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All kinds of medical device OEMs need contract manufacturing support. From start-ups and disruptors with no device manufacturing expertise to established developers looking to change their existing suppliers. But how do you choose the right fit supplier for your project?
9 hot tips for choosing a medical device contract manufacturer
1. Ensure their capabilities match your needs
What classification of product do you need to manufacture? High volume/low complexity class 1 products or the most sophisticated Class 3 in-vitro diagnostic equipment (IVD devices)? Whatever your needs, ensure your chosen partner has the skill set and capacity to deliver. Do you need electronics or mechanical assembly expertise? Do you need design support? Has your chosen CM (Contract Manufacturer) got the experience and client list that demonstrates their track record of success in your product area? Will they be able to fulfil according to your timelines and leverage the global supply chain in the most efficient way possible?
2. Make sure they have gained ISO 13485:2016 and FDA approvals
Your supplier should have gained the QMS standard ISO 13485:2016 and have a track record of meeting regulatory requirements in the regions where you plan to launch. For those wanting to launch in the US, your partner should be compliant with the FDA's Quality System Regulation (QSR) as outlined in 21 CFR Part 820. You should ensure they are an FDA registered manufacturing facility with listed products and a history of successful FDA inspections.
Ask to review their Quality Management Systems and check on the FDA site to see if they have any findings or warning letters against them before you commit.
“A supplier might be offering you preferential rates, but you run the risk of being their operational guinea pig if they haven’t delivered against specific standards and regional regulations before.” Teng Mei Fong - Quality Manager for ESCATEC Medical
3. Look for advanced DfX and VAVE capabilities
Access to design expertise can be a game changer for more complex products. VE (Value Engineering) and DfX (Design for Excellence) capabilities can help you design for manufacturing in ways that will significantly improve performance and extend your product’s lifecycle.
The right contract manufacturing company should add value for you beyond cost and scale. Your partner could help you leverage new IP in the sector, from recommending cutting-edge materials to supporting user-centric design insight.
For example, the team at medical device OEM Vibrosonic needed to find a delivery partner who could help them implement DfM (Design for Manufacturing) plans - to commercialise production of their tiny yet complex hearing device.
ESCATEC’s skill in electronics miniaturisation helped them realise their earpiece designs with cutting-edge materiality and MOEM design capabilities.
“Producing and working with a substrate as thin as this requires specialist skills and equipment, which only a few manufacturers around the world can master.” Dr Dominik Kaltenbacher, Founder and Managing Director of Vibrosonic
You can read more about ESCATEC’s work with Vibrosonic here.
“An end-to-end process centred on precision and quality removes the gaps between design and manufacture that can typically cause friction. This means that products can be safely and efficiently optimised for mass production from the outset, keeping costs low and removing unnecessary production delays. Working this way ensures partners keep full control of their design with full IP.” Harald Schroeder, Director of Business Development, ESCATEC
4. Ensure access for due diligence and beyond
Make sure you’ll have all the access to your supplier you need as part of your due diligence process. Arrange site visits and/or virtual tours of facilities to assess the size and readiness of their operations both locally and overseas. Going forward, you should expect complete visibility and hands-on support throughout your NPI process. You should expect face-to-face quarterly and annual business reviews once the product is in the market, as well as regular global supply chain and business updates from a dedicated accounts team throughout the product lifecycle.
"When we visited Malaysia, we saw that ESCATEC had a first-class production facility. We saw how professional and efficiently managed all their processes and operations were. The visit was an incredible hosting experience and deepened our relationships with the manufacturing team on site - as well as ESCATEC’s local and global management. We experienced Penang as a thriving ecosystem for medical electronics manufacturing operations.” Lisa Krapinger-Rüther, Former Co-CEO of breathe ilo
5. Check out their lifecycle support
Developing medical devices can take a long time and be very expensive. You need a CM to help you bring your product to market rapidly, but also keep it there for as long as possible. The right post-production support can fight early obsolescence and continue adding value to consumers even as rival products in the marketplace start to fail. Look for a partner who can help you:
- Manage obsolescence with design support - ensuring you specify materials and components that are not going to be quickly discontinued or outmoded
- Compliance support post-launch (i.e. RoHS, WEEE, REACH)
- Repair and return support
- Enhanced support for spares and field maintenance kits
- Feature update/upgrade support
“We spoke to a lot of partners, advisors and similar companies. But it became clear that only ESCATEC had the facilities and staff to match all our future needs. ESCATEC could help us in sourcing large quantities of components, which we needed to grow and scale in the near future. But they also had the skills to help us continually modify and improve the product to meet the latest, global med tech standards.” Lisa Krapinger-Rüther, Former Co-CEO of breathe ilo
6. Think about geography
Where your partner is located can make a significant difference to your costs but could potentially undermine your sense of control over a project.
For a complex medical device design and manufacturing OEM based in Europe, working with a large company located thousands of miles away can save you money on labour but may rob you of critical moments of creative input.
Will you be happy feeding back on a prototype if you can’t physically hold it in your hands?
A partner with facilities available locally, as well as internationally can coverage, capabilities and customer service.
The German Fertility tech innovator breathe ilo chose a global medical device manufacturer with facilities local to them for exactly these reasons:
“Escatec’s Swiss NPI team were expert, professional and supportive. Communication was transparent, and there was effective expectation management around timeline and cost." Lisa Krapinger-Rüther, Former Co-CEO of breathe ilo
At the same time, the added dimension of a global manufacturing gave them access to supply chains and specialised labour in Malaysia that offered the ultimate flexibility in production and procurement.
“The local NPI support and close integration with the production team in Malaysia meant we were confident of a successful transition process. There was a smooth transfer from low-volume to high-volume international manufacturing." Lisa Krapinger-Rüther, Former Co-CEO of breathe ilo
7. Consolidate services where possible
Constantly switching between suppliers is a hassle as well as an IP and quality risk. You need to be thinking long-term and holistically as you tender for CM services.
Spending time and effort thinking about existing and future requirements when you are choosing a medical device manufacturing partner, could save you a lot of time and trouble later on.
Consolidating service provision from product design, to manufacture, quality assurance, logistics and servicing can be a long term cost-saving strategy.
“We chose ESCATEC because they could provide us with a complete solution from designing how the product would work right through to the final production process, all conforming to the ISO standard for medical equipment – ISO13485. This is an extremely complex device that people’s lives depend on, so it is vital that it is designed and built to the highest standards.” Peter Rossegger, Former CEO of Carl Reiner GMBH
Read more about Carl Reiner’s groundbreaking work with ESCATEC.
8. Choose a partner - not a supplier
When you’re choosing a CM partner, make sure you’re culturally and professionally aligned. The teams from each side should have a shared understanding of the quality and commercial objectives that you need to drive your project. Handing over responsibility for design and medical device assembly can be a nerve-racking business. Communication is key. Your partner should be proactively involved in keeping you in the loop as the NPI process is designed and implemented. They should keep adding value throughout the product lifecycle. You should feel your CM partner is an extension of your operation.
“Setting up mass production lines is complex, but ESCATEC ensured any problems in our manufacturing process were proactively discovered and jointly overcome. This was enabled by transparent communication and the solution-oriented mindset of ESCATEC employees around the world, working together with us.” Lisa Krapinger-Rüther, Former Co-CEO of breathe ilo
9. Consider the future
Accessing med tech development and manufacturing services can be expensive and fraught with risk. But the most successful partnerships in this space are not short-term and transactional, but long-term and collaborative.
You need to build products as rapidly as possible to see ROI for your investors, but you also need access to innovative design and manufacturing thinking to ensure those products remain relevant and profitable for as long as possible.
“Medical devices often have long product development cycles… at ESCATEC, we don’t mind working to these timescales because we are not driven by quarterly revenue results. We're looking for long-term medical device partnerships that deliver long-term benefits for our clients and their customers.”
Charles-Alexandre Albin, CEO ESCATEC
Choose your partner carefully and you’ll be able to develop and manufacture not just one successful product but a succession of products in the most cost-effective way. You’ll have a blueprint for repeatable NPI success with the mechanisms and support in place to optimise the way you work each time.
“With ESCATEC as our partner, we can confidently scale up production to meet evolving international demand. We have exciting plans to enhance our fertility tracker's functionality, potentially transforming it into a contraceptive device in the future. ESCATEC's expertise and support will be instrumental in realising our vision.” Lisa Krapinger-Rüther, Former Co-CEO of breathe ilo
For more information on 9 hot tips for choosing a medical device contract manufacturer talk to ESCATEC Mechatronics Ltd