| ✓ ISO Class 7 cleanroom | ✓ ISO 13485 certified | ✓ Full process documentation |
| ✓ FDA-aligned processes | ✓ Scalable capacity | ✓ Swiss-engineered quality |
One Partner for a Growing Portfolio. Every Time on Time.
How Früh Packaging supports launch of massive trauma program to market with local for local initiative, across multiple suppliers and product generations.
Challenge
When a MedTech manufacturer needed a packaging and sterilization partner for extension of their portfolio, a next-generation line of trauma implants for hand and wrist, the situation was anything but straightforward. Two different manufacturing partners were involved: both US based manufacturers, with one handling the first product generation and the other the second. With not all product data defined at the start, the program was built to keep growing.
That means a packaging partner cannot just execute once and move on. They need to be structured for continuity and scale up, able to absorb new products, adapt to evolving specifications and maintain compliance across an expanding SKU range.
What We Did
For both product generations, Fruh Packaging in Exton took on the full scope: contract packaging in double peel pouches, gamma sterilization including sterilization and rinsing assessment, engineering support and master label creation. All work was done in compliance with ISO 13485, ISO 11137 – 1 and ISO 11607.
The rinsing assessment was an important step to confirm and define the rinsing program for the implants before sterilization. Getting that right upfront avoided rework later in the process. Because Früh’s existing packaging concepts were already an off-the-shelf solution, the team could onboard new products efficiently without starting from zero each time. That existing infrastructure is what makes scaling a massive trauma program or any other program efficient and possible. In practice, each new product enters a proven process instead of a new project, which gives the customer shorter planning cycles and predictable timelines as the program grows.
Result
The first sterile implants launched in July/August 2025 and have been coming through the Exton facility on a regular basis ever since. The second product generation is on track for May/June 2026. More products from the new trauma program are already planned for submission later in the year.
What started as a new customer relationship has grown into an active production partnership. As the portfolio expands, Früh is already in place: compliant, documented and ready for the next product. The customer gains one accountable partner across multiple manufacturers and product generations, less coordination overhead, and a supply base that scales with the program rather than holding it back.
Miki Velickovski
Sr. Director Sales & Marketing
+1 267 499 32 47
Tell us about your project and we'll help you figure out the best fit.