1. BME-IDEA 2007 TNL Classroom and Homework Exercises to Make the Regulatory Process Real and Interesting Biomedical Engineering-Innovation, Design, and Entrepreneurship Alliance 2007 Workshop September 26, 2007 Los Angeles, CA Terry N. Layton, Ph.D.

2. BME-IDEA 2007 TNL Make the Regulatory Process Real and Interesting Department of Bioengineering, University of Illinois, Chicago 1) GMP and Regulatory Requirements for Medical Devices 2) Product Development 3) Technology Assessment & the Start-Up of A Medical Device Company 4) Emerging Medical Technologies 5) Senior Design I & II

3. BME-IDEA 2007 TNL Semester Assignments, Exercises & Oral Presentations Medical Catheter Selection Product Requirement Definition (PRD) Catheter Complaint Hazard Analysis (HA) Defect/Complaint & Hazard/Harm Catheter Modification 510(k) or Letter to File (LTF)

4. Catheter PRD Who What Where When Why & How Who is using the catheter? Who is it being used on? What procedures? What are the indications? contraindications? What are the sizes or dimensions? When is it used? How is it sold?sterile, non sterile, 6’s, 10’s What other devices is it used with or compatible with? What does it do? What quality or manufacturing tests may be important? Try to list 3 What standards exist? ASTM, ISO, ANSI

5. BME-IDEA 2007 TNL Homework Assignment Define & Provide Example(s), if possible, with your catheter and consider for PRD –Accuracy –Actual Value –Deviation –Nominal –Range –Resolution

6. Catheter Complaint Hazard/Risk/Solution Risk Analysis –Identify the hazard –What is the risk? Estimate risks –Where or when did it happen? Company, Hospital, Doctor, Surgery Risk Evaluation—determine/decide risk acceptability What do I do about it? CAPA (Corrective Action & Preventative Action) Recall Do more tests Change specifications or label/instructions Nothing but Monitor Nothing

7. BME-IDEA 2007 TNL

8. Catheter Modification Submission –510(k) Decision Tree Design Labeling Manufacturing Process Testing –Letter to File(LTF) Documentation –Safety & Efficacy –Tests & Measurements DeLee tip Color- size idSingle loop Clear color 1-5 cm markings 14 Fr Suction Catheter

9. BME-IDEA 2007 TNL

11. Classroom and Homework Exercises to Make the Regulatory Process Real and Interesting Medical Catheter Selection (PRD) Catheter Complaint (HA) Catheter Modification 510(k) or Letter to File (LTF) THANK YOU Terry N. Layton, Ph.D. Visiting Professor,Department of Bioengineering University of Illinois, Chicago tnl@uic.edu Laytech, Inc www.laytechinc.com Tlayton71@aol.com