Build for a person
Assistive technology for one real person, and the regulatory, human-factors, and ethics literacy that device companies live inside.
Everything so far has been for you. This phase is for someone else. You find a real person with a real need, design with them, build, test, and write down the risk analysis and the requirements the way a company would. It is the phase that writes your internship essays, and it is the one where you find out whether you like this work.
The best neuroengineering is done for a specific person. The n-of-one problem forces needs finding, iteration, safety, and ethics in a way no class does. Start by finding the person, through an organization, not by cold-contacting patients. Then spend more time listening than building.
The projects range from a speller for someone with ALS to a sensory-substitution wearable to an adaptive game controller. The right one is the one where you have found the person. Bench to Bedside, DEBUT, and RESNA are structured, funded reasons to do this with a team.
The wings
The other half of this phase is what device companies actually spend their days on: requirements, design controls, risk analysis, human factors, regulatory pathways, and privacy. Almost no undergraduate has written a mock design history file. Write one for your project and you will sound like a third-year employee in every interview.
Projects
Choose one. Do a second if hooked.Project A: A speller for someone with ALS
Hybrid EOG plus SSVEP, designed with a real partner found through the ALS Association or the rehabilitation hospital. Start with the eyes, add EEG for when the eyes fail. That is the clinical progression, and it is the project that writes your internship essays.
ProjectlabProject B: Control for a real user
EMG or EEG control of a wheelchair, a robot arm, or a drone, for a specific person. Drone-by-brain is a demo. Wheelchair-by-muscle for someone who cannot use a joystick is a life.
ProjectProject C: Silent speech
Surface EMG on the jaw, cheek, and throat while a person mouths words without sound. Decode a small vocabulary. A hot research direction with hobby-accessible hardware, and a communication aid for people who have lost their voice but not their articulators.
ProjectProject D: Sensory substitution
Implement the vOICe image-to-sound mapping and wear it for a week. Build the feelSpace compass belt. Build an ultrasonic bat-sense wearable that is real assistive tech for the blind. Three neuroplasticity experiments on yourself, with no risk.
ProjectProject E: Haptic feedback for a prosthetic hand
A force sensor on a prosthetic or robotic hand, encoded into vibration on the user's upper arm. Closing the loop is the frontier in prosthetics, and the University of Utah's NeuroRobotics work is the local reference.
ProjectProject F: An adaptive game controller
A controller for one specific person with a motor disability, through Makers Making Change or the Xbox Adaptive Controller ecosystem. The gentlest Phase 5 project, a real need, and a full needs-finding cycle in a month.
ProjectCompetitions: Bench to Bedside, DEBUT, and RESNA
Structured, funded, deadline-driven reasons to do Phase 5 with a team and mentors. What each competition rewards, how teams form, and how to use them without letting them use you.
Explainers
Theory that attaches to what you just built. Read after doing.Needs finding
The Biodesign method. Observe clinical work, catch the moments that are slow, awkward, or unsafe, write the need without a solution in it, and only then think about technology. The hardest part of device design is not the device.
ExplainerDesign controls and the design history file
What the FDA requires of every device developer: user needs, requirements, design, verification, validation, and the record of all of it. Write a mock design history file for your project and you will sound like a third-year employee.
ExplainerRisk management and the FMEA
ISO 14971 and the failure mode and effects analysis. Every way the device could fail, how bad, how likely, what you did about it, and whether that was enough. Written before the first live test, revised after every one.
ExplainerHuman factors and use error
Designing so that mistakes are hard to make, especially at 3 a.m. by a tired caregiver. IEC 62366, use-related risk, and why watching one person set up your device without help teaches more than any spec.
ExplainerRegulatory pathways
Device classes, 510(k) versus De Novo versus PMA, predicates, breakthrough designation, and the guidance written specifically for implanted BCIs. Twenty hours of reading that make you sound like a third-year employee.
ExplainerPrivacy, neuroethics, and the abandoned implant
Neural data privacy laws, agency and identity questions, the neurorights movement, and what actually happened to patients when their implant company went out of business. The questions companies now hire people to think about.
ExplainerUniversal and accessible design
Designing so the widest range of people can use a thing without adaptation, and designing assistive technology with rather than for its users. The principles, the failures, and the phrase "nothing about us without us."
Ready for Phase 6 when
Checks save on this deviceWhat an interviewer would ask
If you can answer these, you are done here- Give me a need statement for your Phase 5 project. Now tell me what is wrong with it.
- What class would the FDA put your device in, and what would you need to show?
- What happens to a patient with an implant when the company that made it goes out of business? Has this happened?
- Describe a use error your design invited, and how you changed the design.