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Medical device manufacturing – 7 questions to ask a potential partner

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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.

Elos Medtech’s OPEX approach What is in it for me as an OEM?

Elos Medtech’s OPEX approach: What is in it for me as an OEM?

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Do you know our motto? It is striving for excellence in everything we do. However, focusing on operational excellence, built-in quality, and continuous improvement all comes down to one thing: What is in it for you as an OEM? In this post, I break it down to answer the question.

What is OPEX in medical device manufacturing?

OPEX is an abbreviation of Operational Excellence. It is often described as the journey to optimize an organization’s processes so it can create more value for its customers while using smaller amounts of resources.

OPEX is not a fixed goal. It is rather something that is regularly achieved. Therefore, it requires continuous improvements.

To us as a CDMO, OPEX is about ensuring that we operate excellently throughout our organization and always look for ways to improve our performance. It is our way of systematically and continuously improving our processes to become more Lean, reduce waste, and create value for our customers.

To concretize: We want to deliver high-quality products at the lowest cost and in the most efficient way possible while reducing waste.

A leading global CDMO for medical devices.

Our long-term strategy is to strengthen our offering and develop our competencies in our expertise areas to remain a leading global CDMO for medical devices in our markets.

Our OPEX strategy is to develop our production processes continuously and systematically through continuous improvements, waste reduction, visualization, and standardization. Through efficient, automated, and digitized solutions, we can create cutting-edge production.

We do the right things – and we do them right.

Our OPEX work means ”doing the right things and doing them right”. It includes competent leadership, systematically developing our skills, and constantly improving our processes. This way, we achieve built-in quality in every process and world-class operation.

What is in it for me as an OEM of medical devices?

You can ensure your customers that your medical devices are of the highest quality. Your capacity demand and expectations will be met, and you can harness innovation and sustainability from a trusted CDMO.

We work as a global team across borders.

As a company, we recognize that the energy our employees put into their daily work is our most important asset for building world-class manufacturing. The phrase ”stealing good ideas with pride” is a valuable insight when applied within our own organization. By collaborating across borders as one team and sharing expertise between our sites globally, we can build a more robust offering.

What is in it for me as an OEM of medical devices?

No matter where you are or which production site you use for development and manufacturing, you will benefit from our global knowledge and expertise.

We focus on development, learning, and training.

The cornerstone of a learning culture is that everyone has a ”growth mindset”. Our culture is not only to learn and apply what we have learned but also to feel engaged to share our knowledge with others through teamwork. It is crucial for creating long-term results where continuous improvement is more than a technology – it is a way of life.

What is in it for me as an OEM of medical devices?

You will benefit from the results of our growth mindset: The better we get at development, design, and production, the better your products get.

We put the customer first.

Lean is a systematic method for minimizing waste. It focuses on identifying parts of a production process that do not provide customer value. We foster a culture where everyone is committed and empowered to apply Lean to maximize customer value.

What is in it for me as an OEM of medical devices?

You will have your products delivered according to the agreed delivery time, in the correct quantity, and with the highest quality. You can rely on sustainable, no-waste, effective production.

We have a problem-solving mindset.

We have a problem-solving mindset throughout our organization. There are always ways to improve processes, eliminate waste, and create error-proofing methods with problem detection early on. Our culture is based on encouraging ideas and being agile for improvement suggestions.

What is in it for me as an OEM of medical devices?

You can feel confident that we not only detect and solve problems at an early stage but also prevent them from happening in the first place.

We focus on operational efficiency.

Our operations strategy serves as a platform for all our sites to improve performance and add value. Our operations management is our fundamental approach and methodology in our organization, with teamwork as a base and customer satisfaction as a result.

What is in it for me as an OEM of medical devices?

You will benefit from shorter lead times, a flexible supply chain, higher efficiency, and lower cost – ultimately feeling satisfied with our products, services, and capabilities.

We continuously improve our processes.

Continuous improvement is a method for identifying opportunities for streamlining work and reducing waste. The cycle of continuous improvement – identify, plan, execute, review – is a mindset we have adopted across our operations. We constantly improve and systematically develop people and processes to create value and prosperity while reducing waste.

What is in it for me as an OEM of medical devices?

You will benefit from more cost-effective solutions as we do not focus on cost in the first place. By working with continuous improvement and doing the right things throughout the entire process, the total cost will eventually drop.

We empower our people.

We strongly believe that our employees are our greatest strength. Providing each employee with a supportive environment that encourages them to come up with innovative and bright ideas, and do their best, is our way of empowering people.

What is in it for me as an OEM of medical devices?

You can rely on engaged professionals who will go the extra mile, learn more and faster, and be more creative, to work for your advantage.

We focus on what is best for the customer.

In a customer-oriented company, all employees, regardless of role, base their decisions and actions on the belief that what is best for the customer is also best for the business. The basis of our customer focus is to develop collaboration with our customers to get ideas for improvements and cost savings.

What is in it for me as an OEM of medical devices?

You will benefit from the security of a mutually fruitful and valuable customer relationship based on communication, dialogue, and understanding.

We sustain the gains by standardization.

“Sustaining the Gains” is part of our continuous improvement culture. It is the concept that once any improvement has been achieved, the next step is to standardize and maintain it. A high retention rate creates greater opportunities to maintain what we have achieved.

What is in it for me as an OEM of medical devices?

You can rely on your products that are produced with high-quality equipment, efficient production, and stable processes based on proven effective methods.

The result? Medtech Quality Excellence.

Developing and manufacturing medical devices that impact human health comes with great responsibility. Patients put their trust in the tools used to treat their bodies. And the creators of those tools –  you, the OEM – put your trust in us, the CDMO.

And so, the result of all our efforts is Quality Excellence.

Do you need a trusted CDMO for medical devices? Visit our website to learn more.