Project Evaluation and Feasibility

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Questions and Answers

What is the estimated cost of the Smart ETT?

~£100

~£200

~£30 (correct)

~£50

What is the current Technology Readiness Level (TRL) of the prototype device?

TRL 3-4

TRL 5-6 (correct)

TRL 7-8

TRL 1-2

What is the next step in the development of the Smart ETT?

Conduct further animal studies

Apply for FDA approval

Start commercial production

Move to TRL 6-7 (correct)

What is the purpose of the clinical trial mentioned in the text?

To demonstrate safety for UKCA mark (UK) and CE mark (EU) Signup and view all the answers

What is the purpose of the business plan developed for the Smart ETT?

To understand market potential and move technology through TRLs Signup and view all the answers

How many grants have been received for the Smart ETT project?

3 grants from NIHR, MRC (x2) Signup and view all the answers

What is the purpose of engaging with end users, clinicians and patients?

To gather feedback on the device Signup and view all the answers

What is the current stage in the commercialisation roadmap?

Pitch Signup and view all the answers

What is the potential service model for the business?

Free monitoring unit and pay for ETTs and support Signup and view all the answers

What type of assets are likely to be sold in the business?

The entire system, including monitoring unit and single-use ETTs Signup and view all the answers

What is the primary motivation for forming key partnerships?

To optimise the business model and reduce risk Signup and view all the answers

What is the cost of a conventional ETT?

£2-£3 Signup and view all the answers

What is the focus of the business model in terms of cost structure?

Value-driven Signup and view all the answers

What is the key activity in the business model?

Designing, making and delivering a new endotracheal tube Signup and view all the answers

What type of resource is the iTraXS trademark?

Intellectual resource Signup and view all the answers

What is the business partnership with P3 Medical for?

Manufacturing of the ETTs Signup and view all the answers

What is the main purpose of the Preliminary Assessment stage?

To determine market size, potential, and manufacturing feasibility Signup and view all the answers

What is the primary focus of Gate 2 in the New Product Development Framework?

To review customer wish lists and update the 'must meet' and 'should meet' criteria Signup and view all the answers

What is the main objective of Stage 3 in the New Product Development Framework?

To develop the product and create a detailed test, marketing, and operations plan Signup and view all the answers

What is the primary purpose of Gate 5 in the New Product Development Framework?

To focus on the quality of the validation stage and review operating and marketing plans Signup and view all the answers

What is the main objective of the Validation stage in the New Product Development Framework?

To perform in-house product tests, user trials, and pilot production Signup and view all the answers

What is the purpose of the Post-implementation review in the New Product Development Framework?

To disband the 'new product' project and allow it to become a regular product Signup and view all the answers

What is the main focus of the Definition stage in the New Product Development Framework?

To perform market research, competitor analysis, and detailed IP analysis Signup and view all the answers

What is the purpose of Gate 3 in the New Product Development Framework?

To review 'must meet' and 'should meet' criteria and quality check the work performed in Stage 2 Signup and view all the answers

What is the primary purpose of the BS EN ISO 13485:2016 standard?

To specify requirements for quality management systems in medical devices Signup and view all the answers

What is the significance of the commercialisation roadmap?

To outline the stages of product development from idea to commercialisation Signup and view all the answers

What is the approximate time frame for bringing a technology to market in this industry?

15 years Signup and view all the answers

What is the importance of understanding the customer in the commercialisation process?

To understand what the customer is willing to pay Signup and view all the answers

What is the benefit of utilising P3 Medical's distribution network?

To utilise their existing distribution network Signup and view all the answers

What is the significance of the BS EN 556-1:2001 standard?

It specifies the requirements for medical devices designated as 'STERILE' Signup and view all the answers

What is the importance of justifying choices in the business plan?

To support decision-making during the commercialisation process Signup and view all the answers

What is a potential consequence of high cuff pressure?

Tracheal stenosis Signup and view all the answers

What is the main idea behind the commercialisation roadmap?

To describe the stages of product development Signup and view all the answers

What percentage of patients report severe sore throat after intubation?

50% Signup and view all the answers

What is the main purpose of the iTraXS system?

To monitor and maintain appropriate cuff inflation pressure Signup and view all the answers

What is the estimated number of fully trained clinicians in the UK who use ETTs?

13,000 Signup and view all the answers

What is the main benefit of the iTraXS system for anaesthetists, intensivists, and emergency medicine specialists?

Reducing the risk of ventilator-associated pneumonia Signup and view all the answers

What is the main problem addressed by the iTraXS system?

Incorrect ETT cuff pressure Signup and view all the answers

What is the consequence of low cuff pressure?

Pulmonary aspiration of fluids Signup and view all the answers

What is the potential outcome of tracheal injury caused by high cuff pressure?

Post intubation tracheal stenosis Signup and view all the answers

Study Notes

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.

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Description

Assess the viability of a project by evaluating strategic alignment, competitive advantage, and market attractiveness. This stage involves a preliminary assessment of the project's feasibility, including market size and manufacturing feasibility.