Incorporation of Best Industry Practices in Biomedical Engineering Design

1. Incorporation of Best Industry Practices inBiomedical Engineering Design Vincent Pizziconi BME Capstone Design Coordinator

2. Biomedical Engineering Capstone Design Evolution • Early Program Capstone Structure~ 1980’s BME 417 Biomedical Engineering Design • One-semester - 3 Credit Hour Course • Single Instructor, Typically Group Design Projects • Class Size ~20–35; Selected Medical Device Technologies => Paper/Pencil • FDA Regulatory Process - Tell Them But They Mostly Forgot • Capstone Structure ~ 1990’s BME 417/BME 490 Biomedical Engineering Design I & II • Two-semester - 3 Credit Hour Courses • Multi-tiered Instructor/Faculty Mentor Model => Prototype Development • Classes ~ 40 - 60 => Distributed Resource Model & Diverse Medical Devices Tech • FDA Regulatory Process - Show Them and They May Remember • Current Capstone Structure ~ 2000’s BME 417/BME 490 Biomedical Engineering Design I & II • Two-semester - 4 Credit Hour Courses (2006) • Multi-tiered Instructor/Diverse Mentor Model => Prototype Development Class Size ~ 65- 85 => Distributed Resource Model => Dedicated Design Studio • FDA Regulatory Process - Involve Them and They Eventually Understand HARRINGTON d e p a r t m e n t of b I o e n g i n e e r i n g

3. Transition from Design Textbook to Best Industry Practices • Year Long Capstone Design Experience SufficientTransition=>Design Textbook to QSR • 1st semester • - BME Capstone Not Just a Class => Rather a Transforming Experience • - Immerse Design Students in Contemporary Industry [MD&D]) Issues & Views • - Treat as a Medical Device Product Design & Development Mfg Organization • - Introduce Quality System Regulation => Rationale then Requirements • - Show Connectivity and Relevance Between: • Generic Product Design & Development Process => Design Controls • - Emphasize Need for Documentation => DHF, DMR, DHR, QSR • - Intermediate Transition - Design ReportReflects QS Requirements • 2nd semester - • -Less Reliance on Design Textbook => QSR/Design Controls Primary Textbook • QSR Guidance Documents => Drive Product Development Process • Final Transition => QSR-Based FDA Device Submission & DHF, QSR, DMR, (DHR) HARRINGTON d e p a r t m e n t of b I o e n g i n e e r i n g

4. Medical Device & Diagnostic Industry Comprehensive MDDI Profile Health Care Biomedical & Biotechnology Industry Profile => size (no. of establishments), location, employment figures, salaries for various levels of BME industry professionals,employment trends), medical device product types and market 'value' , international trade (imports and exports), how they are commercially classified (e.g., SIC), other pertinent medical device product metrics (trends in marketing, trends in distribution, etc), Contemporary Industry Perspectives on Medical Device Product Design read and report on selected articles from the bioindustry literature, such as the MD&DI, MPMN, EMDM, IVDT, PMPN, MEM and MX among other pertinent bioindustry trade magazines - The Essentials of Research in Successful Product Development August, 2007,MD&DI. - The Medtech Marketplace in 2007 Jan/Feb, 2007 MX - Medical Device Design: Learning from the Consumer Industry February, 2007 MD&DI. - Good Laboratory Notebook Practice January 2005 MD& DI - The Seven Deadly Sins of Medical Device Development Sept 2001 MD&DI - The Tech Group Implements Quality System for New Insulin Device Aug 2006 MD&DI HARRINGTON d e p a r t m e n t of b I o e n g i n e e r i n g

5. Incorporation of Best Industry Practices inBiomedical Engineering Design • Best Industry Practices A process, technique, or innovative use of resources that that consistently produces superior results => has a proven record of success in providing significant improvement in cost, schedule, quality, performance, safety, environment, or other measurable factors which impact the health of an organization. • Medical Device & Diagnostic Industry Best Practices Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured and that meets the requirements of the QSR HARRINGTON d e p a r t m e n t of b I o e n g i n e e r i n g

6. Medical Device & Diagnostic Industry Best Industry Practices Quality Systems Regulations HARRINGTON d e p a r t m e n t of b I o e n g i n e e r i n g

7. Quality Systems Regulations Subpart I Nonconforming Product §820.90 - Nonconforming product. Subpart J Corrective and Preventive Action §820.100 - Corrective and preventive 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 & Traceability §820.60 - Identification.  §820.65 - Traceability. Subpart G Production&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 acceptance.  §820.86 - Acceptance status. HARRINGTON d e p a r t m e n t of b I o e n g i n e e r i n g

8. Medical Device Quality Systems Manual: A Small Entity Compliance Guide • Read both the Preface/Forward and Chapter 1 of the QSR and then address the tasks described in more detail below. You are then requested to provide brief but succinct and well-synthesized responses to the following questions: • (a) In what respect(s) does the FDA Quality Systems Regulations differ from the previous FDA Good Manufacturing Practices? • (b) What is the intent of the FDA QSR? • (c) What is the true intent of the terms ‘appropriate’ or ‘where appropriate’ conveyed mean? • (d) What does the FDA QSR require? • (e) Who and what does the FDA QSR cover? • (f) Are there any establishments of medical devices that are exempt? If so, who/ why? • (g) Who are the mainstream ‘Medical Device Manufacturers’? • (h) Who are ‘Component Manufacturers? • (i) Who are ‘Remanufacturers’? • (j) Who are ‘Custom Device Manufacturers’? • (k) Who are ‘Contract Manufacturers’? • (l) Who are ‘Contract Testing Laboratories’? • (m) Who are ‘Repackagers, Relabelers, and Specification Developers’? • (n) Why does the FDA distinguish various types of ‘medical device manufacturers’? HARRINGTON d e p a r t m e n t of b I o e n g i n e e r i n g

9. Medical Device Quality Systems Manual: A Small Entity Compliance Guide • In order to help us better appreciate the intent of this broad statutory regulation that governs our industry as it applies to your impending medical deviceproduct design, you are requested to read Chapter 2 of the QSR entitled ‘Quality Systems’. • (a) What is a ‘quality system’ and why should it be an integrated effort? • (b) Identify all quality assurance activities • (c) What is the most important aspect of an entity/organization employing a quality systems approach? • (d) Is it enough to simply put a quality systems process in place? If not why? And, if not, then what else is necessary? • (e) Compare and contrast the attributes of the FDA QS regulation and those other Quality Assurance (QA) systems listed in the QS document at hand. • (f) Briefly list the Quality Systems ‘best practices’ and give a brief explanation of what each practice entails. • (g) What is the rationale behind the statement that ‘a medical device manufacturer should NEVER try to operate on the basis that only the quality system organization has primary and direct responsibility for the quality of product’ designed, developed and manufactured. • (h) Please list at least five factors that can have an impact on product quality. HARRINGTON d e p a r t m e n t of b I o e n g i n e e r i n g

10. Incorporation of Best Industry Practices inBiomedical Engineering Design HARRINGTON d e p a r t m e n t of b I o e n g i n e e r i n g www.fda.gov/cdrh/fr1007ap.pdf

11. Product Design And Development Planning Concept Development System-Level Design Detail Design Testing and Refinement Production Ramp-Up Identify customer needs Establish target specs Generate product concepts Select a product concept Test Product Concepts Set Final Specs Plan Downstream Development Perform Economic Analysis Benchmark Competitive Products Build and Test Models & Prototypes Ulrich & Eppinger: Product Design and Development

12. Best Industry Practices Design Controls User Needs Review Design Input Design Process Design Output Verification Medical Device Validation HARRINGTON d e p a r t m e n t of b I o e n g i n e e r i n g

13. Design Reviews HARRINGTON d e p a r t m e n t of b I o e n g i n e e r i n g

14. Involve Them and They Understand ! HARRINGTON d e p a r t m e n t of b I o e n g i n e e r i n g

15. …………. Questions & Comments …………