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This free to attend event was held as part of the INSTILS programme –a project part‐funded by the European Regional Development Fund
27/06/2019
1
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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This free to attend event was held as part of the INSTILS programme –a project part‐funded by the European Regional Development Fund
27/06/2019
2
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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This free to attend event was held as part of the INSTILS programme –a project part‐funded by the European Regional Development Fund
27/06/2019
3
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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This free to attend event was held as part of the INSTILS programme –a project part‐funded by the European Regional Development Fund
27/06/2019
4
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
This free to attend event was held as part of the INSTILS programme –a project part‐funded by the European Regional Development Fund
27/06/2019
5
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
This free to attend event was held as part of the INSTILS programme –a project part‐funded by the European Regional Development Fund
27/06/2019
6
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
This free to attend event was held as part of the INSTILS programme –a project part‐funded by the European Regional Development Fund
27/06/2019
7
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
This free to attend event was held as part of the INSTILS programme –a project part‐funded by the European Regional Development Fund
27/06/2019
8
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
This free to attend event was held as part of the INSTILS programme –a project part‐funded by the European Regional Development Fund
27/06/2019
9
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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This free to attend event was held as part of the INSTILS programme –a project part‐funded by the European Regional Development Fund
27/06/2019
10
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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This free to attend event was held as part of the INSTILS programme –a project part‐funded by the European Regional Development Fund
27/06/2019
11
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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This free to attend event was held as part of the INSTILS programme –a project part‐funded by the European Regional Development Fund
27/06/2019
12
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
This free to attend event was held as part of the INSTILS programme –a project part‐funded by the European Regional Development Fund
27/06/2019
13
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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This free to attend event was held as part of the INSTILS programme –a project part‐funded by the European Regional Development Fund
27/06/2019
14
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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This free to attend event was held as part of the INSTILS programme –a project part‐funded by the European Regional Development Fund
27/06/2019
15
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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This free to attend event was held as part of the INSTILS programme –a project part‐funded by the European Regional Development Fund
27/06/2019
16
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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This free to attend event was held as part of the INSTILS programme –a project part‐funded by the European Regional Development Fund
27/06/2019
17
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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This free to attend event was held as part of the INSTILS programme –a project part‐funded by the European Regional Development Fund
27/06/2019
18
Surepulse CE Certificate – version 2 !
• PCBC, Warsaw, Poland
• Poland Notified Body partner to UL
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This free to attend event was held as part of the INSTILS programme –a project part‐funded by the European Regional Development Fund
27/06/2019
19
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
This free to attend event was held as part of the INSTILS programme –a project part‐funded by the European Regional Development Fund
27/06/2019
20
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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This free to attend event was held as part of the INSTILS programme –a project part‐funded by the European Regional Development Fund
27/06/2019
21
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
This free to attend event was held as part of the INSTILS programme –a project part‐funded by the European Regional Development Fund
27/06/2019
22
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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This free to attend event was held as part of the INSTILS programme –a project part‐funded by the European Regional Development Fund
27/06/2019
23
“Is Surepulse NHS Ready ” ? or “Are the NHS Ready for us ?”
Professor Barrie Hayes‐Gill
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