Johns Hopkins University Center for Bioengineering and Innovation Design

Academics

Academics

Curriculum

David E. Swirnow MSE in Bioengineering Innovation and Design Program Curriculum

The program is designed for a student with an undergraduate degree in an engineering discipline and who also may have industry or research experience. The 11 month program begins at the start of summer and runs continuously through the fall and spring semesters. Students will graduate with the David E. Swirnow Master of Science in Engineering (MSE) in Bioengineering Innovation and Design degree in late May at the Homewood campus commencement.

2011-2012 Curriculum 

Summer Courses:

 

Fall Semester:

 

Spring Semester:

 

Course and Course Description Search

  

 

580.601/602/603 Seminar - Special Topics in Bioengineering Innovation and Design
This year long seminar series features experts from the medical device industry, venture capital firms, FDA, patent attorneys, entrepreneurs, and many more. They will share their real-world insights into the medical device innovation and commercialization process. Some of the topics covered will include bioethics, regulatory and reimbursement planning, medical device recalls, good design practices, and entrepreneurial success stories. The overarching philosophy of this seminar series is to complement the theoretical and practical aspects of the program curriculum, by learning from the experiences and insights of professionals in the field. These seminars are taken in a sequence of summer, fall, and spring. They are required for CBID masters students and are open to those students only.
Summer, Fall, Spring
Faculty: Soumyadipta Acharya

580.604/605/606 The Business of Bioengineering Innovation and Design
This year-long course comprises two distinct but related components. The first is a broad introduction to the terms, concepts, and values of business and management. Particular emphasis will be placed on the economic, financial, and corporate contexts of our business culture, and how they impact the organization, strategy, and decision-making of business firms. The second component is an introduction to the sociological and economic forces that shape the development and diffusion of new technologies. This part is primarily designed to provide a framework for determining the commercial viability of new medical devices and the best path for realizing their value, including how to develop a compelling value proposition, analyze markets and competitors, and protect intellectual property. Throughout, the course utilizes individual exercises, case analyses, and team projects.
Summer, Fall, Spring
Faculty: Lawrence Aronhime

580.607 Regulation of Medical Devices
This summer course introduces CBID graduate students to the medical device regulatory framework, as it pertains to bringing a medical device from concept to market. Topics covered include; FDA Design Controls; Regulatory Approval mechanisms, including the 510k and PMA process; Investigational Device Exemption (IDE); planning clinical trials needed for bringing a medical device to market; and postmarket surveillance. Students learn from a series of invited lecturers from the FDA as well as professionals from the medical device industry.
Summer
Faculty: FDA staff, Soumyadipta Acharya

580.608 Identification and Validation of Medical Device Needs - Clinical Rotations
This summer course teaches the art and skill of identifying medical device opportunities by experiencing real world scenarios in an immersive clinical environment. Students rotate through multiple clinical disciplines and become part of the team of senior clinicians, surgeons, residents, fellows, nurses and medical technologists. They learn to identify unmet medical device needs through direct observations in a variety of clinical settings including the hospital ward and operating room, interviews (with patients, doctors, nurses, hospital administration), literature survey, and more. Concurrently, they learn the process of filtering all observations to a few valid medical device opportunities by assessing the market size, intellectual property landscape, regulatory framework, and competitor dynamics in addition to the clinical impact that such a device could have. The ability to identify a relevant medical device need is an important first step in the medical device innovation cycle; this course aims to provide students with practical hands- on training in that process.
Summer
Faculty: Clifford Weiss, Soumyadipta Acharya

580.611/612 Medical Device Innovation and Design (for US market)
The two-semester design project provides teams of students with hands-on design experience and takes them through a practical journey of the entire medical device innovation cycle for the US market. Student teams select a project after scrutiny of various factors such as clinical impact, commercial viability and potential, and technical feasibility. Next, they define the needs and requirements of such a device, in close consultation with the target user (clinician and patient, typically). This is followed by development of an engineering solution: invention, design and prototyping of the device. Concurrently, teams develop a commercialization strategy that includes planning for regulatory and reimbursement approval, generating and protecting intellectual property, going from prototype to manufacturing, and taking the final product to market either through the startup or licensing route.
Fall, Spring
Faculty: Soumyadipta Acharya

580.613 Identification and Validation of Global Health Needs
In this course, students are introduced to clinical needs in the low resource settings of the developing world which presents unique challenges. Working with partner Jhpiego, a Johns Hopkins affiliate that is a world leader in family health, students develop device projects that will have the greatest clinical impact in these settings. Students will travel in August to the field locations around the world to see first-hand the clinical environment for these projects and meet the health care workers who will be using the devices.
Summer
Faculty: Soumyadipta Acharya

580.614/615 Global Health Innovation and Design
In these courses, students develop device projects that will have the greatest clinical impact in resource-restrained settings around the world. Partnering with Jhpiego, a Johns Hopkins affiliate focusing on maternal and child health, students design, build and test devices that will be used in these setting by a semi-skilled health care workers. Students will work with staff and faculty from Jhpiego as well as other clinicians, engineers, and advisors to make sure the devices work as well as possible at the most affordable price.
Fall, Spring
Faculty: Soumyadipta Acharya

580.415 (3) Ethics of Bioengineering Innovation
Engineers confront problems and make decisions that hold long term social consequences for individuals, organizations, communities and the profession. For biomedical engineers, these decisions may relate to: inventions such as medical devices and pharmaceuticals; neural prosthetics and synthetic biological organisms; responsible and sustainable design; availability of biotechnology in the developing world. Using a combination of cases, fieldwork and readings, we examine the ethical issues, standards, theory and consequences of recent and emerging engineering interventions as a way to understand the profession and to form a basis for future decisions. In addition students will learn and practice multiple forms of communication, including oral, visual and written rhetoric. A particular focus will be communication targeted to different stakeholders including other professionals and the public. Students will apply good communication principle to the discussion of biomedical engineering ethics, develop their own ethical case studies and participate in group projects to aid ethical decision-making, and to improve communication of complex biomedical ethical issues to others.
Fall
Faculty: Eric Rice, Feilim MacGabban, Elizabeth Logsdon, Youseph Yazdi

580.621 Insight Informed Innovation
This course is intended to equip students with a repeatable/structured process and the tools required to:

  1. Identify opportunities for new medical devices through unmet, unarticulated and underserved stakeholder needs
  2. Link these insights to an exhaustive set of potential solutions
  3. Synthesize solutions and features into validated product concepts

Particular emphasis will be placed upon the Front End of Innovation (FEI), Voice of the Customer (VoC) and ethnographic research in a clinical setting. The working assumption for this course is that the (rigorous) FEI/VoC background among incoming students is minimal. The objective, therefore, is to equip students with the process and tools that they will need to:

  • Extract maximum benefit from their clinical rotations; building the research resource from which they will identify their team projects.
  • Scout and/or ideate and prioritize an exhaustive set of potential technical solutions which meet prioritized stakeholder needs
  • Advocate the Voice of the Customer during the concept development process in order to build appropriate stakeholder validated product concepts

The course will be taught primarily in the Fall semester but a rigorous introduction to customer research and capture will be given at the start of the summer semester as students begin to conduct their clinical rotations and gather customer (stakeholder) insight. This course is a distillation of industry best-practice and is taught by industry practitioners.
Fall
Faculty: Paul Fearis, Brandon Craft