Developing digital health innovations
Transkript
Developing digital health innovations
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. 0 / B_LIVE_EMEA1:3129010v1 Thank you Akil Benjamin akil@comuzi.xyz 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. 7 / B_LIVE_EMEA1:3129010v1 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 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. 16 / B_LIVE_EMEA1:3129010v1 Pitfalls in seeking investment Paolo Caldato Managing Associate Simmons & Simmons 11 November 2015 © Simmons & Simmons LLP 2015. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. 17 / B_LIVE_EMEA1:3129010v1 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? © Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. 18 / L_LIVE_EMEA1:29313452v1 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 © Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. 19 / L_LIVE_EMEA1:29313452v1 Doc ID: 16896258 A real-life example… © Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. 20 / L_LIVE_EMEA1:29313452v1 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 © Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. 21 / L_LIVE_EMEA1:29313452v1 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. © Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. 22 / L_LIVE_EMEA1:29313452v1 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. © Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. 23 / L_LIVE_EMEA1:29313452v1 Doc ID: 16896258 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. 24 / B_LIVE_EMEA1:3129010v1 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. © Simmons & Simmons LLP 2015. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. 25 / L_LIVE_EMEA2:-47v-1