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Medical Device Development . Robert Hitchcock, Ph.D. Director of Engineering & Technology Development Sorenson Medical, Inc. What is a Medical Device?.

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medical device development

Medical Device Development

Robert Hitchcock, Ph.D.

Director of Engineering &

Technology Development

Sorenson Medical, Inc.

what is a medical device
What is a Medical Device?

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • 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.
medical device industry
Medical Device Industry
  • Global market for medical devices exceeds $200B
  • US market ~ 42% of WW market
  • US innovation drives the market (more US producers than rest of world combined)
  • However.. it is increasingly difficult to commercialize
  • Consumer v. agency regulation
  • Increasing control improves safety and effectiveness at the expense of commercial progress
  • Overseas manufacturing and product launch
medical device regulation
Medical Device Regulation
  • 1976 Medical device amendments to the FD&CA
  • 1978 GMP
  • 1987 – 1989 Process validation, design control
  • 1990 SMDA – 44% of recalls due to faulty design
  • 1996 QSR – harmonization, FDA, MDD, ISO
the big picture 21 cfr part 820 quality system regulation
The Big Picture - 21 CFR part 820 Quality System Regulation

Subpart I – Nonconforming product

820.90 Nonconforming product

Subpart J – Corrective and preventative action

820.100 Corrective and preventative action

Subpart K – Labeling and packaging control

820.120 Device labeling

820.130 Device packaging

Subpart L – Handling, storage, distribution and installation

820.140 Handling

820.150 Storage

820.160 Distribution

820.170 Installation

Subpart M – Records

820.180 General requirements

820.181 Device master record

820.184 Device history record

820.186 Quality system record

820.198 Complaint files

Subpart N – Servicing

820.200 Servicing

Subpart O – Statistical techniques

820.250 Statistical techniques

Subpart A – General Provisions

820.1 Scope

820.3 Definitions

820.5 Quality System

Subpart B – Quality System Requirements

820.20 Management Responsibility

820.22 Quality audit

820.25 Personnel

Subpart C – Design controls

820.30 Design controls

Subpart D – Document controls

820.40 Document controls

Subpart E – Purchasing controls

820.50 Purchasing controls

Subpart F – Identification and traceability

820.60 Identification

820.65 Traceability

Subpart G – Production and process controls

820.70 Production and process controls

820.72 Inspection, measuring and test equipment

820.75 Process validation

Subpart H – Acceptance activities

820.80 Receiving, in-process and finished device accept.

820.86 Acceptance status

design control
Design Control
  • Design & Development Planning
  • Design input
  • Design output
  • Design review
  • Design verification
  • Design validation
  • Design transfer
  • Design changes
  • Design history file
three key elements
Three Key Elements
  • Design Input
  • Risk Analysis
  • Design Output
design input
Design Input
  • User Needs
    • what & why stated in user terms
  • Marketing Requirements
    • measurable, engineering terms
design input user needs
Design Input – User Needs

Over the Needle Catheter

  • Infuse fluids into subcutaneous tissue
  • Sharp enough to penetrate skin easily
  • Simple to remove needle from catheter
design input marketing requirements
Design Input – Marketing Requirements

Over the Needle Catheter

  • WFI infused at 100 ml/hr, backpressure not to exceed 10 psi
  • Max insertion force through 5 mil latex = 3N
  • Max force to remove needle = 1N
risk analysis
Risk Analysis
  • Failure mode
  • Potential effects
  • Severity
    • 1 to 10 (negligible to potential for multiple deaths)
  • Potential causes
  • Likelihood
    • 1 to 10 (< 1 in 500,000 to > 1 in 2)
  • Risk
    • Likelihood / severity matrix
  • Mitigation
design output testing data
Design Output – Testing & Data

Verification

Validation

the big picture 21 cfr part 820 quality system regulation25
The Big Picture - 21 CFR part 820 Quality System Regulation

Subpart I – Nonconforming product

820.90 Nonconforming product

Subpart J – Corrective and preventative action

820.100 Corrective and preventative action

Subpart K – Labeling and packaging control

820.120 Device labeling

820.130 Device packaging

Subpart L – Handling, storage, distribution and installation

820.140 Handling

820.150 Storage

820.160 Distribution

820.170 Installation

Subpart M – Records

820.180 General requirements

820.181 Device master record

820.184 Device history record

820.186 Quality system record

820.198 Complaint files

Subpart N – Servicing

820.200 Servicing

Subpart O – Statistical techniques

820.250 Statistical techniques

Subpart A – General Provisions

820.1 Scope

820.3 Definitions

820.5 Quality System

Subpart B – Quality System Requirements

820.20 Management Responsibility

820.22 Quality audit

820.25 Personnel

Subpart C – Design controls

820.30 Design controls

Subpart D – Document controls

820.40 Document controls

Subpart E – Purchasing controls

820.50 Purchasing controls

Subpart F – Identification and traceability

820.60 Identification

820.65 Traceability

Subpart G – Production and process controls

820.70 Production and process controls

820.72 Inspection, measuring and test equipment

820.75 Process validation

Subpart H – Acceptance activities

820.80 Receiving, in-process and finished device accept.

820.86 Acceptance status