opportunity to be very hands on, so I’m actually back to doing computer-aided design work using programs like SolidWorks to model up different concepts. I’ve worked at smaller organizations before, but this is my first “startup” startup. I knew when I joined that it was early stage and cutting edge, but I just don’t think you can really get a sense of what that means until you start the work and you’re in the thick of it. Then, you really understand just how new and innovative what we’re doing is.
What are some of the regulatory and compliance issues that accompany developing medical devices?
On the regulatory front, it’s working out what your target markets are and then what regulations you need to satisfy in each of them based on your device classification. Medical devices need to be developed in compliance with a quality management system. Many regions, including the EU and Australia, require the ISO 13485 standard while for the US it’s an FDA regulation (21CFR820). Although there’s significant overlap, it’s important that each target market’s requirements are understood and fully satisfied. In whatever market you plan to enter, you need to demonstrate that you’ve met the regulatory requirements for the product and show that it’s safe and effective for its intended use case.
Regulation is a complicated area. Unfortunately, a lot of startups develop a product and do all the engineering without knowing the regulatory framework. They think of regulatory clearance as something that’s simply done at the end.
Coming to Fertilis was great because the founders knew they’d need to tackle regulatory requirements from the get go, and they hired a fantastic consultant who knows the regulatory space from back to front.
What are the best things about working at Fertilis?
It’s a very collaborative exercise. One of the things that I love about working in medical devices is working with the scientists and practitioners. At Fertilis, the team has an incredible ability to explain why a device feature is important for improving IVF or ICSI without being prescriptive in how to design that feature, so there’s a lot of room for me to consider ideas and solutions that aren’t immediately obvious. I can work on a solution and send it to my colleagues, asking ‘How about this?’ And if it’s not quite right, we’ll keep iterating on it together.
When I worked in IVF before, it always seemed very scientific and clinical. I had previously thought that the way it was done made sense enough. As I learn and understand more from the Fertilis team about how things function and grow without the body and the environment we’re trying to replicate, the more I realize how divergent those ideas are from traditional IVF practices.
I recently explained it to someone as the equivalent of trying to bake a loaf of bread while taking it out of the oven every few minutes to make a change to the dough and thinking that that will produce consistently good bread. All that disruption in the environment is a long way from how things actually work in the body. That’s where I get really excited about our devices. We’re involved in creating something that will replicate the human body far more closely.