SCIE90011 Early Feasibility in Product Development

This flashcard set covers the core definitions and frameworks of Early Feasibility in product development within the biotechnology sector, based on the SCIE90011 lecture.

Early feasibility

A preliminary check using simplified models, early assays, or literature precedents to identify major scientific or technical risks before heavy investment.

Full feasibility

A detailed assessment using robust experiments and relevant biological systems to evaluate scalability, regulatory pathways, and manufacturability.

Validation

A formal demonstration that a method, process, or product consistently performs as intended under defined conditions, ensuring compliance with standards such as GMP.

Technical feasibility

An assessment of whether the underlying science or technology can plausibly achieve required performance and if needed components can be integrated.

User / desirability feasibility

The evaluation of whether intended users will actually use the product, if it fits their workflow, and if it solves a prioritized problem.

Regulatory and safety feasibility

The identification of a product's likely regulatory category (e.g., IVD, GMO) and the assessment of ethical or safety concerns that could block the concept.

Economic and business feasibility

The analysis of whether a concept can be manufactured at an acceptable cost and if there is a plausible payer or customer.

Operational / implementation feasibility

The check of whether a concept can be implemented in real settings given available staffing, infrastructure, culture, and existing processes.

TELOS

A framework for a broad feasibility scan covering Technical, Economic, Legal, Operational, and Schedule considerations.

Schedule feasibility

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

Assumptions

Underlying beliefs about science, users, systems, or money that a product concept rests upon; early feasibility aims to turn these into testable questions.

Prioritisation Matrix

A simple tool used to decide which assumptions to test first by plotting Uncertainty against the Impact if the assumption is wrong.

Desk research

A low-cost feasibility method using literature, guidelines, and simple "back-of-the-envelope" calculations to confirm technical plausibility.

Stakeholder conversations

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

Mock-up prototypes

Simple models, such as paper prototypes or simulated outputs, used to test user reactions without full technical development.

GMP

Good Manufacturing Practice; a set of regulatory standards mentioned in the context of formal validation in biotech environments.

IVD

In Vitro Diagnostic; a possible regulatory classification mentioned for products in the early scanning phase.

RUO

Research Use Only; a classification category used when judging the plausible regulatory pathway of a concept.

GMO

Genetically Modified Organism; a biological category that impacts regulatory and safety feasibility assessments.