Technological Innovation System

Case: Wearable Devices in Healthcare

Industrialisation
Seminar 2

Group 2: Sina Reinberg & Mohammad Allahyari

01 Definition of the TIS 03 Specification of the key
policy issues

02 Identification of the 04 References

structural components
 01
Definition of the TIS
Wearable Devices
“Electronic device designed to be worn close to the skin on the body. These devices used to
collect and monitor data from daily activities over a quantified period.”
● 1961: Edward Thorp and Claude Shannon created first wearable device

● ca. 1 billion wearable devices will be in use globally by the end of 2023

● Used in many areas, e.g.:

○ health care
○ fitness and sports
○ entertainment and gaming
○ military
● Different forms, e.g.:
○ jewelry
○ accessories
○ clothing1
Wearable Devices
in Healthcare
● approximately 30% of adults in the
US use wearable electronics to track
their health and well-being
● help make its user more proactive
regarding their well-being
● enabling doctors to monitor their
patients remotely1
Examples
Diagnostic devices:

● Wearable Fitness Trackers

● Smart Health Watches
● Biosensors
● Sleep Trackers

Therapeutic devices:
● Insulin Pumps
● Respiratory Therapy Devices
● etc.2
 02
Identification of the
structural components
User
● in the last 4 years the use of wearable technology has more than tripled
● increased interest in monitoring own health and vital signs
● Patient-centered approach has become a key enabler in the adoption of medical
wearables2
User
● concerns about privacy of individual healthcare data
● data stored in cloud storage systems are vulnerable to cyber-attacks 3
Healthcare System
● wearable devices provide remote patient monitoring
● could help to achieve quicker and more accurate diagnosis and treatment process
● potential to assist in medical procedures e.g. operations
● could drop hospital costs by as much as 16% over 5 years
● remote patient monitoring technologies could save e. g. US healthcare system
$200 billion over the next 25 years 4
Manufacturers
● traditional medical device companies have difficulty competing with established tech
giant in the wearable medical device market
● tor create software and hardware huge investments and knowledge is required
● approval from regulatory agencies e.g. FDA and patent offices is needed 1
Manufacturers
● Difficulties associated with patenting wearable medical technology

⮚ the industry is still in its early stages and is trying to work through obstacles, incl. the
laws that are associated with patentability 1
Regulatory Agencies

FDA 5

● Class I devices
○ low-risk devices with no
required premarket approval.
● Class II devices
○ moderate-risk devices that
require premarket notification
● Class III devices
○ high-risk devices that require
premarket approval (PMA)
Regulatory Agencies

Conformité
Européenne (CE) 6

● Classification
○ Class I, IIa, IIb, and III based
on their level of risk
● Notified body
○ Independent organization
reviews the technical
documentation and
● Post-market surveillance
CE Weaknesses FDA Weaknesses
● Dependence on self-assessment ● Slow response time
● Limited transparency ● Limited resources
● Inadequate post-market surveillance
Government and Policies
● Technology development processes
○ Research and development funding
○ Providing educational Infrastructure and supporting healthcare providers
● Communication networks
○ Data privacy and security in collecting, sharing and analysing data 7
● Government policies
○ Data privacy and security
○ Regional rules and government support8
○ Reimbursement systems8
 03
Specification of the key
policy issues
Strengths
● High user demand
● Fast growing market
● Great potential for cost
savings in the
healthcare system
Weaknesses
● Data security concerns
● Difficulties associated
with patenting
● Slow pace of regulatory
authorities
Artificial Pancreas Device System
Wearable devices that monitor blood glucose levels in diabetes patients

● High user demand accelerated innovation and investment in this

space.9
● Cost savings for healthcare systems through a better management
of diabetes can reduce hospitalizations
● Developing standardized data formats and communication
protocols between manufacturers and healthcare providers
● FDA is collaborating with other stakeholders to foster
innovations for clinical studies and product approvals 10
● Data security is still a major concern, but the implementation of
big data and AI, along with integration with clinical information
systems, can help to mitigate it.
 04
References
References
1. PatSnap. (2023) Are wearable devices the new healthcare revolution?. News-Medica [Online]. Available at:
https://www.news-medical.net/whitepaper/20230110/Are-wearable-devices-the-new-healthcare-revolution.aspx
(Accessed: 11 May 2023)

2. Insider Intelligence Inc. (2023) Latest trends in medical monitoring devices and wearable health technology (2023).
Available at: https://www.insiderintelligence.com/insights/wearable-technology-healthcare-medical-devices/ (Accessed:
11 May 2023)

3. Polaris Market Research. (2020) Market Research Report: Wearable Medical Devices. Available at:
https://www.polarismarketresearch.com/industry-analysis/wearable-medical-devices-market/request-for-sample
(Accessed: 12 May 2023)

4. eMedCert. (2023) Wearables: Future of Healthcare. Available at: https://emedcert.com/blog/wearables-statistics-

future-of-healthcare (Accessed: 12 May 2023)

5. Brönneke, J. B., Müller, J., Mouratis, K., Hagen, J., & Stern, A. D. (2021). Regulatory, legal, and market aspects
of smart wearables for cardiac monitoring. Sensors, 21(14), 4937. doi:10.3390/s21144937

6. Jiang, N., Mück, J. E., & Yetisen, A. K. (2020). The regulation of Wearable Medical Devices. Trends in
Biotechnology, 38(2), 129–133. doi:10.1016/j.tibtech.2019.06.004
7. Greiwe, J., & Nyenhuis, S. M. (2020). Wearable Technology and how this can be implemented into clinical practice.
Current Allergy and Asthma Reports, 20(8). doi:10.1007/s11882-020-00927-3

8. Binyamin, S. S., & Hoque, Md. R. (2020). Understanding the drivers of Wearable Health Monitoring Technology: An
extension of the unified theory of acceptance and use of Technology. Sustainability, 12(22), 9605. doi:10.3390/su12229605

9. Diabetes - NIDDK. Available at: https://www.niddk.nih.gov/health-information/diabetes (Accessed: 12 May 2023)

10. Center for Devices and Radiological Health. What is the pancreas? what is an artificial pancreas device system? Available
at:
https://www.fda.gov/medical-devices/artificial-pancreas-device-system/what-pancreas-what-artificial-pancreas-device-system#:
~:text=An%20Artificial%20Pancreas%20Device%20System%20will%20not%20only%20monitors%20glucose,no%20input%20fr
om%20the%20patient
.. (Accessed: 12 May 2023).