I.B.1. Unmet Need Identified

Estimated Execution Time

4-6 weeks

Objective

To clearly define a real and relevant unmet clinical or operational need(s). The need must be outcome-oriented and grounded in real-world observations, not assumed solutions.

Who is Involved

Project office department and/or Champion(s) – internal initiator motivated or that has the mandate to detect and solve some of the current unmet needs
Healthcare Professionals – unmet needs holder, will contribute to the identification.
Hospital Departments – diagnostics laboratory, pharmacy, biomedical engineering, radiology, data management – depending on the need will contribute to the identification.

Activities / Tasks

I.B.1.1. Use facilitators

Be or appoint a facilitator. You can consider include some expert consultants to be an external facilitator with proprietary methodology.
Choose a focus area (e.g., emergency department, chronic disease management). This focus area can be selected based on a strategic area of improvement for the centre or the healthcare system.

I.B.1.2. Perform activities for the needs identification

Set up a strategy and methodology to identify the needs, (for example it can be done using the Biodesign methodology by observing clinical teams or mapping patient journeys to uncover pain points)
The need identification can also be framed in the context of an internal program or a structured workshop to brainstorm and share key problems in care delivery.
Use surveys and interviews with the staff and any stakeholder that is involved in that pain point (focus: what’s inefficient, risky, or frustrating?). Homologous stakeholders from other healthcare centres can also be asked to validate if this is a centre-specific need or a general one (this will help you to select the adoption instrument in the future). Also consider step I.C.2 to make sure that is aligned with the interests of the payor to ensure long-term adoption.
Collect data: incident reports, delays, readmission rates, bottlenecks.

I.B.1.3. Synthesize Needs

Cluster problems/needs under the different challenges. (e.g. What is that imped me solve or fulfil my need?)
Write a need statement for each need: “A way to [improve/change a clinical outcome or process] in [specific patient population or workflow] that results in [desired outcome].” (see Biodesign methodology for more background)

I.B.1.4. Prioritize Identified Needs

Score potential needs using clear criteria (e.g., impact, frequency, feasibility, cost to hospital, strategic alignment, feasibility)
Select top-ranked need(s) for innovation procurement process

I.B.1. 5. Validate Final Selection with Decision-Makers

Present the top-ranked needs to clinical leadership, procurement office, and finance department for validation and final approval (see step I.A.4). This will allow for institutional buy-in and resource allocation for addressing the chosen unmet need.
Also, final results of the process can be shared and communicated with the teams involved in that need to make them part of the process.
Validate with healthcare system strategies (see step I.C.2)

Tips / Common Pitfalls

✅ Prioritise those needs for which there is a champion willing to lead the transformation.

✅ Consider citizen/patient input when the need affects citizens (e.g. prevention, early detection) patient experience or outcomes.

❌ Don’t phrase the need as a desired technology (e.g., “we need an AI tool”).

❌ Avoid involving only management, frontline insights are essential.

❌ Avoid imposing adoption of innovations to reluctant teams.

Outcome / Deliverables

1–3 validated unmet need statements, clearly documented with their rationale (why it matters, evidence, who is affected)

Resources

Biodesign Methodology

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