Biomedical Engineering Process Design

Course Description

Biomedical Engineering Process Design is the capstone: a real design problem, in a team, to a requirement, under the regulatory regime that medical devices actually ship under.

⚠⚠ What makes a biomedical capstone different from every other engineering capstone is the regulatory dimension. A device is not finished when it works; it is finished when there is documented evidence that it works, that its risks have been analysed, and that the design was controlled. Design history files, risk analysis and verification and validation are part of the assessment, and they are the part employers ask about.

Carried by two Florida public institutions.

Learning Outcomes

Required Outcomes

• Translate a clinical need into engineering requirements, and defend the translation.
• Execute a controlled design process: requirements, concept generation, selection, detailed design, verification.
• Apply risk management to a medical device, in the ISO 14971 sense.
• Plan and interpret verification and validation testing.
• Produce design documentation to a professional standard.
• Work effectively in a team, with roles, schedule and accountability.
• Apply engineering ethics, and the specific obligations that arise when the user is a patient.

Optional Outcomes

• Work with a clinical sponsor or a real end user.
• Prototyping and fabrication.
• Regulatory pathway analysis — 510(k), De Novo, PMA.
• Intellectual property and business case.

Major Topics

Required Topics

• Clinical needs finding and requirements capture.
• Design controls and the design history file.
• Concept generation, trade studies and selection.
• Risk management; ISO 14971 and failure modes.
• Verification and validation planning.
• Standards: IEC 60601, ISO 10993, ISO 13485 in outline.
• Technical writing, design reviews and presentation.
• Engineering ethics and human subjects considerations.

Optional Topics

• Regulatory pathway selection.
• Prototyping and manufacture.
• Intellectual property.
• Reimbursement and the business case.

Resources & Tools

• The institution’s own capstone handbook is the operative document.
• Ulrich & Eppinger, Product Design and Development; the FDA design control guidance; ISO 14971 for risk management.
• ⚠ The FDA device databases — 510(k), MAUDE adverse events, recalls — are free and are the best possible source of design requirements and cautionary examples for a capstone project.

Career Pathways

Named on the Biomedical Engineer career path, and it is the strongest single item on an entry-level résumé. ⚠⚠ Name the regulatory work explicitly — a graduate who can say they wrote a risk analysis and a verification plan is applying for quality and regulatory roles as well as design roles, and those roles are more numerous.

⚠⚠ And a word about level, because it applies to every course in this prefix. O*NET reports that only 43% of employers treat a bachelor’s as sufficient for this occupation, against 26% naming a master’s and 13% a doctorate — by a wide margin the highest graduate expectation of any engineering discipline. Choose your upper-level courses with that in mind: the instrumentation, signals and imaging cluster is the most employable at bachelor’s level, while the tissue, neural and BioMEMS cluster largely assumes you intend to continue.

Special Information

⚠⚠ Four programmes, four capstone structures

⚠⚠ No two of Florida’s biomedical engineering programmes number their capstone the same way, and a capstone is the hardest course in any degree to transfer because it is assessed on team work done over two terms at one institution. If you are considering a transfer, raise it before the junior year, not during the senior one.

⚠⚠⚠ A single-programme course, and this page says so plainly

FAMU and Florida State are the only carriers and they are one joint college. So this is not two institutions agreeing — it is one curriculum, described once. Treat everything here as specific to the FAMU-FSU College of Engineering, and read the outcomes and topics as that college’s capstone rather than a Florida standard.

⚠ Plan both terms together

The design produced in this course is built, tested and reported in BME4802. A schedule that separates them will not work, because the team disperses. Confirm both are offered in the terms you plan, and treat a graduation date as depending on the pair.

⚠⚠ Where this degree exists in Florida, and where it does not

Biomedical engineering is awarded at bachelor’s level by six Florida public institutions in five cities: UF (115 degrees a year), FIU (79), Florida State (36), USF (29), Florida Gulf Coast (21) and Florida A&M (4). Florida State and Florida A&M share the FAMU-FSU College of Engineering, one joint college in Tallahassee, which is why their records in this prefix are identical down to the title.

⚠⚠ UCF and FAU award biomedical engineering at master’s and doctoral level and no bachelor’s at all, and UNF and Florida Polytechnic carry courses in the prefix without awarding the degree. St. Petersburg College is the only Florida College System institution carrying any BME course.

⚠ So a carrier count in this prefix overstates how many independent programmes exist — a course carried by “FAMU and FSU” is one programme’s course. Read anything stated here about content as a description of a small number of specific curricula rather than a Florida-wide norm. The Biomedical Engineer career path sets out what this means for choosing where to study.

⚠⚠ Read the prerequisite from YOUR catalogue — in this prefix the state record is unusually unreliable

This repository checks every course-looking token in a statewide prerequisite against who actually carries that course. The BME prefix returns the worst result measured anywhere in Florida: of 100 active undergraduate records, 75 name at least one course in their prerequisite field, and fifteen of those 75 — one in five — name a course that no Florida public institution carries. The same test on criminal justice returns about 2%.

⚠⚠ The likeliest cause is age, not carelessness. Biomedical engineering is Florida’s newest and fastest-growing engineering discipline; its programmes were built recently and renumbered as they matured, and the statewide record kept the numbers that were proposed, used briefly or retired along the way. The practical consequence is simply that in this prefix you should read the gate from your own institution’s catalogue every time.

Accreditation and licensure

⚠⚠ Check that your programme is accredited by ABET’s ENGINEERING Accreditation Commission, not the engineering technology commission — the difference is two extra years of experience toward a Professional Engineer licence, and accreditation attaches to a named programme at a named institution rather than to a course list.

Few biomedical engineers license: device manufacturing falls under the industrial exemption. ⚠ The exception is clinical engineering in hospitals and healthcare facility work. Sit the FE examination in your final year regardless — it is inexpensive as a student and expensive to recreate later. Under s. 471.013(1)(a), Florida Statutes, an approved engineering curriculum needs four years of qualifying experience toward the PE.