Built to Scale: Why Manufacturability Must Start on Day One

How Does Manufacturability Impact Medical Device Success?

In medical device development, innovation often takes centre stage. Teams focus on identifying an unmet clinical need, building a prototype to address it, and validating performance through pre-clinical and sometimes even early clinical studies. But too often, a critical question is left until far too late: Can this device actually be manufactured at scale? 

Scalability and manufacturability are frequently treated as afterthoughts, yet they should be foundational considerations. A promising device that cannot be produced reliably, cost-effectively, and in compliance with MDR or FDA requirements will never reach the patients it was designed to help. 

Why Does Delaying Manufacturability Planning Increase Costs?

The early stages of product development are exciting. Teams ask: Is there a clinical need? What’s the market potential? How will our device work? Pricing and adoption curves are modelled, competitor landscapes mapped, and funding milestones carefully planned. Yet rarely does anyone pause to ask: Where will we manufacture? How will we scale? Who is capable of producing this at the required volumes and costs? 

This oversight can have devastating consequences. I have seen projects collapse after millions were invested, prototypes tested in vivo, and even early human studies completed. On paper, the devices looked promising. But when it came to scale-up, no viable manufacturing partner could be identified, or the investment required made the return on investment unattractive. 

In one particularly striking example, a company had frozen its design and entered clinical trials before engaging with a contract manufacturer (CMO). Only then did they discover that one of their chosen raw materials posed major health and safety risks for workers when handled at large scale. The material itself was not a risk to patients, it was removed from the product before release, but staff exposure during manufacture made the process unsustainable. This single oversight forced a reformulation of the device, risking not just process redevelopment but also repeat testing to ensure regulatory compliance. Years of work and investment were jeopardised because manufacturability had not been considered early enough. 

What Strategies Ensure Medical Devices are Scalable?

By contrast, when manufacturability is considered from the outset, the story looks very different. Early collaboration between R&D and manufacturing prevents late surprises, aligns design with practical production methods, and smooths the regulatory path. Instead of redesigning under pressure, teams move more quickly and cost-effectively towards market. 

Which Factors Most Affect Device Manufacturability?

Scalability isn’t something to tack on at the end, it must be woven into the scoping phase. Several key questions should be asked right from the start: 

• Technology fit: Can the chosen technology realistically be scaled? 

• Capabilities: Do in-house facilities or external partners exist that can deliver the required volumes and cost of goods? 

• Supply chain: Are multiple suppliers available for critical raw materials, and are they regulatory compliant? 

• CMO readiness: Do potential partners hold the right certifications (ISO 13485, GMP) and have experience with similar product classifications? 

Drafting a simple process map early helps identify potential bottlenecks and risks before they become costly problems. For example, if only one CMO in the world can produce a critical component, the project may not be commercially viable. Similarly, processes that work at bench scale, such as those involving hazardous solvents, may be impossible to scale safely in a manufacturing environment. By mapping these factors early, teams can make informed decisions about technology, materials, and manufacturing partners. 

Regulation intersects directly with manufacturability. Early classification, whether the product is a medical device, drug, or combination product, sets the bar for certification and dictates the standards your manufacturer must meet. Partnering with CMOs already familiar with MDR or FDA audits saves time and avoids costly course corrections. 

How Can CMOs Support Early-Stage Device Development?

Practical steps can hardwire manufacturability into development: 

• Include target volumes and COGs in design input documents. 

• Make manufacturability a stage-gate criterion before moving from feasibility into development. 

• Engage CMOs early to validate assumptions and gather indicative quotes. 

Cross-functional collaboration is equally important. R&D, regulatory, manufacturing, and commercial teams should not operate in silos. A core project team should be formed early, with extended input from manufacturing and quality. Involving a process engineer at this stage enables proactive process mapping, risk assessment, and streamlined development. Even simple initiatives, such as regular touchpoints or “lunch and learn” sessions, can help build trust across functions and keep manufacturability front of mind. 

I’ve seen the value of this approach first-hand. Over six years ago, I led a project to develop a patch for corneal persistent epithelial defects. Early in scoping, we identified the target cost of goods and volume requirements, then worked closely with the manufacturing teams, not just managers, but the technicians who would later run the processes. Their input proved invaluable, helping us streamline workflows and reduce costs, even as we worked within the constraints of small product size. We further improved efficiency by limiting the number of raw materials in the device formulation. These early considerations meant we avoided expensive redesigns later, proving that collaboration with manufacturing from day one pays off. 

Why Is Collaboration Key to Scaling Medical Devices?

The manufacturing landscape is evolving quickly. Automation is increasingly offered by contract manufacturers as a way to improve throughput, reduce variability, and lower costs. However, automation is rarely “plug-and-play.” Most medical devices are unique, in their design, raw materials, assembly methods, packaging, and these nuances often demand bespoke or adapted processes. Assuming that automation can simply be added on later is a recipe for delay and disappointment. Instead, development teams should stay informed about the evolving automation capabilities of their potential CMOs and how relevant these are to their own processes. Early conversations can reveal whether small adjustments or smart tweaks to your process might enable you to benefit from existing automated lines, saving time and cost, rather than requiring a major investment to set up a bespoke system. By aligning device design with what automation platforms can already deliver, companies can position themselves for smoother, more cost-effective scale-up. 

How Can Automation Improve Medical Device Manufacturing?

Contract manufacturers themselves bring enormous value, but they should be engaged early. I have seen companies wait until design freeze or even clinical trials before approaching a CMO, only to discover their processes or materials were incompatible with large-scale manufacture. The earlier these discussions happen, the more options remain on the table. 

For start-ups or resource-limited teams, manufacturability can feel like a distraction from proving the science. But ignoring it is like designing a car without wheels. Even with minimal resources, some steps are essential. Identify at least three potential CMOs, begin building relationships, and use their feedback to validate manufacturability in your pitch decks. Investors value foresight and demonstrating that manufacturability has been considered reduces perceived risk.

Why Manufacturability Determines Device Viability?

Manufacturability is about scale and viability. Devices designed with manufacturability in mind have a fighting chance to reach patients. Those that aren’t, no matter how promising, rarely survive. Proof of concept alone is not enough. To bring innovation from idea to industry, manufacturability must be considered from day one. 

Disclaimer. The views and opinions expressed in this article are solely those of the author and do not necessarily reflect the official policy or position of Test Labs Limited. The content provided is for informational purposes only and is not intended to constitute legal or professional advice. Test Labs assumes no responsibility for any errors or omissions in the content of this article, nor for any actions taken in reliance thereon.