Lecture 3a New Product Development Framework

What is the purpose of Technology Readiness Levels (TRL)?

TRL is a measurement system used to assess the maturity of a particular technology.

What is the Stage-Gate model in New Product Development?

The Stage-Gate model is a framework where stages (where work is done) and gates (where quality is checked) are used to manage the development of new products. Each gate involves deliverables assessed by senior managers.

What happens during Gate 1 in the Stage-Gate model?

Gate 1 is an initial screen where a gentle decision is made to commit some resources. It checks strategic alignment, project feasibility, market attractiveness, and other criteria.

What is the purpose of Stage 1 (Preliminary Assessment) in the Stage-Gate model?

Stage 1 involves inexpensive activities like library searches, focus groups, and technical assessments to determine market size, potential, and manufacturing feasibility.

What is the main goal of Stage 3 (Development) in the Stage-Gate model?

Stage 3 focuses on the development of the product, including detailed testing, marketing, and operations plans, and updating financial analysis.

What is the Product Life Cycle in New Product Development?

The Product Life Cycle describes the stages a product goes through from introduction to decline, including research, development, tech transfer, and commercialization.

What are the challenges associated with endotracheal tubes (ETT)?

Challenges include ventilator-associated pneumonia (VAP) due to low cuff pressure and tracheal injury due to high cuff pressure.

What is the value proposition of the iTraXS smart endotracheal tube?

iTraXS addresses the need to monitor and maintain appropriate cuff pressure to prevent VAP and tracheal injury, reducing healthcare costs and improving patient outcomes.

What are the key customer segments for iTraXS?

Key customer segments include anaesthetists, intensivists, and emergency medicine specialists, as well as procurement specialists and managers.

What are the key resources needed for iTraXS?

Key resources include physical (outsourced manufacturing), intellectual (patents, trademarks), human (talented people), and financial resources.

What are the key activities for iTraXS?

Key activities include designing, making, and delivering a new endotracheal tube that reduces VAP and tracheal injury.

What is the revenue model for iTraXS?

The revenue model could involve selling the whole system (monitoring unit + single-use ETTs) or a service model where the monitoring unit is provided for free, and customers pay for ETTs and support.

What is the current Technology Readiness Level (TRL) for iTraXS?

iTraXS is at TRL 5-6, having conducted animal and conscious human studies with a prototype device.

What are the main competitors for iTraXS?

The main competitors are Shiley-evac (Medtronic) and Pneux (Venner Medical).

What is the commercialization roadmap for iTraXS?

The roadmap includes developing a business plan, engaging with end-users, securing patents, and working with partners like P3 Medical for manufacturing and distribution.

What is the estimated time to market for iTraXS?

The time to market could be around 15 years due to the highly regulated nature of the medical device industry.

What is the Business Model Canvas?

The Business Model Canvas is a strategic tool that helps define a business model, including customer segments, value propositions, channels, customer relationships, revenue streams, key resources, key activities, key partnerships, and cost structure.

What is the purpose of Gate 2 in the Stage-Gate model?

Gate 2 is a second screen where the project is reviewed based on new information from Stage 1. It reassesses the customer wish list and checks if the project still meets "must meet" and "should meet" criteria.

What happens during Stage 2 (Definition) in the Stage-Gate model?

Stage 2 involves detailed market research, competitor analysis, IP analysis, financial analysis, and technical appraisal. It is the final stage before significant spending on product development.

What is the focus of Gate 4 (Post-Development Review)?

Gate 4 checks the progress and quality of work done in Stage 3 (Development). It reviews financial analysis and future marketing plans.

What activities occur during Stage 4 (Validation)?

Stage 4 involves in-house product tests, user trials, pilot production, and pretest market or trial sell activities to validate the product.

What is the purpose of Gate 5 (Pre-Commercialisation Decision)?

Gate 5 is the final decision point before commercialization. It focuses on the quality of the validation stage and reviews operating and marketing plans. It is the last chance to kill the project.

What happens during Stage 5 (Commercialisation)?

Stage 5 involves implementing the product launch plan, conducting a post-implementation review, and transitioning the product from a "new product" project to a regular product.

What is the key difference between sequential processing and parallel processing in the Stage-Gate model?

Sequential processing involves completing one task before passing it to the next team, while parallel processing involves multidisciplinary teams working on tasks simultaneously during each stage.

What are the deliverables at each gate in the Stage-Gate model?

Each gate requires a set of deliverables (e.g., market research, financial analysis, technical appraisal) that the project owner presents to senior managers for assessment.

What is the purpose of Gate 3 (Decision on Business Case)?

Gate 3 involves reviewing the "must meet" and "should meet" criteria, quality-checking the work done in Stage 2, and defining the Target Product Profile (performance specifications

What is the Target Product Profile (TPP) in the Stage-Gate model?

The TPP defines the performance specifications and requirements for the product, ensuring it meets customer needs and technical/economic feasibility.

What does TRL 1 represent?

TRL 1 represents the basic principles observed and reported. This is the earliest stage of technology development, where scientific research begins.

What does TRL 5 represent?

TRL 5 represents a technology that has been validated in a relevant environment (e.g., laboratory or simulated environment).

What does TRL 7 represent?

TRL 7 represents a technology that has been demonstrated in an operational environment, such as a prototype ready for testing in real-world conditions.

What is the significance of TRL 9?

TRL 9 represents a technology that has been proven to work in its final form and is ready for full commercial deployment.

What is the next step for iTraXS to move to TRL 6-7?

The next step is to conduct first-in-human studies to demonstrate the technology in an operational environment.

What is the relationship between TRL and the Stage-Gate model?

TRL is used to assess the maturity of a technology at each stage of the Stage-Gate model, helping decision-makers evaluate progress and readiness for the next stage.

What is the importance of TRL in the commercialization roadmap?

TRL helps track the progress of a technology from initial research (TRL 1) to full commercialization (TRL 9), ensuring that the technology is mature enough for each stage of development.

What is the difference between TRL 4 and TRL 6?

TRL 4 involves component validation in a laboratory environment, while TRL 6 involves system/subsystem model or prototype demonstration in a relevant environment.

What is the role of TRL in securing funding for new technologies?

RL helps investors and grant funders understand the maturity and risk level of a technology, making it easier to justify funding for further development.