“A Journey from Bench to Cot‐side”...Nottingham) •2008: CE Awarded ‐MDD93/42 – ......

This free to attend event was held as part of the INSTILS programme –a project part‐funded by the European Regional Development Fund

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A joint venture between

A 16 year journey to CE

“Every Second Counts”

Professor Barrie Hayes‐GillUniversity of Nottingham

Surepulse Medical (RELEASE)

“A Journey from Bench to Cot‐side”

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Content• University Research

• Monica Healthcare – brief Case Study– The KE model

– Clinical Engineering interaction

• Surepulse Medical Ltd Case Study– Same KE model ….Clinical Engineering interaction

– Research and Commercial funding

– Company Operation, Hospital engagement

• Summary lessons

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Background ‐ Medical Devices Research

• Faculty of Engineering, UoN

• Electronic Engineering Medical devices, such as: Laser Doppler Blood Flow cameras

Capillary refill measurement

Heart rate recorders

Fetal Monitors, etc

• Monica Healthcare Ltd

• REF – University league Tables– Impact is now 25%

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Background – Monica HealthcareFetal Heart Rate and Contraction Monitor:

• 1990: PhD researchers – working with QMC/City H– Clinical Eng , BS5724 shock ! Red LEDs

– Early recordings feasibility

• 1996: Action Medical Grant ‐ £75K– QMC Clinical Engineering safety check

• Filed 2 patents in 1999 and 2002– 500 recordings

• 2005: Monica Healthcare Ltd4


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Background – Monica Healthcare Cont. • 2006: Pre compliance testing

– Electrical safety & EMC (Clinical Eng)

• 2007: Clinical Trials– Study in Utrecht, Holland (City H back up, Nottingham)

• 2008: CE Awarded ‐ MDD93/42 –FHR/Contractions

• 2011: 9 patents in place

• 2012: FDA 510k Approval – USA Hosp.

• 2015: GEHC distributor5


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Monica Healthcare Commercial Model • 1990 – 2017

– PhD Researchers and Research Grants

– Regulatory – Clinical Engineering, pre‐compliance testing

– Hospital Access – Clinical Engineering and Ethics

– Underpinned by Intellectual Property & great team !

–World sales of Fetal Monitoring Product

• Proven successful model

• We hope Surepulse will be a similar story ……6


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Now ……Surepulse Medical Ltd• Surepulse Medical Ltd

– 10% of all births require some form of resuscitation

– Heart Rate (HR) is the best indicator of stabilisation

– Currently use stethoscope ‐ 10 seconds

– Loss of time and errors affects management

– We have developed an optical HR device inside a newborncap

– Spin out, 9 employees ‐ based in Medicity

– 2019: CE Awarded MDD93/42

• Developed again from our research lab benches at UoN

S h did t t thi iti ?7


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Surepulse – Early days• 2003 ‐2006: EPSRC PhD CASE Award with Rio Tinto

• Physiological monitoring using Personal Protective Equipment (PPE)

• Heat stress (hard hat):– Temperature/Humidity

– Heart Rate (HR)• Using optical detector

• 2006: Patent 1 & 2 filed8


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Surepulse – Miners to Minors• 2006: Hard hat Presentation to QMC – John Crowe

• Moved from Hard Hats to Soft caps

• Newborn baby monitoring

• Miners to Minors !

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Surepulse – Newborns• 2007‐11: Two large grants Newborns

– 2007‐09: Action Medical Grant

– 2009‐11: MRC DPFS grant

– Dr Don Sharkey, School of Medicine

• Modified Monica CE AN24 Device

– Faster route into hospital

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Surepulse ‐ Newborns• Monica Experience of MDD 93/42

– Essential Requirements, Elec Safety: 60601‐1

– EMC 60601‐1‐2: (Anechoic Chamber)

– 10993 Biocomp, 14971 Risk Assess ..

• Clinical Eng (trolley) & ethics sign off

• 2012: Published Results

• Demonstrated device works in newborns

PPA(cf to ECG +/‐10 bpm)

RMSE (cf to ECG)

95% 5.7 bpm

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MHRA: 2007 ‐ 2011 • MHRA – Bulletin 18

– “Proposed study falls under exemptions for healthcare establishments”

– “….. A device developed within healthcare establishment and trialled within same establishment.”

– “ …. No intention to commercialise device at this stage hence approval from MHRA not required.”

– “ … Healthcare establishment required to take full liability for use of device.”

• UoN Insurance– excludes children !– amendment “CE like”

• Fortunate: Technical file Clinical Engineering12


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Surepulse ‐ Company Set Up • 2012 ‐2014: Commercial funding search

• James Carpenter – PhD in writing up year, CEO ?

• …..but working capital required

• Small “tick‐over” grants:– UoN Internal IAA/KTS awards ‐ ~£25K

• 2012: KTP Hard hats ‐ Tioga, Derby (Monica Man.)

• 2013: Set up Joint Venture (£50K + £50K) between:

• 2014: HEARTLIGHT SYSTEMS LTD created.

+

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Innovate UK BMC Award – CE Trial• 2014‐17: Surepulse lead on Innovate UK BMC award

– £1.7M Innovate UK Award (SPM, Tioga & UoN)• Changed Headband to Cap

• Smaller sensor and electronics module

• Wireless BT

– 114 Newborns (N~350 )

– Now a commercial venture• MHRA involved – required near detailed CE technical file + £4.5K

• Monica experience again very useful

– 2014: CHEATA – Centre Healthcare Equipment And Technology Adoption• From “Clinical Engineering” UoN Hospitals

• Electrical safety, EMC, biocompatibility, risk assessment etc…

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April 2017 – Innovate UK Trial completed

NICU (n=10,393)

Delivery Room (n=1,180)

ACCURACY(RMSE) 2.7bpm 4.2bpm

RELIABILITY(PPA) 99.6% 98.4%

Results analysed:

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Improving Patient Outcomes

Short Term Long Term Litigation

NeonatalIntensive Care cost ~£1,200 /patient /day

Cerebral Palsy – lifetime cost ~£20mn

£2.2bn payouts by NHS Resolution 2017/8 (30% up on 2016/7)

• Accurate and reliable HR• Reduce errors in HR • Decrease HR acquisition time• Instrumented cap with CPAP and Intubation fittings• Improve short‐term and long‐term outcomes and reduce hospital stays

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2017: CE MDD 93/42 Submission• Final device:

• October 2017: Submitted CE technical file to Notified Body– Reduction in NBs, MHRA rules, independent clinician, BREXIT !

• 16 months later Jan 2019: CE Awarded !

CapDisplay

Modules

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Surepulse CE Certificate – version 2 !

• PCBC, Warsaw, Poland

• Poland Notified Body partner to UL

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Are we now NHS ready ?• We now have CE approval

• So the rest should be easy ? … just poll up at any NHS hospital !

• Not so easy – required significantly more evidence– Published results – latest paper nearly completed

– Value Proposition – CHEATA, draft report completed

– Seeking Reference site ….

– Fill out as many forms as there are hospitals !

– Very busy NHS staff with no extra capacity and risk averse

• But our burn rate is high !

• Hence, we are now in Europe and FDA USA ....19


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Surviving as a UK Company in Med Tech• All eggs in one NHS basket ?

– Not a smart move commercially !

– Require reference sites but explore different country models

• We have now gone to EU ……– Distributors

• 4 signed up (Sp, Austria, Swed, Norway) & 2 discussions (Holland, Fr) (+1 UK)

– Hospitals• 5 live reference Sites: Gothenburg, Halmstad, Copenhagan, Madrid (x2)

• 2 agreed and 6 In early discussion (4 UK)

• Start FDA 510k (USA) approval process early– 2015: FDA Pre‐submission route (Innovate UK)

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What have we learned?• Monica and Surepulse models are very similar

– Early stage Development (PhDs and Grants)

– Clinical Trial records

– MDD 93/42 knowledge essential

– Interaction with Clinical Engineering (CHEATA) vital

– IP protection necessary

– Seek Commercial Funding partners

– CE Application underpinned by Research Applications

– Market penetration (CE part + research device)

– Look at UK, EU, USA and wider ….21


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Closing Summary of Surepulse• 10% of newborns need some form of Resuscitation. HR is best indicator of success

• Surepulse: Fast, reliable and accurate HR at birthUnderpinned by 4 patents

• Safety & Regulatory support by CHEATA • Company must take part in CE MDD93/42 process

• Explore other territories not just NHS UK

• We now have our CE mark

• So I will leave you with this question…………

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“Is Surepulse NHS Ready ” ? or “Are the NHS Ready for us ?”

Professor Barrie Hayes‐Gill

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“A Journey from Bench to Cot‐side”...Nottingham) •2008: CE Awarded ‐MDD93/42 – ......

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