Top 10 Business Requirements for Combination Products

By Alberto Velez
November 4, 2016


• Categories: 04-Product Design & Development, Combination Products, RC - Medtech Regulatory Resource Center

Often the excitement of a finding a novel drug device combination product overshadows the business reality of developing and introducing to the market such a combination product. A well-defined business case process that addresses the following can significantly improve the likelihood of a successful combination product.

Product Definition

• Confirm one of the constituents will dominate a key product attribute or address an unmet need. The other constituent must be competitive in its performance.  Preferably both constituents deliver an important value to the therapy.
• Ensure there is a process and capability to link these product characteristics to the product and process company system.

Project Team

• The team should have a leadership with the competence to apply the unique regulatory requirements and the relevant combination product technologies.
• Team members should have the aptitude, versatility and authority to effectively execute the multiple systems that will be necessary to launch a reliable combination product.

Project Management

• There should be a project management process that can integrate multiple functional project deliverables and is effectively deployed. The process should include mechanisms for assessing the likelihood of project launch. The process should include risks to project launch such as internal and external barriers, technology maturity (new to market vs. new to organization), financial, etc.
• A fully dedicated and experienced project manager responsible for developing and executing an integrated project plan that includes resource, progress and communications.

Sponsor

• Ensure there is a commercial owner with P&L responsibility who has the influence as well as the authority to see the project through to completion.
• Once the sponsor’s role and responsibilities are defined, ensure there is a mechanism to support the sponsor, such as timely flow of key, actionable information.

Governance & Management

• Understand how the financials of the project align with the organization’s project investment patterns and how the combination product’s business risk compare to normal project’s business risk (return on investments, net present values, etc.).
• Ensure the senior management has visibility to the market potential, competitive landscape, regulatory requirements, etc., and how the new combination product is strategically relevant to the organization.