Medicine 276: Introduction to Medical Technology Industry ...



Medicine 276: Introduction to Medical Technology Industry and its Careers

Autumn 2006

Tuesdays 4:15 ~5:05 (note: it starts at 4:15, not 3:15)

Location: 200-034 (Building 380 is in the Main Quad, the History Corner. 200-034 is in the basement of Building 200)

Course Website:

Handouts: visit Coursework ().

Course Description:

The goal of this course is to introduce concepts in biomedical technology industry to students, and to help students enter this field and be prepared for careers in this field. Topics covered in this course include: industry overview; innovation in research and development; intellectual property and business development; product development; clinical trials, regulatory issues and agencies; manufacturing; marketing; capital structure and fundraising; ethics.

Course Outline:

(The topics/speakers and the ordering of the topics are subject to change.)

|Oct 3, 2006 |Entrepreneurship 1 |

| |Adnan Shennib (Center for Medical Device Innovation) |

|Oct 10, 2006 |Engineering |

| |Bill Main, Ph.D. (Accuray) |

|Oct 17, 2006 |Venture Capital |

| |Kevin Wasserstein (Versant Ventures) |

|Oct 24, 2006 |Research and Development |

| |Daniel Lerner, M.D. (FoxHollow) |

|Oct 31, 2006 |TBA |

|Nov 7 |TBA |

|Nov 14 |Entrepreneurship 2 |

| |Steve Rudy (Fluid Medical) |

|Nov 21 |Thanksgiving, no class |

|Nov 28 |Product Development |

| |Kenny Dang (Boston Scientific) |

|Dec 5 |TBA |

Units and grading:

1-2 units

The lectures (4:15~5:05PM) are mandatory for everyone, and the sections are mandatory for those taking Med276 for 2 units and optional for those taking it for 1 unit. Students are strongly encouraged to enroll in 2 units. The 2-unit component consists of activities that are designed to help you understand medical technology industry and innovation process.

Two unit/grading options:

(1) 1 unit, credit/no-credit: attendance in the lectures.

(2) 2 units, letter grade: lecture attendance + projects.

(Grading in Med276 is not based on a curve. Rather, grading is based on each student's own efforts and progress.)

2-unit projects:

* Team project to evaluate medical technology inventions. Provide consultation for the Stanford Office of Technology Licensing.

Learning objective: understand the process of turning an idea into a solution that can benefit patients.

Tasks: evaluate the clinical need, assess the market potential, study technical feasibility, research competing technologies and prior arts, investigate potential financing, marketing, and regulatory issues, and propose potential business and licensing models.

Tentatively, current projects include a stent invention, a drug delivery invention, an osteoporosis invention, and other projects.

* Extra Credit: a project to come up with novel inventions or prototype new ideas in medical technology.

Course Topic Outline:

Medical Technology Industry Overview

Key topics:

1. What are the key clinical needs addressed by the medical technology industry? (e.g., cardiology, neurology, orthopedics, ophthalmology)

2. What are the key pieces of knowledge about the pathophysiology and clinical procedures of these clinical needs? (e.g., atrial fibrillation, tremor, spinal cord injury, glaucoma)

3. What are the main products addressing the clinical needs?

4. Who are the players in the medical technology industry that work on these products?

Further Introduction of Medical Technology Industry

Key objectives:

1. Who are the major players in the medical device industry (companies, regulatory, organizations)?

2. What are the major companies and what products do they make?

3. Where are the geographical hot spots of medical technology industry?

4. What is the medical technology development process?

5. What campus resources are available for Stanford students?

Medical Technology Product Development and Manufacturing

Key topics:

1. (More information than the last lecture) What are the products that address the clinical needs (e.g., pacemaker, defibrillator, stent, catheter, MRI), and what are their key scientific and engineering principles (i.e., how do they work)?

2. How are these products developed, and how are they manufactured? In other words, how are these products made?

3. How do you ensure that you meet the customers’ need and assure the product quality?

Career topics

4. What are the main tasks of one’s work in product development and manufacturing?

5. What are the career highlights and challenges working on product development and manufacturing?

6. What are the career pathways in product development and manufacturing?

Career Planning vs. Job Hunt

Key objectives:

1. What is the difference between a “career” and a “job”?

2. What are the worst ways of finding a job?

3. What are the best ways of finding a job?

4. What are the main career pathways in medical technology industry?

Medical Technology Research and Development

Key topics:

1. Where do ideas and innovations come from?

2. How are ideas assessed?

3. What are the key research and development activities in the industry? (e.g., ME, EE, bio, materials, ChemE)?

4. What are the key trends and main activities in R&D in the industry?

Career topics

5. What are the main tasks in one’s work in R&D?

6. What are the career highlights and challenges working on R&D?

7. What are the career pathways in R&D?

April 19, 2005 Section

Discovery your interests and your skills

Key objectives:

1. What motivates you and what are important to you in considering careers?

2. What are your interests?

3. What are your favorite skills?

4. Are you on a career pathway that leads to your passion? What are the career pathways that would lead you to your passion?

Medical Technology Clinical Trials and Regulatory Affairs

Key topics:

1. How does one design and conduct clinical trials to test the safety and efficacy?

2. How are medical technology products regulated, and how do companies conform to the regulations?

3. What are possible outcomes of clinical trials and what reactions do companies take？

Career topics:

4. What are the main tasks in one’s work in clinical trials and regulatory affairs?

5. What are the career highlights and challenges working on clinical trials and regulatory affairs?

6. What are the career pathways in clinical trials and regulatory affairs?

Medical Technology Financing

Key topics:

1. How do startup companies get funded?

2. How do medium size companies get funded?

3. How does an investor make decisions on investment?

Career topics

4. What are the main tasks in one’s work in financing?

5. What are the career highlights and challenges working on financing?

6. What are the career pathways in financing?

Medical Technology Entrepreneurship

Key topics:

1. How are scientific ideas turned into start-up companies?

2. How does one start a medical technology company? What are the steps?

3. How are the risks assessed and handled in entrepreneurship?

Career topics

4. What are the main tasks in one’s work in entrepreneurship?

5. What are the career highlights and challenges working on entrepreneurship?

6. What are the career pathways in entrepreneurship?

Medical Technology Product Management and Marketing

Key Topics:

1. Who are the payers, users, and consumers of medical technology products? How does reimbursement work?

2. What are the means for a company to market their products?

3. How does a company communicate with physicians? How does a company manage its products?

Career Topics:

4. What are the main tasks in one’s work in marketing and product management?

5. What are the career highlights and challenges working on marketing and product management?

6. What are the career pathways in marketing and product management?

Medical Technology Business Development and Corporate Strategies

Key Topics:

1. What are the deals that a company makes and why do companies make these deals? For start-ups? For public companies? (e.g., partnership, merger/acquisition)

2. How are the deals made?

3. What (ethical) strategies can a company take to go ahead of its competitors?

Career Topics:

4. What are the main tasks in one’s work in business development and corporate strategies?

5. What are the career highlights and challenges working on business development and corporate strategies?

6. What are the career pathways in business development and corporate strategies?

Medical Technology Intellectual Property

Key Topics:

1. What is intellectual property (IP)? What are the types of IP relevant to medical technology? 2. What’s the importance of IP? How is it protected?

3. What (ethical) IP strategies can a company take to go ahead of its competitors?

Career Topics:

4. What are the main tasks in one’s work in IP?

5. What are the career highlights and challenges working on IP?

6. What are the career pathways in IP?

Optional Reference:

Bolles, What Color Is Your Parachute? A Practical Manual for Job Hunters and Career Changes. (Ten Speed Press, 2005).

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