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Maria Ljung

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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.

Orthopaedic OEMs’ Choice Of The Right Contract Manufacturer

Orthopaedic OEMs’ Choice Of The Right Contract Manufacturer

To surround yourself with the right people is known to be a factor for success. This is very much applicable in the medtech industry, where a fruitful collaboration between an OEM and a contract manufacturer is key when producing a new medtech device. There are a lot of things to consider when choosing the right contract manufacturer. In this article, I will share some key aspects that a contract manufacturer needs to live up to.

An OEM’s requirements on a contract manufacturer

As an orthopaedic OEM you constantly strive towards saving time and money, and at the same time be unique on the market by offering something that your competitors don’t. In order to be competitive, you must add value to your products to improve their performance and significance. Alongside producing high value products, it is also in your interest to get the products to market quickly and to meet regulatory requirements. Obviously, you as an OEM have many aspects to consider when choosing a contract manufacturer to collaborate with.

Long-term relationships in the medtech industry help meet customer requirements

Depending on the extent of the project, you can save up to one-third of the total production costs by involving the right contract manufacturer as early as possible in the development process. To be able to deliver the products quickly to market, to reduce overall costs and to maximise product quality, the best solution is to build long-term relationships with highly qualified partners. A prerequisite for a close relationship in the medtech industry is to have an open dialogue and to invite your partners to share their knowledge and expertise through all phases of the process. When the contract manufacturer is involved in your concept and design stages, it increases your chances to develop an impeccable design and production process that will result in a product that meets the customers’ requirements.

A contract manufacturer brings knowledge to the table

When you are looking for a contract-manufacturing partner, it is important to evaluate how the contract manufacturer will assist you in the entire process, from idea to production and delivery. It should be in the contract manufacturer’s interest to fully engage in all development stages and contribute with experience and extensive knowledge in producing medical devices. All medical device projects are driven by economic goals, which are best attained when you and your contract manufacturer collaborate.

Keep track of the latest news and trends in the medtech industry

An important function for the contract manufacturer is to comprehend the product users’ needs early in the design phase to be able to optimize the manufacturing process.
Another important role for the contract manufacturer is to keep track of the latest trends and news; for example improved prototyping and injection moulding technologies, additive manufacturing and 3D printing capabilities and product delivery systems – all of which are evolving very quickly. Contract manufacturers are experts within these fields since they work with a variety of clients and project types across the medical device industry.

Elos Retractor™ is specially designed for use in anterior lumbar spine surgery

As an OEM you emphasise the importance of being able to rely on the contract manufacturer and its knowledge in how to manufacture a medtech device. You probably also highly value that the contract manufacturer has a broad understanding of how to use the device in a medical related context, and has a close connection to both hospitals and doctors. One example of a successful cooperation with a doctor is the development of Elos Medtech’s spine product Elos Retractor™

Minimal invasive surgery (MIS) is an increasing trend in spine surgery compared to traditional/open surgery. The Elos Retractor™ is an innovative instrument for minimally invasive surgical approach allowing safe, easy retraction by providing superior access to the intervertebral disc in anterior lumbar spine surgery. Its unique design allows secure retraction with slim retractor elements in a simple procedure, eliminating the need for large rigid blade retractors and table-mounted devices. The instrument will be introduced to distributors within the spine market and is specially designed for use in anterior lumbar spine surgery.

Spine product that simplifies the operational technique of minimally invasive surgery

There was a great need for a new product that could simplify the operational technique in these types of operations. The product needed to be faster, safer and easier to use, compared to the other alternatives existing on the market. The cooperation was based on a close communication in the process of finding the perfect prototype. The cooperation did not only include the surgeon, but also other personnel that are present in the operating room, and in the preparatory phases of a surgery. Elos Medtech contributed with expertise in the development and manufacturing phase, and above all, assisted with knowledge concerning rules and regulations when producing and CE-marking a medical device.

Since the production of Elos Retractor™ was not a collaboration with an OEM, but with a spinal surgeon at Sahlgrenska University Hospital, in Sweden, it shows that Elos Medtech has a great versatility as a contract manufacturer. Elos Medtech does not only manufacture products in cooperation with OEMs, but also has the capacity of working directly with doctors and hospitals. The experiences and characteristics coming out of working closely with both doctors and hospitals are very beneficial to have when working with an OEM.

Obviously, there are a lot of things to take into account when choosing the right contract manufacturer. I hope you enjoyed reading my article, where I covered some of the contract manufacturers’ most important qualities. If you have any questions, please contact me, or visit our website. You are also welcome to comment on the article in our social media channels.

ISO Registered Solution Partner Medtech

Why You Should Choose an ISO Registered Solution Partner as Contract Manufacturer

Medical devices have a significant impact on human lives. Therefore patient safety should be top priority when manufacturing these products and components. A solution partner as contract manufacturer that is registered with ISO can guarantee high quality, safety and efficiency.

International standards make things work

ISO is an international standard-setting body composed of representatives from various national standards organisations. The international standards give world-class specifications for products, services and systems, to ensure quality, safety and efficiency. They are instrumental in facilitating international trade and impact everyone, everywhere.

The international standards cover almost every industry, from technology, to food safety, to agriculture and healthcare. For medical devices there are a few essential ISO standards that a preferred contract manufacturer should comply with:

  • ISO 9001 for quality management system
  • ISO 13485 for quality management system and regulatory purposes
  • ISO 14001 for environmental management system
  • ISO 17025 for testing and calibration laboratories

ISO 9001 for quality management system

The ISO 9000 family addresses various aspects of quality management and contains some of ISO’s best known standards. The standards provide guidance and tools for companies that want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved. Certification is performed by an independent registrar, not by ISO.

ISO 9000 includes definitions and terminology that clarify concepts in the ISO 9001 requirements process standards used for certification. ISO 9001 is reviewed every five years and an updated version is expected in 2015.

ISO 13485 for quality management system and regulatory purpose

This standard specifies the requirements for companies providing medical devices and related services. This quality management system ensures they meet customer requirements and the regulatory requirements.

The primary purpose of ISO 13485 is to facilitate harmonised medical device regulatory requirements for quality management systems. It generally corresponds to the ISO 9001 guidelines, but it is not equivalent. ISO 13485 adds extra medical device-related requirements that are not included in ISO 9001, and removes others that are not applicable to their development.

ISO 14001 for environmental management system

This standard outlines how to put an effective environmental management system in place. It applies to those environmental aspects that a company identifies, can control and influence. ISO 14001 is designed to help companies remain commercially successful without overlooking environmental responsibilities. The standard provides the framework to allow companies to meet increasingly higher customer expectations of corporate responsibility as well as legal or regulatory requirements.

ISO 17025 for testing and calibration laboratories

This standard specifies the general requirements for the competence to carry out tests or calibrations, including sampling and documentation. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods. The standard is applicable to all companies performing tests or calibrations.

We are registered with the FDA and operate in accordance with QSR

Companies that develop medical device in the US must follow the Food and Drug Administration (FDA) Quality Systems Regulations (QSR). They are required by law to establish consistency with quality systems worldwide. Naturally, at Elos Medtech we are registered with the FDA and operate in accordance with QSR and also Good Manufacturing Practice (GMP).

We can meet all of our customers’ management and quality needs

We apply the same quality standards to all our medical device products and processes. This means that we maintain the same high quality regardless of application, market or classification. We can meet all of our customers’ management and quality needs and easily adapt to their processes. The medical technology products and components we manufacture are always safe to use, clean and sterile, consistent in quality and regularly controlled.

For more information about our registration numbers at FDA, certificates, CE-marking as well as classifications for cleanrooms and test-labs, check out our Regulatory Requirements.

For more tips, trends, news and updates, keep an eye out here on the blog and on our social media channels!