James Porter , Vice President of Sales and Business Development, Beacon MedTech Solutions10.17.22
In some ways, selecting a contract manufacturing organization (CMO) or contract development and manufacturing organization (CDMO) seems simple. Identify the capabilities you need and choose a company that can offer you the best cost to make your parts.
In reality, it is significantly more complex. Think of the complexity we have seen in supply chains recently. Think of the surging demand for many components, driven by a global pandemic and other unforeseen issues. Think of all this, while your customers still rightly expect your products to perform exactly as intended.
If you still think the responsibility for your components should be left to just any contract manufacturer that meets your minimum specs, it is time to look for something more.
Today’s smart OEMs are engaging in deeper contract manufacturing and development partnerships. They’re leaving more of their complex product manufacturing processes to these experts, and they’re getting much more support along the way. This article will explore what’s behind this trend and what medical device OEMs must look for to establish these more robust relationships.
A CDMO may be able to handle more steps—providing design engineering support; coordinating multiple materials, smaller components, or subassemblies—taking manufacturing burdens away from their OEM customers. This, in turn, gives an OEM more freedom to concentrate on what matters.
But the potential value from the right partnership doesn’t end there. From a rebound in elective surgeries driving increases in disposable parts, to the need for new vaccines driving demand for single-use technologies for upstream bioprocessing systems, to interruptions in supply of critical medical devices across the industry, to reshoring initiatives, there is a greater need than ever for more advanced manufacturing technologies, materials, and processes. A strong partner may also drive collaboration and innovation in design, as well as investments in manufacturing technologies, to help meet these evolving demands.
1. Improving product performance and functionality: The right contract manufacturing partner may be able to leverage vast technical engineering competencies and invest resources to ensure the design-for-manufacturability critical to quality, operational efficiency, and cost. This support can either be in collaboration with your internal engineering team, or in place of it, to support your team’s already limited capacity.
2. Optimizing manufacturing processes: Early CDMO involvement can deliver process innovations that improve quality, speed and costs—all before the first design freeze. OEMs should expect a process that leverages sophisticated, customized advanced manufacturing technologies, an optimized process from tool design through inspection, and process validation.
3. Adding value throughout the program: A contract manufacturer may be able to take significant burdens off your shoulders by offering vertically integrated in-house capabilities, including:
5. Scaling up and down quickly: When sales projections don’t equate to reality, an agile contract manufacturing partner can help weather the ups and downs on the road to entering new markets and launching new projects, without assigning cost penalties for more frequent, lower-volume deliveries.
So, if you, like many OEMS, are going to rely on fewer manufacturers for more—and more crucial—support, how do you trust them to do what you’ve historically done yourself? How do you ensure your partners are equipped to handle whatever the market throws your way?
Following are several fundamental considerations.
You’ll notice I did not mention cost. While your contract manufacturing partner should be cost effective and fiscally responsible, it is important to weigh the value this team can provide—not just the dollars and cents of it.
You must also be aligned with your partner regarding the shape of your relationship. Are you purely looking for a transactional relationship and a shoot-and-ship molder to produce standard parts at a high volume? Or does your team need niche expertise or a more vertically integrated contract manufacturer? Whatever your answer, defining your needs upfront can ensure you’re able to maximize the investment in your partnerships.
Having more of these niche capabilities under one roof enables contract manufacturers to handle even more of the supply chain in house. This is accomplished by offering these capabilities from a single source and owning the responsibility for design for manufacturability (DFM); sourcing materials, stock sub-components, packaging, and more; and providing full product assemblies from part design to complete assembly and kitting.
You must also look for more than a basic claim of a capability. Does the contractor have a record of helping companies like yours with similar applications? Do they have the established quality management system (and ISO 13485 and 9001 certifications), existing infrastructure and footprint, and knowledge of all things regulatory that you can count on to help with your challenges?
Further, it’s not just about experience in a particular medical application either. Insight from other industries, technologies, and processes can open the door to breakthroughs. The biggest benefit often comes from bringing people together with different perspectives—technical, engineering, production/operations—to solve problems together in new ways.
Hiring and employee engagement practices are also important. Look for a clear focus on retaining best-in-class talent to ensure a contract manufacturer can continue to provide the expertise you need.
Transparency, commitment and collaboration can make all the difference in accelerating the collective success of the OEM-contract manufacturer relationship through better quality, better delivery, and better performance.
James Porter brings more than 20 years of diverse experience in senior-level sales, product management, business development, quality, and customer support experience in the plastics and medical device industries. As VP of sales and business development for Beacon MedTech Solutions, Porter leads the company’s sales, commercial, business development, and marketing efforts while working directly with customers to accelerate success. He previously held roles with Asahi Intecc, Danaher, Hocoma, JPSA Laser, Blueshift Technologies, Cameca Instruments, and Westfall Technik.
In reality, it is significantly more complex. Think of the complexity we have seen in supply chains recently. Think of the surging demand for many components, driven by a global pandemic and other unforeseen issues. Think of all this, while your customers still rightly expect your products to perform exactly as intended.
If you still think the responsibility for your components should be left to just any contract manufacturer that meets your minimum specs, it is time to look for something more.
Today’s smart OEMs are engaging in deeper contract manufacturing and development partnerships. They’re leaving more of their complex product manufacturing processes to these experts, and they’re getting much more support along the way. This article will explore what’s behind this trend and what medical device OEMs must look for to establish these more robust relationships.
Why CM Partnerships Matter More Today
With intensifying challenges in supply chains and production management, it’s getting harder every day for medical device OEMs to focus on core competencies like product innovation and device safety.A CDMO may be able to handle more steps—providing design engineering support; coordinating multiple materials, smaller components, or subassemblies—taking manufacturing burdens away from their OEM customers. This, in turn, gives an OEM more freedom to concentrate on what matters.
But the potential value from the right partnership doesn’t end there. From a rebound in elective surgeries driving increases in disposable parts, to the need for new vaccines driving demand for single-use technologies for upstream bioprocessing systems, to interruptions in supply of critical medical devices across the industry, to reshoring initiatives, there is a greater need than ever for more advanced manufacturing technologies, materials, and processes. A strong partner may also drive collaboration and innovation in design, as well as investments in manufacturing technologies, to help meet these evolving demands.
What Opportunities Could You Be Overlooking?
If you’re still evaluating your suppliers on cost, rather than value, you may be missing major opportunities to drive innovation, speed, and quality. Industry-leading medical, life sciences, and bio-pharma OEMs are finding enhanced value and know-how in contract manufacturers’ in five key areas:1. Improving product performance and functionality: The right contract manufacturing partner may be able to leverage vast technical engineering competencies and invest resources to ensure the design-for-manufacturability critical to quality, operational efficiency, and cost. This support can either be in collaboration with your internal engineering team, or in place of it, to support your team’s already limited capacity.
2. Optimizing manufacturing processes: Early CDMO involvement can deliver process innovations that improve quality, speed and costs—all before the first design freeze. OEMs should expect a process that leverages sophisticated, customized advanced manufacturing technologies, an optimized process from tool design through inspection, and process validation.
3. Adding value throughout the program: A contract manufacturer may be able to take significant burdens off your shoulders by offering vertically integrated in-house capabilities, including:
- Material analysis and specification—Combined with the ability to manage supply pricing and secure alternative materials if availability and price require it.
- Customization of advanced manufacturing technologies and equipment—Through established partnerships with equipment suppliers.
- Sourcing of components or subassemblies—Reducing OEM time and labor costs in production builds, inspection, and testing.
- Value-add capabilities—Offering additional in-house expertise beyond the molding process including ultrasonic welding, heat staking, press fit assembly, pad printing, adhesive bonding, solvent bonding, plastics machining, and more.
5. Scaling up and down quickly: When sales projections don’t equate to reality, an agile contract manufacturing partner can help weather the ups and downs on the road to entering new markets and launching new projects, without assigning cost penalties for more frequent, lower-volume deliveries.
Secure the Right CM Relationships
Selecting the right partner to realize the full potential of a contract development and manufacturing relationship is not a decision to be taken likely. Equipment malfunction, natural disasters, and other environmental factors that can cause supply chain hiccups are nearly impossible to predict. Market fluctuations, increasing end-user expectations, exacting part specifications, and a rapidly evolving regulatory environment also put your supply chain to the test every day.So, if you, like many OEMS, are going to rely on fewer manufacturers for more—and more crucial—support, how do you trust them to do what you’ve historically done yourself? How do you ensure your partners are equipped to handle whatever the market throws your way?
Following are several fundamental considerations.
Determine Your Team’s Non-Negotiables
Is it critical for your new partner to have in-house capabilities in both tooling and Class 7 and 8 cleanroom molding? What about competencies in insert and overmolding? Do you need a CMO or a CDMO? Is their proximity to you more important? No matter your requirements, decide upfront where you are—and are not—willing to negotiate.You’ll notice I did not mention cost. While your contract manufacturing partner should be cost effective and fiscally responsible, it is important to weigh the value this team can provide—not just the dollars and cents of it.
You must also be aligned with your partner regarding the shape of your relationship. Are you purely looking for a transactional relationship and a shoot-and-ship molder to produce standard parts at a high volume? Or does your team need niche expertise or a more vertically integrated contract manufacturer? Whatever your answer, defining your needs upfront can ensure you’re able to maximize the investment in your partnerships.
Search for Compatible Capabilities and Know-How
What are the capabilities and expertise you don’t have in your own organization or your existing contract manufacturer(s) that could provide the greatest benefit to your customers? This range of capabilities may include both liquid silicone rubber (LSR) and thermoplastic injection molding, insert and overmolding, in-house tooling, or assembly and kitting.Having more of these niche capabilities under one roof enables contract manufacturers to handle even more of the supply chain in house. This is accomplished by offering these capabilities from a single source and owning the responsibility for design for manufacturability (DFM); sourcing materials, stock sub-components, packaging, and more; and providing full product assemblies from part design to complete assembly and kitting.
You must also look for more than a basic claim of a capability. Does the contractor have a record of helping companies like yours with similar applications? Do they have the established quality management system (and ISO 13485 and 9001 certifications), existing infrastructure and footprint, and knowledge of all things regulatory that you can count on to help with your challenges?
Further, it’s not just about experience in a particular medical application either. Insight from other industries, technologies, and processes can open the door to breakthroughs. The biggest benefit often comes from bringing people together with different perspectives—technical, engineering, production/operations—to solve problems together in new ways.
Ensure Your Partners Have the Right Partners
Nobody can go it alone. It is important to understand if your CDMO has built a high-functioning supply chain of its own. You need to ensure there is a supporting team in place to make good on commitments—even when circumstances arise that are beyond the contract manufacturer’s control. Seek partners who share a bias for proactivity and driving positive outcomes. Leading contract manufacturing partners have long-standing, mutually beneficial partnerships with suppliers who can move with the rapid-fire response needed to meet today’s fast-changing conditions and needs.Seek Insight on Vision and Commitment
In your review, don’t forget the intangibles. Successful supplier relationships begin and end with people who share your values, who understand your business, and who communicate openly. Especially in our world, where the parts we make may help save lives or drive groundbreaking transformations, we need to find people we can trust.Hiring and employee engagement practices are also important. Look for a clear focus on retaining best-in-class talent to ensure a contract manufacturer can continue to provide the expertise you need.
Getting Started
If you’re under pressure to start running parts right away, you might be wary of taking the time to vet contract manufacturers with such rigor. Taking a little more time and care up front, however, can really pay off.Transparency, commitment and collaboration can make all the difference in accelerating the collective success of the OEM-contract manufacturer relationship through better quality, better delivery, and better performance.
James Porter brings more than 20 years of diverse experience in senior-level sales, product management, business development, quality, and customer support experience in the plastics and medical device industries. As VP of sales and business development for Beacon MedTech Solutions, Porter leads the company’s sales, commercial, business development, and marketing efforts while working directly with customers to accelerate success. He previously held roles with Asahi Intecc, Danaher, Hocoma, JPSA Laser, Blueshift Technologies, Cameca Instruments, and Westfall Technik.
