585.702.81 - Medical Device Innovation and Design

Applied Biomedical Engineering
Spring 2024


This course introduces you to the process of medical device design and innovation. You will learn the art and skill of identifying medical device opportunities through observations, interviews, and research. Through a combination of lectures, hands on activities, and interactions with clinical stakeholders, you will gain the ability to identify unmet, unarticulated, and underserved needs. Subsequently, you will learn the process of developing well thought out conceptual designs, that meet those needs. You will learn to apply an iterative approach towards innovation, by involving and engaging multiple stakeholders and their perspectives throughout the process. Throughout the course modules, you will also follow the journey of several innovative startups/products/ services, that started at JHU-CBID and went through the process outlined in this course.


Profile photo of Soumyadipta Acharya.

Soumyadipta Acharya

Course Structure

The course materials are divided into modules which can be accessed by clicking Course Modules on the course menu. A module will have several sections including the overview, content, readings, discussions, and assignments. You are encouraged to preview all sections of the module before starting. Most modules run for a period of seven (7) days, exceptions are noted in the Course Outline. You should regularly check the Calendar and Announcements for assignment due dates.

Course Topics

Module #

Module Title

Module Overview




Introduction to the Iterative / Spiral model of Healthcare Technology Innovation.


In this module we will introduce an iterative approach to healthcare innovation. We will begin by discussing the importance of starting with a problem or unmet need as the first step in the innovation journey. We will illustrate how needs and opportunities can arise from four quadrants-clinical, commercial, technical, and organizational insights. We will also discuss why and how factors across these four quadrants need to be iteratively considered with increasing depth and detail, throughout the innovation lifecycle.






Preparing for your innovation journey: Background research


In this module, you will learn how to conduct background research prior to direct ethnography (clinical observations and interviews). We will discuss strategies to maximize the insights that can be generated whenever there is an opportunity for firsthand interactions with stakeholders (observations, interviews).

We will discuss how to explore and summarize the pathophysiology of the underlying disease state, treatment options, epidemiology, stakeholder journey mapping (including the patient, the health care provider, the health facility, etc.), the cycle of care, the flow of money, and a preliminary market analysis.




Conducting clinical observations and interviews.


In this module you will learn how to prepare, conduct, and document observations in a clinical environment. You will also learn how to prepare for and conduct stakeholder interviews. You will also learn to plan your interview and prepare interview guides.

Subsequently you will learn how to document and deconstruct these clinical/ stakeholder encounters using mind-mapping.




Root cause analysis, Needs Statements, and Needs Prioritization - I



In this module you will learn how to extract meaningful insights and unmet needs from your ethnographic research by conducting a root cause analysis.

You will learn how to translate these insights into needs statements. You will also learn how to sort through hundreds of needs discovered through this process, using clustering and abstraction methods, and by gathering primary stakeholder feedback and preliminary four-quadrant analysis.





Prioritizing unmet needs - II. From a few to one:

Detailed stakeholder analysis, commercial opportunity, technical feasibility, and strategic alignment





In this module you will learn how to develop in-depth needs prioritization criteria, including:

 Methods in stakeholder analysis, market and economic analysis, competitive landscape, technical feasibility, etc.          








Midterm presentation

 In your respective teams, you will present your top unmet clinical need, from amongst the numerous that you have investigated in the previous modules. This will form the basis for your team project for the rest of the course. You will present the background of the problem, the clinical and commercial value proposition, and preliminary technical feasibility analysis. 



Developing solutions-I: Revisiting the root causes, through Genealogy mapping.

Defining Innovation targets.


In this module you will learn to deconstruct a clinical problem/ need into its underlying root causes, translating those into specific innovation targets, and developing high level mitigations to each innovation target.






Developing solutions- II: Introduction to ideation methods.

MECE maps as a framework for the ideation landscape.


In this module you will learn multiple methods to ideate and develop solutions to specific innovation targets. You will learn about frameworks such as MECE (Mutually exclusive, comprehensively exhaustive) to ensure that your ideation/ solution scouting is comprehensive. You will then apply those methods to generate competing solutions to the same underlying innovation targets.




Concept generation



In this module you will learn methods to generate multiple product/ service concepts for any given need, using frameworks such as Morphological Boxes. You will learn methods to obtain primary stakeholder feedback on some of your concepts using methods such as storyboarding, and prototyping.



Concept Prioritization and value analysis.

In this module you will be introduced to methods for prioritizing and ranking concepts generated. You will learn to conduct a value analysis for your concept(s) as a method to prioritize and select the ones that should be developed further. You will learn and apply methods for generating actionable user feedback on your concepts



Medical Device Regulation.

Intellectual Property (IP) basics.


In this module you will learn about medical device regulation and intellectual property basics

Topics covered include:

Overview of FDA and CDRH
Device Classification
Determining device class and burden of evidence for market access
Introduction to regulatory strategy

IP basics.
Freedom to operate
Introduction to IP strategy.



Reimbursement basics and strategy








In this module you will learn about reimbursement basics and strategy.

Topics covered will include:

Overview of reimbursement basics. Developing reimbursement strategy
Overview of medical device reimbursement pathways.
CPT codes, bundled payments, and other pathways for getting paid for the use of a new product of service.
Process for getting coverage
Process for establishing new CPT code.
Reimbursement strategy and the burden of evidence
Overview of Clinical evidence generation strategy




Creating a business plan.

In this module, you will revisit and refine the value proposition of your solution including assumptions (about clinical efficacy, customer adoption, Payer response, etc.).  You will learn to develop strategies to test those assumptions.
You will also learn how to develop and test key business assumptions that will inform the optimal business plan for the product/service
You will also learn how to develop a detailed business plan based on a chosen business model.


Final Presentation.

Comprehensive final presentation – The Problem and the Unmet Clinical Need. The Proposed Technical Solution. The Commercialization Strategy and Business Plan.



Course Goals


Course Learning Outcomes (CLOs)


Biodesign: The process of innovating medical technologies. 2nd edition. Yock et al.

Student Coursework Requirements

Formative weekly individual and/or group assignments (48% of the total grade)
Weekly discussion (18% of the total grade)
Final project (34% of the total grade divided between two checkpoints- 14% midterm presentation, 20% final presentation)

Grading Policy

Score RangeLetter Grade
100-98= A+
97-94= A
93-90= A−
89-87= B+
86-83= B
82-80= B−
79-77= C+
76-73= C
72-70= C−
69-67= D+
66-63= D
<63= F

Academic Policies

Deadlines for Adding, Dropping and Withdrawing from Courses

Students may add a course up to one week after the start of the term for that particular course. Students may drop courses according to the drop deadlines outlined in the EP academic calendar (https://ep.jhu.edu/student-services/academic-calendar/). Between the 6th week of the class and prior to the final withdrawal deadline, a student may withdraw from a course with a W on their academic record. A record of the course will remain on the academic record with a W appearing in the grade column to indicate that the student registered and withdrew from the course.

Academic Misconduct Policy

All students are required to read, know, and comply with the Johns Hopkins University Krieger School of Arts and Sciences (KSAS) / Whiting School of Engineering (WSE) Procedures for Handling Allegations of Misconduct by Full-Time and Part-Time Graduate Students.

This policy prohibits academic misconduct, including but not limited to the following: cheating or facilitating cheating; plagiarism; reuse of assignments; unauthorized collaboration; alteration of graded assignments; and unfair competition. Course materials (old assignments, texts, or examinations, etc.) should not be shared unless authorized by the course instructor. Any questions related to this policy should be directed to EP’s academic integrity officer at ep-academic-integrity@jhu.edu.

Students with Disabilities - Accommodations and Accessibility

Johns Hopkins University values diversity and inclusion. We are committed to providing welcoming, equitable, and accessible educational experiences for all students. Students with disabilities (including those with psychological conditions, medical conditions and temporary disabilities) can request accommodations for this course by providing an Accommodation Letter issued by Student Disability Services (SDS). Please request accommodations for this course as early as possible to provide time for effective communication and arrangements.

For further information or to start the process of requesting accommodations, please contact Student Disability Services at Engineering for Professionals, ep-disability-svcs@jhu.edu.

Student Conduct Code

The fundamental purpose of the JHU regulation of student conduct is to promote and to protect the health, safety, welfare, property, and rights of all members of the University community as well as to promote the orderly operation of the University and to safeguard its property and facilities. As members of the University community, students accept certain responsibilities which support the educational mission and create an environment in which all students are afforded the same opportunity to succeed academically. 

For a full description of the code please visit the following website: https://studentaffairs.jhu.edu/policies-guidelines/student-code/

Classroom Climate

JHU is committed to creating a classroom environment that values the diversity of experiences and perspectives that all students bring. Everyone has the right to be treated with dignity and respect. Fostering an inclusive climate is important. Research and experience show that students who interact with peers who are different from themselves learn new things and experience tangible educational outcomes. At no time in this learning process should someone be singled out or treated unequally on the basis of any seen or unseen part of their identity. 
If you have concerns in this course about harassment, discrimination, or any unequal treatment, or if you seek accommodations or resources, please reach out to the course instructor directly. Reporting will never impact your course grade. You may also share concerns with your program chair, the Assistant Dean for Diversity and Inclusion, or the Office of Institutional Equity. In handling reports, people will protect your privacy as much as possible, but faculty and staff are required to officially report information for some cases (e.g. sexual harassment).

Course Auditing

When a student enrolls in an EP course with “audit” status, the student must reach an understanding with the instructor as to what is required to earn the “audit.” If the student does not meet those expectations, the instructor must notify the EP Registration Team [EP-Registration@exchange.johnshopkins.edu] in order for the student to be retroactively dropped or withdrawn from the course (depending on when the "audit" was requested and in accordance with EP registration deadlines). All lecture content will remain accessible to auditing students, but access to all other course material is left to the discretion of the instructor.