bim final

Electrogoniometers

these use strain gauges or potentiometers to correlate movement to voltage changes

Waterfall Design Process

this process outlines the steps necessary to produce a medical device

Functional MRI

This imaging modality observes brain activity by detecting blood flow in the brain by seeing the difference between oxygen-rich and oxygen-poor blood

Product Development "Core Team"

People from R & D, Quality, Marketing, Regulatory, Supply chain, Clinical affairs, Operations, and Finance come together to form this

musculoskeletal biomechanics

The application of fundamental principles of mechanics to study neuromusculoskeletal tissues, structures and systems

Carotid ultrasound

Can assess blockages in the carotid artery that could cause stroke

Wilhelm Röntgen

discovered the x-ray

Dense tissue is best imaged with

x-ray

Reliability

the ability of the device (or component) to perform the desired function, for a stated period of time under expected use conditions without failure

Manufacturability

minimizes the amount of parts, labor, assembly steps, cycle times, and maximize efficiency

Mammography

x-rays that produce 2D images of the breast

Positron Emission Tomography

images made with radiation from tracers injected into the body

Intravascular ultrasound

ultrasound used to assess the inside of the artery

MRI

magnetic resonance imaging aka images made with magnets

Echocardiograms

ultrasounds used to see how blood flows in the heart

Mechanics

a sub-discipline of physics and the branch of applied mathematics dealing with motion and forces producing motion

IMU

(inertial measurement unit) inertial/acceleration-based technologies such as a gyroscope and accelerometers

Sun

Where nature get its energy

Industrial, Crops, Biologics, Synthetic Biology Companies

parts of the bio economy

responsibilities/expectations that you have as a student

take ownership of your education, Prepare for advising meetings ahead of time, Explore, reflect on, and identify current educational, career and life goals.

the product development process

Formulation > Design and Development > Final Validation > Product Launch

A good needs statement will address each of these questions:

What is the problem/need? Who has the problem/need? Why is it important to solve?

the value of making low-resolution prototypes

It doesn't cost much, Allows you to evaluate design decisions early in the prototyping process, Supports iterative design in an inexpensive way

Delrin

a material that has low moisture absorption and high strength & stiffness

Delrin repels most adhesives.

true

technologies found in the TEAM Lab

FDM Printing, Stereolithography (SLA) Printing, Carbon Clip Printing, Laser cutter

file is needed for laser cutting

Drawing file

scale is needed for the file to be sent to the laser cutter

1:1

Research

take in data to learn about the problem

Design Imput

create a specific solution based off research

Design output

measured capabilities of the device or component

a medical device

an instrument, implement, apparatus, machine contrivance, implant, invitroreagent, or other similar related article including a component or accessory which is
- recognized in the official nationally formulary, or the US pharmacopeia
- is meant to aid humans or animals
- NOT metabolized

Biologic

a virus therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative and is specifically directed towards human beings

Drug

recognized by the united states pharmacopeia for diagnosis, cure, mitigation, treatment or prevention of disease

7

number of branches in the FDA

CFSAN

Center for Food Safety & Applied Nutrition

CDER

Center for Drug Evaluation & Research

CBER

Center For Biologics Evaluation & Research

CDRH

Center for Devices & Radiology Health

CVM

Center for Veterinary Medicine

NCTR

National Center for Toxicological Research

CTP

Center for Tobacco Products

Need statemet

goal, population, and desired outcome are 3 components of this

basic transcriptional unit

an operator, promoter, coding sequence, and terminator make up this unit

verification

this type of testing ensures that design specifications are met

hyaluronic acid

this polysaccharide chain contributes to the viscosity of joint synovial fluid

teamwork

this is a critical component of all design activities

gene therapy

this type of therapy utilizes a nanoscale delivery system to introduce new proteins within a viral particle

Viscosupplementation

this osteoarthritis treatment approach aims to increase viscosity of joint synovial fluid

Chemical

the FDA regulates medical devices as those that do not function with this type of mechanism

motion capture suites

these consist of multiple cameras and body markers to capture movement

doppler

this technology utilizes functional ultrasound imaging and can deterimine direction of blood flow

nanometers

raw materials for engineering biological systems are in this size scale

translation

proteins are when RNA undergoes this process

Rosalind Christian

you must meet with this undergraduate advisor at least once annually to release your annual mandatory advising hold

brainstorming

the process used to generate ideas

DNA

information about how to build properties of biological systems are stored here

Static and Dynamic analysis

these analyses are fundamental engineering equations used in biomechanics

allografts

immune rejection and disease transmission are limitations of what type of graft

3

the number of main components in tissue engineering

cells, biomaterial, and biologically active factors

the main components of tissue engineering

validation

this type of testing ensures that all identified user needs are met

RNA

DNA undergoes transcription to create this

biomechanics

Study of the physics exhibited or produced by biological systems

computed tomography (CT)

this imaging modality creates 3D x-ray scans

medical device companies

these companies are often concentrated in regions known for other high-tech industries

xray

this imaging modality produced the first medical images of the inside of the body

Albert Einstein

said "the best design is the simplest one that works, but no simpler"

10 stakeholders

Patients
Patient Advocacy Groups
Physicians
Professional Associations
Nurse practitioners
Health Care Facilities
Facility Trade Groups
Private Payers
Public Payers
Government Officials

6 considerations when filtering needs

Severity to the patient
Market Size
Competition
Preclinical Model
Clinical Trial/Regulatory Path
Reimbursement