Do you need a partner for manufacturing medical devices? Medical device manufacturing is a complex process that requires a high degree of precision and quality control. Choosing the right partner is critical to the success of your products. Here are 7 questions to ask a potential partner to ensure efficient medical device manufacturing and a beneficial partnership.

1. What is your potential partner’s view on partnership?

The first thing to ask a potential partner is how they view partnership. While contract manufacturers (CMOs) provide manufacturing services, there are also full-service CDMOs. Those can guide you from concept, design, and development through regulatory, prototyping, testing, and validation to manufacturing and delivery.

  • Does your potential partner view their role in the partnership as a tactical provider with the manufacturing capacity needed to complete a project?
  • Or are they a strategic partner with expertise also in design and development?
  • Can they take responsibility for all steps throughout the entire process from design to delivery, if needed?

2. What capacity and equipment does your potential partner have?

Next, ask about your potential partner’s equipment and facilities. Today’s medical devices are complex and often require special manufacturing equipment, automated processes, and controlled environments to meet today’s strict regulations for quality and safety.

  • Does your potential partner have the manufacturing capacity that you need?
  • Are they prepared to invest in increased capacity as your business grows?
  • Can they offer automated processes and spaces such as cleanroom production and testing laboratories?

3. What capabilities does the medical device manufacturer have?

It is very important that your partner’s capabilities align with your needs. You might have to increase manufacturing capability, scale production volumes, or add new medical devices or components to your production. Perhaps, you want your partner to be able to bring new products to market without you having to take the expense of ownership.

  • Does your potential partner have the capabilities required in R&D, design, engineering, manufacturing, assembly, quality control, and testing?
  • Do they have the resources to invest in production equipment and other things?
  • Can they scale up production in a controlled manner and according to your plan?

4. What level of specialization can your potential partner provide?

Today’s medical devices often have complex geometries that require optimized design for manufacturing, advanced surface treatments, and high cleanliness. The dedicated expertise, knowledge, and specialization you can find in a full-service CDMO are often extremely valuable to medical device companies and OEMs.

  • Does your potential partner understand your medical technologies and have the technical expertise required?
  • Can they provide qualified engineers, experts, and professionals specialized in specific development and manufacturing processes?
  • Can they give you insights and create innovations to launch a successful product?

5. Can you rely on your medical device manufacturer for quality?

Quality control is crucial in medical device manufacturing as government agencies regulate products, and the manufacturing process must meet strict quality standards. Also, regulations evolve and become more complex. As an OEM, you want a partner with a robust quality management system in place and patient safety in focus.

  • Can your potential partner help you navigate the highly regulated framework required by authorities in different markets?
  • Can they provide you with extensive knowledge about regulatory requirements?
  • Do they use validated production processes and advanced verification?

6. Can your potential partner bring your products fast to market?

Bringing new medical devices to market is a complex process. It requires careful planning and attention to detail to ensure safety, efficiency, and regulatory compliance. As an OEM, you need a competent and skilled partner that pays attention to details.

  • Does your potential partner have insights into the market segments you target?
  • Can they provide you with the skilled and experienced professionals you need to accelerate time to market and avoid unnecessary costs?
  • Can they take your product to market quickly, cost-effectively, and successfully?

7. Is your potential partner responsive, committed, and flexible?

As an OEM, you know that the medical device market is characterized by a rapidly changing healthcare environment. This demands a partner that is highly responsive, committed, and flexible – while at the same time delivering exceptional quality.

  • Does your potential partner understand your specific medical device market?
  • Will they adapt to your needs, make timely decisions, and take necessary action to move your business forward?
  • Can they solve complex problems and deliver quality that is second to none?

Elos Medtech – from innovative vision to manufacturing precision – your reliable CDMO

I hope this article gave you some help and insights into what questions to ask a potential partner for medical device manufacturing. Elos Medtech has worked with many OEMs, transforming medical technology and advancing quality of life worldwide since 1923. In fact, this year, we celebrate 100 years in the business!

Are you looking for a reliable CDMO and a strategic partner? Contact us today. We are happy to answer any questions that you might have! Together, we will find out if your needs align with our competencies.