Lecture 1: Part B

Introduction to Medical
Instrumentation
Principles of Design of
Medical Instrumentation
Fall 2018
Different Medical Device Categories –
loosely classified

•Diagnostic vs Therapeutic

•Wearable, Portable, or bench

•Invasive vs Noninvasive
Important organizations you will encounter
along the way to developing and testing your
novel medical device. Learn what do they do.
Institutional

a)institutional review board (IRB):

b)Institutional animal care and use committee (IACUC)
c)conflict of interest committee

External (Government)

a)the patent and trademark office (USPTO)

b)the food and drug administration (FDA)
c)center for disease control (CDC)
 Food and Drug Administration (FDA)
Government body entrusted with the responsibility to regulated
medical devices, drugs, etc.
Primary task: certify safety and efficacy
FDA regulates through FDA Instrumentation
Categories
Labeling Class I
Design Control Class II
Premarket Approval Class III

Give examples of medical devices that belong to each of

the Classes.
 FDA Device Regulations

• Class I – General Controls

– Required to perform registration, labeling, and good
manufacturing practices and to report adverse effects
• Class II – Performance Standards
– Required to prove “substantial equivalence” via the 510(k)
process
• Class III – Pre-market Approval (PMA)
– Requires extensive testing and expert scrutiny
– PMA is necessary for devices used in supporting or
sustaining human life
Identify the following devices as
• ECG electrodes
– (e.g. your answer could be ECG electrode:
Class II, noninvasive, diagnostic).
• External defibrillator
• Implanted pacemaker with pH sensor
• Surgical mask
• EEG based neurological monitor
• Phrenic nerve stimulator for artificial
respiration
• Endocardial catheter for heart ablation
 Medical Instrumentation
It’s a Process

• Medical device design process…need to

idea…to feasibility…to prototype and final
application (FDA etc) … …path to clinical and
commercial product… from prototype to
patent to … manufacturing, marketing and
profits

• Get the big picture!

 Organizations: institutional,
external
What do the following organizations do?
a) animal care and use committee (IACUC),
b) institutional review board (IRB),
c) conflict of interest committee,
d) United States Patent and Trademark Office
(USPTO),
e) Food and Drug Administration (FDA).
 Study Questions
• What are the different medical
instrumentation categories (in terms of their
use in monitoring or treating)?
• FDA regulation – Give examples for each of
the classifications
• Describe a few critical regulatory oversight
steps you need to assure to
– Protect your invention
– Carry out experimentation and testing (on
animals, patients)
– Manufacture and sell a product.
 Medical Devices Case Studies
• Electrocardiogram (ECG) Monitoring and
pacemakers, defibrillators
• Electromyogram (EMG) monitoring and
applications to prosthesis, rehabilitation
• Electroculogram (EOG) monitoring and
human-machine interface
• Electroencephalogram (EEG) monitoring for
brain monitoring and brain machine interface
 Discussion 2
• You have built a heart monitoring wrist watch: what agency will regulate this
device? What class of regulation does this device fall into?
• You come up with the idea of using lasers to cut tissue in surgery. What class of
regulation does this device fall into? What ethical consideration and regulatory
approval (institutionally) would you need?
• Generate examples of medical devices. Come up with one new application for
each of the different signals (ECG, EMG, EOG, EEG).
• Now a) identify its basic block diagram, from sensors, to instrumentation
components, to processing, b) identify steps from prototype (what would you
demonstrate for feasibility) to manufacturing (fully finished, operational
device).
• Take an example: A group of student inventors are proposing a wrist watch
with the capability measure physical activity and heart rhythms for fitness and
health monitoring. Develop the block diagram, determine the sensors, basic
electronic subsystem, and a graphic of the prototype. Now, as a challenge, add
some innovative features (in hardware or software). Render this prototype in a
more finished manufacturable and marketable prototype).