The Proven Process That Powers Medical Solutions

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by Stephen Gould
May 6, 2025
By Stephen Gould
May 6, 2025

In the complex world of medical, pharma, and biotech packaging, we do more than check a box, we solve the whole puzzle.

At Stephen Gould, our end-to-end process sets us apart. While others offer just one piece, we deliver complete, production-ready solutions, from design through delivery, all through a single, seamless point of contact. The result? Less risk, more speed, and packaging that works just as hard as you do. That’s why industry leaders and breakthrough innovators alike, from cutting-edge startups to major OEMs, trust our process.

It’s the driving force behind packaging solutions for companies like BioTel, BodyPort, Bigfoot, and Vave Health.

In the medical sector, packaging isn’t just about protection, it’s about precision, compliance, and optimizing the user experience. But our clients often face common challenges, including:

  • A fragmented vendor landscape that requires juggling multiple suppliers for one project
  • Limited internal packaging engineering resources
  • Complex regulatory demands around sterilization, validation, and labeling
  • Frequent device design changes that impact every element of the packaging system
  • Even a small tweak can trigger updates to pouches, trays, cartons, labels, and shipping configurations. Without tight coordination, timelines slip, and costs escalate fast.

That’s where our process makes the difference.

We eliminate common roadblocks by delivering single-source solutions tailored to the unique demands of the medical space. From concept to commercialization, every phase of our approach is designed to streamline complexity, reduce risk, and accelerate speed to market.

Here’s how we do it:

  • Client Collaboration and Discovery 

    We start by listening. Each project begins with a deep dive into the device specs, sterilization pathway, user needs, logistics challenges, and regulatory requirements. By gathering key insights upfront, we lay the foundation for a more effective solution.

  • Integrated Component Design 

    We take a systems approach, designing all components, thermoformed trays, Tyvek® pouches, folding cartons, IFUs, labels, and shipping cartons, to work together as one cohesive solution.

  • Rapid Prototyping and Iterative Testing 

    We move quickly to prototype, test, and refine. On average, our medical projects go through 15+ iterations, catching issues early, validating functionality, and ensuring a better end result.

  • Commercialization & Beyond

    Once validation is complete, we oversee the production ramp-up to ensure consistency, quality, and uninterrupted supply as the product enters the market.

  • Concept Development and User-Centered Design 

    Armed with a clear understanding, our in-house Design Centers develop packaging concepts that prioritize both protection and real-world usability. We consider every detail, from sterile field interaction to shelf presence.

  • Vendor Alignment and Production Management 

    Through our trusted network of ISO-certified vendors, we manage sourcing and production with precision. Our clients benefit from working with one point of contact, rather than coordinating across five or more suppliers.

  • Regulatory Testing and Validation Support 

    We guide clients through validation protocols, including sterilization, transit, and shelf-life testing. Our involvement early on ensures that packaging meets global regulatory standards without costly delays.

The result?

A faster, smoother path to market. Less internal strain. And packaging that performs as well in the OR or lab as it does on the loading dock.

Our holistic approach has earned the trust of innovators across the medical landscape, whether it’s designing a sterilization-sensitive bulk shipping solution or building full-system packaging for cutting-edge diagnostic devices. Whatever the challenge, we deliver expertise that supports every stage of the product lifecycle.

Explore More

Discover how our expertise in Medical Device, Pharmaceutical, Biotech, Procedural, and Testing/Validation packaging solutions can accelerate your next project.

Ready to get started?

Contact Stephen Gould today to learn how our proven process can support your medical packaging needs.