Program Structure

The Master's in Translational Biomedical Engineering consists of nine courses (27 credits), including four required core courses, five complementary courses, and an 18-week industry internship (18 credits).


Master's in Translational Biomedical Engineering

Core Courses (12 credits)

Four 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 External link, Partner, Norton Rose Fulbright
Affiliate Member, Department of Biomedical Engineering

Term

Winter 2023

Course Outline

PDF icon 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
Professional Consultant External link, Medical Device Quality Management & Regulatory Affairs
Affiliate Member, Department of Biomedical Engineering

Term

Fall 2022

Course Outline

PDF icon 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 2023

Course Outline

PDF icon BMDE 655 Biomedical Clinical Trials - Medical Devices

 

BMDE 656 Medical Device Reimbursement

Course Description

This course gives an overview of the reimbursement principles used by public and private insurers in Canada, the United States, England, Germany, and Taiwan. Most manufacturers do not realize it is essential to develop a reimbursement strategy - an actionable plan whose purpose is to demonstrate that their new medical device meets the justification to obtain regulatory approval and broad coverage by payers. This course will provide students with the knowledge and understanding of the importance of a medical device company’s reimbursement strategy.

Learning Outcomes

  1. Learn the “4 Pillars of Reimbursement”: (1) Regulatory Approval; (2) Coding; (3) Coverage; and (4) Payment.
  2. Explain the Necessity of Coding – ICD-10 Codes for Diagnosis; HCPCS Codes for Medical Devices; CPT Codes for Medical and Surgical Procedures; and Inpatient Diagnostic-Related Group (DRG) Codes used by Medicare.
  3. Assess/critique what drives public- and private-payer insurance companies in their coverage decision-making process.
  4. Recognize all other adjuvant activities needed to attain an all-inclusive reimbursement strategy.
  5. Perform critical analysis of real-life medical device reimbursement case studies.
  6. Identify types of healthcare reimbursement methodologies in Canada, the United States, England, Germany, and Taiwan.

Instructor

Dr. Vincent Jaeger
Professional Consultant External link, Medical Device Reimbursement

Term

Winter 2023

Course Outline

PDF icon BMDE 656 Medical Device Reimbursement

 

Complementary Courses (15 Credits)

Five courses from specialized areas in biomedical engineering: 

Other graduate & postdoctoral courses at McGill External link (500-level or higher) may be taken with approval of the Program Director.

General Biomedical Engineering

BMDE 501 Selected Topics:Biomedical Eng 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

Biomedical Signals and Systems

BMDE 502 BME Modelling & Identification 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 503 Biomedical Instrumentation 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 512 Finite-Element Modelling:BME 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 519 Biomedical Signals & Systems 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

Medical Imaging

BIEN 530 Imaging & Bio Instrumentation 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 610 Functional Neuroimaging Fusion 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 650 Advanced Medical Imaging 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

MDPH 607 Medical Imaging 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

Biomaterials and Tissue Engineering

BIEN 510 Eng'd Nanomtls for Biomed Appl 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 504 Biomaterials & Bioperformance 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 505 Cell and Tissue Engineering 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

Biosensors and Devices

BIEN 550 Biomolecular Devices 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BIEN 560 Design of Biosensors 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 503 Biomedical Instrumentation 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 508 Intro. to Micro & Nano-Bioeng 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

Seminars in Biological & Biomedical Engineering

BBME 600D1 Seminars in Biol & Biomed Eng 1.5 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BBME 600D2 Seminars in Biol & Biomed Eng 1.5 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

 

Industry Internship (18 Credits)

Full-time, 18-week, experiential learning in the medical technology industry:

Summer Internship

BMDE 657D1 Biomed. Eng. Industry Intern. 9 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 657D2 Biomed. Eng. Industry Intern. 9 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer


Meet the Faculty


The Graduate Certificate in Translational Biomedical Engineering consists of five courses (15 credits), including three required core courses and two complementary courses.


Graduate Certificate in Translational Biomedical Engineering

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 External link, Partner, Norton Rose Fulbright
Affiliate Member, Department of Biomedical Engineering

Term

Winter 2023

Course Outline

PDF icon 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
Professional Consultant External link, Medical Device Quality Management & Regulatory Affairs
Affiliate Member, Department of Biomedical Engineering

Term

Fall 2022

Course Outline

PDF icon 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 2023

Course Outline

PDF icon BMDE 655 Biomedical Clinical Trials - Medical Devices

 

Complementary Courses (6 Credits)

Two courses from specialized areas in biomedical engineering: 

Other graduate & postdoctoral courses at McGill External link (500-level or higher) may be taken with approval of the Program Director.

General Biomedical Engineering

BMDE 501 Selected Topics:Biomedical Eng 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

Biomedical Signals and Systems

BMDE 502 BME Modelling & Identification 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 503 Biomedical Instrumentation 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 512 Finite-Element Modelling:BME 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 519 Biomedical Signals & Systems 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

Medical Imaging

BIEN 530 Imaging & Bio Instrumentation 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 610 Functional Neuroimaging Fusion 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 650 Advanced Medical Imaging 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

MDPH 607 Medical Imaging 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

Biomaterials and Tissue Engineering

BIEN 510 Eng'd Nanomtls for Biomed Appl 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 504 Biomaterials & Bioperformance 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 505 Cell and Tissue Engineering 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

Biosensors and Devices

BIEN 550 Biomolecular Devices 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BIEN 560 Design of Biosensors 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 503 Biomedical Instrumentation 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

BMDE 508 Intro. to Micro & Nano-Bioeng 3 Credits
    Offered in the:
  • Fall
  • Winter
  • Summer

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