Industrialisation Support for Generic DPI

Device suitable for Abbreviated New Drug Application (ANDA) submission to the FDA

Device Functionality Profile, Tolerance Analysis, Tolerance Allocation, Substitutability, Risk Management

Challenge 

Working to support the industrialisation and scale-up of a generic equivalent to a well-established Diskus inhaler. The objective was to design, develop, and industrialise a bioequivalent device suitable for Abbreviated New Drug Application (ANDA) submission to the FDA.

Approach 

Given the complexity of dry powder inhaler mechanisms, this project demanded not only precision engineering and regulatory rigour but also comprehensive risk control and robust planning methodologies.

We worked closely with the client to provide inhaler industrialisation engineering support, to develop a device that met bioequivalence and functional equivalence requirements to the reference Diskus inhaler, in order to bring the device closer to market.

Outcome 

The project provided our client with new insights into the design, function, and manufacturability of their device, critical for the progressing the design into commercial tooling.

 

 

To progress development and industrialisation, our client required specialist engineering support, and Cambridge Medtech Solution were asked to join the team.

For this project, CMS provided additional expertise in mechanical and production engineering, medical device risk management, and device testing and verification.

Services to our client included:

  • Preparation of the Device Functionality Profile (DFP) in accordance with ISO 20072 and other applicable standards, based on the requirements specification,
  • Led Tolerance Management (allocation and analysis) activities, where critical dimensions, tolerances and process capability expectations were a key consideration when placing orders for multi-cavity tooling and assembly equipment,
  • Identified functional critical-to-quality (CTQ) features for control.
  • Contributed to Substitutability Planning
  • Participated in Risk Management activities,
  • Supported Tooling Strategy for development of multi-cavity tools with offshore toolmakers.
  • Supported Device Manufacturing Strategy Planning, from PK Study to Commercial Scale,
  • Supported Design Verification Planning, in accordance with Device Functionality Profile.

Client project leader commented “Industrialisation of a generic DPI brings its own particular engineering and regulatory challenges, and we benefited from Cambridge Medtech Solutions’ considerable experience and insight in inhaler development and industrialisation.”

This project illustrates how expert consultancy input – combining tolerance engineering, risk management, industrialisation engineering, and structured project execution – can significantly de-risk complex drug delivery device development. Our partnership enabled the client to accelerate their ANDA programme with confidence in both device performance and industrial viability.