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©2015 Pathfinder Software 1
Earlyvangelists and the Metrics that Matter:
Lean Startup in MedTech
Bernhard Kappe, Founder and President, Pathfinder Software
bkappe@pathf.com
©2014 Pathfinder Software 2
Connected
Device
Cloud
Algorithms
Data
Analytcs
Sensor and
Input Data
FeedbackData
Other Data
Source
Wearable
Sensors
Mobile + Web
Digital Solutions for Medical Devices and Pharma
©2014 Pathfinder Software
Applications
3
Continuous Monitoring
Continuously monitor physiological
measures, enabling “aging in place”
Early Detection/Prevention
Analysis of Monitoring Data to
provide early detection or prediction
of change in health status
Measure and Improve Therapies
Leverage sensors and portable
wireless devices to provide
augmented feedback in the home
Manage Chronic Conditions
Using data from sensors, diagnostics
and devices with other inputs to
enable better management
Improve Adherence
Monitor and provide feedback to
systems and participants
Perioperative Management
Pre and post operation monitoring and
feedback to improve outcomes
Behavior Change
Use feedback and interactions with
patients, caregivers and clinicians
©2015 Pathfinder Software
Agenda
1. Lean Startup 101
2. Lean Startup in Medtech
3. Medtech Ecosystem
4. Evidence
5. Earlyvangelists
6. Crossing the Chasm
©2015 Pathfinder Software
Lean Startup 101
©2015 Pathfinder Software
What we used to think
©2015 Pathfinder Software
All I Need to Do is Execute the Plan
©2015 Pathfinder Software
All I Need to Do is Make the Forecast
©2015 Pathfinder Software
Business Plan Makes First Contact With Customers
©2015 Pathfinder Software
No Business Plan Survives First Contact With Customers
©2015 Pathfinder Software
More startups fail from
a lack of customers than from a
failure of product development
©2015 Pathfinder Software
Lean Startup/Customer Development
©2015 Pathfinder Software
Lean Startup/Customer Development
©2015 Pathfinder Software
WhereAll Business Models Start
Guess
Guess
Guess
Guess
Guess
Guess
Guess Guess
Guess
Guess
Guess
Guess
Guess
©2015 Pathfinder Software
WhereWe Need to GetThem
Fact
Fact
Fact
Fact
Fact
Fact
Fact Fact
Fact
Fact
Fact
Fact
Fact
©2015 Pathfinder Software
©2015 Pathfinder Software 17
Build-Measure-Learn Loops
©2015 Pathfinder Software 18
©2015 Pathfinder Software
©2015 Pathfinder Software
Get Out of the Building
©2015 Pathfinder Software
Lean Startup
Companies have business models that need to be
executed.
Startups have business model hypotheses that
need to be validated.
Lean Startup reduces risk through rapid
hypothesis testing
Test hypotheses by getting out of the building
(Genchi Genbutsu)
Minimal Experiments
©2015 Pathfinder Software
Lean Startup in Healthcare
Part 3
©2015 Pathfinder Software
TraditionalCommercialization Process
Via Steveblank.com
©2015 Pathfinder Software
No Business Plan Survives First Contact With Customers
©2015 Pathfinder Software
Lean Startup: Parallel Processes
Via Steveblank.com
©2015 Pathfinder Software
Start with the Highest Risk Hypotheses
©2015 Pathfinder Software
The Healthcare Ecosystem
"Poster". Licensed
under Fair use via
Wikiversity -
http://en.wikiversity.or
g/wiki/File:Poster.gif#/
media/File:Poster.gif
©2015 Pathfinder Software
©2015 Pathfinder Software
©2015 Pathfinder Software
Healthcare Market Players
©2015 Pathfinder Software
Anatomy of Healthcare Delivery
Healthcatalyst.com
©2015 Pathfinder Software
©2015 Pathfinder Software
Healthcare/Life Sciences Startups
Therapeutics | Diagnostics | Medical Devices | Digital Health
They overlap, especially with Digital Health
Different customers, business models, funding and journeys
Often multisided markets with complex enterprise behavior
Conservative, risk averse industry
©2015 Pathfinder Software
What’s your evidence?
©2015 Pathfinder Software
Coverage and Reimbursement are Based on Evidence
CLINICAL UTILITY CONTINUES TO BE THE “STUMPER” IN TERMS OF EVIDENCE
Lifecycle
Stages
Technical Validation
How accurately and
reliably the m-health
intervention performs to
technical specifications
Clinical Validation
How consistently and
accurately the m-health
intervention detects or
predicts the intermediate
or final outcomes of
interest
Clinical Utility
How likely is it that the
m-health intervention will
cause clinicians to act in
a different (clinically
meaningful) way
Comparative
Effectiveness
Is the m-health
intervention more
clinically and cost
effective than other SOC
interventions?
High
LevelofClinical
AdoptionofTest
Low
Early M-health Maturity (Level of Evidence) Established
Real world clinical utility
documentation starts
Comparative effectiveness
analysis remains rate-limiting to
clinical and payer adoption
Investigational
SOC=Standard of Care
Intervention Commercially Available
Payer Involvement
REIMBURSEMENT
©2015 Pathfinder Software
Different Levels of Evidence
©2015 Pathfinder Software
Long Timelines
Medical Device
Digital Health
©2015 Pathfinder Software
Medical Device Challenges
©2015 Pathfinder Software
So are you screwed?
©2015 Pathfinder Software
Enter the Earlyvangelist
©2015 Pathfinder Software
Earlyvangelists
‱ They have a problem or need.
‱ They understand they have a problem.
‱ They’re actively searching for a solution
and have a timetable for finding it.
‱ The problem is so painful that they’ve
cobbled together an interim solution.
‱ They’ve committed, or can quickly
acquire, budget dollars to purchase.
©2015 Pathfinder Software
Approaching Earlyvangelists
‱ Sell the vision, deliver the minimum feature
set.
‱ They will stick with you through the bad and
give you feedback because they share your
vision.
‱ The minimum feature set is spec’d with
earlyvangelist interaction.
‱ Minimum feature set reduces engineering
waste and gets the product into the hands
of earlyvangelists soonest.
‱ They need an 18 to 36 month product vision
past the minimum feature set.
©2015 Pathfinder Software
Pain: Referral management is still paper based, with 25% leakage and lots of time spent by staff following up, lack of
visibility and transparency
Solution: Fibroblast is a referral management platform that fixes the broken referral process by empowering providers
with the tools they need to actively manage referrals. By closing the referral loop, Fibroblast eliminates network
leakage and maps referral patterns in real-time.
Initial Pilot: Cofounder’s own practice.
First (Paying) Customers: Small practices that already knew and trusted the co-founders.
‱ Why they bought: Had the pain and frustration, belief in the vision and trust in the founders.
‱ Users: Practice Staff, Patients
‱ Evidence collected: More inbound and outbound referrals, less time spent chasing down follow up = $
earned and saved. Patient satisfaction.
Later Customers: Large hospital systems ($1 billion+)
‱ Why they bought: Had the pain and frustration, saw the evidence collected, willing to believe the vision
for hospital systems.
‱ Users: Practice Staff, Patients, Hospital System admin staff
‱ Evidence collected/metrics that matter: Active users (at least one referral sent or accepted. Trends in
number of in-network referrals.
Next set of Customers: TBD
©2015 Pathfinder Software
Changing Customers in Medical Devices
First: Earlyvangelists, Research Docs, Pioneering
Hospital Systems, theVA?
Second: The FDA
Third: Key opinion leaders, CMS and Insurers?
Or: Acquirers Key Opinion Leaders
Fourth: Medical Device Companies (Acquirers)
©2015 Pathfinder Software
Climbing the Evidence Curve
©2015 Pathfinder Software
Filling the EvidenceTable
In the Beginning
I II III IV V
Metric 1
Metric 2
Metric 3
Metric 4

Awareness of Strengths and Weaknesses
©2015 Pathfinder Software
Filling the EvidenceTable
Tomorrow
I II III IV V
Metric 1
Metric 2
Metric 3
Metric 4

Focused on Strengths
©2015 Pathfinder Software
For each deal you do:
What evidence does this let us generate?
Who cares about that evidence?
©2015 Pathfinder Software
Crossing the Chasm
©2015 Pathfinder Software
Crossing the Chasm – Geoffrey Moore, 1991
©2015 Pathfinder Software
Where are the earlyvangelists?
©2015 Pathfinder Software
Where are the Earlyvangelists?
Where is there painful change happening in the industry?
(At risk contracts, payments bundling, 30 day readmissions, etc.)
Who is showing that they’re passionate about this?
(Leading Research Physicians, people who write, blog, talk at conferences, etc.)
Where is there competition?
(Interventional Cardiologists and Radiologists vs. Surgeons, Hospital System vs. Hospital System)
Who shows pioneering instincts in other areas (business models, technology adoption, etc.)
(Research Hospitals, Innovation groups, NIH,VA)
Who is not in a five sided market?
VA, Integrated providers, NIH
©2015 Pathfinder Software
Want More?
Read: Startup Owners Manual, Business Model Generation,Value
Proposition Design
Browse: steveblank.com/category/life-sciences-nih/
Attend: Chicago Lean Startup Circle – next meeting April
22nd: Khan Siddiqui of HIGI
Participate: Lean Startup Challenge/Healthcare Lean Startup
Challenge
Do: Get out of the building. Talk to 10 customers next week.
©2015 Pathfinder Software
Start with the Highest Risk Hypotheses
©2015 Pathfinder Software
Regulatory
IP
Reimbursement
Clinical Trials
Proving claims about
costs/outcomes is
hard, long and
expensive
Clinical Trials.
Quality Management
Compelling Clinical
Need – dramatic
outcomes difference
Create demand and
drive it to channel –
SABs, KOLs,
conferences, articles,
etc.
Who is the patient type
for whom it would be
malpractice not to use
your device?
Direct Sales: Sales
person + clinical
application
specialist
Sales to Acquirers
KOLs
Proving claims – trials and data
Development under FDA regulations
Sales - $500,000 per salesperson, 6 to 9 months to
Revenue
Quality Processes
Canonical BMC for Medical Devices
Improve or match
clinical outcomes and
reduce price
When do you reduce
costs? - Day one?
Length of Stay?
Fewer
Reospitalizations?Cou
rse of therapy or
condition?
Flip or Swing for the
fences?
Physician: Device User
Follow the money!
Acquirers – long term
customers
Hospital: Economic
Buyer
Payer: Keep Costs
Down – what gets
purchased
Regulator: what can be
legally sold
Regulatory
IP
Reimbursement
Clinical Trials
Quality
Management
Design & Dev
Sale of Product, Per Procedure, Rental, Licensing,
Value based > cost based, recurring > one time
Medicare and medicaid must get the lowest price you charge any
customer.
Prices rarely go up.
Reimbursement often bounds pricing (unless new market)
©2015 Pathfinder Software 57
http://pathfindersoftware.com
T: 877.548.7248 F: 312.803.1941
bkappe@pathf.com
Accelerating Innovation
©2015 Pathfinder Software
Regulatory
IP
Some folks on the
in early customer
segments
Platform players
Proving claims about
costs/outcomes is
hard, long and
expensive.
Development,
Marketing, Sales
Can be like medical
device
- Sales, IP
Can be like medical
device or
consumer/enterprise
product
Pateint: Device User
Direct – to
enterprise and/or to
end consumer
Potential digital
channels
Revenue Strategy + Pricing Tactics
Fixed or Dynamic – value based > cost based
Subscription based on number of users +
Market Type: Existing, Resegmented, New
CAC
Development
Canonical BMC for Digital Health
Improve or match
clinical outcomes and
reduce price
When do you reduce
costs? - Day one?
Length of Stay?
Fewer
Reospitalizations?Cou
rse of therapy or
condition?
Flip or Swing for the
fences?
Physician: Device
User
Producer – maintain
price and margin
Hospital: Economic
Buyer
Payor: Keep Costs
Down – what gets
purchased
Regulator: what can be
legally sold
Employer: Economic
Buyer
©2015 Pathfinder Software
Customer Interviews
Early and often
At least 10 per new hypothesis
More segments = more interviews
Don’t skip steps – value prop and customer
segments first.
Five whys, contextual enquiry, ranking,
referrals
©2015 Pathfinder Software
Minimal Experiments
Medical Device Regulations –Yes or No?
No – Concierge mvps, test marketing sites, a/b
testing in production are all fair game.
Yes – feasibility, prototyping, human factors
testing, IRBs, trials, Development under design
controls. No marketing until clearance (class II).
Yes and No – do careful risk segmentation.
©2015 Pathfinder Software
Medical Device Investment Readiness Level
©2015 Pathfinder Software
Digital Health Investment Readiness
Level

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Earlyvangelists and the Metrics that Matter in Healthcare

  • 1. ©2015 Pathfinder Software 1 Earlyvangelists and the Metrics that Matter: Lean Startup in MedTech Bernhard Kappe, Founder and President, Pathfinder Software bkappe@pathf.com
  • 2. ©2014 Pathfinder Software 2 Connected Device Cloud Algorithms Data Analytcs Sensor and Input Data FeedbackData Other Data Source Wearable Sensors Mobile + Web Digital Solutions for Medical Devices and Pharma
  • 3. ©2014 Pathfinder Software Applications 3 Continuous Monitoring Continuously monitor physiological measures, enabling “aging in place” Early Detection/Prevention Analysis of Monitoring Data to provide early detection or prediction of change in health status Measure and Improve Therapies Leverage sensors and portable wireless devices to provide augmented feedback in the home Manage Chronic Conditions Using data from sensors, diagnostics and devices with other inputs to enable better management Improve Adherence Monitor and provide feedback to systems and participants Perioperative Management Pre and post operation monitoring and feedback to improve outcomes Behavior Change Use feedback and interactions with patients, caregivers and clinicians
  • 4. ©2015 Pathfinder Software Agenda 1. Lean Startup 101 2. Lean Startup in Medtech 3. Medtech Ecosystem 4. Evidence 5. Earlyvangelists 6. Crossing the Chasm
  • 7. ©2015 Pathfinder Software All I Need to Do is Execute the Plan
  • 8. ©2015 Pathfinder Software All I Need to Do is Make the Forecast
  • 9. ©2015 Pathfinder Software Business Plan Makes First Contact With Customers
  • 10. ©2015 Pathfinder Software No Business Plan Survives First Contact With Customers
  • 11. ©2015 Pathfinder Software More startups fail from a lack of customers than from a failure of product development
  • 12. ©2015 Pathfinder Software Lean Startup/Customer Development
  • 13. ©2015 Pathfinder Software Lean Startup/Customer Development
  • 14. ©2015 Pathfinder Software WhereAll Business Models Start Guess Guess Guess Guess Guess Guess Guess Guess Guess Guess Guess Guess Guess
  • 15. ©2015 Pathfinder Software WhereWe Need to GetThem Fact Fact Fact Fact Fact Fact Fact Fact Fact Fact Fact Fact Fact
  • 17. ©2015 Pathfinder Software 17 Build-Measure-Learn Loops
  • 20. ©2015 Pathfinder Software Get Out of the Building
  • 21. ©2015 Pathfinder Software Lean Startup Companies have business models that need to be executed. Startups have business model hypotheses that need to be validated. Lean Startup reduces risk through rapid hypothesis testing Test hypotheses by getting out of the building (Genchi Genbutsu) Minimal Experiments
  • 22. ©2015 Pathfinder Software Lean Startup in Healthcare Part 3
  • 24. ©2015 Pathfinder Software No Business Plan Survives First Contact With Customers
  • 25. ©2015 Pathfinder Software Lean Startup: Parallel Processes Via Steveblank.com
  • 26. ©2015 Pathfinder Software Start with the Highest Risk Hypotheses
  • 27. ©2015 Pathfinder Software The Healthcare Ecosystem "Poster". Licensed under Fair use via Wikiversity - http://en.wikiversity.or g/wiki/File:Poster.gif#/ media/File:Poster.gif
  • 31. ©2015 Pathfinder Software Anatomy of Healthcare Delivery Healthcatalyst.com
  • 33. ©2015 Pathfinder Software Healthcare/Life Sciences Startups Therapeutics | Diagnostics | Medical Devices | Digital Health They overlap, especially with Digital Health Different customers, business models, funding and journeys Often multisided markets with complex enterprise behavior Conservative, risk averse industry
  • 36. Coverage and Reimbursement are Based on Evidence CLINICAL UTILITY CONTINUES TO BE THE “STUMPER” IN TERMS OF EVIDENCE Lifecycle Stages Technical Validation How accurately and reliably the m-health intervention performs to technical specifications Clinical Validation How consistently and accurately the m-health intervention detects or predicts the intermediate or final outcomes of interest Clinical Utility How likely is it that the m-health intervention will cause clinicians to act in a different (clinically meaningful) way Comparative Effectiveness Is the m-health intervention more clinically and cost effective than other SOC interventions? High LevelofClinical AdoptionofTest Low Early M-health Maturity (Level of Evidence) Established Real world clinical utility documentation starts Comparative effectiveness analysis remains rate-limiting to clinical and payer adoption Investigational SOC=Standard of Care Intervention Commercially Available Payer Involvement REIMBURSEMENT
  • 38. ©2015 Pathfinder Software Long Timelines Medical Device Digital Health
  • 42. ©2015 Pathfinder Software Earlyvangelists ‱ They have a problem or need. ‱ They understand they have a problem. ‱ They’re actively searching for a solution and have a timetable for finding it. ‱ The problem is so painful that they’ve cobbled together an interim solution. ‱ They’ve committed, or can quickly acquire, budget dollars to purchase.
  • 43. ©2015 Pathfinder Software Approaching Earlyvangelists ‱ Sell the vision, deliver the minimum feature set. ‱ They will stick with you through the bad and give you feedback because they share your vision. ‱ The minimum feature set is spec’d with earlyvangelist interaction. ‱ Minimum feature set reduces engineering waste and gets the product into the hands of earlyvangelists soonest. ‱ They need an 18 to 36 month product vision past the minimum feature set.
  • 44. ©2015 Pathfinder Software Pain: Referral management is still paper based, with 25% leakage and lots of time spent by staff following up, lack of visibility and transparency Solution: Fibroblast is a referral management platform that fixes the broken referral process by empowering providers with the tools they need to actively manage referrals. By closing the referral loop, Fibroblast eliminates network leakage and maps referral patterns in real-time. Initial Pilot: Cofounder’s own practice. First (Paying) Customers: Small practices that already knew and trusted the co-founders. ‱ Why they bought: Had the pain and frustration, belief in the vision and trust in the founders. ‱ Users: Practice Staff, Patients ‱ Evidence collected: More inbound and outbound referrals, less time spent chasing down follow up = $ earned and saved. Patient satisfaction. Later Customers: Large hospital systems ($1 billion+) ‱ Why they bought: Had the pain and frustration, saw the evidence collected, willing to believe the vision for hospital systems. ‱ Users: Practice Staff, Patients, Hospital System admin staff ‱ Evidence collected/metrics that matter: Active users (at least one referral sent or accepted. Trends in number of in-network referrals. Next set of Customers: TBD
  • 45. ©2015 Pathfinder Software Changing Customers in Medical Devices First: Earlyvangelists, Research Docs, Pioneering Hospital Systems, theVA? Second: The FDA Third: Key opinion leaders, CMS and Insurers? Or: Acquirers Key Opinion Leaders Fourth: Medical Device Companies (Acquirers)
  • 47. ©2015 Pathfinder Software Filling the EvidenceTable
In the Beginning I II III IV V Metric 1 Metric 2 Metric 3 Metric 4 
Awareness of Strengths and Weaknesses
  • 48. ©2015 Pathfinder Software Filling the EvidenceTable
Tomorrow I II III IV V Metric 1 Metric 2 Metric 3 Metric 4 
Focused on Strengths
  • 49. ©2015 Pathfinder Software For each deal you do: What evidence does this let us generate? Who cares about that evidence?
  • 51. ©2015 Pathfinder Software Crossing the Chasm – Geoffrey Moore, 1991
  • 52. ©2015 Pathfinder Software Where are the earlyvangelists?
  • 53. ©2015 Pathfinder Software Where are the Earlyvangelists? Where is there painful change happening in the industry? (At risk contracts, payments bundling, 30 day readmissions, etc.) Who is showing that they’re passionate about this? (Leading Research Physicians, people who write, blog, talk at conferences, etc.) Where is there competition? (Interventional Cardiologists and Radiologists vs. Surgeons, Hospital System vs. Hospital System) Who shows pioneering instincts in other areas (business models, technology adoption, etc.) (Research Hospitals, Innovation groups, NIH,VA) Who is not in a five sided market? VA, Integrated providers, NIH
  • 54. ©2015 Pathfinder Software Want More? Read: Startup Owners Manual, Business Model Generation,Value Proposition Design Browse: steveblank.com/category/life-sciences-nih/ Attend: Chicago Lean Startup Circle – next meeting April 22nd: Khan Siddiqui of HIGI Participate: Lean Startup Challenge/Healthcare Lean Startup Challenge Do: Get out of the building. Talk to 10 customers next week.
  • 55. ©2015 Pathfinder Software Start with the Highest Risk Hypotheses
  • 56. ©2015 Pathfinder Software Regulatory IP Reimbursement Clinical Trials Proving claims about costs/outcomes is hard, long and expensive Clinical Trials. Quality Management Compelling Clinical Need – dramatic outcomes difference Create demand and drive it to channel – SABs, KOLs, conferences, articles, etc. Who is the patient type for whom it would be malpractice not to use your device? Direct Sales: Sales person + clinical application specialist Sales to Acquirers KOLs Proving claims – trials and data Development under FDA regulations Sales - $500,000 per salesperson, 6 to 9 months to Revenue Quality Processes Canonical BMC for Medical Devices Improve or match clinical outcomes and reduce price When do you reduce costs? - Day one? Length of Stay? Fewer Reospitalizations?Cou rse of therapy or condition? Flip or Swing for the fences? Physician: Device User Follow the money! Acquirers – long term customers Hospital: Economic Buyer Payer: Keep Costs Down – what gets purchased Regulator: what can be legally sold Regulatory IP Reimbursement Clinical Trials Quality Management Design & Dev Sale of Product, Per Procedure, Rental, Licensing, Value based > cost based, recurring > one time Medicare and medicaid must get the lowest price you charge any customer. Prices rarely go up. Reimbursement often bounds pricing (unless new market)
  • 57. ©2015 Pathfinder Software 57 http://pathfindersoftware.com T: 877.548.7248 F: 312.803.1941 bkappe@pathf.com Accelerating Innovation
  • 58. ©2015 Pathfinder Software Regulatory IP Some folks on the in early customer segments Platform players Proving claims about costs/outcomes is hard, long and expensive. Development, Marketing, Sales Can be like medical device - Sales, IP Can be like medical device or consumer/enterprise product Pateint: Device User Direct – to enterprise and/or to end consumer Potential digital channels Revenue Strategy + Pricing Tactics Fixed or Dynamic – value based > cost based Subscription based on number of users + Market Type: Existing, Resegmented, New CAC Development Canonical BMC for Digital Health Improve or match clinical outcomes and reduce price When do you reduce costs? - Day one? Length of Stay? Fewer Reospitalizations?Cou rse of therapy or condition? Flip or Swing for the fences? Physician: Device User Producer – maintain price and margin Hospital: Economic Buyer Payor: Keep Costs Down – what gets purchased Regulator: what can be legally sold Employer: Economic Buyer
  • 59. ©2015 Pathfinder Software Customer Interviews Early and often At least 10 per new hypothesis More segments = more interviews Don’t skip steps – value prop and customer segments first. Five whys, contextual enquiry, ranking, referrals
  • 60. ©2015 Pathfinder Software Minimal Experiments Medical Device Regulations –Yes or No? No – Concierge mvps, test marketing sites, a/b testing in production are all fair game. Yes – feasibility, prototyping, human factors testing, IRBs, trials, Development under design controls. No marketing until clearance (class II). Yes and No – do careful risk segmentation.
  • 61. ©2015 Pathfinder Software Medical Device Investment Readiness Level
  • 62. ©2015 Pathfinder Software Digital Health Investment Readiness Level