Course of Study

The following curriculum presents the 12-month course of study required to earn the MBID professional master’s degree.

Fall Semester

BMED 6501

Fundamentals of Biomedical Innovation and Development Processes
Sathya Gourisankar, Ph.D.
Credit Hours = 3
Distribution: 1.5 hours lecture, twice a week
Location: TEP

 

BMED 6502

BioiD Clinical Literacy and Experience
Jeremy Ackerman, M.D., Ph.D.
Credit Hours = 3
Distribution: 2 hours lecture, 3 hours lab/rotation
Location: Emory

 

BMED 6503

Medical Markets and Clinical Specialties
Rafael Andino, M.S., M.B.A.
Credit Hours = 3
Distribution: 1.5 hours lecture, twice a week
Location: TEP

 

BMED 6505

Product Planning and Project Management
Michael Smith, Ph.D.
Credit Hours = 3
Distribution: 1.5 hours lecture, twice a week
Location: COB

BMED 6501: The development and commercialization of medical products entail multiple stakeholders and unique regulatory requirements for engineering design, clinical testing, and FDA pre-market notification or approval of safety and effectiveness. This course will provide the framework in the design and commercialization process of medical products, including requirements and interdependencies of key stakeholders such as medical professionals (users), patients, and engineering development personnel, as well as regulatory requirements, intellectual property protection, commercialization strategy, project funding, clinical validation studies, manufacturing, distribution, reimbursement, and post-marketing surveillance requirements.

BMED 6502: Development engineers must interface with medical professionals and be effective in clinical environments, including understanding hospital protocols and communicating and working with clinicians, surgeons, nurses, and medical technical staff. Content will focus on hospital and surgical protocols; physician, surgeon, nursing, and technical support functions; medical terminology; ethnology research on how to observe and gather information in clinical settings; and HIPPA requirements for protection of patient confidentiality and information. Students will also learn the necessity of building professional trust in order to define user requirements, verify engineering design requirements, and obtain user feedback for design validation.

BMED 6503: In this course, BioID students will study the breadth of their industry, its structure, markets, specialties, and commercial opportunities. U.S. medical device and biologics markets generate over billions of dollars in annual commercial sales. This business relies on continued research, innovation, and translational development to deliver advancements in medical diagnosis techniques, therapies and treatment modalities, rehabilitation, and home healthcare. Changes in technologies, demographics of patient populations, national healthcare policies, and reimbursement continue to reshape the industry and healthcare delivery in the U.S., Europe, and developing countries.

BMED 6505: Innovation, development, and commercial success for medical products require in-depth knowledge of complex and independent factors such as identifying patient and user needs, engineering development processes, business planning, financial support, FDA quality systems regulations, good manufacturing practices (GMPs), and medical device regulatory requirements for commercialization. Topics to be covered in this course include identifying and evaluating market and product opportunities, marketing strategy project/product strategy development, business planning and project management methods, and development of a sound business plan.

Spring Semester

BMED 6504

Financial Planning for Projects
Arnold Schneider, Ph.D.
Credit Hours = 3
Distribution: 1.5 hours lecture, twice a week
Location: COB

BMED 6508

BioiD Team Masters Project I
Sathya Gourisankar, Ph.D.
Credit Hours = 3
Distribution: 1 hr lecture, 6 hours lab
Location: TEP

BMED 6504: Financial planning, forecasting, and budgeting for projects are essential requirements for successful development and commercialization of new products, product improvements, and product line extensions. This course covers the basics of financial planning, analysis techniques, and justification in order for engineering/development personnel to collaborate effectively with senior management, company financial management, and other essential business entities.

BMED 6508: Masters Project I and II courses provide BioID graduate student teams with opportunities to work with healthcare professionals and companies on the creation and development of innovative products to address unmet needs for patient care. Project Course I provides hands-on experience with industry-focused design and commercial development processes, including needs definition, solution alternative generation and analysis, project planning, concept and prototype development, design verification testing, FDA quality systems regulations, design controls, and regulatory pathways for commercialization of medical devices. Additionally, business functions such as marketing, sales, manufacturing, finance, intellectual property, and their effects on the product development process are integrated into the required projects and reports.

Summer Semester

BMED 6509

BioiD Team Masters Project II
Sathya Gourisankar, Ph.D.
Credit Hours = 6
Distribution: 2 hr lecture, 12 hours lab
Location: TEP

BMED 6506

Professional Communications for BioiD
Sathya Gourisankar, Ph.D.
Credit Hours = 3
Distribution: 1.5 hours lecture, twice a week
Location: TEP

BMED 6507

Fundamentals of Medical Device Regulatory Processes
Ty Cowart
Credit Hours = 3
Distribution: 1.5 hours lecture, twice a week
Location: TEP

BMED 6509: Project Course II focuses on construction of iterative prototypes and performance evaluation for the solution proposed in Course I. Semester deliverables include preparation of a FDA 510(k) regulatory submission package and development of a written commercialization business plan for the project.

 

BMED 6506: Effective communication is an essential component of medical device engineering, design, and business success. Composition skills, project/grant proposal writing, technical/project report writing, oral presentations tailored to specific purposes and audiences, "slide" design and projected presentations, and related techniques will be taught and practiced in class. Principles, methods, and techniques taught in this course will be coordinated with the sequence of required deliverables in BioID master’s program courses. Specific deliverables for this course will be assignments in preparing abstracts, business letters and communications, progress/project reports, and segments of business plans.

 

BMED 6507: U.S. and international regulations and standards are essential requirements for commercialization of medical products, including design and development, clinical testing, manufacturing, distribution and promotion, and post-market surveillance. This course will address ISO standards for medical devices and other regulatory requirements for the U.S. and selected other countries.