Assignments
Course Objective
Developing a new medical device requires identifying an unmet diagnostic and/or therapeutic need, solving technical challenges, meeting regulatory requirements, preserving intellectual property (IP), identifying a reimbursement model, and establishing a successful business model. We believe that a proven way to learn the medical device engineering process is delve into an actual device project.
The ultimate objective of the class is to teach medical device design and innovation. The best approach is to plan that your project will be successful in the marketplace. However, even successful medical companies do not succeed with every new medical device they try to develop. We do expect that a real medical need be addressed and that all aspects of the design process be rigorously addressed. You will find that many challenges will present themselves along the way, but hopefully you will also experience the thrill of presenting your prototype to a potential user and seeing their impressions firsthand. The skills developed by committing oneself to tackle the complexities of a real device will help your career whether it is in your own startup or within another company.
MDE260ABC Sequence
MDE 260A
The fall quarter will focus on identifying your project to pursue and begin ordering prototyping components. Areas identified over the summer will be explored further. In-depth literature review should be performed, and the viability of preliminary design solutions explored (at least 3). Areas of constraint such as regulatory pathway, IP review, and reimbursement strategy should be started. FDA design controls will be used to guide the project. The grade in 260A will be based upon the depth of problem identification, overall project progress, and clarity of presentations and progress on FDA Design History File.
MDE 260B
The winter quarter will focus on tackling the primary technical challenge areas. Hardware should be built that illustrates proof-of-concept of the project. The grade in 260B will be based on the level of prototype development, overall project progress, and clarity of presentations and progress as demonstrated in the FDA Design History File.
MDE 260C
The spring quarter will pull together the various aspects of the MDE project. At this point prototypes should be presented to potential customers (sometimes under non-disclosure) for feedback. The project will be summarized in a Design History File and presentation before a mock panel of technical experts and investors. The grade in 260C will be based on the overall project and final presentation.
Schedule for Fall 2017
Meetings at UCSD will occur approximately very other week. The first part of each MDE 260 class will be spent in small group meetings discussing your project with the faculty technical adviser. The second half of the MDE 260 class will be oral presentations of designated students. Each students will present twice a quarter, and will be an important part of the class grade.
In-between UCSD meetings, students will arrange for a Skype type consultation meeting with their assigned adviser.
9/29 - Course Intro
10/6 - Skype consultation with faculty
10/13 - 1st Presentations by Group 1
10/20 - Skype consultation with faculty
10/27 - 1st Presentations by Group 2
11/3 - 2nd Presentations by Group 1
11/10 - Skype consultation with faculty (coordinate with faculty due to Veterans Day)
11/17 - 2nd Presentations by Group 2
12/1 - Skype consultation with faculty
12/8 - Final presentations by both groups (till 1:30pm)
Project Selection
The starting place for a project is to identify an unmet medical need (even better if this need is being neglected by others). The key to identifying need areas is through Customer Discovery where one observes, doctors, nurses, and patients and listens carefully to the details of their daily challenges and concerns.
Having identified a passion for an unmet “clinical need” it is important to identify reimbursement and regulatory pathway options. This will help form a more realistic strategy to determine design concepts that will address safely and effectively the unmet clinical need.
What about competitors? If you find someone else in the same space, it validates that you are working on something considered promising. In the current healthcare system there is always room for lower costs, higher quality at established costs, and more effective diagnosis, treatment or combined diagnosis with treatment.
Select a project were it is possible to make significant progress towards a prototype within the duration of the MDE 260 course. Your learning experience will be much richer if you can bring your project to the point where you demonstrate a prototype and get feedback.
Medical Advisors
A key factor for successful project is high quality feedback. Each student should have both technical and medical mentoring. The technical advisor will be one of the MDE 260 instructors and will be assigned based upon your project area. The medical adviser will typically be a physician or care-provider located during Customer Discovery and is critical for providing real-world feedback regarding the viability of the design project. It is the responsibility of the student to find a medical adviser, but the MDE 260 will provide contacts and assistance. In addition to a primary medical mentor, each student should identify a number of potential customers from which they can get feedback.
Each MDE student can work on his or her own project, or a pair of students can propose working together. MDE students can also partner up with medical students and residents. Some physician mentors may wish to play an active role in the design process as well. All models are viable, but it is up to each MDE student to explicitly define their role in the project. It is also suggested that IP ownership issues be discussed early on with team members and collaborators.
Confidentiality
Confidentiality is important for many medical devices. Project webpages can be password protected and faculty and fellow classmates all sign a confidentiality agreement. However, ultimately to be an appropriate MDE 260, one must be willing to discuss the details of the project in a classroom setting and share the project webpage with classmates and instructors. The experience of presenting your project with feedback interactions with fellow students and faculty is one of the most valuable aspects of the MDE Program.
Students Working in Pairs
Students can work in pairs with instructor approval. The quantity of work is expected to be twice that of individual student projects. The budget for a team project will be that of a single individual project, $2,000. However, the pair can apply for an additional $2000 with appropriate justification.
Grading
We expect that each student will pursue a project that addresses a real medical need and pursue an approach that that has potential for development of a new medical device. It is expected that every topic area with have both pros and cons, we just want to make sure each student is aware of all the cons and has plans to address them. It is also fine to switch topics within the fall quarter, but we want to get started on delving into specific project areas. The grading criteria will be based on the quality of the project and will include:
Quality of customer discovery and stakeholder group (at least 6 interviews in fall quarter).
Completeness of Competitive Analysis
Range of Concept Generation
Identification of both technical and business risks.
Documentation support on webpage.
The grade breakdown includes:
Presentation 1 20%
Presentation 2 20%
Final Presentation 50%
Class Participation 10%
Each student is responsible for conducting their own customer discovery interviews (See Medical Device Design Text for some tips and examples). Some Physician and Nurse contacts are accessible for MDE students at the Piazza website: https://piazza.com/class/iak4nuz6q92ot, but others can be found through course faculty or your own initiative.
Oral Presentations
The class will be divided into 2 groups, and every class meeting one of the groups will give an oral presentation. Each presentation will be timed for 10-12 minutes and should focus on a single need area being pursued. The presentation should include:
Brief overview of the medical area.
Describe the medical issue, often with a figure.
List the target number of possible users
Describe the need.
Clearly describe the need being solved - not the solution being proposed.
List who you spoke with in customer discovery
Review existing solutions (a comparison table is a good way)
Identify early adopters for whom the need is compelling
Present 2-3 possible design solutions
Identify high risk technical areas and possible risk reduction efforts
Identify high risk business area and possible risk reduction efforts
Emphasis should be placed on clarity and good use of graphics when needed. See How to Give Winning Presentations - MDE.
Post your presentation slides on your website before your presentation, so that feedback can be provided on your material.
Individual Consultations
Each MDE student will be assigned to a faculty mentor, and is to give a progress update on a weekly basis. For weeks in which there is no UCSD meeting, the consultations are to be performed in a Skype type meeting. PowerPoint slides should be prepared and shared before the call (see Status Reports below). Each student should coordinate the time for the consultation, which should be close to the Fridays for which there is no UCSD meeting.
Students can solicit input from any other MDE 260 faculty, along with their assigned mentor.
Documentation
Each student will maintain a webpage for the project, based upon the project template. Access to these webpages will be restricted to MDE260 students and instructors.
Updates are to posted on-line prior to each class. Include:
Accomplishments in last 2 weeks.
Objectives for the next 2 weeks.
A key component of the course is for each student to provide feedback to the other students. Some of this feedback will be given in class, but in addition each student is expected to post questions and suggestions in the comment area of your teammates' website.
All presentations should be at a professional level with emphasis on clarity. Figures, comparison tables, and flowcharts should be used where appropriate. References and copies of articles should be posted on your project page.
Status Reports
The status report will be presented to a faculty advisor in a small group meetings. The report should be in powerpoint format, but will be presented while sitting around a table. The presentation should take 5-10 minutes to present and should include:
Brief overview of the project and the need statement.
Update on the new customer discovery interviews performed.
Marketing risks update:
Does evidence indicate that indeed the need is compelling.
Update on the competition (comparison tables work well).
List of marketing risks from FDA approval to reimbursement.
Design Solutions: Present at least 3 concepts:
Show figures, flow charts, etc.
List pros and cons of each concept.
List high risk technical issues.
Risk Reduction Plan
Present a plan of action that will allow you to determine if your concept is viable.
Address both technical risks reduction (typically though a hardware test) and marketing risk reduction (typically through interviews and presentation of a minimum viable product).
Timeline. This can start in fall quarter, but should be completed by end of winter quarter if not sooner. List key milestones.
Pivots: A student can switch their project during fall quarter, in which case their status update should provide a more in-depth discussion of the problem.
Addressing faculty feedback: Please review all faculty and classmate comments provided in the last class meeting. While you do not have to agree with all feedback, you do need to address the issues raised.
Patent Assignment
Read Intellectual Property Overview and note assignments due on 2/2/2018 and 2/16/2018 at end of document.