Design Drivers for Medical Device Manufacturing

Product design and prototyping in medical devices continue to bring innovative new products to market. The medical device development process and associated tools are well-established, and R&D teams have become experts at using them. Technology has also made the process faster and more efficient, allowing designers to simulate devices and systems earlier and more cost effectively than ever before, increasing speed to market and reducing risk. 

“The level of activity in the medical device design space is dynamic,” said David Kisela, managing director for Twinsburg, Ohio-based SMC Limited, a provider of design, development, and manufacturing services to the medical device industry. “From start-ups to large medical device manufacturers, companies are innovating to bring new therapies and treatments to the medical community.”

Device development is sped along by rapid prototyping, which is now a key, mainstream capability—”fast iterations from computer-aided design (CAD) to looks-like/feels-like/works-like prototypes can happen in hours, at far lower cost than traditional one-off machining or tooling,” said Jim Kasic, founder and chairman of Boulder, Colo.-based Boulder iQ, a contract firm specializing in medical device design, engineering, and regulatory affairs. “This speed is reshaping the front end of product development.” 

Within today’s rapid prototyping environment, medical device teams rely on a wide range of coating technologies, each with specific requirements to deliver consistent performance. “Speed to market is no longer a competitive advantage—it is an expectation,” said Dr. David Kissel, director of R&D for Norwood, Mass.-based Applied Plastics, which develops advanced surface treatments for the medical device industry.

There is a trap, however—the better prototypes look, the easier it is for stakeholders to think the device is “almost done.” In medtech, the gap between a slick prototype and a market-ready product is still substantial—”biocompatibility, sterilization compatibility, labeling, verification/validation, design controls, and full documentation don’t go away just because a model looks finished,” said Kasic.

Although prototyping is faster than ever, the companies that win are the ones that pair rapid iteration with disciplined planning—”designing with the end in mind and building the ‘real work’—manufacturing reality plus regulatory reality—into the plans early,” he added.

Latest Trends

Advances in machine learning have dramatically accelerated the ability to process vast amounts of data, which is reshaping product design across the medical device industry. The current trend is toward systems specifically built to gather higher-resolution data, process it locally or remotely, and transmit it wirelessly with greater efficiency, reliability, and speed.

“Nowhere is this more evident than in neurotechnology and implantable medical devices,” said Ian Berve, principal mechanical design engineer for Cirtec Medical, a Brooklyn Park, Minn.-based medical device contract development and manufacturing organization (CDMO). “Emerging applications such as brain computer interfaces, implantable chemical sensors, and next-generation cochlear and ocular implants are pushing the boundaries of what is manufacturable. The design challenge is no longer conceptual or algorithmic; software and artificial intelligence capabilities are advancing rapidly. Instead, the constraint has shifted to hardware.”

Key challenges include:

• Developing hermetic enclosures that are both ultra-compact and long-term reliable
• Increasing lead and contact array density without compromising durability
• Maintaining signal integrity amid higher channel counts and tighter geometries
• Enabling robust, low-power wireless data transmission

There is also strong demand for neurostimulation platforms that can simultaneously sense, learn, adapt, and stimulate in real time, essentially creating closed-loop intelligent systems. These devices must integrate sensing, processing, telemetry, and stimulation within extremely constrained size and power budgets.

In many ways, software is no longer the limiting factor at the cutting edge. “The industry’s focus is shifting back toward mechanical and electrical miniaturization, advanced materials, packaging innovation, and precision manufacturing,” said Berve. “Expanding the horizon of what’s possible now depends on solving these deeply physical challenges, making smaller, more reliable systems that can unlock the full potential of AI-driven medicine.”

Artificial intelligence (AI) is no longer just a “feature” but a core element to the overall product architecture. AI-native devices (not just AI-enabled but fundamentally designed with AI at their core) will continue to be a major part of product design. AI is now embedded across diagnostics, imaging, surgical tools, and remote monitoring. Design teams must think about software transparency/bias, continuous learning systems (post-market updates), as well as data pipeline design, as part of their product systems.

“Product design now includes data design plus model lifecycle plus user experience, not just hardware/software,” said Joe Dombrowski, vice president of engineering for Lumitex, a Brecksville, Ohio-based provider of custom design, development, and delivery of lighting systems for medical technologies and products. 

Engineers are constantly pushing the boundaries of design, looking for that unique edge that will provide a competitive difference in the market. One way this can be achieved is through expert material evaluation and selection. “In our space, medical device manufacturers are asking for new substrate materials as a means of achieving next-level performance in their devices,” said Kissel. “We work closely with development teams to identify these materials, which we test internally to ensure that the application-specific coating they select will perform and adhere as expected. This helps to solidify their design and deliver the design benefits they are looking for.”

Awareness of the importance of design for usability continues to grow. Standards such as IEC 62366 and guidelines like ANSI HE75 help, “but it now seems that this is no longer the preserve of the usability engineer and the regulator,” said Mark Costello, design and development director for Synecco, an Arterex company based in Galway, Ireland, that provides contract design and manufacturing services to the medical device and life science sectors. “Usability sensibility has increased across all disciplines involved in the development program.” 

Great Expectations

For product design, medical device manufacturers (MDMs) consistently prioritize speed to market, high quality, and low, non-recurring engineering (NRE). To achieve these, MDMs want high-performing designs with rigorous requirements. However, exceeding every specification at any cost does not necessarily create value. “Designers do not earn extra credit for dramatically overengineering a product if it drives up timelines, complexity, or spend,” said Berve. “The real skill lies in knowing where to push performance and where the standard is truly good enough.”

Requirements should clearly define exactly how well a design must perform to be safe, effective, and commercially viable. Overly conservative or poorly defined requirements can inflate cost and delay launch without improving outcomes.

Risk management tools such as hazard analysis and failure mode and effects analysis (FMEA) should actively guide the design process, ensuring products meet requirements across:

• Foreseeable use conditions
• Manufacturing variability
• Environmental stresses
• Residual risk scenarios

“The designer’s responsibility is straightforward in principle—ensure design outputs fully satisfy design inputs, while proactively managing risk,” said Berve. 

MDMs also expect their CDMOs to field a team that speaks their language and acts as an extension of their own team. These CDMOs require subject matter experts to fill in capability and capacity gaps, such as usability, finite element analysis (FEA), design for manufacturability (DFM), industrial design, prototyping strategy, fluid dynamics, design for assembly (DFA), process development, microfluidics, and optics, as well as mechanical, electrical, and software engineering. “This expertise allows our clients to minimize risk during the early discovery phases, navigating avoidable pitfalls,” said Matt Giza, senior vice president for Arterex, a Mansfield, Mass.-based provider of turnkey contract engineering design and manufacturing of complex single-use devices, electromechanical devices, and active implantables.

MDMs also want predictable development times. “They expect to be guided through the development process by battle-hardened experts who have seen this all before and can identify and mitigate budget, schedule, and technical risks before they affect regulatory submission and ultimately delay launch,” said Giza. “Guiding MDMs through effective technical, schedule, and budget risk management and mitigation throughout the development process is more critical than ever.”

New Tech, New Tools

In the last decade, AI has become an instrumental part of product design for medical devices. AI is becoming the “go-to” tool for optimizing the design process. For example, AI can analyze a 3D model and recommend alternate geometries that minimize weight, maximize strength, and streamline manufacturing. AI can quickly analyze hundreds of materials and their properties and recommend the best material selection for a specific design—much faster than traditional analysis. “Combining AI with FEA can result in a much faster and more accurate analysis of a design performance when simulated in its intended-use environment,” said Dombrowski.

From an R&D perspective, one of the most impactful advancements in recent years is the increased use of simulation tools alongside structured methodologies such as design of experiments (DoE) and Six Sigma. “Together, these approaches are changing how we design, validate, and scale coating solutions,” said Kissel.

Simulation tools allow engineers to evaluate performance earlier in the design cycle, whether for understanding lubricity, wear rates, or adhesion under real-world conditions. For applications such as pull wires, where performance depends on repeated deflection and dynamic forces, this early insight is critical. It enables teams to identify potential failure modes and refine designs before committing to physical builds.

At the same time, structured methodologies remain the foundation of reliable development. DoE and Six Sigma provide a disciplined framework for iterating quickly, while still maintaining control.

DoE enables the systematic evaluation of multiple variables, such as coating thickness, surface preparation, and process parameters, so engineers can understand not just individual effects, but how those variables interact. Six Sigma methodologies then ensure those optimized conditions are repeatable and scalable, reducing variability as we move from development into production. “The real advantage comes from combining these approaches,” said Kissel. “Simulation helps us focus on where to experiment, and DoE ensures we learn as much as possible from every iteration.”

A side benefit of AI and the digitization of regulatory workflow is that it forces teams to be more structured and consistent with their data and documentation. For example, the FDA made eSTAR mandatory for most 510(k)s starting October 1, 2023—pushing submissions into a standardized digital format. This forces better internal discipline, which pays off in design history, design inputs/outputs, and traceability. 

“AI is showing up in the regulatory ecosystem itself,” stated Kasic. “The FDA launched Elsa, an agency-wide generative AI tool, built in a high-security GovCloud environment. FDA maintains that Elsa’s models do not train on regulated industry-submitted data. Whether you love it or hate it, it is a signal—regulatory review is becoming more AI-assisted, and developers will benefit by making submissions and datasets clean, consistent, and logically organized.” 

Arterex has experimented with AI for researching topics and for idea generation in both mechanical design and industrial design. The company has developed internal plans for addressing the effective use of AI in various business and engineering use cases, while ensuring intellectual property is protected. “We see the potential of AI for rapid research, idea generation, data analysis, supply chain, and certain technical troubleshooting and software development and debugging,” said Giza. “Many of our development projects involve tightly coupled integrated circuits and processor subsystems operating at millisecond precision timing loops. While AI currently provides some value, today we continue to rely on core engineering experience. However, AI is evolving quickly, so we expect this area will be one of continued evolution in many areas, including the medical device R&D world.”

Design Challenges

DFM/DFA, parts reduction, and proper material selection are still very important to ensure a project does not stall in the verification and validation process. “The pragmatic implementation of design elements to satisfy the technical performance of the device, while being fabricated on the component level and assembled at the device level, to capture the full design intent, is essential for moving the device through the regulatory process smoothly and successfully,” said Kisela.

One of the most significant product design challenges today, especially in compact, high-density sensing devices, is managing the physical realities that emerge at small scales. As systems become smaller and more complex, traditional considerations such as DFM, material selection, inspection strategy, packaging, and sterilization become increasingly interdependent.

“A major issue we are seeing is thermal expansion mismatch,” said Berve. “In highly compact, multi-material assemblies, even small temperature changes can introduce meaningful mechanical stress. For implantable or wearable devices, something as simple as a patient moving from a climate-controlled room to a cold outdoor environment can create sufficient strain across a poorly coefficient of thermal expansion [CTE]-matched joint to affect signal integrity.”

At these scales, the consequences are not just mechanical, but also functional. Micro-movements or stress-induced deformation can introduce electrical noise, baseline drift, or intermittent artifacts. In sensing platforms, corrupted data can cascade downstream, muddying machine learning models or misleading clinicians.

This makes several design disciplines especially critical:

• Careful material selection, with close attention to CTE compatibility
• Thorough tolerance stack-up analysis, particularly across bonded or welded joints
• DFM that accounts for real-world process variability
• Long-term mechanical considerations, such as battery swelling, creep, residual stress relaxation, and encapsulant aging
• Design for inspection, ensuring critical interfaces can be validated before final assembly

As devices shrink and integration increases, physics becomes less forgiving. “The challenge is no longer just fitting more functionality into less space, but also ensuring that compact, multi-material systems remain stable, reliable, and accurate over years of real-world use,” said Berve.

From an R&D perspective, common product design challenges are less about any single variable and more about how well the entire system is engineered to work together, from concept through commercialization. One of the biggest challenges is ensuring a design can be produced consistently at scale. For example, in catheter-based devices, that often means balancing tight tolerances, material selection, and component interactions, especially when coatings are involved. 

“A design that works in a prototype environment can quickly break down in production if manufacturability is not considered at the bench,” said Kissel. “Material properties and surface conditions also play critical roles in coating performance. Substrate selection, surface preparation, and geometry all impact adhesion, lubricity, and durability. If these factors are not aligned upfront, you risk variability, delamination, or inconsistent performance during use.”

Sustainability is becoming a design requirement for single-use medical devices, driven by new procurement requirements within hospital groups/primary buying groups, such as lifecycle assessments. This may lead to a device brief that “requires a reduction in the size of the device, minimizing the amount of material used in both the device and packaging, sustainable material selection, and reducing the amount of energy used in manufacturing,” said Costello. “This trend is also noticeable in pharmaceutical delivery devices like autoinjectors, where innovative materials and device configurations are used to increase sustainability and reduce waste.” 

Minimally Invasive Designs

Minimally invasive (MI) procedures are driving device design toward smaller, more complex, and higher-performing systems, with special emphasis on process control. These surgeries are in high demand because they reduce recovery time, lower complication rates, and improve patient experience—which also raises the bar for product design. “The electronic industry’s continued focus on miniaturization and higher levels of functional integration, combined with advances in material strength, flexibility, coatings, and joining technologies, all drive devices into smaller footprints and packages,” said Giza.

At a fundamental level, even simple mechanical tasks become exponentially more complex when performed three feet away from the operator, through a narrow, tortuous pathway, and within dynamic, deformable tissue. Designers must account for:

• Navigation through curved or branching anatomical pathways
• Limited visualization and constrained working space
• Variable and moving tissue structures
• Wide anatomical variation across a patient population
• Incomplete understanding of how certain disease states manifest in vivo

“Under these conditions, something as seemingly straightforward as deploying an implant in the correct position and orientation can become a major engineering challenge,” said Berve. “Precision, force transmission, torque response, flexibility, and tactile feedback must all be carefully balanced within tight size constraints.”

Successful design for MI devices starts with building a deep understanding of anatomical and physiological boundary conditions. 

Cirtec Medical often collaborates with trained surgeon key opinion leaders (KOLs). These partners help define meaningful user needs, realistic product requirements, and critical failure modes that may not be obvious from an engineering perspective alone.

KOLs also play a key role in developing representative benchtop anatomical models. Investing the time to create accurate simulation models that reflect a range of patient anatomies and disease presentations can dramatically improve prototype evaluation. High-fidelity benchtop testing allows teams to iterate quickly, uncover edge cases, and de-risk later preclinical and clinical stages.

In MI design, “success depends on more than miniaturization,” noted Berve. “It also requires translating complex anatomy, clinical nuance, and procedural variability into reliable, intuitive tools that perform predictably in some of the most constrained and unforgiving environments in medicine.”

A key part of MI procedures is appropriate lighting. Surgeons work through smaller access points and operate deeper within the body, making it difficult for traditional overhead operating room lights to reach the areas that require illumination. As a result, surgical lighting must become more precise and targeted. “It is not just a matter of increasing brightness—the light must be directed accurately, and the beam must be carefully controlled to provide consistent visibility in deep surgical cavities,” said Dylan Ash, senior product manager, surgical, for Lumitex.

The trend in surgical lighting is toward more versatile, handheld solutions that can be used across a wide range of procedures. This includes portable, battery-powered systems that reduce dependence on fixed capital equipment, offering greater flexibility for surgical teams. “These innovations allow lighting to adapt to the unique challenges of minimally invasive surgery, improving visualization, efficiency, and outcomes in the operating room,” added Riham Alabed, project engineer for Lumitex.

Moving Forward

What excites Kasic the most is the convergence of digital evidence and real-world constraints. “Higher-credibility simulation, including digital twin concepts, is moving toward reducing reliance on slow, expensive physical iteration—supported by regulators’ increasing willingness to evaluate computational evidence rigorously,” he said. 

Further, AI is becoming real in the places that used to be purely manual—for example, regulatory review workflow (Elsa), submission structure (eSTAR), and CAD environments (AI companions/generative workflows). “These combinations can significantly shorten cycle time—if development teams keep their data clean and their logic consistent,” said Kasic. 

Some of the most exciting developments in product design are happening in surgical robotics and image-guided procedures. These technologies all rely on light. Fluorescence or specific wavelengths could help differentiate between nerve and vessel tissue, improving precision in surgery. “On the therapeutic side, advances in photoimmunotherapy aim to sensitize molecules to prime cancer cells, allowing treatments to be delivered to the right location for maximum impact,” said Matt Valego, chief commercial officer for Lumitex.

Sustainability is here to stay as a core principle of the medical device industry and is forcing true innovation—not just “green marketing.” For example, ethylene oxide (EO) sterilization emissions regulation, alternative sterilants such as chlorine dioxide, and packaging efficiency are all reshaping design decisions, which is driving new thinking across the industry. 

The product design process varies greatly throughout the device design community. “The best way to develop any device is still to define what the device must do, may do, and will not do—in other words, align on a scope and specification,” said Kisela. “Develop this into a robust verification and validation plan and enable the development team to ideate, collaborate, and execute to achieve the desired results in the shortest possible time.”

“My core advice is simple,” added Kasic. “Begin with the end in mind. Do not let the ‘phase-gate habit’ force linear thinking. Work in parallel with development teams to design a device that can be manufactured, tested, labeled, packaged, sterilized, and supported, all with credible evidence.”

Mark Crawford is a full-time freelance business and marketing/communications writer based in Corrales, N.M. His clients range from startups to global manufacturing leaders. He has written for MPO and ODT magazines for more than 15 years and is the author of five books.