Using the Lean Startup approach for the development of a medical imaging device

Theeraporn ThiramonthSupervisors: Madelen Lek, Sunton Wongsiri

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Agenda

Background Aim and research question Delimitations Methods Ethical considerations Results Discussion Conclusion

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Introduction

SuccessFailure

Marketing stage

Development stage

25% of new medical

devices• Outside market needs • Too late

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Background – product development

Idea generation Concept evaluation Feasibility testing Product definition Design development

Prototyping Confirmative testing Pilot production Production Launch and follow-up

Idea Productlaunch

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Background – the Lean Startup approach

Ideas

Build

Product

Measure

Data

Learn

Minimum amount of efforts

• Pivot, or • Persevere

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Background – a medical imaging device

A 3D foot scanner Generate 3D models Measure anatomical dimensions (e.g. length, width)

Class-I medical device (EC Directive 93/42/EEC) Non-invasive device Only contact intact skin Active device without emission of ionizing

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Aim and research question

Aim To implement the Lean Startup approach for developing

a medical imaging device To find out the advantages and disadvantages of using

the Build-Measure-Learn feedback loop

Research question“What are the advantages and disadvantages of employing

Lean Startup’s Build-Measure-Learn feedback loop on medical imaging device development?”

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Delimitations

Focused on product development activites related to the Lean Startup approach

Class-I medical device

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Methods

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Ethical considerations

Forum of Ethical Review Committee in Thailand (FERCIT) Anonymity Information sheet Data consent

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Results

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Results – preliminary market research

Market research Unmet needs

Professional users: physicians, physical therapist and podiatrists Customers: healthy people, patients with foot problems

Technology feasibility The trend of 3D modeling grew up

Freedom-to-operate analysis License of using Software Development Kit (SDK)

Competitor search More than 10 existed customers worldwide Heavy, higher price

The most important stage

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Results – Build-Measure-Learn

Build phase Two monthes, two engineers, US$300 (one system) The simplest and cheapest plan was chosen to build an MVP

Measure phase Satisfying prototype More necessary features

Learn phase Persevere

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Results – advantages of using Lean Startup

The ability to identify unmet needs The reduction of resource expenditures

time, cost, human resource The opportunity to introduce the new product to potential

customers

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Results – disadvantages of using Lean Startup

The biased findings of customer perspectives The disappointment due to unsatisfying product

Outside market needs Uncomfortable ergonomics

The reveal of venture idea to competitors

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Discussion in relation to literature

The Lean Startup Speed up the development process, the least time consume

Entering the Build phase as soon as possible Create a better product

User involvement Classification of users: end users, professional users Early stage - identyfying unmet needs Development stage - giving feedback Related standards:

ISO 13407: Human-centered design processes for interactive systems ISO 9241-11: Ergonomic requirements for office work with visual

display terminals (VDTs)

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Discussion in relation to literature (2)

Similar approaches

PlanDo StudyAct

Plan-Do-Study-Act Human-centered design (ISO 13407)

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Discussion – strengths and limitations

Strengths Real situations were observed as a case study (in-depth analysis) Data triangulation was used to validate the reliability of the findings

Limitations The studied company had no experience in using Lean Startup

approach before The data was only collected from the product development team

regarding one iteration of Build-Measure-Learn Interview transcriptions and content analysis were done manaually

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Conclusion

The Lean Startup’s Build-Measure-Learn was suitable for developing Class-I medical devices Identifying unmet needs form user perspectives Reduce resource usage Reduce the risk of market entry failure

Thank you

1 June 2016Theeraporn Thiramonth 20