Attention MIT-CIMIT Design of Medical Devices Class of 2011-2012: Calling for Proposals!

CIMIT Clinicians, do you have a clinical challenge that needs a new medical device?

For the last 7 years CIMIT has sponsored MIT course 2.75 which focuses on the design of medical devices. CIMIT affiliated clinicians are invited to submit applications to work with teams of MIT mechanical (and some electrical) engineering students to create prototype solutions to clinical challenges.

Beginning in September, clinicians whose projects are selected will team with a small group of students and course staff in an aggressive, but efficient 14-week design process. Firstly, the team will develop a detailed understanding of the clinical need and a resulting set of design specifications. Then they will follow a deterministic design process to create strategies, concepts and prototype solutions for testing. Final prototypes will be presented in December to a clinical and medical device industry audience. CIMIT provides for each team to receive a prototyping budget. Particularly successful projects will be invited to continue on into a spring course for further development.

This course is in effect an efficient idea generation engine and has yielded significant IP and over 27 papers, served as a pipeline for creating new research areas for both clinicians and students and fostered licensing deals and a few start-ups. Clinicians and students have enjoyed the process and often continued collaborating beyond the course.

Course and CIMIT staff will review applications and (nominally) select 12 which are suitable for presentation to the class. Students will make the final selection of 6—8 projects as they form teams after the presentations.

Additional Course Information

• Course website
• Current projects
• Select past projects

Key Dates

• Two page proposals due: July 15, 2011 Extended to August, 15 2011
• Submission via e-mail: mdic@mit.edu with subject: “2011 2.75 Submission”
• Finalists notified: August 15, 2011 September 1, 2011
• Presentation to students: 3rd week of September
• The final selection of 6—8 projects will be made by the students with minimal instructor intervention.

Proposal Guidelines

Your proposal is limited to 2 pdf pages, including pictures and references, and must contain:

1. Name, affiliation and direct contact information (phone & e-mail).
2. Background on the current clinical procedure, with pictures, links to videos and references.
3. Statement of clinical challenge and its significance.
4. Functional requirements of desired solution, but not a description of concepts already conceived.
5. Disclosure of any relevant previous work (research notes, publications or patents filed).

We ask that clinicians please avoid proposing a particular solution, rather present the problem as precisely as possible. Prior experience has shown that the final solutions are more creative when the team starts with blank sheets of paper.

Each project submission should have one clearly defined clinician, practicing in the area of the identified need, who serves as the project champion and interfaces directly with the students over the semester. (This person can facilitate interaction with other clinicians and resources as needed.)

We understand that you have numerous ideas, but only one application per clinician per year will be accepted, so please pick your favorite. Do not hesitate to contact us if you would like guidance.

Finalist Selection Criteria

Course and CIMIT staff will conduct the initial screening of projects. Nominally 12 proposals will be selected for presentation to the students by applying the following criteria:

1. Will the students start with a clean slate?There should be no obvious pre-existing solutions and, while the clinicians are encouraged to participate in idea development with the team, they should not have settled upon a particular solution or have an existing device that only needs improvement.
2. Does the problem require the creation of new mechanical or mechatronic hardware? The instructors should perceive that a solution space exists within the realm of mechanical engineering.
3. Can the solution be accomplished within time and budgetary constraints? Working from problem to proof-of-concept device should take a 3—5 student team on average 12—15 hours per week for the 14-week term. Parts, materials and custom fabricated components should not exceed $4,000.
4. Is the clinician ready to be an active team member? Clinicians must agree to frequent interaction with their teams and engaging in the design process as described in the following.
5. Does the project seem fun and exciting? Good design requires passion!

Clinicians whose proposals are selected as finalists for presentation to the class will be provided with a PowerPoint template to assist in preparing a 10-minute presentation to “pitch” their idea to the class; this will be followed by 10 minutes of Q&A. These presentations are tentatively scheduled for Tuesday, September 13 and Thursday September 15 between 3:00 p.m.—5:00 p.m.

Subsequently, students will typically form 6—8 teams consisting of 3—5 persons.

We will endeavor to provide feedback on proposals that are not selected and, whenever possible, offer suggestions as to other means of pursuing solutions.

Design Process

Once teams are formed they will follow a demanding 14-week design process consisting of:

1. Understanding the clinical challenge and crafting of mission statement.
2. Prior art and literature search.
3. Creating a set of functional requirements. As opposed to specific features or technical specifications, these are capabilities that the prototype device should enable.
4. Individual thought and then brainstorming and selection of preferred strategy.
5. Bench-level prototyping and experimentation.
6. Individual thought and then brainstorming and selection of preferred concept.
7. Detailed mechanical design, with emphasis placed on most critical module.
8. Manufacturing of components.
9. Integration and testing.
10. Presentation and documentation.
11. Evaluation of IP and path forward.

It is essential that the clinicians commit to becoming active team members throughout the course and, often, beyond, meeting with students, providing hospital and laboratory access to view procedures, engaging in device testing in an appropriate clinical or laboratory environment and resourcing medical equipment. At minimum, students need direct engagement with clinicians on a bi-weekly basis. The fuller the participation the more fruitful the experience!

Course instructors serve the role of project managers and technical advisors/consultants and will meet weekly, outside of lectures, with each team for design reviews during which they will assess the past week’s progress, brainstorm solutions for current design challenges and help identify the crucial tasks for the next week. Clinicians are encouraged to join these meetings and generally enjoy participating in the design process.

Deliverables, Publications & Intellectual Property

In December, teams will demonstrate their final prototype to a clinical and industry audience. Clinicians are encouraged to participate in these presentations. Teams will also write a conference-ready paper to which the clinician is expected to contribute substantially and thus be an author. All good papers will be invited to submit to the ASME Design of Medical Devices Conference which is held every April in Minneapolis. Many papers have been accepted for publication and have subsequently fostered both ASME Journal of Medical Devices and clinical publications.

Intellectual property (IP) is often generated in this course, and thus it is essential that all team members keep bound, signed and witnessed design notebooks to record individual contributions.  The more engaged a clinician is the greater the likelihood that he or she will contribute specific features (claims) to the IP and thus be formally considered an inventor. (US Patent law states that merely framing the problem does not make someone an inventor.) In the case where a team member (student or clinician) contributes to the development process, but does not specifically create claim elements, i.e., is not an inventor, they can, by mutual agreement by all inventors, be included in revenue sharing (should any ever occur in the future). All patent filings are managed by the MIT Technology Licensing Office in conjunction with the clinicians’ licensing offices.  More information will be provided once the projects are selected and teams formed.The class MIT TLO officer is Thomas G. Tachovsky.

Path Forward

All projects will be reviewed at the end of the semester and promising projects will be invited to continue through a follow-on class, “Development of Mechanical Products” (MIT course 2.753), a senior thesis or graduate research together with the clinicians. The primary focus of this spring class is to evolve a proof-of-concept prototype into a refined prototype suitable for presentation to potential licensees or investors.

While clinicians are not initially required to provide financial resources for the initial prototyping in the fall term, project funding is not guaranteed in the spring term. Taking the next steps to move from proof-of-concept prototype, to a device suitable for presentation is expensive and teams are encouraged to seek further development funding from CIMIT, the clinicians’ institutions, MIT competitions, and external grants and prizes. Hence clinicians are asked to take the lead in reaching out to industry contacts who might be interested in supporting or acquiring the project.  It is the goal of both CIMIT and the course instructors to focus on placing high potential projects on the path towards rapid commercialization!

2010—2011 Data

In 2011, 27 project submissions were received of which 15 were selected for presentation to the class of 41 students. Teams were formed around 8 projects. Of the eight final papers, 7 were submitted to the April ASME Design of Medical Devices conference in Minneapolis and were all selected for poster presentation and publication. In addition, two of the teams won prizes for “pitching” their projects. At the end of the fall term 5 projects continued into the spring class; of which provisional patents were filed on 4. One project is a finalist for CIMIT’s Primary Healthcare Prize and will soon receive an IRB for continued testing and another team just completed their first animal trial.

Questions?

This is an exciting opportunity to work closely with highly-motivated students in addressing a pressing challenge and we look forward to your applications. Please do not hesitate to contact us if we can assist in any way.

• For questions pertaining to the class in general, please contact Professor Alexander Slocum.
• For questions pertaining to proposal specifics, please contact Nevan Hanumara, 617-258-8541
• For questions pertaining to CIMIT, please contact Dr. Rajiv Gupta