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6 Key Considerations When Choosing a Medical Device Contract Manufacturing Partner

20 October, 2021

6 key considerations when choosing a medical device contract manufacturing partner

When it comes to choosing the perfect contract manufacturing partner for your medical device, there are many aspects to consider. Aspects such as a proven process, industry experience, engineering expertise, robust quality management system and extensive manufacturing capabilities. Selecting a contract manufacturing partner is a crucial decision that is not to be taken lightly as this relationship may last the entire lifecycle of your product. Therefore, it is important to make the right choice to ensure the future success of your product.

To establish a successful partnership, the following six areas must be critically reviewed and analyzed as part of the selection process:

1. Company Culture

First and foremost, it is important to ensure that your partner has an organisational culture and values that are similar to yours. This is because your relationship usually lasts for the entire lifecycle of your product, due to the initial OEM and partner investment required. The question is: How is culture defined?

According to the Harvard Business Review, there is universal agreement that company culture exists, and that it plays a crucial role in shaping behaviour in organisations, however, there is little consensus on what organisational culture is. In short, Robbie Katanga said, “Culture is how organisations do things”. There are several factors that can contribute to a company’s culture such as company vision, core values, norms, systems, symbols, language, assumptions, beliefs, and habits. With these factors at the forefront of your mind, choose a partner that fits with your ethos to ensure a successful partnership.

2. Quality Management System

Quality is one of the most important factors in this decision-making process as a focus on quality will ensure product safety and save you both time and money in the long run. The first question you should ask a potential partner is: “Are you ISO 13485:2016 certified?” Who is your registered accreditation body? Ask to see their quality manual, procedures and certificates. Will they prepare a quality plan for your product? Performing a quality system audit should provide an accurate picture of compliance.

3. Trust & Reliability

Many have said that trust, like respect, is not given, but must be earned. Both parties need to have complete trust and confidence in each other’s capabilities, processes, and structures. To enter into a partnership without trust extended at the beginning is to withhold many of the most critical characteristics on which a partnership depends. Trust is driven by transparency and accountability on both sides. The best contract manufacturers will be open and transparent with you from the beginning to the end. Establishing trust and accountability is key to a truly collaborative partnership.

4. Medical Device Experience

Does the potential partner have a track record in manufacturing medical devices? How long have they been in business? What type of products have they experience in manufacturing? What are their current assets and equipment? The potential partner’s knowledge of the industry is a value add that is often overlooked but this can be of the greatest worth to your company as an experienced CM partner can apply their past knowledge and experience to new projects.

5. Technical Capabilities

Do they have the expertise and capabilities required for your particular project? Who is on the team and how experienced are they? Experienced engineers follow all standard testing methodologies and use the correct test equipment for part qualifications. Ask for customer testimonials or speak to a current customer with their permission.

6. Visit – in person

As a final step before handing over the project, a site visit along with your quality representatives would be of benefit. In the age of Covid-19, this might be tricky to organise but with the necessary precautions and adherence to the safety measures & social distancing guidelines, it should still be possible.

What to do on the site visit?

  • • Meet the project team to discuss the next steps and start dates
  • • Be prepared to ask lots of challenging questions to see how different team members respond and provide solutions to your challenges
  • • Be sure to also have a conversation with the production line as well as the senior management
  • •Make sure the manufacturing standards (technology, processes, cleanliness etc.) meet your expectations

Remember your goal is to engage in a long-term partnership with your selected supplier so both sides need to feel there is potential to form a successful relationship.


The better you analyze your potential contract manufacturing partners, the more chance you have of selecting the right partner for a long successful partnership.

While the price is always a factor, it is important to remember that the costs associated with the wrong choice can quickly eliminate any savings. And if it boils down to two providers who both tick all the boxes, then go with your gut feeling! Pick the partner who you feel would go that extra mile in making the partnership and product a success!

Once you have ticked all these boxes it is then time to transform your idea into a reality!

Advant Medical. The trusted “Partner of Choice” for contract manufacturing

Advant Medical is a trusted Contract Manufacturing Partner to Global Medical Device Companies. We have built up considerable expertise over 30 years in medical device contract manufacturing of Class I, II, III devices. We focus our service on 3 key pillars:

1. Continuous Collaboration
For every project, our team maintains a strong level of communication contributing to a trusting working relationship. This is the reason Advant Medical has become the ‘Partner of Choice’ within the medical device industry.

2.Lean Manufacturing
We strive to ensure that the manufacturing flow is optimised for efficiency and cost savings.

Advant Medical’s Quality Management System (QMS), ISO 13485:2016 accreditation and FDA registration supports a productive and successful project.

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