This proposal is open to students in any UK COE engineering department. The skills that students will gain from this project include teamwork, imagination, pragmatism and a willingness to step outside of their comfort zone.
While instructors can suggest ideas, students should play an active role in writing the proposal. The environment in which the medical device shall be used should be described and the user and beneficiary of the device function within that environment should be defined. The proposal should compare and contrast how and why an existing medical device may not function as needed in the defined environment, and the constraints or special requirements within that environment that are cause for this new or modified medical device design.
The successful project will meet one or more critical milestones for the project as defined and approved in the team’s written project plan. The initial project plan to be submitted shall define stage-gating milestones relevant to the proposed medical device development scheme.
- If the device must be FDA regulated, determine the most likely approval pathway, including if it could be difficult to clinically evaluate the device outside the extreme environment (e.g. can you simulate its use?)
- How will the proposed capstone project intend to address the identified unmet needs?
- What quality and evaluation systems will be necessary in order to verify the performance of the medical device and to produce the product to medical grade standards?
Means of Support
Modest support funds are available at the College of Engineering for a proposed project in any senior engineering major. It is expected that a budget will be included in the project plan and can include possible industrial or governmental sources for funding. Financial support is to be used for supplies, testing and prototyping for projects and based upon estimates put forth in the project proposal. Students are advised to consult with the College concerning receipt of outside funds and potential proprietary technology rights.
A project is expected to require two full semesters to complete and reflect the scope of the year-long goals starting at definition of user requirements through to testing prototypes. Multi-year programs and/or projects that involve more than one department of the college may be proposed. Any such project must receive prior approval from sponsoring departments and be planned accordingly. Student teams are expected to present their project status at the end of the semester, and when the project is complete, or at interim milestones if multi-year project.
Proposed projects are required to identify one or more supporting collaborator/advisers. Collaborators may include faculty members in UK College of Engineering from any department but should also include at least one collaborator and/or support group (advisors) such as the Department of Biomedical Engineering and Mechanical Engineering-Aerospace, NASA Kentucky, the College of Medicine, College of Dentistry, College of Design, College of Pharmacy, and industry or government agencies, etc.
Because this project is open to students in any engineering discipline with approval from the CAPSTONE advisor and department chair, this is only a suggested timeline. The project must follow the home department rules for Capstone Projects. A successful project shall be evaluated based upon meeting the clearly defined design constraints and user needs, as well as the team’s ability to meet the project milestones. The following may be altered based upon the project and requirements of the sponsoring department./p>
In the first two weeks of the term, the students will select their teams based on interest and their personal expertise and support from the instructors and collaborators. Thus if this project scope is selected, the team members should have interest in how a medical device need may be deployed in an extreme environment.
The team shall submit a prospectus for the project and present an outline to the instructor t. Projects shall be approved by the instructor based upon the quality and feasibility of the proposal. NOTE: it is not necessary that a device must be manufactured for use within one year to be determined to be feasible.
Teams work with their sponsors to define the requirements and other constraints. Risk analysis of the performance of the proposed device is a key deliverable. From the risk analysis the teams shall develop the requirements for verification and validation of the device. Delegation of assignments for individual contributions shall be defined by scope of work and due date.
Individual project contributions are to be finished and culminate in the team defined deliverables, which may include Preliminary Design Specifications and elaborated Project Plan. The team shall conduct a formal Design Review and summary.
On Senior Design Day, the students shall showcase the the project to the public in the form of design requirements, risk requirements, plan for verification and validation and estimated time for completion of the next phase of the project .
The team shall define requirements for building a prototype, or as necessary, key components of the device that are critical to performance within the defined environment. At the end of this period the team should be working from detailed specifications for their medical device design solution. The team may choose to product a project video that helps to present the project scope, requirements and proposed solutions. A Design Review is to be held which confirms the requirements and methods.
System integration and testing. In week 13, the prototype of the device (or critical component as necessary) has been resolved and the final presentation and final report are due. Videos, if the team has determined this is an ideal means of presentation are almost complete.
Senior Design Day allows students to showcase their final prototypes to the public. In the alternative a live simulation may be provided.
The following websites may provide additional inspiration to the student.
3D printing medical devices in space for Astronauts https://www.imedicalapps.com/2017/02/3d-printing-medical-devices-astronauts/
https://www.airspacemag.com/ search medical
https://www.docseducation.com/blog/dentistry-space dentistry in space
The following individuals may offer advice and guidance to students interested in making a proposal.
George Pantalos, Professor, Cardiovascular and Thoracic Surgery and Bioengineering, University of Louisville. “Developing Surgical Capabilities for Exploration Spaceflight”
Charles, John, PhD scientist in Resident at Space Center Houston, Manned Space Flight Education Foundation.
Elaine Duncan, MS.ME. RAC, AIMBE, Adjunct Professor, F. Joseph Halcomb III, M.D. Department of Biomedical Engineering, President Paladin Medical, Inc., www.paladinmedical.com
Twyman Clements,CEO, President & Co-Founder, Space Tango, Inc. www.spacetango.com
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