In this edition of Procept Talk we’re discussing the MedTech industry and the particular challenges this type of product presents to the development journey. In the hot-seat today is Adrian Crouch, co-founder of Procept and delivery lead on a number of our MedTech projects.
MedTech in Australia:
What do you think is unique about the MedTech industry in Australia?
Adrian: While the size of the MedTech industry here in Australia is quite small relative to what you can find in other parts of the world, we really do have a pretty awesome mix of design companies and definitely have a knack for some pretty cool innovation in this field. Going off our cases alone there are some incredibly innovative projects like Cochlear and GKC’s KinetiGraph™ .
How has MedTech changed in Australia over the past 5 years?
Aaron: We have seen over the last 5 years the start-up community growing hand over fist. The fact that we have incubators and all of these meet-ups with successful people sharing their stories – I think that within itself is helping to grow the eco-system. It gets people inspired, it has people feeling that it is achievable.
If we look back at when Procept was founded in 2006 the number of MedTech projects we had was minimal. Back when we were developing as a company it was all about mining (naturally given the mining boom) as well as instrumentation, control and automation. Back then we were only working with established businesses. However, we now see a change, there is a greater focus on start-ups and the start-up community. Companies are now growing from start-ups developing new innovations. They aren’t just taking technology from the U.S. and Europe and bolting it together to sell it in Australia, we are now creating our own IP and product.
Building a MedTech device:
What is the most difficult part about building a medical device vs. other devices?
Adrian: The regulatory environment for medical devices is definitely the single most significant contributor to the complexity of developing a medical device vs any other product. This has an impact on all areas of the product from design to supplier selection to manufacturing and support. It also has a bearing on product registration. Just understanding the different medical device registration requirements that apply in each market is a significant task alone.
From a pure engineering point of view, there are actually relatively few differences. Managing risk is the key. The ongoing need to assess risk associated with any particular design element or decision does feature heavily in the design process.
What happens if my medical device gets audited? How can I avoid this?
Adrian: You really can’t avoid being audited. This is just part of the medical device regulatory landscape now. To avoid problems arising in audits, you need to make sure that you don’t see the conclusion of the product development phase as the end of the project. Maintaining proper process and documentation throughout the product life cycle is just as critical as getting the original design release.
Procept in MedTech:
What has been your greatest achievement in medical device development?
Adrian: Every medical device project I’ve been involved with has presented unique challenges. It is getting through these challenges that I’ve always found most rewarding.
Usually these challenges have been related to the regulatory compliance and making sense of one (or more) obscure regulatory clauses. This also happens when figuring out how they can/ should be applied/interpreted in the design. For example, understanding how to do a risk assessment when dealing with using a mobile application for the user interface/control. The same applies for providing appropriate security for transmission and storage of personal data when dealing with cloud based storage in a medical device.
In other cases, the real challenge has been to bring together a number of different designers based in physically different sites to collaborate on a single project. Rarely is this easy. Particularly when trying to end up with a single set of (coherent) design documentation that aligns with different companies Quality Management Systems.
How much time do you think the right PD company can cut down for a MedTech start-up?
Aaron: Working with the right PD company can save between 30-40% of the effort involved. However that does not take into consideration the risk that we mitigate. That would be assuming it is a perfect smooth project. Especially in MedTech with all of the regulatory requirements that come into play, start-ups spend a lot of time trying to understand them and get past them. Or they may spend a lot of time re-doing things because they were unaware of a particular requirement in a specific country they want to sell in.
These are the key areas that we are experts in and have years and years of experience thinking through. Although they are ever changing, it is our job to stay on top of it and provide our customers with the key information and knowledge they need to get their product to market. Not only from a regulatory aspect, but also in a networking and community space. Sometimes it can take start-ups up to 12 months to build the right team and create connections for each stage of their project. PD companies work with other PD companies whether it’s manufacturers or industrial designers. It’s important for people to view it as an eco-system. When they enter the Product Development world they have access to this eco-system which brings the right disciplines to the project at the right times.