What medical device companies must consider when selecting an EMS provider
There are a number of factors that have contributed to the growing relationship between medical device companies and EMS providers; not least the ever-increasing pressure to quickly deliver new products at lower costs.
Other contributing factors include the rise of personalized medicine, rigorous regulatory requirements, and increasing product complexity due to technology innovation. These are all areas that EMS providers have become experts in on behalf of medical device companies, freeing them to focus on medical device innovation.
Today, some EMS providers are taking this collaboration a step further, providing support to medical device companies who are faced with complex challenges as they design new products. The design phase is a critical period when many important decisions need to be made in a short period of time, adding further pressure to an already involved process.
Unfortunately, a medical device company may opt to work with the first available supplier or implement the first component offered to them, simply because they are time poor and don’t have the bandwidth or internal resources to thoroughly research alternative options.
Some single source suppliers will try and capitalize on this situation. All too often, this results in a scenario whereby a medical device company gets ‘locked in’ with a supplier that fails to meet its commitments or gets stuck with a high cost component during the lifecycle of a regulated medical product. This leaves them no alternative but to spend time and expense implementing a change that requires them to go through all of the regulatory reviews and approvals for a second time.
To avoid these pitfalls, there are five key considerations medical device companies should consider when looking to partner with an EMS provider on the design of new medical products:
End-to-end manufacturing solutions
EMS providers should have advanced services for handling all aspects of production, including high-quality complex product assembly, manufacturing processes, testing, regulatory certifications, prototyping, NPI, documentation management, supplier management, as well as maintenance and repair services. Medical device companies should also bear in mind that project requirements will likely vary over time and plan for the future. Therefore, they should select an EMS partner that has capabilities for everything from design services all the way through to after-market services. Retaining product knowledge within a single EMS organisation ensures seamless knowledge transfer over the lifecycle of a product.
Compliant manufacturing process and IT system
A manufacturing execution system (MES) platform that is integrated with a comprehensive quality management system can ensure that production processes are ‘mistake proof.’ This includes well-defined parameters that are pre-built into the system to automatically prevent a product from moving from one stage of the production line to the next if it does not pass a test at each gate. An integrated IT and quality system also enables all materials required for regulated products to be tracked throughout production, with their histories logged in an electronic device history record (eDHR) for streamlined regulatory compliance and audits.
Design-led manufacturing services and compliant manufacturing infrastructure
Complex medical products including digital X-ray machines, MRI machines and blood analysers all require in depth understanding of the functionality, materials, and parts in order to produce them. The ideal EMS provider should have both high-level assembly and proven systems-level capabilities to produce complex products such as these. Having expertise working with multiple sophisticated technologies, moving parts, fluidics, centrifuges, electronics, and user interfaces is also essential. In addition, EMS providers must be able to make important decisions that improve quality, while remaining compliant in accordance with the most current medical regulations.
An EMS provider with a global presence will have access to an extensive network of talent, resources, and suppliers, as well as strong buying power that will benefit the quality and cost of final products. Many newer medical device companies are partnering with larger EMS providers that have a global presence as a way of demonstrating to the MedTech sector that they have the capability to scale, thereby hoping to increase confidence among potential investors.
Highly experienced team of sourcing managers and engineers
Medical device companies should look to work with experts that can act as advisors during the design phase of new products, helping them make impactful decisions that improve cost, quality, and time to market. These individuals should have both detailed product knowledge and deep industry connections in order to propose alternative supply chain options and low-cost products that provide the same reliability and functionality as well-known brands. Obtaining customer references that illustrate how the EMS provider has successfully partnered with other companies is the best way to gauge this capability.
Today, leading EMS providers have all of the resources and expertise to help medical device companies make the best decisions when it comes to developing new products. Acting as a trusted advisor, they can bring a highly experienced team and proven capabilities to the collaboration. A combination of end-to-end services, global reach and deep regulatory knowledge can aid medical device companies to quickly bring high quality and compliant products to market.
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