Developing digital health innovations

Transkript

Developing digital health
innovations
Organisers:
Dr Adesina Iluyemi, Healthtronics
Consulting
Paolo Caldato, Simmons &
Simmons LLP
© Simmons & Simmons LLP 2015. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
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Thank you
Akil Benjamin
[email protected]
innovations
Organisers:
Consulting
Simmons LLP
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Medical Devices for the 21st Century
Digital / Data-driven / Disruptive
A Journey……….
Keith Errey
CEO
Isansys Lifecare Limited
8
A New Kind of Healthcare Business
Medical Devices
Combining
Clinical
Services
Healthcare IT/
Big Data
Data & Information Business
9
The
Problem
Wasteful & Unnecessary
10
The Solution:
Patient Status Engine
Measure
Model
Vital signs &
biomarkers
Patient
Predict
Actions
Patient
Status
Clinician / Carer
Real Time Patient Data
Acquisition and Analysis Platform
11
Typical Med-Tech Development Phases
Phase
Strategic Goal
Key Actions
Key
Requirements
Time
Scales
Isansys
Status
1
Demonstrate
working device.
Develop idea.
Build prototype
Raise funds and
manage funders
3–4
years
Not
Necessary
2
Establish clinical
viability of devices,
methods and data
Engage clinicians.
Proof of Concept
studies.
Minimum viable
product. (PSE 1)
Regulatory
Approvals.
3-4
years
Completed
3
Establish economic
viability of system
and strategic /
statutory necessity
Engage providers.
At-scale test
deployments to
provide evidence.
Complete system
(PSE 2)
Compliance
processes
3-4
years
In progress
4
Provide operating
income and ROI for
investors
Deliver products
and services via
direct and indirect
sales channels.
Sales and logistic
functions. Working
capital.
3 years
and
beyond
Starting
2016
Isansys
12
Engaging Clinicians
• Built a product that was innovative but useful for clinical
teams without requiring a whole new pathway or work flow.
• Dialogued with as many doctors and nurses as possible. Built
first generation Patient Status Engine as a Minimum Viable
Product.
First gen Lifetouch
Wireless ECG sensor
Innovate UK
Smart Award
First gen PSE wireless
monitoring system in a box
• Focus on hospitals and patients on critical care pathways
• Maintain our lean “Disappearing Device” design strategy
throughout
13
Engaging Providers
• First generation PSE provided
proof of concept and useful data
for clinical teams
• Angel Finding
• SBRI Phase 1 and Phase 2
contracts
• Wellcome / DoH funds
for at scale deployment
Second generation PSE
Networked, scalable, accurate,
robust continuous patient data
14
Current PSE Implementations /
Contracts – Engaging Payers
£1 million funding from SBRI Healthcare to scale
technology to manage every patient in hospital and
extend to home care. Several locations.
Follow on from two Phase 1 projects
Healthcare - @home PSE acute
deterioration in cancer patients (sepsis).
At-scale deployment for early
detection of deterioration in
paediatric patients.
Hyderabad,
India
Early detection of deterioration in
advanced liver disease patients.
Kerala Institute of
Medical Sciences
Trivandrum,
India
15
innovations
Organisers:
Consulting
Simmons LLP
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Pitfalls in seeking investment
Paolo Caldato
Managing Associate
Simmons & Simmons
11 November 2015
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Introduction – misrepresentation
Selling your business over-zealously
 Early-stage business characteristics
–
Cash-poor
–
Directors’ loans
–
“Off-balance sheet” liabilities
–
Other undisclosed factors (e.g. IP difficulties, technology challenges etc.)
 If investors/other sources of funding are not expressly told about such issues,
can they discover them for themselves?
 Should they have to?
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Doc ID: 16896258
Misrepresentation
“If only I’d known, I would not have invested…”
 Representation of fact (statement, omission, conduct)
 Made with the intention that it be relied upon by the investor
 Investor does in fact rely on it
 Statement is untrue
 Investor suffers a loss as a result
 If statement is known to be untrue when it is made, that is fraud
 Remedies for misrepresentation can include rescission of contract and/or
damages
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Doc ID: 16896258
A real-life example…
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Doc ID: 16896258
What can I do to reduce my exposure?
Contractual methods
 Limitation/exclusion clauses
 Liability caps
 Non-reliance statements/“entire agreement” clauses
 You can never exclude/limit liability for fraud
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Doc ID: 16896258
What can I do to reduce my exposure? (continued)
Non-contractual methods
 Ask yourself searching questions
 Tell proposed investors the true position
 Establish a paper-trail
–
Meeting/call minutes
–
Briefing notes, e-mails
 Ensure that the paper-trail is preserved
–
Capture/store paperwork
–
Back up e-mails
–
Documents on tablets/smartphones etc.
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Doc ID: 16896258
Conclusion and questions
Where can I find out more?
 Elexica, Simmons & Simmons’s award-winning
free online legal resource
Questions?
“Life is too precious to be
spent in this weaving and
unweaving of false
impressions…”
1856 Letter to Mrs Peter Taylor, 08
June. Collected in G S Haight (ed) The
George Eliot Letters (1954), vol.2.
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Doc ID: 16896258
innovations
Organisers:
Consulting
Simmons LLP
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simmons-simmons.com
elexica.com
This document is for general guidance only. It does not contain definitive advice. SIMMONS & SIMMONS and S&S are registered trade marks of Simmons & Simmons LLP. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated practices.
Accordingly, references to Simmons & Simmons mean Simmons & Simmons LLP and the other partnerships and other entities or practices authorised to use the name “Simmons & Simmons” or one or more of those practices as the context requires. The word “partner” refers to a member of
Simmons & Simmons LLP or an employee or consultant with equivalent standing and qualifications or to an individual with equivalent status in one of Simmons & Simmons LLP’s affiliated practices. For further information on the international entities and practices, refer to simmonssimmons.com/legalresp. Simmons & Simmons LLP is a limited liability partnership registered in England & Wales with number OC352713 and with its registered office at CityPoint, One Ropemaker Street, London EC2Y 9SS. It is authorised and regulated by the Solicitors Regulation Authority.
A list of members and other partners together with their professional qualifications is available for inspection at the above address.
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Developing digital health innovations

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