Key Considerations when Engaging with a Medical Contract Manufacturer

The available options and rationale for engaging with a contract manufacturer or an outsource partner can appear daunting and often complicated. Some of the common questions are:

  • How can I develop a relationship with a new partner with whom I am unfamiliar?
  • How do I determine which one is best for me and how do I engage with them?

For everyone from the first-time entrepreneur with a novel innovative technology to a seasoned executive in a multinational, outsourcing can appear to be a minefield.

Why Outsource?

This is the first question to pose – what is the risk and reward, what is the return on the time and finance invested in outsourcing? The answer will depend on a number of factors but the size and resources of your business and where your technology is in its lifecycle is critical.

Some of the reasons include accelerating your time to market and facilitating faster return on investment (ROI). Time to market is fundamental to your technology’s success. Having a
knowledgeable partner allows you to expedite this and gets you to market faster. Outsourcing and developing a contract manufacturing partnership also allows you to use specialized expert knowledge without tying up
much of your own internal resources. A good contract partner will have an existing supply chain to work with for critical components and often contract pricing meaning your cost of goods is significantly reduced.

Cost and speed are not the only benefits of engaging the right partner. Your partner will advise you on your optimum design for functionality, manufacturing and, essentially for medical devices, risk. In recent years supply of particular commodities,materials and components has been affected by various influences be they natural, economic or political. The right outsource partner will be able to offer advice on how to mitigate these risks in the supply chain by evaluating multiple sources and solutions while balancing design and functionality. It is critical that these are considered as early as possible in anticipation of the regulatory pathway of your device. Qualifying single sourced or rare components jeopardises your business continuity in the future. This can lead to supply issues to customersand falling sales at worst, to expensive re-qualifications and repeated regulatory submissions at best.

For a new technology company in the start up phase your outsource partner will take on the burden of product development and optimization more cost effectively and faster than developing these skills in-house.This will allow you to focus on raising finance, building intellectual propertyand focusing on the market for your product.

Characteristics of the Right Medical Outsource Partner

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Trust and Confidentiality

First to market has immense value, work to develop a deep relationship with your partner, assure that they respect and understand the need for discretion. Trust that they understand that your reputation and success is entangled with their performance.

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Active Engagement and Collaboration

Your partner has to be proactive. It goes beyond a typical vendor – customer relationship. Your partner needs to actively offer solutions that are optimized for your device development and production. They must always be aware of potential challenges in the supply chain and offering solutions.

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Reliability

You need to have security that your partner can stand up to the rigour and scrutiny of medical device regulation and auditing standards. Make sure they have the necessary experience and qualifications.

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Flexibility

Supply chain management can be cyclical and seasonal. Products are frequently revised, enhanced and augmented. Your outsource partner has to have the ability to ramp up and down as your demand does, allocate the right engineering resources for New Product Introduction (NPI) and to give you the peace of mind that you are maximising all opportunities.

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Aligned Vision

You and your partner need to have a shared vision of the future. Seek a partner that has a proven track record in bringing new technologies from concept to maturity over many years. Make sure your partner is being innovative and is at the cutting edge in their field of expertise.

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Honesty

Your partner needs to understand their limitations and where they can bring value to your innovation and technology.

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Varied Experience

Your partner should have customers of various sizes from large multinationals to start up technology companies. This mix of experience demonstrates that your partner understands the challenges specific to your business and can support you as you grow and your needs evolve.

“Outsourcing can be an enriching and rewarding experience, choosing a partner that is right for you is central. M&M Qualtech is a design and manufacturing services company specialising in electronics for challenging applications including medical devices. Talk to us today about how we can get your innovative device to market quickly- M&M Qualtech – “technology with velocity”.

Brian Clarke, Managing Director, M&M Qualtech

Talk to us today about how we can get your innovative device to market quickly.

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