Medical Case Study

merxin

Challenge

Merxin is a disruptive, fast-moving designer, developer and supplier of generic and customised drug delivery and medical device platforms.  When developing their MRX003 generic capsule based inhaler they needed to have production-quality injection mouldings & cleanroom assemblies in an accelerated timescale in order to hit an aggressive clinical trials schedule.

Solution

Working in accordance with jointly-developed cleanroom manufacturing & assembly protocols, FRP produced ultra-rapid, single cavity steel mould tools and multiple batches of cleanroom mouldings to enable Clinical Trials in a fraction of the time usually required to reach this key milestone.  This included semi-automated cleanroom assembly of over 130,000 devices in accordance with ISO13485:2016 practices. 

Result

Merxin were able to massively de-risk the next stage of scale-up Production with their chosen CMO and maintain their timelines for Product Launch.

“We used conventional 3D printing and a cassette-based moulding provider to develop and rapidly iterate our Stage 1 designs for MRX003 before retaining FRP to help take us through to the critical Clinical Trial phase.  Their knowledge and experience of this specific niche proved extremely valuable in helping us to de-risk and achieve scale up transition much faster than would have been possible otherwise. Using mouldings and assemblies from FRP, we were able to demonstrate equivalence with the originator design in terms of airflow, NGI profile and audible feedback – all key factors in a generic product of this type.”

Philippe Rogueda, CBO, Quality Director- Merxin