Post on 11-Nov-2015
description
Neonatology/Biomedical Optics Research Laboratory
5/12/2015 Page 1
Health Monitoring
Prof. Martin Wolf
Biomedical Optics Research Laboratory
Clinical Research Priority Program Tumor Oxygenation
Department of Neonatology
University Hospital Zurich
Neonatology/Biomedical Optics Research Laboratory
What does the patient need?
Human beings consist of mind, soul and body Mind/spirit: Thinking, speaking, reasoning (e.g. science):
Autonomy, responsibility, decision making, planning
Soul: Feeling, like, dislike: Well-being, freedom of adverse feelings (pain), safety, privacy
Body: Visible, physical part: Integrity, ability to move, support and therapy in case of physiological
disorder
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Neonatology/Biomedical Optics Research Laboratory
What does the physician need?
Cares mostly about the body and needs:
Diagnostic information Reliable Accurate Timely Relevant
Treatment decision
Implement therapy:
EBM is the integration of clinical expertise, patients preference, and the best available evidence into the decision making process for patient care. (DL Sackett et al. BMC 1996; 312:71-2)
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Neonatology/Biomedical Optics Research Laboratory
What do the regulatory bodies need?
Documents to prove that everything is legal:
Compliance with norms (e.g. ISO)
Risk analysis
CE mark or notification to Swissmedic
Research: Approval of ethical committee
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Neonatology/Biomedical Optics Research Laboratory
What does the engineer/scientist need?
Motivation to help the patient
Clinically relevant aim
Knowledge in physiology
An idea how to address the aim
Specifications for the device
Thorough risk analysis
Ability to implement the device
Strong perseverance to complete all the paperwork (legalese)
Close contact to medical staff (interdisciplinary collaboration)
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Neonatology/Biomedical Optics Research Laboratory
Need in the future for health monitoring Patient will be older
Increased morbidity
Higher need for monitoring devices
The need to ensure autonomy and safety
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Monitoring device
Non-invasive
Reliable
Appropriate
Continuous
Safe
Unobtrusive
Sustainable
Costeffective, affordable
Neonatology/Biomedical Optics Research Laboratory
Application examples (ParaTex, TecInTex)
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Aim: Prevention of pressure ulcers in paraplegics
Neonatology/Biomedical Optics Research Laboratory
ObesenseAim: Monitoring of energy expenditure to limit the consequences of obesity.
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Neonatology/Biomedical Optics Research Laboratory
SmartSphincterAim: Restore anal sphincter function and continence
Aim: Restore the sensation of touch
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WiseSkin
Neonatology/Biomedical Optics Research Laboratory
NewbornCareAim: Novel contactless system to improve reliability of vital signs monitoring in neonatal intensive care.
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Neonatology/Biomedical Optics Research Laboratory
NewbornCareProblem: Many false alarms (85%). Lead to crying wolf syndrome and stress
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Neonatology/Biomedical Optics Research Laboratory
NewbornCare
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Neonatology/Biomedical Optics Research Laboratory
Challenge: Comfort and wearability
If the monitoring system is not comfortabel, it will not be used.
Textile solution for sensors
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Neonatology/Biomedical Optics Research Laboratory
Challenge: Energy consumption
BodyPoweredSense
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Neonatology/Biomedical Optics Research Laboratory
Challenge: Data analysis and artificial intelligence
Event Identified MissedApnea 6 0Bradycardia 6 0Apnea & bradycardia combined 7 0Critical situation 14 0False alarm 174 1
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Incidence of false alarms: 85% Idea: Use artificial intelligence (Fuzzy logic) to remove false alarms
Neonatology/Biomedical Optics Research Laboratory
Challenge: Regulatory affairs
New law on human research requires extensive paperwork
Ethical committees treat medical devices similar to medication (risk category C)
Medical devices without CE mark require notification of Swissmedic (Heilmittel)
Does the device lead to a treatment?
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Clinical Study Protocol final V_02, 30.11.2014 Page 1 of 46
(ClinO/KlinV/OClin)- the SPIRIT statement and - ICH-GCP E6, section 6 - EN ISO14155:2011: Annex A - Swiss clinical trials portal (http://www.kofam.ch/en/swiss-clinical-trials-portal.html)
This template attempts to provide a general format applicable to all clinical trials evaluating an investigational product (drugs or medical devices). Note that instructions are indicated in blue italics and they need be deleted (or alternatively may be formatted as hidden Text that will not show in printing).Section headings and template text formatted in regular type red gives you reference to the legal requirements. This text may be deleted. Section headings and template text formatted in regular type (black) should be included in your protocol document as provided in the template. Header and footer should contain the following information (on all pages): [Protocol Title], [Page x of xx], [version x, DD/MM/YYYY], [Study ID] In places where the information is redundant, it is acceptable to reference another section, to document or to state its redundancy but the section has not to be deleted. Refer questions regarding use of this protocol template to swissethics/AGEK, info@swissethics.ch,phone: +41 (41) 440 26 67, www.swissethics.ch.
Neonatology/Biomedical Optics Research Laboratory
Challenge: Reliability
Determine sensitivity and specificity:
Sensitivity = # true positives detected / # all positives Specificity = # true negatives detected / # all negatives Optimally both 100%
False alarms are costly
Technical reliability
E.g. battery expiry
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Neonatology/Biomedical Optics Research Laboratory
Challenge Intervention
What do you do, if the device detects an alarm situation?
The doctor will be called.
ParaTex: The patient will be alarmed and can handle the situation himself
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Neonatology/Biomedical Optics Research Laboratory
Elderly patients:
Mind:
It the patient able to operate the device?
Recharging batteries
Exposing the device to unfavorable conditions (e.g. washing, heat)
Cannot replace the physician!
Soul: Does the patient feel safe, comfortable?
Body: Miniaturized device: can the patient read the messages and discern the keys? (e.g mobile phone)
Is the financial burden acceptable?
Challenge: The user
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Neonatology/Biomedical Optics Research Laboratory
Conclusion
Health monitoring is a field with tremendous potential
For effectiveness, needed:
Relevant application (interdisciplinary collaboration): Benefit for patient needed
Realistic knowledge of the application (interdisciplinary collaboration)
Mechanism of funding for interdisciplinary projects is important
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