Project Evaluation and Feasibility

New Product Development Framework

• The framework consists of five stages: Preliminary Assessment, Definition, Development, Validation, and Commercialisation.
• Each stage has a gate review to assess progress and decide whether to proceed or stop the project.

Stage 1 - Preliminary Assessment

• Inexpensive stage that involves library search, engagement with key users, focus groups, and concept test.
• Technical assessment of development and manufacturing feasibility.
• Purpose is to determine market size, potential, and manufacturing feasibility, and to define 'must meet' and 'should meet' criteria.

Gate 2 - Second Screen

• Repeat of Gate 1 based on new information from Stage 1.
• Review customer wish list (must and should meet).

Stage 2 - Definition

• Final stage before product development (significant spending).
• Involves market research, competitor analysis, detailed IP analysis, and detailed financial analysis (cash flow).
• Technical appraisal to determine if customer needs are technically and economically feasible.
• Preliminary design/laboratory work.

Gate 3 - Decision on Business Case

• Review 'must meet' and 'should meet' criteria.
• Quality checking work performed in Stage 2.
• Review financial analysis.
• Define Target Product Profile (performance specifications).

Stage 3 - Development

• Development of the product.
• Detailed test, marketing, and operations plan.
• Update financial analysis.
• Review IP.

Gate 4 - Post-Development Review

• Check progress and quality of work.
• Review financial analysis.
• Review future marketing plans.

Stage 4 - Validation

• In-house product tests.
• User trials.
• Pilot production.
• Pretest market or trial sell.

Gate 5 - Pre-Commercialisation Decision

• Final point to kill off project.
• Focus on quality of validation stage.
• Review operating and marketing plans.

Stage 5 - Commercialisation

• Implement product launch plan.

Post-Implementation Review

• Disband the 'new product' project and allow it to become a regular product.

iTraXS Smart Endotracheal Tube Case Study

• Background: iTraXS smart endotracheal tube aims to prevent ventilator-associated pneumonia and tracheal injury.
• Business model canvas:
  • Customer segments: anaesthetists, intensivists, and emergency medicine specialists.
  • Value proposition: monitoring and maintaining appropriate cuff inflation pressure.
  • Key resources: patents, trademarks, design rights, and talented people.
  • Key activities: designing, making, and delivering a new endotracheal tube.
  • Key partnerships: working closely with P3 Medical on manufacturing.
  • Cost structure: value-driven with costs offset by reduction in VAP.

Technology Readiness Level

• Conducted animal and conscious human studies with a prototype device (TRL 5-6).
• Funding to take this to 1st in human studies (TRL 6-7).

Stage Gate Model

• Initial discussion with clinicians (2013).
• Review progress and business case after each project.
• Clinical trial to demonstrate safety for UKCA mark (UK), CE mark (EU), or FDA approval (US).
• Further clinical trials to provide evidence of reduction of ventilator-associated pneumonia.

Commercialisation Roadmap

• Plan: business plan developed to move technology through TRLs and understand market potential.
• Position: market segment identified, main competitors identified.
• Pitch: engagement with end users - clinicians and patients.
• Patent: intellectual property protection.
• Product: development and testing.
• Pass: regulatory approval.
• Production: outsourcing manufacturing to P3 Medical and other partners.
• Profits: understanding customer willingness to pay and utilising P3 Medical distribution network.