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Using the Lean Startup approach for the development of a medical imaging device
Theeraporn ThiramonthSupervisors: Madelen Lek, Sunton Wongsiri
Theeraporn Thiramonth 21 June 2016
Agenda
Background Aim and research question Delimitations Methods Ethical considerations Results Discussion Conclusion
Theeraporn Thiramonth 31 June 2016
Introduction
SuccessFailure
Marketing stage
Development stage
25% of new medical
devices• Outside market needs • Too late
Theeraporn Thiramonth 41 June 2016
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
Theeraporn Thiramonth 51 June 2016
Background – the Lean Startup approach
Ideas
Build
Product
Measure
Data
Learn
Minimum amount of efforts
• Pivot, or • Persevere
Theeraporn Thiramonth 61 June 2016
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
Theeraporn Thiramonth 71 June 2016
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?”
Theeraporn Thiramonth 81 June 2016
Delimitations
Focused on product development activites related to the Lean Startup approach
Class-I medical device
Theeraporn Thiramonth 91 June 2016
Methods
Theeraporn Thiramonth 101 June 2016
Ethical considerations
Forum of Ethical Review Committee in Thailand (FERCIT) Anonymity Information sheet Data consent
Theeraporn Thiramonth 111 June 2016
Results
Theeraporn Thiramonth 121 June 2016
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
Theeraporn Thiramonth 131 June 2016
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
Theeraporn Thiramonth 141 June 2016
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
Theeraporn Thiramonth 151 June 2016
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
Theeraporn Thiramonth 161 June 2016
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)
Theeraporn Thiramonth 171 June 2016
Discussion in relation to literature (2)
Similar approaches
PlanDo StudyAct
Plan-Do-Study-Act Human-centered design (ISO 13407)
Theeraporn Thiramonth 181 June 2016
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
Theeraporn Thiramonth 191 June 2016
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