Considerations in Design and Development of Novel Combination Drug-Delivery Devices

Developing a novel (as opposed to utilizing a platform technology) drug delivery device is a complex, and highly iterative endeavor. There are several considerations to keep in mind, and West will be publishing a series of blog posts to detail those considerations; the first post in the series will focus on how to successfully land on the right problem definition and ensure appropriate scoping as that’ll have a significant impact on timelines, program cost, and realization of outcomes.

Scoping Projects & Problems

Scoping projects and problems in medical engineering is the "Phase 0" or  Initiation stage where clinical needs are translated into a formal, manageable project structure. This process prevents "scope creep" and ensures the device fulfils a genuine market and regulatory need. 

1. Problem Identification & Definition

Before a project begins, the core healthcare challenge must be articulated clearly.

• Problem Statement: Draft a concise description of the clinical pain points for patients, caregivers, or clinicians.
• Clinical Need & Intended Use: Formally define what the device will do, who will use it, and how it will improve patient outcomes.
• Unique Selling Point (USP): Identify the device's key differentiators from existing solutions to confirm market viability.

2. Opportunity & Risk Analysis

Engineers evaluate the project's feasibility to decide if it should proceed to formal development.

• Market & Competitor Research: Analyse existing products and potential gaps in the current healthcare landscape.
• Initial Risk Assessment: Identify high-level technical, clinical, and safety risks early, often using tools like SWOT or FMEA.
• Regulatory & IP Scoping: Determine the device's likely classification (e.g., FDA Class I, II, or III) and investigate the patent landscape to avoid infringement.

3. Defining Project Boundaries

This step sets the "In Frame" and "Out of Frame" parameters to focus resources.

• Scope Statement: Create a detailed document outlining specific objectives, deliverables, and—crucially—what is  excluded  from the project.
• Constraints & Parameters: Establish non-negotiable limits such as size, weight, budget, and required regulatory standards (e.g., ISO 13485).
• Deliverables: List the tangible outputs, such as working prototypes, test reports, and regulatory submission files.

4. Resource & Stakeholder Planning

Scoping involves assembling the right multidisciplinary team and securing support.

• Stakeholder Identification: Engage all relevant parties—from corporate administrators to end-user clinicians—early to align expectations.
• Resource Allocation: Identify necessary people, materials, equipment, and financial funding.
• Roles & Responsibilities: Clearly define who is responsible for specific activities, often visualized through an organizational chart or process map.

5. Finalizing the Project Charter

The phase concludes with a formal agreement to move into design.

• Estimates & Timelines: Develop high-level schedules with key milestones and decision "gates".
• Acceptance Criteria: Define measurable metrics that will be used to judge the project's success at the end of the lifecycle.
• Approval: The Project Manager seeks formal sign-off on a  Scoping Report  or  Project Charter from the sponsor.

The next blog post in this series will walk through the mechanical design considerations when developing a combination drug-delivery device.

Learn more about how West can help you address complex combination product development challenges.