SCIE90011 Early Feasibility in Product Development

SCIE90011: From Lab to Life

Course Information

  • University: The University of Melbourne

  • Instructors:

    • A/Prof. Greg Kubik

    • Dr. Daniel Czech

    • Dr. Heshan Peiris

Copyright Notice

  • Material reproduced under section 113P of the Copyright Act 1968 (Act).

  • Subject to copyright protection; further reproduction or communication may be restricted.

Acknowledgment of Traditional Owners

  • The University of Melbourne acknowledges the Traditional Owners of the land:

    • Wurundjeri Woi-wurrung and Bunurong peoples (Burnley, Fishermans Bend, Parkville, Southbank, and Werribee campuses)

    • Yorta Yorta Nation (Dookie and Shepparton campuses)

    • Dja Dja Wurrung people (Creswick campus)

  • Indigenous Cultural Knowledge: Recognizes the importance of Indigenous knowledge and practices that have been part of Australia for over 60,000 years, paying respect to Elders past, present, and future.

Intended Learning Outcomes

By the end of this lecture, students should be able to:

  • Explain what early feasibility means in product development and why it matters.

  • Identify key assumptions and risks embedded within a product concept.

  • Distinguish different types of feasibility:

    • Technical

    • User/desirability

    • Regulatory/safety

    • Economic

    • Operational

  • Prioritize which assumptions to test first using simple tools.

  • Apply low-cost methods to gather early feasibility evidence (prior to full validation or scale-up).

Feasibility Across the Development Journey

Feasibility Overview

  • Early Feasibility:

    • A preliminary evaluation of whether a biological concept or technology could function.

    • Often utilizes simplified models (early assays, proof-of-concept data, literature precedents).

    • Aims to identify major scientific or technical risks prior to significant investments.

  • Full Feasibility:

    • A comprehensive assessment utilizing more robust experiments and relevant biological systems.

    • Evaluates the realistic potential to develop a product including scalability, regulatory pathways, and safety considerations.

  • Validation:

    • A formal process to demonstrate that a method, assay, process, or product performs as intended under specified conditions.

    • Required in regulated biotechnological environments to ensure reliability, reproducibility, and adherence to safety, quality, or regulatory standards (e.g., Good Manufacturing Practices - GMP).

Importance of Early Feasibility

  • Early feasibility is critical to identify risks that lead many ideas to fail, not due to impossibility but due to unrecognized risks:

    • Saves Time and Resources: Identifies 'non-starters' quickly.

    • Improves Decision-Making: Facilitates informed concept screening.

    • Refines Concepts: Encourages teams to address constraints, regulations, and costs early on.

Types of Feasibility to Consider

  1. Technical Feasibility:

    • Assesses whether the underlying science/technology can achieve the required performance.

    • Identifies any known scientific or engineering obstacles.

    • Evaluates integration of necessary components.

  2. User/Desirability Feasibility:

    • Considers if users will utilize the product effectively.

    • Evaluates fit within user workflow and constraints.

    • Examines if it addresses a prioritized problem for users.

  3. Regulatory and Safety Feasibility:

    • Determines potential regulatory categorization (IVD, medical device, therapeutic, GMO, biosafety level).

    • Identifies safety and ethical concerns that may hinder progress.

    • Looks for feasible pathways to compliance with regulations.

  4. Economic and Business Feasibility:

    • Examines if the concept can be manufactured and delivered at an acceptable cost.

    • Identifies potential buyers or customers.

    • Recognizes any existing economic barriers.

  5. Operational/Implementation Feasibility:

    • Determines if the concept can be executed given staffing, infrastructure, and organizational culture.

    • Evaluates the need for specialized skills or equipment.

    • Considers compatibility with existing processes and incentives.

TELOS Feasibility Study Framework

  • TELOS: A broad framework for initial feasibility scanning comprising:

    • Technical Feasibility: Can it be built? Is it scientifically plausible?

    • Economic Feasibility: Is it financially viable? Evaluates rough costs against benefits.

    • Legal Feasibility: Evaluates intellectual property, regulatory, and standards compliance.

    • Operational Feasibility: Can it mesh with current operations and culture?

    • Schedule Feasibility: Can development complete in a reasonable timeframe (e.g., prior to patents expiring)?

Assumptions and Risks in Product Concepts

  • Every product idea hinges on several assumptions:

    • Scientific Assumptions: Confidence in the targetable pathway within biology.

    • User Assumptions: Expectation for clinicians' behavioral change.

    • System Assumptions: Belief that regulators will accept the provided evidence.

    • Financial Assumptions: The expectation that hospitals will pay the proposed price.

  • Early feasibility involves identifying and testing these assumptions:

    • Evaluates uncertainty levels.

    • Assesses the impact of erroneous assumptions.

Common Categories of Assumptions

  1. Technical Assumptions:

    • The biology, chemistry, or engineering functions as anticipated.

    • Required performance metrics (accuracy, reliability, speed, scale) are achievable.

    • Components can successfully integrate into a cohesive system.

  2. User/Behavior Assumptions:

    • Users will adopt and correctly utilize the product.

    • Adjustments to existing workflows are feasible.

    • Training requirements are manageable.

  3. Regulatory/Safety Assumptions:

    • The product aligns with existing regulatory categories.

    • Risks associated with safety and biosafety can be controlled within reasonable parameters.

    • Ethical matters can be generally resolved.

  4. Economic/Market Assumptions:

    • Buyers exist and are willing to pay the established price.

    • The manufacturing cost can be minimized sufficiently.

    • Competing solutions are not overly dominant in the market.

  5. Operational/Implementation Assumptions:

    • Necessary infrastructure (connectivity, lab facilities) is accessible.

    • Staff capacity and supply chain logistics are feasible.

  • The goal of early feasibility is to translate these assumptions into testable inquiries and find viable answers.

Prioritizing Assumptions: What to Test (First)?

  • Testing priorities should focus on cost-effective and rapid assessments.

    • Use a matrix of impact and uncertainty to determine which assumptions to test first:

    • High Impact / High Uncertainty: Confirm / Test First

    • Low Impact / Low Uncertainty: Skip / Can Wait

Low-Cost Early Feasibility Methods

  1. Desk Research and Back-of-the-Envelope Checks:

    • Utilize literature and guidelines to confirm technical plausibility and explore regulatory precedents.

    • Perform simple calculations to assess process time compatibility, material costs, and potential scales.

  2. Stakeholder Conversations:

    • Engage in structured discussions with clinicians, lab staff, process engineers, and managers.

    • Aim to validate the problem/need and gauge acceptability for workflow changes.

  3. Early Regulatory and Safety Scanning:

    • Determine likely classifications (IVD vs. RUO; device class; GMO category).

    • Identify any potential red flags such as dual-use concerns or high biosafety requirements.

    • Use agency guidelines and biosafety resources for plausible regulatory paths.

  4. Simple Experiments and Prototypes:

    • Conduct small-scale proof-of-concept experiments to evaluate key technical uncertainties.

    • Create mock-up prototypes (e.g., paper prototypes of interfaces) to test user reactions.

Example: Bioprocess Monitoring System

  • The system utilizes integrated in-line NMR sensors and analytics for real-time monitoring of metabolites in pilot-scale bioreactors.

  • Assumptions:

    • Technical: Low-cost sensors must provide accurate metabolite data.

    • User/Behavior: Trust and usage reliability by process engineers must be established.

    • Economic/Operational: Ensure retrofitting without major downtime and justify costs through reduced failures/improved yield.

Summary

  • Early feasibility aims to minimize uncertainty around product concepts early in the process.

  • It is an integrated first step in the concept screening process.

  • Feasibility includes multidimensional aspects: technical, user/desirability, regulatory/safety, economic, operational.

  • Each concept involves assumptions needing verification.

  • Use low-cost assessment methods during this stage (literature review, simple calculations, stakeholder interactions, small experiments, mock-ups) without comparing disparate ideas or concepts.

Questions

How do early feasibility studies and idea screening relate to each other?

Both processes aim to eliminate non-viable concepts before significant resources are expended, ensuring that only the most promising ideas advance into detailed development.

  • Early feasibility studies = assess the viability of a concept against market needs and technical capabilities.

  • Screening = narrows down options based on predefined criteria and potential impact. Non-viable, ideas filtering.

What is the difference between a generic product and the expected product?

  • Generic Products: A broad category of products aimed at general market needs without unique features or customisation.

  • Expected Product: Specific version of a product that includes unique features, benefits, and value propositions designed to meet customer expectations and stand out from competitors.

Discuss the following statement: We should not make any assumptions during product development. Do you agree or disagree? Disagree

Every product concept rests on assumptions. Every concept is a bundle of assumptions that need to be tested.

which can influence the design and development process significantly. Therefore, it is crucial to validate these assumptions through market research, customer feedback, and prototype testing to mitigate risks and ensure alignment with customer needs.

Assumptions provide:

  • foundational framework that guides the initial stages of product development.

  • defining the target market,

  • identifying potential user needs,

  • formulating hypotheses about the product's functionality.

Without these starting assumptions, the team may lack direction and focus, leading to wasted resources and time. Additionally, making informed assumptions allows teams to prioritise features and allocate resources efficiently, ultimately paving the way for innovation and effective problem-solving.