Ensuring Scalability Throughout the Medical Device Lifecycle—A Medtech Makers Q&A

By Sean Fenske, Editor-in-Chief

All medtech manufacturing requires some level of scaling between the design and development of a product and full-scale production. It may also take place after commercial launch if demand increases significantly. Unfortunately, not all companies prepare properly for scaling, regardless of when it takes place. For example, processes used to prototype a device may not be suitable to use for manufacturing.

As such, it’s critical for organizations to keep the production environment and processes in mind during design stages. Those that do will enjoy a smooth transition from development to manufacturing and beyond. When this aspect is neglected, however, it can lead to delays and increased costs.

Strategic manufacturing partners can assist with scaling considerations. Through capabilities such as design for manufacturability, they can determine key areas that may need to be adjusted in design to accommodate scaling a product. With this in mind, Jay Gurgens, Director of Commercial Operations at Vantedge Medical, responded to a series of questions about scalability.

Sean Fenske: For the purpose of this discussion, can you start by first explaining what scalability is?

Jay Gurgens: In medical device manufacturing, scalability is the ability to reliably increase production volumes, whether transitioning from prototype or pilot builds or responding to growing market demand for an already commercialized device, without compromising quality, cost, or regulatory compliance.

It’s not just “making more units”; it’s ensuring the design, materials, processes, tooling, and supply chain are all capable of supporting that growth.

In essence, scalable manufacturing processes and inspection methods enable OEMs to meet growing demand by increasing production in a predictable, compliant, and cost‑effective manner while maintaining process control and quality performance.

Fenske: How does the need to ensure scalability affect early design and development of a device?

Gurgens: The need to ensure scalability has a significant impact on early device design and development, as many foundational decisions made at this stage directly affect the ability to manufacture the device reliably at higher volumes while preserving its intended function and purpose. Scalability considerations influence choices around material selection, tolerances, manufacturing equipment, process development, inspection methods, and sourcing strategies.

From a materials standpoint, design engineers must evaluate not only application and functional requirements, but also long‑term availability and supply stability. Materials should be available in sufficient quantities to support future demand and carry minimal risk of discontinuation or obsolescence. Additional factors such as material stress relief, machinability, compatibility with required coatings or surface treatments, biocompatibility considerations, and compatibility with joining and fastening methods such as welding or other bonding processes must be considered to ensure consistent performance at scale.

Additionally, early consideration of design and process controls is critical to enabling repeatable, validated manufacturing processes that can scale reliably as volumes increase.

Scalability also drives early decisions related to manufacturing equipment and processes. This includes selecting equipment capable of higher throughput, assessing opportunities for automation, planning for capital investments, and designing appropriate tooling and work‑holding fixtures. Processes must be developed with repeatability and validation in mind to ensure they can transition smoothly from low‑volume builds to full production.

Addressing scalability early avoids process changes and redesign cycles later, which are costly, time-consuming, and can trigger SCRs (supplier change requests) and additional regulatory work. By designing with scalable manufacturing processes in mind from the beginning, organizations reduce downstream risk and support a more efficient path to commercialization and growth.

Fenske: What is often neglected or not considered regarding scalability in the design/development phase? Where are the early mistakes/missteps made?

Gurgens: One common gap is inspection method alignment between the contract manufacturer and the OEM, where in‑process or final inspection methods used by the manufacturer are not well aligned with the OEM’s receiving inspection methods. Differences in inspection techniques, measurement equipment, or acceptance criteria can lead to scrap, false rejects, supply disruptions, and rework as volumes increase.

This issue is frequently amplified by subjective or poorly defined cosmetic callouts, which introduce interpretation‑based decisions that vary between manufacturing and receiving inspection. What is acceptable at low volumes with close oversight can quickly become unmanageable at scale.

Early decisions around inspection strategy are particularly important. Custom inspection gauges, including functional gauges, may be necessary to support high‑volume verification while maintaining throughput. All inspection methods should be supported by appropriate validation for their intended use, including test method validation (TMV) and applicable measurement system analysis (MSA) activities such as gauge R&R (GRR) or attribute agreement analysis.

Design tolerancing and GD&T practices are another frequent source of scalability challenges. Improper application of GD&T, overly tight tolerances, or excessive callouts that are not required for fit, function, or performance can unnecessarily constrain manufacturing processes. When tolerances exceed functional need, they drive increased inspection burden, higher scrap and rework rates, constrained process capability, and added cost—effects that are often amplified as production volumes scale.

Workholding and fixturing practices are another frequently overlooked scalability factor. Uncontrolled clamp force, including inconsistent use of torque‑controlled fasteners, can distort parts during manufacturing or inspection, creating geometry that does not reflect free‑state conditions. These effects are often not fully revealed during early validation and may only emerge as production scales, introducing variation, scrap, and false rejects. This reinforces the need for repeatable, robust process steps and for minimizing human-dependent variation through controls such as torque tools, standardized methods, or automation where appropriate.

Material‑related factors are also commonly neglected. Material lot‑to‑lot variation, along with material stress relief and thermal expansion effects, may not be sufficiently challenged during early builds or validation, leading to unexpected variation when production volumes increase or additional lots and suppliers are introduced.

From a design control perspective, early manufacturing process development appropriately begins during prototyping and development. However, achieving a design freeze before finalizing and validating production processes is critical. Stable design inputs enable robust and well‑optimized manufacturing processes, tooling, inspection methods, and validations to be developed with confidence, minimizing rework and revalidation as production volumes ramp.

Several other scalability risks can be overlooked during early qualification and validation phases. These missteps often stem from decisions that prioritize short‑term validation success over long‑term production realities. While installation qualification (IQ) and operational qualification (OQ) establish foundational and controlled operating conditions, performance qualification (PQ) may unintentionally be executed under non‑representative circumstances, such as the use of highly skilled operators rather than standard production personnel. As a result, true process variability may be underestimated, creating challenges as production volumes increase.

Finally, scalability is often constrained by directed suppliers with proprietary processes specified in drawings, limiting sourcing flexibility and creating single‑supplier dependencies. Coupled with a lack of foresight regarding future regulatory or compliance changes, these early decisions can significantly hinder the ability to scale manufacturing efficiently and compliantly.

Fenske: In the transition from design to manufacturing/production, what needs to be done or kept in mind to ensure scalability is possible or optimized?

Gurgens: Ensuring scalability during the transition from design to production requires early design for manufacturability (DFM) engagement and strong cross‑functional collaboration between the OEM and the contract manufacturer. Early alignment between design, manufacturing, quality, supply chain, and operations helps ensure design intent can be realized consistently at scale and reduces downstream risk during production ramp‑up.

As a device transitions from design into manufacturing and production, ensuring scalability requires deliberate focus on standardization, control, and organizational readiness. This phase is critical, as decisions made here determine whether the manufacturing process can expand reliably without introducing variation, quality risk, or operational bottlenecks.

Manufacturing processes should be designed with error prevention in mind, incorporating poka‑yoke mechanisms wherever possible to reduce reliance on operator intervention and minimize the risk of defects as volumes increase. In parallel, clear, documented work instructions must be established to ensure consistent execution and eliminate dependence on tribal knowledge that does not scale well across shifts, facilities, or growing teams.

Cross‑training of personnel is also essential to support scalability. A flexible, well‑trained workforce reduces single‑point dependencies on specific operators and allows production capacity to increase without a proportional increase in risk or variability.

Robust process controls must be established to effectively manage production processes and support volume growth. This includes proper ECO (engineering change order) documentation, a fully defined and controlled DMR (device master record), and clear traceability to approved work instructions, training records, and validated inspection methods and frequencies. These controls must also extend through receiving inspection, material and lot control, structured data collection, complete and accurate DHRs (device history records), formal lot release and certification processes, and controlled packaging and shipping operations to ensure product conformity is maintained across scaled production.

Scalability must be supported by effective S&OP (sales and operations planning). Alignment between demand forecasting, production capacity, staffing, supplier readiness, and inventory management ensures that demand increases can be absorbed without destabilizing manufacturing operations or compromising quality.

Together, these elements create the foundation for predictable, compliant, and scalable manufacturing as the device moves from development into sustained production.

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