The path from concept to commercialization is filled with uncertainty. While every interventional device program faces risk, many of the challenges that��ultimately impact��timelines, budgets, and product success can be traced back to decisions made during the earliest stages of development.��

At first glance, investing additional time and resources into risk mitigation during concept development may seem difficult to justify.��The costs are immediate, while the benefits often��remain��invisible if everything goes according to plan. However, effective risk mitigation is not about doing more work;��it is about doing the right work at the right time.��Early investment in identifying and addressing risk reduces the likelihood of costly downstream surprises.��

When risks are not properly��identified��and prioritized, they often��emerge��later in the form of design rework, failed verification testing, manufacturing challenges, delayed technology transfer, or unexpected regulatory hurdles. These issues can significantly increase development costs and delay market entry.��

For early-stage MedTech teams developing interventional devices, these decisions can have an outsized impact. R&D leaders are often balancing clinical uncertainty, varied physician feedback, manufacturing and supply-chain constraints, evolving regulatory expectations, strict cost / reimbursement dynamics, and aggressive development timelines simultaneously. The ability to��identify��and address risk early in development can significantly influence both��time��to market��and the overall investment��required��to get there.��

Where Risk Begins��

Many early-stage interventional device programs��encounter��similar challenges. While each project is unique, the underlying sources of risk are often surprisingly consistent.��

Translating Clinical Needs into Product Requirements��

Clinical stakeholders often focus on outcomes and procedural workflows rather than technical specifications. Development teams must bridge that gap, converting clinical insights into requirements that guide engineering decisions while��remaining��achievable from a manufacturing and regulatory perspective.��

When requirements��remain��ambiguous or evolve without proper evaluation, risk accumulates throughout the program.��

Balancing Performance, Manufacturability, and Cost��

A device that performs exceptionally in a prototype environment may not be practical to manufacture at scale. Likewise, a design��optimized��solely for manufacturing efficiency may��fail to��meet clinical performance expectations.��

Finding the right balance between performance, manufacturability, and cost requires teams to evaluate tradeoffs and make tough decisions early, often before there is clear data to guide them. Design decisions made during concept development can have lasting impacts on production yields, supply chain requirements, scalability, and overall program economics.��

Preparing for Regulatory and Quality Requirements��

The bulk of regulatory and quality assurance work takes place during the later stages of development, but many of the decisions that influence regulatory success are made during��concept��selection.��

An FDA analysis found that 44% of voluntary medical device recalls were associated with design issues that could have been mitigated through stronger design controls earlier in development, highlighting��the direct connection between early design decisions and downstream product performance, safety, and compliance.��

Design controls, documentation practices, risk analyses, and verification planning��become��increasingly difficult to implement retroactively. Building these considerations into the development process from the outset helps reduce the likelihood of unexpected compliance challenges later.��

Finding, Defining, and Prioritizing Risk��

Perhaps the��greatest challenge is simply knowing which risks matter most.��Not every uncertainty requires immediate action, but the ability to��identify, define, and prioritize risks allows teams to��focus��resources where they will have the greatest impact. Addressing critical risks early often prevents expensive redesigns and program delays further down the��road.��

Partnering with a CDMO that has experience across design, development, and commercial manufacturing can further strengthen risk management efforts. These organizations bring first-hand visibility into downstream manufacturing, quality, regulatory, and supply chain challenges, allowing potential issues to be��identified��and mitigated during the��early stages��of product development. This integrated perspective can help reduce surprises later in the process and support a smoother path to commercialization.��

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Building Risk Reduction into the Development Process��

Successful device programs do not��eliminate��risk entirely. Instead, they create processes that continuously��identify, evaluate, and reduce risk as the design matures.��

Rapid Prototyping and Iterative Development��

One of the most effective ways to reduce uncertainty is through rapid iteration.��Building and testing prototypes early allows teams to evaluate concepts, gather clinical feedback, and��identify��potential issues before they become deeply embedded in the design. Rather than relying on assumptions, teams can make decisions based on real-world data and observations.��

Focused iteration cycles create opportunities for learning while minimizing the cost of��change.��

Design Controls and Risk Management Practices��

Design controls and risk management should not be viewed��strictly��as documentation exercises.��When implemented effectively, they provide structure for decision-making throughout development.��

Formal risk analyses help teams understand potential failure modes, evaluate their impact, and prioritize mitigation activities. This approach supports more informed design decisions while creating a stronger foundation for future regulatory submissions.��

Designing for Commercialization��

Teams that consider manufacturing, supply chain requirements, scalability, and cost targets early are better positioned to transition from development into production. Designing with commercialization in mind reduces the likelihood of major redesigns during technology transfer and manufacturing scale-up.��

Cross-Functional Collaboration��

Engineering, testing, manufacturing, quality, and regulatory teams each bring unique perspectives that can uncover potential challenges before they become significant issues. Early collaboration helps ensure decisions are evaluated from multiple viewpoints, reducing blind��spots��and strengthening overall program execution.
��

The��Value��of an Integrated Development Partner��

As medical devices become more sophisticated and development timelines continue to compress, organizations are increasingly looking for development partners that can support multiple phases of the product lifecycle. Rather than managing separate vendors for design, prototyping, testing, and manufacturing, companies can��benefit��from working with a single partner that provides a coordinated approach from concept through commercialization.��

An integrated development partner helps streamline communication, reduce project handoffs, and��maintain��continuity throughout the development process. With engineering, testing, and manufacturing��expertise��working together, teams can��identify��potential challenges earlier to make informed design decisions and accelerate development without sacrificing quality. This collaborative model reduces risk, improves efficiency, and shortens��time to��market.��

91�����’ AGILE Product Development® team helps customers navigate the journey from concept through validation by combining engineering��expertise, rapid prototyping, testing, and manufacturing knowledge within a coordinated development process.��

This integrated model enables customers to move more efficiently toward commercialization. By bringing engineering and manufacturing specialists together early,��91�������helps��identify��potential challenges sooner,��optimize��designs for manufacturability, reduce development risk, and accelerate progress toward validation and production.��

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Real-World Example:��Reducing Risk Through Early Collaboration��

One early-stage interventional device company partnered with us to transform evolving clinical concepts into functional prototypes that could be tested and refined. Like many early-stage programs, requirements continued to evolve as clinical feedback shaped the direction of the device.��

Rather than locking into specifications too early, the team focused on rapid iteration. Prototypes were developed quickly, evaluated by clinicians, and refined based on real-world feedback. This approach helped uncover key design considerations��early, when��changes were faster and more cost-effective to implement.��

As one R&D leader involved in the program explained, “Our physician has a lot of ideas, and they come fast. The team has been��really good��at listening to all of them, then distilling that input into something that can��actually be��built and tested.”��

By��maintaining��a fast feedback loop between clinical input and prototype development, the team was able to reduce uncertainty, make informed decisions, and keep the program moving forward.��

��

Managing Risk with Greater Confidence��

Risk mitigation is not about��eliminating��uncertainty. It is about��identifying��the right risks and addressing them before they become costly challenges.����

While these efforts can require��additional��investment early in development, they often help prevent delays, redesigns, and manufacturing challenges later in the commercialization process.��

One of the most effective ways to reduce risk is by incorporating manufacturing��expertise��early in the development process. When design, prototyping, testing, and manufacturing teams work together from the start, potential challenges can be��identified��sooner, designs can be��optimized��for manufacturability, and development cycles can move forward with greater efficiency. Access to rapid prototyping capabilities and specialized��expertise��across technologies such as catheters, nitinol components, laser processing, and tubing further enables teams to evaluate concepts quickly and make informed decisions before advancing to production.��

This approach is at the core of��91�����’ AGILE Product Development model. By integrating product development, rapid prototyping through our Lightspeed Labs ®, testing, and high-volume manufacturing��expertise��within a single organization,��91�������helps customers��identify��and address risks earlier, more quickly, and more��efficiently. The close collaboration between design and manufacturing teams enables faster iteration, informed decision-making, and a clearer path toward commercialization.��

Let us put our��expertise, technology, and processes to work on your next ground-breaking idea to help improve patient outcomes worldwide.��

��

Learn more about AGILE Product Development

Talk to an engineer to discuss your next project

The post Reducing Risk in Interventional Device Development: Lessons from Early-Stage Programs appeared first on Driving Innovation in MedTech & Life Sciences.

• Dave Rezac, who leads sales for��91�����’��AGILE Product Development��services division, joined the company through its 2021 acquisition of Distal Solutions, the engineering design consultancy he founded.��

• 91�������is a leading Contract Development and Manufacturing Organization (CDMO) in the medical technology sector. The company’s end-to-end model pairs its AGILE Product Development group (engineering and manufacturing support across all development phases) with its Lightspeed Labs team (rapid prototyping and process development) to compress customer timelines from prototype to finished device.��

• The AGILE Product Development engineers work with many start-up and other��fast moving��medical device companies.��

• A key differentiator is the��Lightspeed Labs��model, where customers run in-person “lab days” to iterate rapidly on prototypes (dozens of iterations in a single day) instead of relying on slower remote back-and-forth.��

• 91�������has recently signed a deal to��acquire��Resolution Medical, expanding its design, development, engineering, finished device, and sub-assembly capabilities to deliver integrated, end-to-end solutions across the medical technology product lifecycle for the interventional, structural heart, and neuromodulation markets. ����

• Rezac cites strong internal retention and mobility (the first voluntary departure from his original team came��18 months��after the acquisition) as evidence of a successful cultural integration and��91�����’ ability to develop and��retain��top��talent.��

• Medical��technology startups must maximize every funding round and market opportunity by advancing products quickly and efficiently. With a proven��track record��of success,��91�������helps shorten development cycles through on-demand engineering, rapid prototyping, and vertically integrated manufacturing.��

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91�����’ Quick Turn Catheter Shaft program is built to address the need for fast prototyping during early-stage product development. By pre-stocking commonly requested sizes of laser-cut tubing and raw��hypotubes, materials that would normally involve long lead times,��91�������can implement a customer’s specific cut pattern and deliver a fully jacketed catheter shaft in as little as two weeks. The program is framed as a meaningful time-saving advantage for device developers who need to iterate quickly before committing to long-term specifications.��

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This video introduces��91�����’ Agile Product Development team, a group of more than 50 design, quality, and new product introduction engineers spread across three sites and��focused on interventional device development such as catheter-based implants and therapies.

The team positions itself as a flexible, full-lifecycle partner that meets customers wherever they are in development, whether starting from an early, undefined clinical need, taking a conceptual solution with some existing IP and engineering it into a working device, or improving an already-clinical product for commercial scale, manufacturability, or new functionality.

Speed and infrastructure are highlighted as core strengths, with fully equipped labs and clean rooms supporting rapid prototyping, testing, and manufacturing. A specific example given is the Quick Turn Catheter Shaft program, which pre-stocks commonly used laser-cut tube and��hypotube��sizes��so custom, fully jacketed catheter shafts can be produced in as little as two weeks.

The team frames quality and risk decisions through a simple heuristic, asking whether they would use the device on their own grandmother, and uses that hesitation as a prompt to��identify��further testing or design improvements needed. Throughout, the video emphasizes close collaboration with customers, including on-site work, and a consistent patient-centered philosophy guiding engineering and design decisions.��

The post AGILE Product Development appeared first on Driving Innovation in MedTech & Life Sciences.

This brochure outlines how 91�����’ AGILE Product Development team accelerates innovation with catheter shafts made from advanced materials like PTFE liners and FEP heat shrink and enhanced with custom laser cut hypotubes. You’ll also find a detailed size guide, material options, and the full range of therapeutic applications including structural heart, neurovascular, and drug delivery systems.

Learn about:

• The different use cases for choosing laser cut tubing (LCT)
• Size, material, and application specifications for 91�����’ off-the-shelf catheter shaft solutions

Read the brochure for more information.

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With a limited supply of subject matter experts specializing in catheter design on the East Coast, AGILE Product Development, a division of 91�����, is growing its own talent pool through Northeastern’s co-op program. About one-third of co-ops hired by AGILE have taken full-time engineering positions with the company.

Originally featured in  website on September 25, 2024.

The AGILE Product Development division of 91����� makes novel catheter-based devices for a variety of therapeutic and diagnostic applications in the heart, lung, brain, and vascular system. The work requires highly technical and specific skill sets that blend engineering fundamentals and creativity to develop components for life-saving procedures.

Northeastern co-ops are playing a key role in growing this business.

“When we get comparable resumes from different schools, there’s just no match for the student with co-op experiences,” says Dave Rezac, E’07, mechanical engineering, and global vice president of AGILE. The AGILE business is the result of 91�����’ acquisition in 2021 of Distal Solutions Inc., a medical device engineering firm that Rezac founded in 2014.

Rezac says the West Coast and Twin Cities areas are conventionally viewed as the main catheter design centers of excellence in the US medical device industry, resulting in a smaller pool of qualified job candidates on the East Coast, where AGILE is headquartered. The co-op program has enabled his team to hire through Northeastern and help grow expertise organically. “The co-op program has been a great tool for us, and we actively recruit through it,” Rezac adds. “We have found that Northeastern has a healthy supply of strong talent.”

“If you’re looking for a mid-level engineer, they will be tough to find on the free market regionally,” Rezac adds. “So, we’ve taken the approach of actively developing those resources in-house,” Rezac says.

Since 2018, when Rezac was leading Distal Solutions and through his time to date at AGILE, Rezac has hired about two dozen co-ops, seven of whom were subsequently hired for full-time positions.

While his team works with co-ops, they evaluate students’ potential for a full-time role. “It enables a try-before-you-buy approach for both sides, and we’ve had a strong conversion rate,” Rezac says.

Co-ops also enable AGILE to staff projects with various levels of expertise, freeing up the most highly qualified engineers to tackle the most critical work. “Our customers are coming to us for a high level of service and expertise,” he says. “That is ultimately being driven from the most experienced members of the team, which provide active mentorship and development opportunities to our more junior engineers and co-ops.”

Rezac says he has been impressed with the technical contributions co-ops make. “Contract design services is a fast-paced, high-demand environment,” Rezac adds. “We’ve had many co-ops that are capable of diving right in at the level of a degreed full-time engineer, oftentimes surprising customers when they find out the co-op is still in school.”

Rezac’s own successful co-op experience influenced his decision to establish a program at Distal Solutions/91�����. His co-op at TDC Medical, which was eventually acquired by Vention Medical and is now part of Nordson, helped him determine that he wanted to work in the medical device industry and enjoyed the fast-paced nature of contract product development. Prior to that experience, he was concerned there would be too much government regulation and red tape, but the co-op showed him there were plenty of opportunities for creativity and invention. In fact, during his career, Rezac has been named on over 20 pending or approved patents.

“One great aspect of the co-op program is how it helps you mitigate risk in early career development. The worst thing that can happen is you realize a particular role or segment of the industry just isn’t for you, in which case you’ve simply committed 6 months to a key learning opportunity,” Rezac says about co-ops. But in his case, the opposite occurred. “I really fell in love with an industry and role I had been skeptical about.”

TDC Medical hired Rezac upon graduation, where he worked for seven years with mentors who ultimately fueled his desire to start Distal. “When I look back on some of the more fortuitous inflection points of my career, many can be traced to my involvement as a Northeastern co-op,” Rezac says.

Learn more about Resonetic’s AGILE product development capabilities.

Contact our team today!

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This free whitepaper from 91����� provides a detailed technical evaluation of braiding compared to laser cut tube for reinforcement in interventional catheter shafts. A series of test results are shared that compare functional performance of the components related to:

• Torque Transfer
• Kink Resistance / Ovality
• Tensile & Compressive Strength

The post Interventional Catheter Shaft Performance Analysis appeared first on Driving Innovation in MedTech & Life Sciences.