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Successfully Managing a Combination Product Project

Having a promising drug candidate is not always enough. Emendo R&D was brought on board when a Nordic pharmaceutical company faced the challenge of developing and later managing the procurement and development of a new user-friendly injection device.

Industry:Pharmaceutical Manufacturing
Year:2023

INTRODUCING

Combination Products

Combination products present unique challenges in development, commercialization, and regulatory compliance, as they require adherence to multiple sets of guidelines governing both drug and device components.

Listen as our Scientific Senior Consultant, Tanguy Floch, covers some of the challenges associated with developing and managing a complex combination product and how to avoid costly mistakes.

The Challenge

Navigating Uncharted Waters

Handling combination products can be challenging for pharmaceutical companies, who may be less familiar with working with medical device components. This was the realization of one Nordic company facing a new challenge. They wanted to develop an injection device for a promising drug candidate to treat a rare disease. However, the pharmaceutical company lacked experience in medical device development, creating a significant knowledge gap in the effort to bring a combination product to market. In their search for a solution, they turned to Emendo R&D.

The Approach

The team took on the primary challenge of bridging the knowledge gap and successfully assisted in the development of a pre-filled autoinjector that would enable patients to self-administer their medication without external assistance. In addition, Emendo R&D navigated the complex landscape of regulatory requirements and procurement practices for injection devices, which added another layer of complexity to the project.

Developing and Managing Complex Combination Product

Emendo R&D began by conducting a series of workshops with the pharmaceutical company to educate the client on medical device development methodologies and establish a foundation for understanding the complexities of combination product development as well as defining design requirements and assess user risks. However, as the project progressed, the task were expanded to support the customer with tasks related to supplier selection and project and outsourcing management.

Supplier Selection Among Injection Device CMOs

Emendo R&D was hired to align customer requirements with potential device suppliers, developing a comprehensive Request for Proposals (RfP), and coordinating with suppliers to ensure high quality proposals. Furthermore, the team was tasked with streamlining supplier communication for efficiency and transparency, obtaining accurate proposals to eliminate potential surprises later in the project, as well as leveraging multiple proposals to compare prices and negotiate cost savings for both project development and future production.

Project and Outsourcing Management

The tasks of Emendo R&D was expanded to cover working with the pharmaceutical company to provide inputs into the contract, aligning project plans between companies and project coordination, as well as identifying and mapping the required studies. Furthermore, the tasks included working with the CMO to refine device specifications and align them with syringe specifications, supporting technical troubleshooting, and reviewing and approving design control documentation provided by the CMO.

The Results

The guidance and hands-on management from Emendo R&D throughout the project led to the successful development of a combination product: a prefilled, user-friendly autoinjector. By successfully bridging the gap between pharmaceutical and medical device development, Emendo R&D achieved cost savings while ensuring compliance with regulatory standards.

During the project, Emendo R&D managed:

  • Training of the customer to be self-driven within Combination Device
  • Timely development of the syringe
  • A 10% savings in fixed project costs
  • A 5% savings in unit costs for future productions

Contact Tanguy

If you have any questions about the case or our services, get in touch with our specialist Tanguy.

Tanguy Floch

Tanguy Floch

Scientific Senior Consultant

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