Introduction to Medical Devices

1
Introduction to Medical Devices

• The objective of this lectures is to define what
  a medical device is, identify which federal
  bodies govern their regulation, and describe the
  industry that develops them.

2
What is Biomechanical Engineering?

• Biomedical Engineering

• Bioelectrical Engineering
• bioelectrical signal analysis
• myoelectric prostheses

• Biochemical Engineering
• biodegradable polymers
• drug delivery

• Biomechical Engineering
• artificial joints
• wheelchairs
• prosthetic heart valves

Research
Medical Device Design
3
Medical Devices

• Medical devices range from simple tongue
  depressors to more complex implants that provide
  function of an entire joint.
• If a product is labeled, promoted, or used in a
  manner that meets the definition of a medical
  device of a countrys federal food and drug act
  (or equivalent), the device will be regulated
  under a federal regulatory body and subject to
  pre-marketing and post-marketing controls.

4
Medical Devices (Canada)

• A medical device in Canada is
• Any article, instrument, apparatus or
  contrivance, including any component, part or
  accessory thereof, manufactured, sold or
  represented for use in
• (a) the diagnosis, treatment, mitigation or
  prevention of a disease, disorder or abnormal
  physical state, or its symptoms, in human beings
  or animals,
• (b) restoring, correcting or modifying a body
  function or the body structure of human beings or
  animals,
• (c) the diagnosis of pregnancy in human beings or
  animals, or
• (d) the care of human beings or animals during
  pregnancy and at and after birth of the
  offspring, including care of the offspring, and
  includes a contraceptive device but does not
  include a drug

5
Medical Devices (United States of America)

• A medical device in the United States of
  America is
• An instrument, apparatus, implement, machine,
  contrivance, implant, in vitro reagent, or other
  similar or related article, including a component
  part, or accessory which is
• (a) recognized in the official National
  Formulary, or the United States Pharmacopoeia, or
  any supplement to them,
• (b) intended for use in the diagnosis of disease
  or other conditions intended conditions, or in ,
  the cure, mitigation, treatment, or prevention of
  disease, in man or other animals, or
• (c) intended to affect the structure or any
  function of the body of man or other animals, and
  which does not achieve any of it's primary
  intended purposes through chemical action within
  or on the body of man or other animals and which
  is not dependent upon being metabolized for the
  achievement of any of its primary intended
  purposes.

6
Medical Devices (European Union)

• A medical device in the European Union is
• Any instrument, apparatus, appliance, material or
  other article, whether used alone or in
  combination, including the software necessary
  fused for its proper application intended by the
  manufacturer to be used for human beings for the
  purpose of
• (a) diagnosis, prevention, monitoring, treatment
  or alleviation of disease
• (b) diagnosis, monitoring, treatment, alleviation
  of or compensation for an injury or handicap
• (c) investigation, replacement or modification of
  the anatomy or of a physiological process
• (d) control of conception
• and which does not achieve its principle intended
  action in or on the human body by
  pharmacological immunological or metabolic
  means, but which may be assisted in its function
  by such means.

7
Medical Devices (ISO Standards)

• A manufactured product is defined as a medical
  device under ISO 13485 if it is used to
• Cope with human disease
• Prevention, Diagnosis, Treatment, Alleviation,
  Monitoring
• Care for human injuries
• Diagnosis, Treatment, Alleviation, Monitoring,
  Compensation
• Meet human anatomical needs
• Investigation, Replacement, Modification,
  Support
• Maintain human physiological functions
• Investigation, Replacement, Modification,
  Support

8
Medical Devices (ISO Standards)

• Support or sustain human life
• Control human conception
• Disinfect human medical devices
• Examine specimens taken from human bodies

9
Design of Biomechanical Devices

• Mechanical Devices for Humans

• Implantable Devices
• artificial joints

• External Devices
• wheelchairs

• Medical Instruments
• orthopaedic surgery

10
External Medical Devices

• These were among the first medical devices
  developed.
• The first documented design of a foot orthosis
  was circa 700 AD
• An external medical device is a medical device
  that primarily operates external to the human
  body.

11
Implantable Medical Devices

• An implantable medical device is a medical device
  is that
• is partly or totally inserted into the human body
  or a natural orifice and is expected to stay
  there for 30 days or more, or
• is used to replace an epithelial surface or the
  surface of the eye and is expected the to stay in
  use for 30 days or more
• In addition, surgical or medical procedures are
  required to insert and remove the implantable
  medical device.

12
Medical Instruments

• Medical instruments are tools designed for
  precision work (e.g. surgical and diagnostic
  tools). Note that medical instruments are
  classified as medical devices according to
  federal regulations.

13
Medical Device Industry

• Over 80 of medical device companies have fewer
  than 100 employees

14
Medical Device Industry

• However, over 80 of the sales dollars are from
  large companies

15
Medical Device Industry

• RD as a percentage of sales based on company
  size

16
Medical Device Industry

• Innovation is the cornerstone of the industry
• RD as a percent of sales 6.8
• Double the national average for all industries
• Median percentage of spending
• Medical Devices 6-11
• Diagnostics 4.7
• Total Industry 9.1
• All Manufacturing Companies 4.1

17
Medical Device Industry

• Biomedical engineering jobs will increase by 31.4
  percent through 2010.
• This is double the rate for all other jobs
  combined.
• (US Department of Labor)