ISO Class 7 cleanroom ISO 13485 certified ✓ Full process documentation
✓ FDA-aligned processes ✓ Scal­able capacity ✓ Swiss-engi­neered quality

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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.

Filmprinting
Filmprinting
Fruh_Mitarbeiter_Miki Velickovski

Miki Velickovski
Sr. Director Sales & Marketing
+1 267 499 32 47

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