The medical device industry is predicted to achieve an annual growth rate of 5.6 percent over the coming years, bringing total revenues from USD $443 billion in 2022 to almost USD $585 billion in 2027. Innovations in product design will be a key factor in achieving this predicted growth, as will corporate M&A and investment strategies. However, there are pressing challenges faced by companies across the industry.
Those challenges have the potential to limit innovation and increase time to market for new products, two issues that are continuous focus areas for large medical device companies.
There is also the risk that new, agile, and innovative start-ups will struggle to enter the market or gain traction because of the challenges the industry is facing. Given the important role start-ups and smaller companies have played throughout the history of MedTech, this is a cause of concern for many.
Generally, the outlook is positive for companies in the medical device industry, but overcoming the challenges is essential.
Challenge 1: Design and Development Capacity
Established medical device companies need to continuously improve existing products to maintain market position and revenue share. They also need to develop novel products to improve competitiveness, branch into new markets, and create new business opportunities. Therefore, design capacity is crucially important.
All too often, however, available capacity is insufficient, restraining progress in both novel product development and existing product improvement.
Start-ups also face design and development capacity issues, as they often struggle to find design partners with available capacity who also have service delivery models that meet the specific requirements of early-stage businesses.
How Arrotek Addresses Design and Development Capacity
Arrotek prides itself on building capacity into our business model, as we have a well-established and growing design team. Crucially, we also offer a flexible approach to the delivery of design and development services. This is demonstrated in our brand-new office and cleanroom expansion in Ireland, and our new design and development office in Boston, USA.
For large medical device companies, we offer a modular approach to service delivery. For example, we are equally comfortable delivering full end-to-end design services as we are taking on a sub-element of a novel product development project.
Challenge 2: Regulatory Compliance
The regulatory compliance requirements for medical device manufacturers are becoming more stringent across many key markets. For example, it is now much more complicated to obtain regulatory certification for the EU market under the recently implemented MDR. This is a trend that is set to continue as devices become more complex, new regulatory challenges emerge, and regulatory standards converge across jurisdictions.
This challenge of regulatory compliance is further exacerbated by the lack of adequate regulatory consultancy services.
How Arrotek Addresses Regulatory Compliance Challenges
At Arrotek, we have an in-house Quality Management System accredited to ISO 13485:2016 and EN ISO 13485:2016. We also have regulatory experts on our team who can provide consultancy services for certification projects in the US, EU, and other jurisdictions.
Challenge 3: Supply Chain Resilience
A number of factors have combined to create significant pressure on supply chains across the medical device industry. Those factors include labour shortages, the impact of the Covid-19 pandemic, raw material shortages, geopolitical upheaval and uncertainty, rising energy prices… the list goes on.
As a result, a primary objective for many in the MedTech industry is to significantly increase supply chain resilience.
How Arrotek Addresses Supply Chain Resilience
Supply chain resilience has been a crucial focus for Arrotek for several years now. Our design services take supply chain resilience into account too, and we are also part of a wider group of companies that can help solve supply chain issues. Our sister companies offer custom production for both service and OEM divisions, within the sphere of minimally invasive medical devices. We also offer an effective material Kanban system to proactively secure the supply of key raw materials.
Challenge 4: Manufacturing Capacity
Companies across the medical device industry are facing a range of manufacturing capacity issues. As with the previous point, the reasons for this challenge are multifactorial. Examples include labour shortages, insufficient process automation, and increasing demand.
Furthermore, the manufacturing capacity challenges that currently exist extend beyond established medical device manufacturers. For medical device start-ups and companies looking for contract manufacturing partners, finding available manufacturing capacity is equally difficult.
How Arrotek Addresses Manufacturing Capacity Challenges
Within Arrotek and through our sister companies, we offer extensive manufacturing capabilities in both Ireland and the United States. We have invested heavily in our manufacturing equipment and the skills of our production teams, and we continue to expand our facilities with additional production and cleanroom floorspace.
Get in Touch
At Arrotek, our flexible and highly experienced approach can help you achieve your growth plans for the coming years and beyond. To arrange a free consultation with a member of our team, please complete the form below.