Case Study

Advanced wound care manufacturing transfer: securing a more resilient, global supply model

Region Malaysia serving US and Europe markets Sector Medical Devices, Surgical Devices Capabilities

Discover how a major production transfer enabled a global leader in advanced wound care to secure the long-term supply of a commercially–established biosynthetic wound dressing for use across multiple markets, including the US and Europe. 

The challenge

Our customer’s advanced wound care product is a commercially-established, silicone-based biosynthetic wound dressing, supplied in multiple formats and sizes, including sheets for pediatric and adult use. 

Manufacture relies on a high-touch, multi-step, chemistry-driven process, with long processing cycles and multiple controlled operations. Securing sustainable long-term supply meant exploring how the labor intensive nature of production could be optimized without compromising safety, effectiveness, reliability, or performance. 

Additional complexity came from regulatory and market requirements associated with transferring a mature product. The program required CE Mark re-certification from Class IIb to Class III, supported by redevelopment of documentation, Standard Operating Procedures (SOPs), and validation activities to generate an updated technical file for registrations into additional markets. 

The solution

The carefully controlled transfer was executed from an established US-based manufacturing setup to Ensera’s FDA-registered, ISO 13485 certified manufacturing site in Malaysia, a geographically and geopolitically stable Southeast Asian hub for medical device manufacturing. The program rebuilt a complex, chemistry-driven process within a customer-dedicated cleanroom ISO Class 7 and chemical processing environment, establishing a resilient, optimized and diversified manufacturing model to support long-term commercial supply. 

The solution focused on: 

  • Rebuilding the manufacturing process within a customer‑dedicated, controlled environment 
  • Translating historically evolved techniques into documented, repeatable operations 
  • Supporting manufacturing footprint diversification while maintaining supply continuity 
  • Preserving alignment with the customer’s established quality, supplier, and release model 
  • Enabling regulatory readiness through structured process redevelopment, validation, and technical documentation

This ensured the transferred program was scalable, controlled, and suitable for long-term commercial production. 

This program went well beyond a manufacturing transfer. We were able to replicate and then optimize a stable production platform for resilient, scalable production of a complex, chemistry-driven product within a controlled and regulated environment.

- Colin Donnelly, VP Contract Manufacturing at Ensera

The execution

In order to create a dedicated manufacturing capability for our customer’s program, we custom-designed cleanroom and chemical processing rooms which were configured for formulation, material handling, and multi-step production. 

We then translated manufacturing processes into SOP-led operations reflecting actual operating techniques. This enabled consistent execution of: 

  • Chemical formulation and material suspension  
  • Controlled spreading and curing  
  • Embedding, cutting, and conversion  
  • Manufacturing of accessories including stitching of dressing materials  

To support the highly specialized nature of production, we rolled out extensive technical and chemical training to enable our teams to execute the process and support re-validation within the new cleanroom ISO Class 7 environment. 

Use of our dedicated laboratory was also established to support in-process, performance, and finished product testing, integrating verification directly into manufacturing. 

Our production model incorporated downstream operations, including: 

Alongside these enhancements, we were able to retain existing customer-specified suppliers within the operating framework, implementing Unique Device Identification (UDI) and supporting documentation to enable accurate traceability and support global regulatory submissions. We also maintained the established release pathway, with product transferred for final testing and release prior to distribution. 

Impact

By combining chemical engineering expertise, structured process redevelopment, and in-region operational capability, Ensera enabled the secure relocation and long-term sustainability of a critical advanced wound care product within a more resilient global supply model. 

  • Cost optimization achieved without compromising product safety, effectiveness, performance or execution 
  • Reduced geographic risk by establishing manufacturing in a geopolitically stable Southeast Asian hub with robust regulatory compliance and operating conditions 
  • A strong governance model that translated historically evolved know-how into repeatable SOP-led operations, supported by extensive training and re-validation 
  • Embedded testing capability (chemical, performance, finished product) supporting ongoing process control 
  • Strengthened regulatory readiness for re-certification and global registration activities  
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