Early Feasibility in Product Development

These vocabulary flashcards define the key concepts of early product feasibility, various feasibility dimensions, the TELOS framework, and low-cost testing methods as presented in the SCIE90011 lecture.

Early Feasibility

A preliminary check using simplified models, such as early assays, literature precedents, or proof-of-concept data, to uncover major scientific or technical risks before heavy investment.

Full Feasibility

A detailed assessment using robust experiments and relevant biological systems to evaluate whether a technology can realistically be developed into a product, including scalability and regulatory pathways.

Validation

A formal demonstration in regulated biotech environments, such as $GMP$, showing that a method, assay, process, or product consistently performs as intended under defined conditions.

Technical Feasibility

An evaluation of whether the underlying science or technology can plausibly achieve required performance and if there are known show-stoppers.

User / Desirability Feasibility

Assesses if intended users will actually use the product in practice, if it fits their workflow, and if it solves a prioritised problem.

Regulatory and Safety Feasibility

The identification of the regulatory category for a product, such as $IVD$ or medical device class, and determining if a plausible pathway to compliance exists.

Economic and Business Feasibility

Determines if a concept can be manufactured and delivered at an acceptable cost and if there is a plausible payer or customer.

Operational / Implementation Feasibility

An assessment of whether a concept can be implemented in real settings given staffing, infrastructure, and culture, without clashing with existing processes.

TELOS

A framework used for an early, broad scan of feasibility, standing for Technical, Economic, Legal, Operational, and Schedule feasibility.

Legal Feasibility

A component of the TELOS framework focusing on IP, regulatory requirements, contractual obligations, and standards compliance.

Schedule Feasibility

A component of the TELOS framework evaluating if a project can be completed in a reasonable timeframe, such as before patents expire.

Assumptions

The underlying beliefs about science, users, systems, and money that every product concept rests upon and which early feasibility aims to surface and test.

Prioritisation Matrix: Test First

The quadrant representing assumptions that have both high uncertainty and a high impact if wrong, which should be tested at the earliest stage.

Desk research and back-of-the-envelope checks

A low-cost feasibility method involving literature reviews, regulatory precedent identification, and simple calculations like process time or rough materials costs.

Stakeholder conversations

Short, structured discussions with clinicians, lab staff, or managers to validate needs, explore workflow acceptability, and uncover hidden constraints.

Mock-up prototypes

A low-cost method using simple models, such as paper prototypes for interfaces, to test user reactions before building a functional device.