Can Venture Manufacturing Be the Key to Scaling Your Diagnostic or Life Science Device from Concept to Commercialization?

Bringing a life sciences or medtech device from benchtop to market is no easy feat. Developers face a dual challenge: refining a working prototype and then building a cost-effective, scalable manufacturing pathway to commercial production. While regulatory and market hurdles are often unavoidable, many technical and operational roadblocks can be mitigated — or even avoided — with the right support.

That’s where Drummond Scientific’s venture manufacturing model comes in. This hybrid approach combines contract manufacturing expertise with venture-style partnership principles to help medtech innovators scale efficiently, without overspending or sacrificing quality.

In this Xtalks Spotlight interview, Michael Lutz, Chief Business Officer, and Scott Ferguson, Director of Venture Manufacturing at Drummond Scientific, shared how their team helps device developers avoid common manufacturing pitfalls, accelerate product readiness and build a smoother path from concept to commercialization.

What Is Venture Manufacturing — and Why Is It Needed?

For many startups and early-stage innovators, the jump from prototype to mass production — what Drummond calls the “1-to-1,000,000 problem” — is just as daunting as initial product development. According to Lutz, that’s exactly where venture manufacturing comes in.

“There are two really difficult things that we see for companies that are building out, whether they’re diagnostic devices or life science devices,” said Lutz. “There’s the 0-to-1 problem — that’s developing one unit that’s going to work on a bench top — and that’s extremely hard… But then there’s the 1-to-1,000,000 model we call, and that’s also a unique challenge in and of itself.”

“We developed this venture manufacturing program to combine what we see as our expertise as a contract manufacturer with a venture appetite.”

— Michael Lutz

To address this gap, Drummond developed its venture manufacturing model — a hybrid approach that combines the technical infrastructure of a seasoned contract manufacturer with the flexibility and long-term mindset of a venture partner.

The need for this model became clear after seeing too many companies hit avoidable roadblocks. Often, developers engage manufacturing partners too late — after they’ve already made costly design or tooling decisions. At that stage, reversing course is difficult and expensive.

By engaging earlier in the development timeline, venture manufacturing helps startups avoid these missteps. Drummond leverages its 75+ years of experience, robust infrastructure and in-house expertise to support customers at a stage when they need it most — before scaling challenges become critical.

“It really allows the founders to focus on what they’re excellent at — the science and developing a new product… and allow us to focus on the manufacturing for that,” Lutz added.

In short, venture manufacturing isn’t just about building products — it’s about building the right foundation for sustainable growth and smoother commercialization.

Bridging Prototype to Production — Without Breaking the Bank

Designing a great device is only half the battle. The other half is ensuring that the device can be manufactured reliably, at scale and within budget — a point Ferguson emphasized as a common stumbling block for startups.

“All too often, really good technology that’s on the bench top fails because it’s not designed specifically for that high-throughput automation,” said Ferguson.

One of the most common mistakes developers make is locking in design decisions too early — before they’ve validated whether the product can be manufactured efficiently or meets automation requirements. These early decisions, if made in isolation, can lead to costly rework later on.

“It’s really important that you can partner with someone who can take you from that prototype stage through the production stages and grow with you.”

— Scott Ferguson

That’s why engaging a manufacturing partner with deep engineering and design expertise from the outset can be impactful. By identifying automation limitations early and iterating on design through small-scale assembly and prototyping, companies can make more informed choices before investing in high-cavitation tooling or large-scale production runs.

Ferguson explains that at Drummond, this upfront guidance is built into their venture manufacturing approach.

This flexibility allows startups to hit key milestones — whether for investor updates, clinical validation or regulatory submissions — without overcommitting resources too early. It also means they can adjust based on feedback before committing to expensive manufacturing assets.

The result? A leaner, more strategic path to scale-up that can minimize waste, lower capital requirements and shorten time-to-market, without compromising quality or manufacturability.

Scaling for Success: What the 1-to-1,000,000 Journey Really Looks Like

Once a prototype is proven, the real challenge begins: building a scalable manufacturing process that ensures product quality, regulatory compliance and operational efficiency.

This next phase — scaling from initial production to high-volume manufacturing — is where Drummond’s expertise becomes critical, addressing what they earlier described as the “1-to-1,000,000” challenge.

Drummond’s infrastructure is purpose-built for this transition, offering cleanroom environments, dry room capabilities and automation readiness that many startups would otherwise have to build from scratch.

What sets Drummond apart, according to Ferguson, is their vertically integrated approach. This involves a tightly coordinated team that includes mechanical, electrical and automation engineers, machinists and a full quality and operations staff. This team works to ensure devices meet both ISO 13485 and FDA requirements from the start.

That means products are designed not only to function, but to be manufactured, packaged, labeled and shipped at scale — all within regulatory guardrails.

Beyond engineering talent, Ferguson emphasized the importance of end-to-end readiness. “Your partner should have full scale and capabilities of small, medium and large throughput, the ability to package, the ability to label and ship — all of those things are crucial for success.”

Startups often underestimate how complex — and costly — this stage can be. From automated inspection systems to validation protocols and documentation, every aspect must be aligned with quality and regulatory standards. A misstep here can lead to delays in FDA clearance, supply chain bottlenecks or costly redesigns.

That’s why having a manufacturing partner with deep institutional knowledge, flexible infrastructure and a long-term mindset is essential.

With the right systems in place, the jump to large-scale production can become a carefully managed, data-driven progression toward commercialization.

When to Engage? The Earlier, the Better

When it comes to manufacturing strategy, early engagement can make the difference between a smooth commercialization path and a costly detour.

“There’s no such thing as too early,” said Lutz. “We work with customers… sometimes it’s months, but many times it’s years as they build out their products for benchtop units all the way through to commercialization.”

Engaging early opens the door to long-term collaboration, risk mitigation and — when appropriate — even investment. Drummond’s venture manufacturing model includes the possibility of equity partnerships, allowing the company to invest in startups.

This model provides startups with more than just operational support. It offers strategic financial advantages. By lowering the capital needed for manufacturing scale-up, companies may be able to avoid large VC rounds, retain more equity and access a broader range of funding options, including angel investments.

“It makes commercialization cheaper,” said Lutz. “It allows companies to get to commercialization on less capital, which will make your early investors happy. You can get a bigger return, [and it] allows founders to retain more equity.”

Ultimately, engaging a manufacturing partner early offers greater flexibility — in design, funding and scale-up strategy — and helps create a more resilient path to market.

This article was created in collaboration with the sponsoring company and the Xtalks editorial team.