As technology innovation, personalized medicine and regulatory oversight have increased over the years, medical device companies have transferred the complexities of building products to EMS providers, so that they can remain focused on developing product IP. EMS providers have risen to the challenge, becoming a trusted partner in all aspects of manufacturing operations.
Leading EMS providers are now taking on an even more collaborative role, helping customers solve complex problems as they design new products. The design phase of medical device development is a critical period when many important decisions need to be made in a short period of time. Getting locked in with the wrong supplier or stuck with an expensive component can be the unfortunate result of not performing the right due diligence up front.
When evaluating EMS partners to support a successful design process, medical device companies should look for the following attributes:
Depth and breadth of experience. Look for a team of highly-skilled sourcing managers and engineers who can act as expert advisors during the design phase of new products, helping to make decisions that improve cost, quality and time to market. This includes a global network of talent, extensive product knowledge and deep industry connections. They should be able to propose alternative supply chain options and low-cost products that provide the same reliability and functionality as well known brands.
Design and compliance are top priorities. Complex medical products such as blood analyzers, digital X-ray machines or MRI machines require a deep understanding of their functionality, materials and parts. EMS providers should have both proven systems-level and high-level assembly capabilities to produce complex products that are in accordance with the most current medical regulations.
Complete solution. EMS providers should have advanced services for handling all aspects of production, including prototyping, NPI, manufacturing processes, high-quality complex product assembly, test, regulatory certifications, documentation management, supplier management and repair services. Medical device companies should also take into account that projects may vary over time and plan for the future, ensuring that their EMS partner has everything from design services to after-market services.
Compliant processes and systems. A manufacturing execution system (MES) platform that is integrated with a comprehensive quality management system can ensure that production processes are ‘error proof,’ with parameters coded into the system that automatically prevent the most common manufacturing mistakes. This integrated IT and quality system also tracks all materials required for regulated products throughout production, with digital histories recorded in an electronic device history record (eDHR) for streamlined regulatory compliance and audits.
Today, leading EMS providers have the knowledge and resources to help medical device companies make superior decisions during the design of new products. EMS providers act as a trusted advisor, leveraging a highly experienced team with proven capabilities. Their end-to-end services, extensive reach and deep regulatory knowledge can help medical device companies navigate all of the complexities required to bring high quality and compliant products to market.