Available in a range of different material options based on the application’s needs, elastomeric tubing can help deliver essential functionality repeatedly over the course of a device’s useful life. (Credit: Kent Elastomer)

Manufacturers in all industries rely on networks of specialized suppliers to effectively source the components they need to serve their customers. Trust, reliability, and consistency are important — and for producers of medical devices, these qualities are especially critical, given the often life-saving nature of their end-use products.

And in many applications, components for these devices are sourced from a network of specialized contract manufacturing partners who are called on to deliver on stringent design specifications for reliable performance. Such partners typically offer niche expertise in specific areas that a manufacturer may not have in house, and they can often help realize cost efficiencies, increase speed to market, and provide scalability and flexibility depending on need and offer other benefits. Indeed, medical device designers and manufacturers often place considerable trust in their supply network to successfully develop and market important end-use products.

Scrutiny of such partners must be more stringent for medical product companies than in other industries. Medical component contract manufacturers must adhere to rigorous regulatory compliance, offer precision processing to meet rigorous medical specifications, and provide material science expertise for components, many of which may be used inside a human body. Further, the nature of medical devices requires intuitiveness, ease of use, and reduction of the potential for human error. Good device design contributes to improving efficiency and reducing risks during procedures — and thus, optimized device components that meet such needs are essential.

Ultimately, contract manufacturers providing medical device tubing should be able to guide an OEM toward the proper material choice, based upon the required performance characteristics and depending upon the needs of an application. (Credit: Kent Elastomer)

Considering that there many supply chain partners with varying competencies, capabilities, and experience, medical device designers cannot compromise. This article explores how a reliable partnership is increasingly critical for success in the medical device industry, how contract manufacturers can deliver greater value for device designers, and why they are such an important part of the modern medical supply chain.

Case Study: Maintaining Essential Specifications

Medical device componentry is wide and varied and must meet a broad range of needs and demands. These components generally have their own individual specifications and performance requirements. A contract manufacturing partner should be closely aligned with the needs of the end-use application.

Consider elastomeric tubing: Available in a range of different material options based on the application’s needs, elastomeric tubing can help deliver essential functionality repeatedly over the course of a device’s useful life.

For example, polyvinyl chloride (PVC) is a popular choice for medical applications due to its low cost and versatility, and it can be deployed for general fluid transfer applications including oxygen and respiratory tubes, IV tubing, and more. It is lightweight and can be manufactured with varying degrees of flexibility. It also lends itself well to solvent bonding, making it easy to work with. PVC is a strong choice for applications that require stability and excellent resistance to tears, corrosion, weather, chemicals, impact, and electricity.

However, because PVC incorporates plasticizers to soften the material, some of which have been classified as potential carcinogens, PVC faces some limitations based on the product’s intended application. PVC is not suitable for use in tubing applications where the product is implanted in a patient, for example.

Comparatively, thermoplastic elastomers (TPEs) combine the properties of plastic and rubber, providing flexibility and strength without needing plasticizers. TPE tubing is often used as an alternative to PVC in applications where flexibility and chemical resistance are necessary, like catheters and IV tubing. Because TPE is easy to sterilize and offers excellent cleanliness properties and good biocompatibility, TPE tubing is a good choice for many medical applications.

TPE mimics many of rubber’s most desirable properties, such as flexibility and a soft feel. But high-quality, specialized TPE can exhibit greater resistance to heat or chemicals than rubber, making it a more stable, durable material choice in certain applications. High-performance TPE demonstrates excellent elasticity, flexibility, and elongation properties. Depending on the compound, TPE products can also offer good tensile strength and tear resistance.

Alternatively, latex rubber has long been used in the medical industry, offering excellent flexibility and elasticity for applications that require it. Medical-grade latex is generally safe for skin contact and is often chosen for applications that come into prolonged contact with the body. However, since latex allergies have become a more common consideration when designing and producing medical components, manufacturers typically offer alternatives for patients with latex allergies. Latex is resistant to tearing and puncturing, which makes it suitable for applications requiring reliable, durable parts like catheter balloons and tourniquets.

Ultimately, contract manufacturers providing medical device tubing should be able to guide medical OEMs toward the proper material choice, based upon required performance characteristics and depending upon the needs of the application. Questions to consider include:

  • Does the use case require elasticity or rigidity?
  • Will components require repetitive use?
  • Does the tubing frequently come into contact with human skin, thus needing to provide an unobtrusive tactile experience?

Regardless of the component being sourced, these are just some of the conversations that should be solved with a contract manufacturing partner. Two-way communication and collaboration are essential to achieve the best results, and the contract manufacturer’s ability and willingness to collaborate on the best solution for the application is something medical device designers should heavily weigh when choosing a partner.

Reliable Partnership, No Matter the Application

A contract manufacturing partner who understands the parameters and demands of the application is essential, but so are some important general qualities that medical device designers should seek out. Some of them include:

Quality. Component quality can make or break a finished product. Poor-quality medical components can lead to product failure and may potentially threaten patient outcomes. The stakes are high — and sacrificing quality for the sake of short-term savings could be more costly in the long term. Also important is quality consistency. It takes just one poor-quality component to lead to suboptimal outcomes.

Responsiveness. Ideally, supplier partners should be responsive to the OEM’s needs. This means listening to concerns or questions and providing answers and solutions in a timely manner. In an ideal scenario, a supplier may even proactively offer solutions in anticipation of the OEM’s needs, business conditions, or other variables.

Capacity. When demand increases, an OEM needs to trust that a supplier has the capacity to deliver higher volumes to meet the production schedule; if they can’t, that inability will create an artificial cap on production volume. Consulting with suppliers about capacity early and often is critical.

Communications. Indeed, a true partnership — and not just a vendor/buyer relationship — hinges upon open, two-way communication.

A Strong Domestic Presence

Given the state of global supply chains and shifting geopolitical concerns, relying on imported goods can sometimes pose a challenge for reliably producing finished devices on time and on spec.

Maintaining a network of dependable suppliers can cover an OEM’s needs in the event that a preferred supplier falls short. Dual sourcing some critical components may enable an OEM to cover unexpected supply gaps. What’s more, a partner network primarily based in the OEM’s region may offer solutions for international shipping woes and provide stronger, more responsive service in meeting an OEM’s needs.

The Trade Agreements Act (TAA) is a federal law requiring that products purchased by the U.S. government to be made in the United States or within a designated TAA-compliant country. For medical device manufacturers, this is an important designation for selling to U.S. government-operated facilities like hospitals overseen by the U.S. Department of Veterans Affairs.

Qualifying a Medical Manufacturing Partner

In addition to their ability to meet an OEM’s design specifications, it’s important that contract manufacturing partners maintain some critical baseline qualifications, including:

  • ISO 13485 Compliance. ISO 13485 is the medical industry’s optimal quality management system standard. It helps ensure that all medical devices are manufactured with suitable quality controls. It’s important validation for contract manufacturers serving the medical industry; a jack-of-all-trades extrusion house may be able to make tubing, for example, but may not maintain compliance with medical industry standards.
  • Intellectual Property (IP) Assurance. Outsourcing component design and production often involves sharing proprietary designs, specifications, and potentially sensitive IP with suppliers. For medical device manufacturers, this can lead to concerns about unauthorized IP use or IP leaks, especially when suppliers serve multiple clients, including competitors. Unauthorized IP use can erode a company’s competitive advantage and result in product imitations in the market, not to mention increase the potential for lengthy and costly legal disputes. Reputable supplier partners should be willing to sign strong contractual nondisclosure agreements (NDAs), as well as be willing to submit to regular IP audits.
  • Assembly Services. It’s worth investigating whether a contract manufacturer can perform additional assembly services for medical device components. This kind of service can help streamline manufacturing processes and logistics and get products to market quicker.

Contract manufacturing partners play a vital role in the medical device supply chain. Their capability to meet precise design specifications is essential. When they consistently deliver high-quality results on schedule and within budget, they provide substantial value, helping manufacturers reduce risk, accelerate time to market, and maintain regulatory compliance.

This article was written by Brian Lipowski, Director of Quality, Regulatory and Technical Services, Kent Elastomer Products, Kent, OH. For more information, visit here  .

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    This article first appeared in the May, 2025 issue of Medical Design Briefs Magazine (Vol. 15 No. 5).

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    Overview

    The document emphasizes the evolving landscape of procurement, highlighting that it has transitioned from merely seeking the lowest price to establishing strategic partnerships with suppliers. It underscores the importance of aligning procurement decisions with the broader goals of the organization, taking into account factors such as sustainability, compliance, and stakeholder priorities.

    Key points include:

    1. Strategic Partnerships: Suppliers are viewed as strategic partners rather than just vendors. This shift requires procurement professionals to seek suppliers who align with their company’s values and long-term objectives, fostering relationships built on trust, reliability, and shared goals.

    2. Beyond Price: While cost remains a significant factor, the document argues that procurement decisions should prioritize long-term value over short-term savings. Factors such as geopolitical conditions, manufacturing standards, and ethical practices are crucial in making informed decisions.

    3. Supplier Relationship Management (SRM): Effective SRM is essential for managing supplier relationships. The document cites expert opinions that emphasize the need for procurement to focus on strengthening these relationships, which can significantly impact business success.

    4. Risk Management: Understanding suppliers' operational, financial, and ethical practices is vital to mitigate risks. The document warns that failing to vet suppliers can lead to severe consequences, including legal issues and financial penalties, particularly in light of regulations like the Foreign Corrupt Practices Act (FCPA).

    5. Collaboration and Communication: The importance of collaboration among various stakeholders within the organization is highlighted. Engaging with departments such as legal, engineering, and quality assurance ensures that procurement decisions are well-informed and aligned with the company’s overall strategy.

    6. Sustainability and Corporate Citizenship: The document stresses that procurement decisions should reflect a commitment to sustainability and good corporate citizenship, which can enhance the company’s reputation and appeal to customers who value these principles.

    In conclusion, the document advocates for a holistic approach to procurement that transcends traditional purchasing practices. By fostering strong supplier relationships, prioritizing ethical standards, and aligning procurement strategies with corporate goals, organizations can achieve sustainable growth and mitigate risks effectively. The new procurement paradigm focuses on long-term partnerships that contribute positively to both the organization and its suppliers.