UTSAAH Laboratory

Universal Technology Solutions for Accessible and Affordable Healthcare Laboratory


PD233: 2021

Design of Bio-medical Devices and Systems (2:1)

First Class on Tuesday 10th Aug 2021, 10AM

Join class via MS Teams

Topics Covered / Syllabus

Medical Device Definition and Classification, Bioethics and Privacy,  Design Control & Regulatory Requirements. Introduction to specific medical technologies: Biopotentials measurement (EMG, EOG, ECG, EEG), Medical Diagnostics (In-vitro diagnostics), Medical Diagnostics (Imaging), Minimally Invasive Devices, Surgical Tools and Implants,  Biocompatibility and Biomaterials Testing, Clinical Trails, Digital Healthcare, Medical Records and Telemedicine.

The course will include guest lectures by healthcare professionals giving exposure to unmet needs in the healthcare technologies and systems.

Reference Books:

  • B Ravi, The Essence of Medical Device Innovation, 2018, ISBN(13): 9789387282186, E-Book online
  • Paul H. King, Richard C. Fries, Arthur T. Johnson, Design of Biomedical Devices and Systems, Third Edition, ISBN 9781466569133
  • Peter J. Ogrodnik, Medical Device Design: Innovation from Concept to Market, Academic Press Inc; 1 edition (2012), ISBN-10: 0123919428
  • Stefanos Zenios , Josh Makower , Paul Yock , Todd J. Brinton , Uday N. Kumar , Lyn Denend , Thomas M. Krummel, Biodesign: The Process of Innovating Medical Technologies, Cambridge University Press; 1 edition (2009), ISBN-10: 0521517427
  • John G. Webster (ed), Medical Instrumentation: Application and Design, 2007
  • Khandpur, Handbook of Biomedical Instrumentation, 2004


  • Lectures Mondays and Thursdays 9-10AM.
  • Lab session: Tuesday 10AM -13Noon

Lecture Notes:

Lecture notes for 2019 run – Updated notes which will shared along with live sessions.

  1.  Lecture 1 : Introduction PD233-Lecture1
  2.  Lecture 2 : Bioethics PD233-Lecture2-Bioethics
  3.  Lecture 3 : PD233-Lecture3-Empathy
  4.  Lecture 4:  PD233-Lecture4-What is a Medical Device
  5.  Lecture 5: PD233-Lecture5 Design Documentation
  6.  Lecture 6: PD233-Lecture6 BioPotentials1
  7.  Lecture 7: PD233-Lecture7 BioPotentials2
  8. PD233-Lecture8-MedicalImaging1
  9. PD233-Lecture9-MedicalImaging2
  10. D233-Lecture10_MedicalImaging3
  11. PD233-Lecture11
  12. PD233-Lecture12
  13. PD233-Lecture13
  14. PD233-Lecture14
  15. PD233-Lecture15
  16. PD233-Lecture16




Course project will involve designing a product/device for real world problem taken in collaboration with clinical experts.

Other Online Resources:

Mayo Clinic  Health Information Pages

Pubmed – Biomedical Research Papers

Stanford Biodesign

CDSCO Medical Devices Section

GOI Medical Device Rules Notification (Jan2017 -English)

CDSCO Notidifed Medical Devices as of May 2019

Clincal Trial Rules 2019

Medical Device Classification as per EU MDD

National Digital Health Blueprint