Eugene Canavan, medical design director, Design Partners, and Derek Kelly, managing director, MeHow, spoke to Med-Tech Innovation News about how years of collaboration resulted in them developing essential PPE during the COVID-19 pandemic.
Design Partners
A key design principle was comfort and fit – how long did it take to find the right design?
As time to delivery was a factor Design Partners carried out short sprints of primary research, prototyping and user testing to iteratively define and test solutions. Our medical product development process was used to define the product requirements and usability challenges early in the process. These insights were then carried into sprints of design conceptualisation and prototyping for usability testing. Engineering and design for manufacture aspects were addressed in parallel by our in-house engineering team in consultation with MeHow Medical on the materials and manufacturing challenges.
The key challenge of comfort and fit was understood and defined early in the product development life cycle. It was addressed by using a PVC material designed to provide a combination of structural stiffness around the lens area and softness against the user’s skin. This was achieved in the same component part by changing the structural design of the PVC. The lens area also provides structural robustness when assembled into the PVC element, while still allowing the PVC to be soft and conformable. This helped address another challenge which was the propensity for products such as this to fog up and impair user visibility.
Why did Design Partners choose MeHow?
Design Partners has a long partnership with MeHow Medical Ireland, so they would be a first point of contact for expert advice. Design Partners’ initial user research and conceptualisation pointed to a design solution of both hard and soft materials to answer the fit and comfort requirements. We knew from our experience of working with MeHow that they had a lot of expertise in medical grade materials that could answer this requirement, and could rely on its international capability and expertise to fill other manufacturing knowledge gaps. Also, a key requirement for this project was finding local solutions to provide PPE to ease supply chain challenges. As Design Partners and MeHow are both located in Bray, it was perfect.
Were already approved components and materials a major consideration?
One key requirement was the solution, including manufacture, was to be provided in Ireland. This requirement was set by the Department of Health and HSE in Ireland to ease PPE supply chain challenges. The fundamental project challenge was to meet regulatory design and manufacture standards in a new product. Both Design Partners and MeHow Medical are ISO 13485 certified; Design Partners for usability, design and engineering and MeHow for manufacture. MeHow can produce components in certified cleanrooms using recognised medical grade materials and resins. Therefore, the only real challenge was to CE mark our BioVue Goggle product. We answered this new challenge together with BSI.
MeHow
How challenging was going from stent manufacturing to goggle manufacturing?
The challenge was not as great as you would initially think, because:
- Our partnership and history of working with Design Partners has allowed us the confidence of designing and manufacturing safety goggles that are best in class. Design Partners engaged with the HSE and front-line workers in order to understand their requirements from a fit and function point of view. The main feedback received was to design googles that were comfortable to wear for long periods of time. We chose the most suitable resin which allowed us to deliver a product that meets the full specifications required for PPE and is comfortable to wear with clear vison and anti-fog protection.
- In MeHow, we had all the manufacturing ingredients to make the goggles including injection moulding, class 100K cleanrooms and lens coating expertise from our telecom days. This lens coating expertise assisted in recognising the requirements needed for the anti-fog and scratch resistance required for the lens. This allowed us to commit to the design and functionality of the goggle, while simultaneously giving the HSE a commercial solution to their requirement.
The only real, and brand-new, challenge was to learn how to CE mark the BioVue Goggles.
What was your initial reaction after receiving the call from Design Partners?
It was to say that we make highly technical components for stent delivery systems and we have no experience in making ‘goggles’. However, once Design Partners explained the work the COVID-19 Alliance group was doing and its objective of making safety goggles for the HSE to protect our front-line workers, we embraced the challenge.
Design Partners and MeHow:
What lasting effect will COVID-19 have on Irish medtech manufacturing?
EC: Ireland has a known and highly respected medtech sector that is resourced by a highly skilled work force with specialised expertise. It has successfully supported large medtech corporations for decades and will continue to do so. However, there is an opportunity to leverage this capability in supporting home grown medtech start-ups where an agile approach to innovation creation, although smaller in scale, is still of high value. New medical technology start-ups combined with the ability to realise it into a manufactured end product is a compelling combination. Expert manufacturing in Europe, especially automated and at high value is cost effective and trustworthy. Also, as extended supply chains are problematic, and manufacturing in far away locations can no longer be justified based on cost alone due to other concerns such as sustainability, means essentials critical to the population health are sourced locally.
DK: I believe the lasting effect will be positive as this pandemic has challenged Irish manufacturing as never before. Many companies have made their own brand products as a result of shortages in supply of product on the island of Ireland particularly in PPE.
Irish medtech manufacturing has generally existed to support the larger corporations in Ireland. Over the last 20 years we have built up a strong expertise which is respected worldwide. This has allowed our sector to build up a highly skilled workforce in conjunction with best-in-class manufacturing facilities including cleanrooms, manufacturing equipment, metrology, automation, etc. Therefore, when the pandemic hit, Irish medtech manufacturing had all the skills in hand to deliver for Ireland. It can use this new confidence to manufacture and distribute its own brand products to markets further afield.
