The Convergence of The Convergence of Software in the Medical - PowerPoint PPT Presentation

The Convergence of The Convergence of Software in the Medical Software in the Medical Device Industry Device Industry Joseph Azary 203-944-9320 Info@azarytech.com

FDA Regulations & Quality Requirements

Clinical Sterilization FDA Regulations & Quality Requirements Software Engineering

Medical Device Definition Medical Device Definition An Instrument, Apparatus, Implement, Machine, Contrivance, An Instrument, Apparatus, Implement, Machine, Contrivance, Implant, In Vitro Reagent, or other similar or related article, Implant, In Vitro Reagent, or other similar or related article, including any component, part, or accessory which has the including any component, part, or accessory which has the following characteristics: following characteristics: • • Is recognized by USP or National Formulary Is recognized by USP or National Formulary • • Intended for use in diagnosis of disease or other conditions or in Intended for use in diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease the cure, mitigation, treatment, or prevention of disease • • Is intended to affect the structure or any function of the body Is intended to affect the structure or any function of the body • • Achieves its primary intended purpose through physical action, Achieves its primary intended purpose through physical action, and not chemical or metabolic action. and not chemical or metabolic action.

Nanotechnology • Biochips • Surgery Nanotechnology • Implantable BioMEMS • Surface Modification • Nanosystems for Drug Delivery • Point-of-Care Diagnostic • Hybrid Bio/Artificial • Nanoprobes

Telemedicine Telemedicine

Remote Robotic Surgical System Remote Robotic Surgical System

Computed Aided Diagnosis Computed Aided Diagnosis

Software Controlled People Software Controlled People

Medical Device Industry Facts Medical Device Industry Facts •Global Market of $169 Billion •U.S. consumes >40% of medical devices in world •Steady annual rate of growth (7%) •70% have <50 employees •25,905 device manufacturers in U.S. •Aging Population • High Tech

North East North East • Massachusetts – 686 • Massachusetts – 686 • New York - 842 • New York - 842 • Connecticut – 298 • Connecticut – 298 • Rhode Island – 73 • Rhode Island – 73 • New Jersey – 440 • New Jersey – 440 *Manufacturers (not including specification developers or *Manufacturers (not including specification developers or contract sterilizers – source fDA fDA DSMA) DSMA) contract sterilizers – source

Trends in Device Industry Trends in Device Industry • Aging Population • Aging Population – By 2020 53.7 million people over 65 By 2020 53.7 million people over 65 – • Chronic Illness • Chronic Illness • Reimbursement • Reimbursement • Lifestyle • Lifestyle – >8 million cosmetic surgeries in 2000 >8 million cosmetic surgeries in 2000 – • Reuse of Single Use Devices • Reuse of Single Use Devices

Trends (continued) Trends (continued) • Group Purchasing Practices • Group Purchasing Practices • Outpatient Treatment • Outpatient Treatment • Telemedicine • Telemedicine • Regulatory / Legal • Regulatory / Legal • Moving devices into new areas • Moving devices into new areas – Drug coated devices Drug coated devices – – Artificial organs Artificial organs – – Nanotechnology Nanotechnology –

Regulated Industry Regulated Industry • Heavily Regulated by • Heavily Regulated by FDA, as well as FDA, as well as ministries of health ministries of health around the world around the world • European Medical • European Medical Device Directives Device Directives • Canadian Medical • Canadian Medical Device Bureau Device Bureau

Harmonization Harmonization • In 1996 FDA harmonized medical device • In 1996 FDA harmonized medical device GMPs (Good Manufacturing Practices) with GMPs (Good Manufacturing Practices) with ISO 9001:1994. ISO 9001:1994. • Facilitate compliance for medical device • Facilitate compliance for medical device companies. companies. • Facilitate global harmonization. • Facilitate global harmonization.

What Is GMP What Is GMP • GMP stands for • GMP stands for G Good ood M Manufacturing anufacturing Practices ractices P

Food & Drug Administration Food & Drug Administration • FDA is responsible for • FDA is responsible for protecting public protecting public health by regulating health by regulating products such as: products such as: – Medicine / drugs Medicine / drugs – – Blood supply Blood supply – – Medical devices Medical devices – – Food Food – – Cosmetics Cosmetics –

History of GMPs History of GMPs • 1905 Food and Drug Act • 1905 Food and Drug Act • 1962 Drug Amendments • 1962 Drug Amendments • 1982 Tamper Resistant Packaging • 1982 Tamper Resistant Packaging • 1985 AIDS Testing for blood supply • 1985 AIDS Testing for blood supply

History of GMPs History of GMPs

Goal Goal • Control the process • Control the process – To make improvement to the quality of the To make improvement to the quality of the – software software – To reduce impact of changes and errors To reduce impact of changes and errors – – To ensure user requirements are understood To ensure user requirements are understood – and met and met – To increase reliability and usability To increase reliability and usability –

Automated Processes •Validate processes that cannot be fully verified. •Examples (molding, welding, sterilization, robotics, automated processes) •Computer or automated data processing systems used in production or the quality system •Validation is to ensure process consistently produces a result that meet specifications

Process Validation •Validation Protocol •Defines the testing to be conducted, pass/fail criteria, and responsibilities •Validation Report •Outlines the test results •Define processes that require validation •Define changes that require revalidation

Process Validation Process Validation • Establishing by objective evidence that a • Establishing by objective evidence that a process consistently produces a result or process consistently produces a result or product meeting its predetermined product meeting its predetermined specifications. specifications. – Installation Qualification (IQ) Installation Qualification (IQ) – – Operation Qualification (OQ) Operation Qualification (OQ) – – Performance Qualification (PQ) Performance Qualification (PQ) –

Process Validation (continued) Process Validation (continued) • Pharma • Pharma – “Validate the performance of – “Validate the performance of those manufacturing processes that may those manufacturing processes that may be responsible for causing variability” be responsible for causing variability” • Device – “Where the results of a process • Device – “Where the results of a process cannot be fully verified”, “the process cannot be fully verified”, “the process must be validated” must be validated”

Processes Requiring Validation Processes Requiring Validation • Water Purification • Water Purification • Freon • Freon Degreasing Degreasing • Air Systems for Clean Rooms • Air Systems for Clean Rooms • Cleaning • Cleaning • Sterilization • Sterilization • Sterile Packaging Sealing • Sterile Packaging Sealing • Plastic Injection Molding • Plastic Injection Molding

Molding Molding • 32 Cavity Mold • 32 Cavity Mold • Use 90 shots (One shot fills all 32 cavities) • Use 90 shots (One shot fills all 32 cavities) • Vary Time and Pressure • Vary Time and Pressure Time Low Med High Time Low Med High Pressure Pressure Pressure Pressure Pressure Pressure 4 secs secs 10 shots 10 shots 10 shots 4 10 shots 10 shots 10 shots 5 secs secs 10 shots 10 shots 10 shots 5 10 shots 10 shots 10 shots 6 secs secs 10 shots 10 shots 10 shots 6 10 shots 10 shots 10 shots

Software Software • 242 recalls between 1992 – 1998 were • 242 recalls between 1992 – 1998 were attributed to software failures. attributed to software failures. • Of the software failures 79% were caused • Of the software failures 79% were caused by software defects introduced when by software defects introduced when changes were made to the software after changes were made to the software after initial release. initial release. • Validation and design controls are • Validation and design controls are supposed to help avoid such defects. supposed to help avoid such defects.

Software Software • All devices that contain software are • All devices that contain software are subject to design control requirements as subject to design control requirements as found in 21 CFR 820.30. found in 21 CFR 820.30.