Prof. Martin Wolf at Nano-Tera 2015

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


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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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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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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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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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


Application examples (ParaTex, TecInTex)

5/12/2015 Title of the presentation, Author Page 7

Aim: Prevention of pressure ulcers in paraplegics


ObesenseAim: Monitoring of energy expenditure to limit the consequences of obesity.



SmartSphincterAim: Restore anal sphincter function and continence

Aim: Restore the sensation of touch


WiseSkin


NewbornCareAim: Novel contactless system to improve reliability of vital signs monitoring in neonatal intensive care.


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NewbornCareProblem: Many false alarms (85%). Lead to crying wolf syndrome and stress


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NewbornCare



Challenge: Comfort and wearability

If the monitoring system is not comfortabel, it will not be used.

Textile solution for sensors



Challenge: Energy consumption

BodyPoweredSense



Challenge: Data analysis and artificial intelligence

Event Identified MissedApnea 6 0Bradycardia 6 0Apnea & bradycardia combined 7 0Critical situation 14 0False alarm 174 1


Incidence of false alarms: 85% Idea: Use artificial intelligence (Fuzzy logic) to remove false alarms


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?


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, [email protected],phone: +41 (41) 440 26 67, www.swissethics.ch.


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



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



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



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


Prof. Martin Wolf at Nano-Tera 2015

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