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2024  \nBME1801F Regulatory & BME Page 1 of 22  \nDr. Jayson L. Parker  \nAssociate Professor (teaching stream) Dept. of Biology  \nMBiotech Program (Digital Health) University of Toronto Mississauga  \nBiomedical Engineering (BME; cross appointment)  \nUniversity of Toronto  \nEmail: [jayson.parker@utoronto.ca](jayson.parker@utoronto.ca)  \n[Twitter: @Jayson_Parker](Twitter: @Jayson_Parker)  \nCell: 647-929-5315  \nPhD (University of Toronto)  \nMSc (University of Toronto)  \nMBA (Wilfrid Laurier University)  \nProfessional Interests  \nDigital health technology, medical device regulation, clinical trial design, biomarkers, health and wellness.  \nMy publications: [https://](https://)  \n[www.researchgate.net/profile/Jayson_Parker/](www.researchgate.net/profile/Jayson_Parker/)  \nImpact  \nMy interests stem from my time conducting research in medical imaging, brain trauma and drug addiction. My commercial experience in investment banking and the pharmaceutical industry also animate my research goals.  \nResearch on clinical trial failure rates in the context of new medicines and biomarkers is one of my main areas. Recently, we have started to combine this with advanced tools in machine learning.  \nThe “Dark Data” project is my main activity in the context of digital health. We are looking at lifestyle choices can predict improved health and wellness outcomes within 24 hours. This project makes extensive use of wearable technology.  \nDigital health and more broadly medical device regulation, are active areas of research.  \nMiscellaneous  \nHobbies include: Dungeons and Dragons, 3D-printing, digital modelling, tabletop wargaming (Warhammer 40k), computer games (MMOs, Fallout) and miniature painting.  \nBME1801F Regulatory & BME Page 2 of 22  \nClass Location: WB130  \nClass Times: Tuesdays (10:10 AM-2:00 PM)  \nInstructor: Dr. Jayson Parker, M.B.A., M.Sc., Ph.D.  \nOffice Hours: Office meetings are by appointment.  \nTA: [Ms. Kate MacQuarrie. ](Ms. Kate MacQuarrie. k.macquarrie@mail.utoronto.ca)[k.macquarrie@mail.utoronto.ca](Ms. Kate MacQuarrie. k.macquarrie@mail.utoronto.ca)  \nBME1801F Regulatory & BME Page 3 of 22  \nCourse Description  \nThe goal of the course is to understand medical device product development with a strong emphasis on medical device regulation.  \nStudents will be able to:  \n1. Given a medical device, identify and argue for possible pathways for medical device regulation for product approval.  \n2. Reverse engineer from a regulatory pathway to create a medical device.  \n3. Apply hazard analysis to medical devices in support of your arguments.  \n4. Navigate the FDA website and use FDA guidance documents and medical literature appropriately.  \n5. Forecast future thinking by the FDA on emerging innovative medical device issues.  \nCourse Overview:  \n\n| Course Element | Weighting |\n| --- | --- |\n| Course Engagement | 5% |\n| Tutorial I: ICD Hazard Analysis | 10% |\n| Tutorial II: ICD 510k Submission | 10% |\n| Major Project: |  |\n| Customer Need Identification | 5% |\n| Feedback on your Design from Experts | 10% |\n| Final Report and Presentation | 25% |\n| Final Exam | 35% |\n\n\n| Assignment | Due Date | Mode of Submission |\n| --- | --- | --- |\n| Team Formation | Sept 17th before class | Coordinate with the TA. |\n| Tutorial I: ICD Hazard Analysis | Sept 24th before class | Email to both TA and instructor. CC all team members. |\n| Tutorial II: ICD 510K Submission | Oct 8th before class | Email to both TA and instructor. CC all team members. |\n| Major Project: User Feedback | Nov 5th | Email to both TA and instructor. CC all team members. |\n| Major Project: Design and Expert Feedback. | Nov 12th before class | Email to both TA and instructor. CC all team members. |\n| Major Project Due | Nov 24th by Noon | Email to both TA and instructor. CC all team members. |\n| Major Project Slide Deck Due | Nov 25th 5:00 PM | No animations and no“links”to presentations.","cbCaihQy2HbjBCDW","https://ap.wps.com/l/cbCaihQy2HbjBCDW","pdf",313568,22,"English","# Course Description\n## Learning Outcomes\n# Course Overview\n## Course Element Weighting\n## Assignments and Due Dates\n# Course Activity Schedule","[{\"question\":\"What is the main goal of BME1801F Regulatory \\u0026 BME?\",\"answer\":\"The course goal is to understand medical device product development with a strong emphasis on medical device regulation.\"},{\"question\":\"What skills will students be able to demonstrate by the end of the course?\",\"answer\":\"Students will be able to identify and argue possible regulatory pathways, reverse engineer a medical device from a regulatory pathway, apply hazard analysis, and use FDA guidance documents and medical literature appropriately.\"},{\"question\":\"How is the course evaluated?\",\"answer\":\"Evaluation includes course engagement (5%), tutorials (ICD hazard analysis 10% and ICD 510k submission 10%), major project components culminating in a final report/presentation (25%) and a final exam (35%).\"},{\"question\":\"When are key tutorial assignments and the major project due?\",\"answer\":\"Team formation is due before class on Sept 17, Tutorial I is due Sept 24, Tutorial II is due Oct 8, major project user feedback is due Nov 5, expert feedback and design is due Nov 12, major project is due Nov 24 by noon, and the slide deck is due Nov 25 at 5:00 PM.\"}]","BIOMEDICAL ENGINEERING - BME1801F Regulatory & BME - Course Syllabus | PDF",1791335971,55]