In a world that is increasingly threatened by disease, with a population getting inexorably older, medical device manufacture is an understandably big business.
Building – even modifying – medical devices is a complex, costly and high-stakes endeavour. As hospitals, laboratories and physicians look for ever more innovative solutions and products, more manufacturers are looking to contract their medical manufacturing needs, where the market is expected to grow from circa. $55 billion last year to an estimated $91 billion by 2024.
But as the technology evolves, so do the challenges: companies must stay on top of rapidly changing requirements around compliance, regulation, standards, localization, data security and other issues.
The biggest challenge facing medical device manufacturers, however, has not changed – ensuring product quality and reliability – which starts at the design stage.
“The better you design the product, the greater the win for client and manufacturer alike,” says Mark Costello, Head of Design with Synecco, an Irish-based global provider of design and contract manufacturing solutions for the medical devices market.
“Better-designed products will not only ensure higher quality but will ultimately increase both the margin and volume of the device in question,” he says. “Our best projects are the ones where we meet the customer early, understand their needs and drive that understanding all the way through the manufacturing process. These types of projects are the real win-wins.”
Synecco is in the happy position of being able to do just that. Based in Galway, home to Ireland’s famous medtech ‘cluster’, the firm offers the complete medical device service from innovation, design and engineering right through to commercial manufacture and supply, providing solutions for a who’s-who of industry names including Medtronic, Siemens, De Royal, Cook Medical and others.
“We offer services for customers who are developing clinical solutions and need a range of supports from design to development and right through to the production of components and fully assembled devices, depending on the client needs,” says Costello.
“One area that we focus on at the early stages of an engagement is design for usability, which is about understanding the needs of the end-user, but also about safety which brings IEC 62366 into play – an international standards governing the application of usability engineering in the design of medical devices” he says. “Usability needs to be supported by mechanical and industrial design because the product needs to be able to do what it’s supposed to do as well as representing the brand in question.
“Design for manufacture and assembly is another area that Synecco places a lot of emphasis,” he adds. “This is about understanding how the product is going to be made efficiently and effectively at volume, and it’s where customers really benefit from being engaged as early as possible with the organization that is going to make their product.”
Close, ongoing engagement is a recurring theme of the Synecco business model. Unlike many larger organizations where design and manufacture often take place in separate silos, this Irish firm is a strong believer in running a tight-knit operation.
“Early engagement and close collaboration throughout the project mean that everyone in the system understands the importance of all the features and aspects of a device or component,” says Mark Costello. “It’s the best way to maintain design intent, which is one of our core beliefs in offering turnkey solutions to clients.
“What we can offer as a small, tight group of engineers, designers and manufacturers is a synergy that can be difficult to replicate in larger organizations,” he says. “We have a multi-disciplinary team that works in unison throughout a project, with representatives of all the key stakeholders involved. It’s a more holistic solution that ensures continuity.”
Since its foundation in 2004, the company has maintained a manufacturing footprint in China but a game-changing moment arrived in 2017 when Synecco acquired a factory premises in Co. Clare, less than an hour’s drive from the firm’s HQ in Galway. The new 66,000 square foot facility with a 3000 square foot Class 8 cleanroom is certified to ISO13485, providing a springboard for further growth at home and abroad.
“We’ve done a lot of work within Ireland where there are some very big players, and we’ve seen strong growth across Europe, particularly in markets like Italy and Austria,” says Costello. “But the US is the big one for us, especially on the design side where there is greater recognition of the need for really effective, user-centric design.
“The US is our main market in terms of potential for design solutions because medical device companies there are ahead of the curve in terms of design for usability and human factors,” he says. “We’ve worked with many customers in the US, but we’ve still probably only scratched the surface there, so that’s where we’re focused in terms of growth.”
Having won a coveted iF International Design award and been shortlisted for Medtech Supplier of the Year in recent years, Synecco is in prime position to take advantage of the soaring global demand for medtech innovation. What areas does the company expect to drive growth in the coming years?
“We’re currently working on a range of programs across cardiology and structural heart with a focus on the handheld manipulator aspect of the delivery system by which the clinician controls the procedure” says Mark Costello. “Through our usability work we’ve moved into the area of wearable sensing devices using technologies such as bioimpedance to detect changes within the anatomy and the electronic enclosures that support these and we work on miscellaneous other devices linked only by the fact that they need usability, industrial design, mechanical design and manufacture.”
“Regardless of the type of work, the synergy we offer and our multi-disciplinary approach helps us to innovate,” he adds. “Maintaining design intent throughout a project is our USP and what sets Synecco apart in a growing marketplace.”