The Graduate Certificate in Translational Biomedical Engineering consists of five courses (15 credits), including three required core courses and two complementary courses.
Core Courses (9 credits)
Three required courses in translational biomedical engineering:
BMDE 653 Patents in Biomedical Engineering
Course Description
This is a practical course on patents with emphasis on biomedical engineering applications. The course offers an overview of intellectual property, patents, and the patenting process. The course also provides insights into the strategies relating to commercialization and exploiting of patents, as well as enforcing patents. This course is designed to help biomedical engineers who will encounter patents in their work and needs to understand the nature and the scope of the patent system, how patents are obtained, and how to commercially exploit a patent.
Learning Outcomes
1. Differentiate the various forms of intellectual property, including copyright, patents, trademarks, industrial designs and trade secrets.
2. Understand the patent system, including the process of obtaining and maintaining a patent, in Canada, US, and Europe.
3. Understand a patent document, with emphasis on patent claims.
4. Have a preliminary experience in drafting patent applications, with emphasis on biomedical engineering subject matter.
5. Conduct a prior art research, and understand different prior art databases.
6. Know basic concepts of patent portfolio management, including the enforcement of a patent, and extraction of value from patents.
Instructor
Pierre T. Nguyen
Patent Agent, Partner, Norton Rose Fulbright
Affiliate Member, Department of Biomedical Engineering
Term
Winter 2022
Course Outline
BMDE 653 Patents in Biomedical Engineering
BMDE 654 Biomedical Regulatory Affairs - Medical Devices
Course Description
Regulatory strategies and quality management systems are critical for medical device development. This course provides an overview of regulatory requirements, and familiarize students with the important ISO and IEC standards pertaining to medical device development. This course will provide biomedical engineers with an understanding of the regulatory and quality requirements to translate a medical device idea into a commercial product, and will draw upon the expertise of invited speakers currently working in the medical devices industry.
Learning Outcomes
1. Understand the FDA’s, Europe (CE Marking) and Health Canada’s requirements for medical devices.
2. Gain insight into the best practices required for timely regulatory clearance and entry of medical devices into USA, Europe and Canada markets.
3. Appreciate the critical role of quality systems and effective process management in the innovation process.
4. Understand quality management definitions, concepts, and guidelines.
5. Understand the requirements of the ISO 13485:2016, ISO 14971:2007, and IEC 62304:2006 standards, and FDA’s Quality System Regulations (21CFR820).
Instructor
Danny Kroo
Consultant, Medical Device Quality Management & Regulatory Affairs
Affiliate Member, Department of Biomedical Engineering
Term
Fall 2021
Course Outline
BMDE 654 Biomedical Regulatory Affairs - Medical Devices
BMDE 655 Biomedical Clinical Trials – Medical Devices
Course Description
This course will train biomedical engineers to understand the clinical and business aspects of transferring a medical device idea into a commercial product. This course provides an overview of the pre‐clinical and clinical testing of medical devices, clinical trials, reimbursement systems, market analysis, sales models, and business models, as pertaining to medical devices. This course will also cover the design of randomized trials, including statistical principles, hypothesis postulating, bias minimization, and randomization methods.
Learning Outcomes
1. Understand different types of clinical trials based on their design, stage, and purpose.
2. Determine how to design a clinical trial based on the unique characteristics of the technology, the targeted patient populations, and the purpose of the trial.
3. Understand basic statistical principles and methods for clinical trial design, analysis, and reporting.
4. Understand the importance of good clinical practice, good laboratory practice, and quality systems in pre-clinical and clinical evaluations of medical technologies.
5. Appreciate the impact of business models, reimbursement strategies, and sales models on the commercial success and the adoption of medical technologies.
Instructor
Dr. Ahmad Haidar
Assistant Professor, Biomedical Engineering
Program Director, Certificate in Translational Biomedical Engineering
Term
Winter 2022
Course Outline
BMDE 655 Biomedical Clinical Trials - Medical Devices
Complementary Courses (6 Credits)
Two courses from specialized areas in biomedical engineering:
Other appropriate courses at McGill (500-level or higher) may be taken with approval of the Program Director
General Biomedical Engineering
Biomedical Signals and Systems
Medical Imaging
Biomaterials and Tissue Engineering
Biosensors and Devices