By Sean Fenske, Editor-in-Chief

From early design decisions to long-term supply planning, medical device manufacturers face a range of technical, regulatory, and operational challenges. While distributors are often viewed simply as a source for components, many are playing a broader role in supporting development teams and helping navigate an increasingly complex medtech landscape.

In the following Q&A, Danielle Arcuri, Director of Product Management at Qosina, discusses how distributors can support engineering teams, help mitigate supply chain risk, and provide insight into evolving regulatory and market dynamics across the medical device industry.

Sean Fenske: In the medical device development space, customization is typically the norm. As such, what is the benefit of working with a distributor of off-the-shelf products?

Danielle Arcuri: Medical devices themselves are often highly customized for a specific clinical application or market, but that doesn’t necessarily mean every component inside the device needs to be custom as well. In many cases, standard, readily available components can meet performance requirements just as effectively. Working with Qosina gives customers access to a curated portfolio shaped by more than 45 years of collaboration with both customers and suppliers, which helps narrow the field to solutions that are already well understood and widely used.

Incorporating off-the-shelf components where it makes sense can reduce unnecessary complexity during development, which often translates into lower costs and faster timelines. With inventory across a broad range of components and a free sampling program for most products, R&D teams can quickly get parts in hand, evaluate different options, and move through early design stages more efficiently. And when a standard component isn’t quite the right fit, we can support custom sourcing through our network of more than 300 approved suppliers. Even in those situations, having a comparable off-the-shelf option often allows teams to begin early testing with a “close enough” solution while the final component is being developed.

Fenske: Many think of a distributor as simply a source for parts. Can you share what value can be obtained from collaborating with a company like Qosina at the engineering level?

Arcuri: Collaborating with a distributor early in the development process can provide support well beyond component availability. When engineers engage with Qosina during the early stages of a project, we can help address technical, regulatory, and commercial considerations that may influence component selection. Because we work closely within the medical device industry, we have a strong understanding of how components are used across different applications and the regulatory expectations that often guide those decisions. That perspective, combined with supply chain experience, can help teams identify solutions that align with their technical requirements, development timelines, and long-term product goals.

Early access to components can also make a meaningful difference during the design process. Through our sampling program, engineers can quickly obtain and evaluate parts as designs evolve. We also provide supporting documentation, including 2D and 3D drawings, material information, and specification sheets, which help engineering, quality, and regulatory teams review the technical details they need without slowing down development. As projects move toward production, we continue supporting customers as manufacturing scales, helping maintain consistency and supply continuity throughout the product lifecycle.

Fenske: Given the long lifecycles of many medical devices and the growing focus on supply chain resilience, how can Qosina help manufacturers ensure product availability while minimizing supply disruptions and obsolescence risks?

Arcuri: Because many medical devices remain on the market for years, long-term supply continuity becomes an important part of component selection. At Qosina, supply chain resilience is built into how we develop and manage our product portfolio. That begins with a robust supplier onboarding process that evaluates not only product fit and regulatory considerations, but also supplier reliability and long-term stability.

Working with hundreds of qualified suppliers across the globe provides flexibility within the portfolio and often allows for alternative component options if supply constraints arise. Most of the components we carry are also stocked based on historical demand, providing built-in safety stock that can help buffer against disruptions or product changes.

We also actively monitor material availability and broader supply chain conditions so we can anticipate potential risks and identify alternatives when necessary. Many suppliers are strengthening their own resilience by qualifying multiple materials or manufacturing sites. If product changes or obsolescence concerns do occur, our internal product team works closely with customers to identify suitable replacements, helping maintain continuity over the life of the device.

Fenske: What role can a distributor play in helping medical device companies achieve better cross-functional alignment during development and commercialization?

Arcuri: Distributors often sit at the intersection of manufacturers, suppliers, and multiple departments within a medical device company, which provides visibility into how different functions interact across the product lifecycle. At Qosina, we regularly engage with teams across supply chain, quality, regulatory, engineering, and product management. That exposure helps us understand how each group approaches component selection, documentation, compliance, and long-term supply planning.

With that perspective, we can often help identify where requirements may overlap or where potential challenges could arise, allowing teams to make decisions that work across functions rather than in isolation.

Another advantage is the cross-industry perspective distributors can bring. Qosina works with customers in both the medical device and bioprocessing markets, which often share technologies and components. Historically, bioprocessing adopted many regulatory requirements from medical device manufacturing, but that dynamic is evolving as the industry develops its own testing standards and regulatory frameworks. At the same time, broader regulatory approaches are shifting toward more risk-based models rather than strictly checklist-driven compliance. Seeing these changes across multiple markets helps us anticipate trends and support customers as they navigate evolving requirements.

Fenske: How does Qosina apply cross-functional alignment internally, and how does that translate into value for customers across different markets and applications?

Arcuri: Internally, cross-functional alignment is something we place a strong emphasis on because it directly impacts the experience our customers have working with us. Our teams collaborate across product management, supply chain, quality, regulatory, and customer support to ensure decisions consider the full picture—from product availability and documentation to compliance and lifecycle planning.

This internal collaboration allows us to respond more effectively to customer needs and provide consistent support across the different departments within their organizations. It also helps guide how we evaluate decisions internally. A question we often ask is whether a particular approach simply makes things easier operationally for us, or whether it truly improves the experience for the teams relying on our products and services. Keeping that perspective front and center helps ensure our internal processes ultimately translate into better support for customers as their projects move from development through commercialization.

Fenske: Does a distributor help with the regulatory submission? What materials/information are provided to aid with this aspect of the product lifecycle?

Arcuri: While distributors are not typically involved directly in regulatory submissions, they can still play an important role in supporting the process by providing the product information and documentation regulatory and engineering teams rely on.

One of the most valuable ways Qosina supports customers is through access to comprehensive product documentation. Many resources are available directly on our website, including 2D and 3D drawings, material documentation, and detailed specification sheets. These specification sheets consolidate key technical and regulatory information in a clear, easy-to-review format, allowing teams across engineering, quality, and regulatory functions to quickly access the data they need. All documentation is managed within a quality-controlled internal database to help ensure consistency and reliability.

In addition to product documentation, Qosina also provides educational resources that help customers stay informed about evolving regulatory expectations. For example, we publish content focused on topics such as EU MDR and the types of documentation or product attributes that may help support compliance efforts.

While Qosina does not currently participate directly in regulatory submissions, we have received significant feedback from customers who are interested in additional regulatory-related services. Expanding support in this area is something we are actively evaluating as part of our roadmap to better meet the evolving needs of the teams we work with.

Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?

Arcuri: One of the things we value most at Qosina is the opportunity to work closely with customers throughout their development journeys. It’s always fascinating to see the ideas and innovations teams are exploring to advance the medtech field. Every project, conversation, or technical question offers an opportunity to learn more, whether it’s about a specific application, an emerging technology, or a new way a component is being used.

Those ongoing conversations with customers, suppliers, and other industry stakeholders help shape how we think about our role in the ecosystem. They influence how we evolve our portfolio, identify areas where additional services may add value, and stay informed about changes in the regulatory and market landscape. In many ways, that continuous dialogue helps us remain responsive and provide better support to the teams developing the next generation of medical devices.

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