Becoming a Preferred Supplier to the Medical Device Industry: What you should know about medical dev

1
Becoming a Preferred Supplier to the Medical
Device IndustryWhat you should know about
medical device regulationsOct 7, 2005
2
What we will discuss

• Types of suppliers
• Regulations that apply to medical device
  manufacturers
• Regulations that apply to you
• Related concerns
• How you can become a preferred supplier

3
Medical Devices are Regulated

• USA Food and Drug Administration
• European Union Competent Authorities and
  Notified Bodies
• Canada Health Canada
• Other countries typically Ministries of Health

4
Devices are

• Contrivances intended by the manufacturer
• To diagnose disease
• To monitor
• To treat
• To prevent
• Contraceptives
• To affect or replace anatomy or function
• Do not achieve results by chemical or metabolic
  means (are not drugs)

5
Accessories

• Separable units
• Can be sold separately (new, not as repair parts)
  
• Are regulated as devices
• Accessories may be sold by the device
  manufacturer or by an independent accessory
  manufacturer/supplier.

6
Components

• Components do not have stand-alone medical
  purpose.
• The distinction between a component and an
  accessory can be vague.
• Components are regulated. Component
  manufacturers are not.
• Who is responsible? The company responsible
  for the device.

7
What is Regulated

• Devices must be approved or cleared to market
• The quality system must meet requirements to
  ensure product is safe, effective, and meets user
  and regulatory requirements

8
Product Approval

• Device has a classification
• US Class 1, 2, or 3
• EU Active Implantable, IVD, or Class
  1, 2a, 2b, or 3
• Canada Class 1, 2, 3, or 4
• The approval method depends on classification
• FDA Class 1 is often exempt
• Class 2 usually needs a 510(k), premarket
  notification
• Class 3 usually needs a PMA, premarket approval.

9
Quality System

• FDA
• Quality System Regulation (21 CFR 820)
• Basic quality system functions
• Design controls
• Production controls (GMP)
• International
• ISO 13485
• Structured like ISO 9001
• Scope depends on regulations and what you do

10
Types of Suppliers

• Medical Device Designers, Manufacturers, and
  Distributors
• Contract Manufacturers of finished devices
• Manufacturers of Accessories
• Manufacturers of Components

11
Medical Device Manufacturers

• Responsible for the product
• Must obtain product approval for each geography
• Must comply with quality system requirements
  including relevant activities of suppliers

12
Medical Device Manufacturers

• Some very large companies with sophisticated
  purchasing and outsourcing
• They demand your conformity
• Many start-up and small companies
• They need your conformity
• Both can work with you to improve technology

13
Contract Manufacturers

• Manufacture a finished device (or accessory)
• Do not design or market the device
• They must register with FDA and are subject to
  inspection for GMP, not design controls.
• For ISO 13485, the product responsible company
  is responsible for ensuring quality conformity,
  not the contract manufacturer.

14
Component Manufacturer

• Does not register with FDA
• Does not need to comply with quality system
  requirements
• May be inspected if FDA is investigating a
  serious device problem.
• The device manufacturer is responsible.

15
Hint 1

• Medical device manufacturers prefer suppliers
  with good product quality and quality systems.

16
Risk The basic criterion

• What does your component do?
• Packaging foam little concern
• Packaging that allows sterilization increased
  concern
• Essential performance component increased
  concern based on function of device
• Synthetic material for an implant major concern

17
Hint 2

• Know the role your component plays in the device.
• What can go wrong?
• What is the risk?

18
Purchasing Specification

• The manufacturer must qualify and evaluate
  suppliers.
• Have credentials, documentation of history, and
  capabilities.
• Respond to questionnaires promptly.
• You may be audited.

19
Purchasing Specification

• What will you supply?
• Dimensions, tolerances
• Material
• Production process
• Quality assurance process
• Certificates, records

20
Purchasing Specification

• Notify the device manufacturer of changes
  sufficiently in advance for assessment of the
  impact of the change on the medical device.
• Form, fit, and function are not enough!!!

21
Changes

• Processes
• Equipment
• Raw materials
• Manufacturing materials (residues)
• Dimensions, tolerances
• Your suppliers

22
Hint 3

• Be a reliable supplier.
• No surprises.

23
What is the manufacturer considering?

• Mechanical, electrical, and physical properties
• How your component works in the device
  manufacturing and assembly.
• Materials
• Biocompatibility
• Residues
• Sterilization, disinfection, and cleaning
  processes

24
Mechanical, electrical, physical properties

• What forces and environment must the component
  tolerate?
• In operation
• In storage
• In transportation
• In user processing
• The component may be intended to provide
  protection

25
Mechanical, electrical, thermal properties

• Is the material intended to conduct, insulate,
  have a specific resistance, or other electrical
  function?
• Patient contacting materials must not exceed
  temperature limits. What is the heat capacity
  and conductance of your material?
• Will your material transmit energy?

26
Device Manufacturing

• Does your component play a critical role in a
  manufacturing process?
• What are critical dimensions or properties?
• Can you suggest changes to make manufacturing
  faster, cheaper, better?

27
Hint 4

• Know the properties of your material (or how to
  find out).
• Help the manufacturer choose the right material.

28
Biocompatibility

• For patient contacting material
• What does it contact?
• Intact skin
• Broken skin
• External connecting cavities (in the body, but
  not crossing a tissue barrier)
• Internal (crossing a tissue barrier)
• Blood contacting

29
Biocompatibility

• How long?
• lt 24 hours
• lt 30 days
• gt 30 days

30
Biocompatibility

• Biocompatibility testing can be long and
  expensive.
• Testing can be shortened or eliminated if known,
  previously tested materials are used.
• Know proprietary materials or materials from the
  U.S. Pharmacopeia.
• Cooperate with test houses.

31
Biocompatibility

• Ongoing characterization testing may be needed to
  ensure material has not inadvertently changed.
• Trace residues of manufacturing material can
  cause reactions.
• Intended material is not adequately removed.
• Unintended material is introduced.

32
Sterilization, Disinfection, Cleaning

• Can your component be cleaned? Without
  degrading?
• Can your component withstand repeated use of
  disinfectants?
• Can your components withstand sterilization?
• Ethylene oxide (permeability and out gassing)
• Radiation
• Heat/steam
• Chemical sterilants

33
Hint 5

• For critical applications, help identify
  products with appropriate biocompatibility,
  cleaning, disinfection, and sterilization
  characteristics.Cooperate with test houses.

34
Postmarket

• Complaint investigations
• Safety notifications and recalls

35
Complaint Investigations

• Help identify the cause and the correction.
• Identify the root cause and prevent recurrence.

36
Safety Notifications and Recalls

• It happens to you and the manufacturer.
• Notify the manufacturer if you learn of a safety
  action to be taken.
• Cooperate with the manufacturer if they have a
  recall. They may need a rush order!

37
Hint 6

• Be a supplier that can be counted on to address
  and correct problems professionally and
  straightforwardly.

38
Hint 7

• Regulators work readily with companies that
  self-identify and self-correct problems.
• Work with regulators openly and sincerely in
  the interest of public health.

39
Massachusetts

• The Commonwealth and surrounding states have one
  of the highest concentration of device
  manufacturers in the USA.
• These companies need reliable suppliers of
  components.
• Your ability to understand, work with, and meet
  the special requirements of these companies lets
  you tap into a lucrative market.

40
MassMEDIC

• Over 300 medical device companies
• Provides education
• Supports companies who make devices and companies
  who serve these companies
• www.massmedic.com

41
Chas Burr

• Boston Healthcare Associates, Inc.
• 75 Federal Street, 9th Floor
• Boston, MA 02110
• 617-482-4004
• cburr_at_bostonhealthcare.com
• www.bostonhealthcare.com