5/20/2010

What is a Medical Device? Medical Device Development
Robert Hitchcock Ph D Hitchcock, Ph.D.
2.

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
1. recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, p y pp 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. Sorenson Medical, West Jordan, Utah USA

Director of Engineering & Technology Development Sorenson Medical, Inc.
Sorenson Medical, West Jordan, Utah USA

3.

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
Sorenson Medical, West Jordan, Utah USA Sorenson Medical, West Jordan, Utah USA

5/20/2010

Medical Device Regulation
• 1976 Medical device amendments to the FD&CA • Picture of medical devices • 1978 GMP • 1987 – 1989 Process validation design control validation, • 1990 SMDA – 44% of recalls due to faulty design • 1996 QSR – harmonization, FDA, MDD, ISO

Sorenson Medical, West Jordan, Utah USA

Sorenson Medical, West Jordan, Utah USA

The Big Picture - 21 CFR part 820
Quality System Regulation
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 820.40 820 40 Document controls D t t l 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 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 g 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

Design Control
• • • • • • • • • Design & Development Planning Design input Design output Design review Design verification Design validation Design transfer Design changes Design history file
Sorenson Medical, West Jordan, Utah USA

Sorenson Medical, West Jordan, Utah USA

5/20/2010

Management Assigns Project and Project Manager

SMI Product Design & Development
Post Market Surveillance

Three Key Elements
1. 2. 2 3. Design Input Risk Analysis Design Output

Design and Development Plan

User Needs Stated in user terms

• User Needs
– what & why stated in user terms

• Marketing Requirements
– measurable, engineering terms

C NET A P AE OCPUL HS S E IF A IO P C IC T N P AE HS P OOY E P A E R T TP HS

Traceability Analysis

T A SE P AE RNFR HS

Marketing Requirements measurable customer needs

Design Review

Traceability Analysis

Risk Analysis

Manufacturing Transfer

Traceability Analysis A l i
Design Review

Product Specifications

Design Review

Traceability Analysis
Design Review

F A DS N P AE IN L E IG HS

Traceability Analysis
Prototype Design

Design Validation

Design Verification Protocols and accceptance criteria

Finalize Documentation

Design Review

Sorenson Medical, West Jordan, Utah USA

Sorenson Medical, West Jordan, Utah USA

Design Input

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

Sorenson Medical, West Jordan, Utah USA

Sorenson Medical, West Jordan, Utah USA

5/20/2010

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

Design Concept

Sorenson Medical, West Jordan, Utah USA

Sorenson Medical, West Jordan, Utah USA

Risk Analysis
• Failure mode • Potential effects • Severity
– 1 to 10 (negligible to potential for multiple deaths)

Design Output - Specifications

• Potential causes • Likelihood
– 1 to 10 (< 1 in 500,000 to > 1 in 2)

• Risk
– Likelihood / severity matrix

• Mitigation
Sorenson Medical, West Jordan, Utah USA Sorenson Medical, West Jordan, Utah USA

5/20/2010

Design Output - Specifications

Design Output - Specifications

Sorenson Medical, West Jordan, Utah USA

Sorenson Medical, West Jordan, Utah USA

Design Output - Specifications

Design Output - Specifications

Sorenson Medical, West Jordan, Utah USA

Sorenson Medical, West Jordan, Utah USA

5/20/2010

Design Output - Specifications

Design Output - Specifications

Sorenson Medical, West Jordan, Utah USA

Sorenson Medical, West Jordan, Utah USA

Design Output – Prototypes

Design Output – Testing & Data Verification

Sorenson Medical, West Jordan, Utah USA

Sorenson Medical, West Jordan, Utah USA

Validation

5/20/2010

The Big Picture - 21 CFR part 820
Quality System Regulation
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 820.40 820 40 Document controls D t t l 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 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 g 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

Sorenson Medical, West Jordan, Utah USA