The Growth of MedTech Design and Development Services
Addressing design and manufacturing together with team members from the same supporting organizations can provide an array of benefits.
Originally featured in Medical Product Outsourcing on November 11, 2026.
Traditionally, most medical device manufacturers enlisted aid from a development partner to design a device before transferring that to a manufacturing service provider to build it. Handoffs were involved where knowledge could be lost, misunderstandings or miscommunication might have crept in, or a lack of optimization between design and manufacturer could take place.
As a result, the industry has been transforming with the emergence of contract development and manufacturing organizations (CDMOs). These firms take a concept through development and onto manufacturing, offering a complete product at the end. OEMs gain the benefit of working with one point of contact for the entire development and production lifecycle.
Taking time to explain the benefits of working with CDMOs is Evan Gyllenhaal, Global VP, Product Development, at Resonetics. In the following Q&A, he tackles a number of questions on design and development services, the advantages of working with a single company providing those services alongside manufacturing, and when to engage with a CDMO on a new project.
Sean Fenske: Why are more contract manufacturers incorporating, developing, and/or acquiring design capabilities? Why are CMOs transforming to become CDMOs?
Evan Gyllenhaal: Medical device development has become increasingly complex, and OEMs are under constant pressure to reduce development timelines while managing technical, regulatory, and manufacturing risk. As a result, there is greater value in bringing design and manufacturing expertise together rather than treating them as separate stages of the product lifecycle.
A partner that understands how a device will ultimately be produced can provide valuable input much earlier in development to help them accelerate their path to market and achieve their objectives. Design decisions involving materials, component geometries, tolerances, assembly processes, testing, and scalability can all have significant implications downstream. When that manufacturing knowledge is incorporated early during development, potential downstream issues can be identified while designs are still relatively easy—and less costly—to change.
That is a major reason we are seeing the industry evolve from the traditional CMO model toward the CDMO model. OEMs are increasingly looking for partners that can do more than just manufacture to print. They want partners that can help anticipate and solve engineering challenges, accelerate iteration, reduce risk, and ultimately provide a more efficient path from an idea to a commercially scalable product.
Fenske: What actions has Resonetics taken to enhance and expand its own design capabilities?
Gyllenhaal: Resonetics has intentionally built an integrated model that connects product development with the specialized manufacturing technologies required to commercialize complex medical devices.
Our product development group provides engineering support from early concept through formal design, development, verification, validation, and launch. An important part of that model is connecting product development engineers with the broader Resonetics network, including our Lightspeed Lab® rapid prototyping capabilities and specialized expertise in areas such as nitinol, laser processing, precision tubing, catheters, sensors, batteries, micro molding, and other advanced manufacturing technologies.
The addition of Resolution Medical significantly complements and expands on that model. Resolution brings extensive expertise in product development, advanced biosimulation, NPI, and finished-device manufacturing across interventional, structural heart, and neuromodulation markets.
Together, these capabilities allow us to engage with customers much earlier and remain involved as programs progress toward commercialization.
Fenske: Could you expand further on how Resolution Medical complements Resonetics’ existing design offerings?
Gyllenhaal: The capabilities are highly complementary. Our product development team has established expertise helping customers translate clinical needs and early concepts into viable device designs while leveraging Resonetics’ broad component manufacturing and materials expertise.
Resolution builds on that offering with significant finished device manufacturing experience and adds capabilities in active implantable and bioelectronic development. The combination gives us greater capacity to serve our customers across the entire development continuum. Depending on the program, we can support an individual engineering challenge, a component or subsystem, or complete device design from early concept through finished-device commercialization.
What is especially powerful is the connection between those development teams and the broader Resonetics manufacturing network. It allows us to bring specialized expertise into a program when it is needed rather than approaching design and manufacturing as isolated activities.
Fenske: What benefits are being realized when OEMs are able to have design and manufacturing performed under one roof through their CDMO partner?
Gyllenhaal: One of the biggest benefits is continuity. Every handoff between a design firm, prototype supplier, component manufacturer, and contract manufacturer creates another opportunity for information to be lost or assumptions to change. When those capabilities are connected within the same organization, engineering and manufacturing teams can collaborate seamlessly throughout the entire device lifecycle.
That means manufacturability can be considered while the design is evolving rather than after it has been finalized. Manufacturing engineers can identify processes, tolerances, materials, or design features that may become difficult to scale, and the development team can address those issues earlier.
It can also accelerate iteration. Development is often paced by the availability of parts. Prototypes can be rapidly built, tested, evaluated, and refined with direct feedback from the people who understand both the design intent and the manufacturing processes that may eventually be used at scale.
Ultimately, the goal is not simply fewer suppliers. It is fewer handoffs, faster learning cycles, better design transfer, and lower development and commercialization risk.
Fenske: When should an OEM engage with the CDMO partner? Do they need to bring a rough design idea, have final concepts developed, or involve the CDMO in ideation (i.e., R&D)?
Gyllenhaal: Earlier is generally better, particularly for technically complex devices.
An OEM does not need to arrive with a finalized design; we work with customers at any stage. Some come to us with a clinical need and a napkin sketch. Others have prototypes that require additional development, and some have mature designs that need to be optimized for manufacturability or transferred into production.
The earlier we are involved, the more opportunities there are to influence decisions that affect manufacturability, cost, performance, risk, and scalability. If a manufacturing partner is brought in only after every design decision has been locked, there may be fewer options for addressing a feature that is difficult or expensive to manufacture.
At the same time, early engagement does not mean immediately locking the product into a production process. Early development should be iterative. You want the freedom to build, test, learn, and make changes. The advantage of involving a CDMO during that process is having commercialization expertise available while those decisions are being made. Resonetics’ development model specifically emphasizes rapid prototyping and iterative learning before designs become deeply embedded and changes become more expensive.
Fenske: What are the common mistakes or challenges you encounter with OEM partners seeking design services?
Gyllenhaal: One common challenge is thinking about development as a linear process: design the device, freeze it, and then figure out how to manufacture it. In practice, successful medical device development is much more overlapping and iterative.
A design may work extremely well as a prototype but become difficult to manufacture repeatedly at commercial volumes. Materials may not be readily scalable. Tolerances that are achievable on a handful of prototypes may create significant yield challenges at volume. Assembly processes may also prove unnecessarily complex. Those issues become much more expensive to address once the design has been frozen.
Another challenge is defining requirements too narrowly or locking in design decisions too early. Development involves continuous learning through prototyping, testing, and manufacturing trials, and that information should help guide the design as it matures.
The strongest programs establish clear product requirements while still allowing the engineering team enough flexibility to evaluate different ways of meeting them. They also bring design, manufacturing, quality, regulatory, and testing perspectives together early so risks can be identified and addressed throughout development rather than at the end.
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?
Gyllenhaal: At its best, a CDMO relationship becomes a true and trusted extension of the OEM’s team. The goal isn’t to replace the OEM’s ownership of the product, but to complement their deep application knowledge with the full capabilities and lifecycle expertise of an end-to-end design and manufacturing partner to achieve a shared objective.
When a partnership starts early and stays engaged throughout the product lifecycle, teams make more informed decisions, iterate faster, and anticipate downstream challenges sooner. Ultimately, this helps deliver what our customers want: the right product on the fastest path to market and built to scale.
