In today’s market, 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 replace existing solutions. But how do you choose the right fit supplier for your project?
9 hot tips for choosing a medical device contract manufacturer
1. Match your needs to their capabilities
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 devices (IVDs)? 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?
Align on core competency —regardless of how capable a CMO executes, requiring that organization to perform activities not in its wheelhouse can potentially result in disaster.
Michael D. Huiras, Flexan
2. Check out their Quality Management System (QMS)
Find out what systems and approaches each potential partner uses to manage risk and meet required quality standards. What documentation will they share with you to ensure you can get the market authorisation in all the territories you need? They should have previously gained ISO 13485 and FDA approvals, but make sure they have a significant track record of controlling their manufacturing to these exacting standards. A new entrant to the med tech contract manufacturing space might be offering you preferential rates, but make sure you won’t be their operational guinea pig as they bring new services online.
Quality is absolute; it needs to be part of the DNA of the organization, system, processes, product, and manufacturing supply.
Michael D. Huiras, Flexan
3. 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
Consider choosing a one-stop-shop provider. The more services a CMO can offer to an OEM, the fewer time delays and adjustments will be required.
Georges Belanger, Industrias Plasticas Medicas (IPM)
4. Look for design expertise
Access to design expertise can be a game changer for more complex products. Even if you are not considering outsourcing design at this stage, it’s worth exploring your options with your chosen suppliers. VE (Value Engineering) and DfX (Design for Excellence) capabilities can help you design for manufacturing in ways that will significantly reduce costs and extend your product’s lifecycle. The right manufacturer can and should add value for you beyond cost and scale. Your partner should help you lever new IP in the sector, from recommending cutting-edge materials to supporting user-centric design insight.
An OEM can accelerate time to market by selecting a CMO that has a ready-made supply chain, an ISO 13485-certified design organisation with experience designing FDA compliant systems, and a compliant manufacturing infrastructure.
Charlie Mason, Senior Vice President, Sanmina
5. 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 supply chain and business updates from a dedicated accounts team throughout the product lifecycle.
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 manufacture project, working with a large company located thousands of miles away can make financial sense, 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 who has facilities available locally to you as well as internationally will likely win on coverage and customer service. A global presence will give you access to supply chains and specialised labour that will give you ultimate flexibility in production and procurement. But local facilities will support faster delivery returns and replacements, as well as offering you face-to-face account support when you need it most.
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. Looking to consolidate service provision from design, to manufacture, logistics and servicing can be a long term cost-saving strategy.
We find that sometimes OEMs see us as being really good at one area of our business, but don’t always identify us for some of the other projects they may have available. In understanding their full capabilities, they can alleviate using multiple suppliers, making project management easier with fewer suppliers to manage.
Raghu Vadlamudi, Chief research and Technology Director at Donatelle
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 commerical objectives that you need to drive your project. Handing over responsibility for the design and/or manufacture of important products 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.
9. Consider the future
Med Tech development and manufacturing is expensive and fraught with risk. 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 need access to innovative design and manufacturing thinking to ensure those products remain relevant and profitable for as long as possible.
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.