BME Exam 1

•State machine vs. Flow Chart

"State" - system waiting to do something, or to transition ex. opening or closing a door

"technological entrepreneur" type of BME

(less common); "(most likely a biomedical design engineer in industry). This individual assumes that the gap between the technological education of the life scientist or physician and the present technological capability has become so great that the life scientist cannot pose a problem that will incorporate the application of existing technology

"engineer-scientist" type of BME

(most likely found in academic institutions and industrial research labs)—is primarily interested in applying engineering concepts and techniques to the investigation and exploration of biological processes

Quantiles

- Divisions of the data where x% of the values lie below the xth quantile. The median is the 50th quantile. Data must be sorted.

Independent & Dependent factors

- Independent factors are the variables that you change that affect the dependent variables value. -Dependent variables - response, y, output -Independent variables - predictor, x, input, factor -

monoclonal antibodies

- Kohler and Milstein, 1975 Antibodies produced by a single clone of B lymphocytes and that are therefore identical in structure and antigen specificity.

Systems Engineering Process Summary

- The SE process considers the complete, Design, Build, Integration, Verification and Validation of the product -SE process looks at the product from "Cradle to Grave" -SE process supports either Incremental or Evolutionary development -Systems Engineering and Quality by Design have common objectives -Design for Six Sigma provides a process, enablers and tools for System Engineering and Quality by Design -The project systems engineering personnel are responsible for the management and execution of the product development activities

Weight

- The amount of influence each data value has on the analysis. Typically all data values have equal weight.

Coefficient of Variation (uniformity/nonuniformity)

- The standard deviation of a data set divided by the mean of the data set. Often multiplied by 100 and expressed as a percent. Gives a scaled measure of the dispersion.

Distribution

- The underlying mathematical function that describe that dataset. There are many standard distributions.

Independence

- When subsequent data points do not depend upon previous values, data is said to be independent.

Medical Imaging: Computed Tomography (CT)

- many X-ray images are recorded as the detector moves around the patient's body. A computer reconstructs all the individual images into cross-sectional images or "slices" of internal organs and tissues

Medical Imaging- Magnetic Resonance Imaging

- strong magnetic fields and radio waves (radiofrequency energy) to make images. The signal comes mainly from the protons in fat and water molecules in the body.

Semiconductor

-(a) Outer shell electron configuration of donor N-type Phosphorus, Silicon (for reference), and acceptor P-type Boron. (b) N-type donor impurity creates free electron (c) P-type acceptor impurity creates hole, a positive charge carrier.

Probability

-A number expressing the likelihood that a specific event will occur, expressed as the ratio of the number of actual occurrences to the number of possible occurrences -Long term relative frequency •French mathematician Buffon tossed a coin 4040 times. Result: 2048 heads, relative frequency 2048/4040 = 0.5069 for heads. •English statistician Pearson tossed a coin 24,000 times! Result: 12,012 heads, relative frequency = 0.5005. •What about an infinite number of tosses?

Sample

-A subset of the population. -An underlying assumption, when sample data are collected, is that the sample comes from a larger set of data. That large set is usually the population that we wish to draw conclusions about, based on the sample. -Because we seldom have the population to work with, we always have uncertainty in our results.

Biosensors: Bioreceptors

-Antibody/antigen interactions -Artificial binding proteins -Enzymatic interactions -Affinity binding receptors -Nucleic acid interactions -Organelles -Cells -Tissue

"Biomedical" Systems Engineering

-Application of SE principles in biomedical device development -Regulatory implications -Substitute "biomedical" for "system"??

•Kantianism, a form of nonconsequentialism

-Based largely on the views of Immanuel Kant, this ethical school of thought insists that there is something uniquely precious about human beings from the moral point of view. According to Kant's theory, humans have certain "rights" that do not apply to any other animal. -For example, the moral judgments that we should not kill and eat one another for food or hunt one another for sport or experiment on one another for medical science are all based on this view of human rights.

Regenerative medicine - stem cells

-Blood forming system -Multiple Sclerosis -Macular Degeneration -Heart Disease -Diabetes

Tissue Engineering

-Bone marrow transplantation - regenerate blood system -Bioreactors - pancreas, liver generate an output product -Biomaterials -tissue regeneration and reconstruction •Artificial heart valve, surgical tools, implants •Provide mechanical support, modulate tissue interactions, biodegrade

•Utilitarianism, a form of consequentialism

-Consequentialism holds that the morally right action is always the one among the available options that has the best consequences. -No specific actions or courses of conduct are automatically ruled out as immoral or ruled in as morally obligatory. The rightness or wrongness of an action is wholly contingent upon its effects. -the morally right course of action is the one that maximizes pleasure, minimizes pain, or both—the one that does the "greatest good for the greatest number."

Data Types: Numerical/Quantitative

-Continuous: dose results, dwell time, temperature -Discrete: particle counts, assay levels

Controllable & Uncontrollable factors

-Controllable factors - Variables or factors can be controlled by you and others -Uncontrollable factors •Variables or factors are often called as "Environmental Factors". •For example, Age, Gender and Marital Status are uncontrollable factor. Temperature and humidity are also considered uncontrollable factors.

•Bridges Traditional Engineering Disciplines

-Electrical, Mechanical, Chemical etc. -SE Bridges Disciplines -"Big Picture" but able to drill down to details

Address four main questions during the semester: •What are the key fields of development in the world of biomedical engineering?

-Guest lectures

Correlation

-If there are relationships between variables, they are said to be correlated. -The most common type of relationship explored is linear correlation.

Covariates

-Independent factors that you can't control but might affect the response. -Examples: Shift, humidity, barometric pressure.

Standard Deviation

-Is an estimator of the population standard deviation. Units are the same as original data.

Data Types: Non-numerical/Character/Qualitative

-Ordered •Ordinal: size of cars, lot numbers, cal lots, pack lots

•Stem Cell Research

-Regenerate -Differentiate -Produce any type of tissue -Technological advances

Addressing 4 main questions during the semester: What makes biomedical engineering different than other fields of engineering?

-Regulatory environment, biology and medicine, medical ethics

•Project Management

-SE is inherent part •Objectives, execution, evaluation, corrective actions -Other management tasks usually done by SE -Often SE is technical project leader

•Mathematics is key to biomedical engineering

-Specialized problem solving / modeling - -Descriptive statistics •Many areas of study - science, economics etc.

•Standard Error of the Mean (SEM)

-The dispersion of the sample mean. Is the sample standard deviation divided by the square root of the sample size. SEM= S/(sqrt(n)

•Probability axioms and properties

-The probability of an event, A, occurring given that another event, B, has occurred is expressed as P (A|B) and is given by:

Population

-The set of all items of interest in a statistical problem

Address four main questions during the semester: What do biomedical engineers do?

-What do biomedical engineers do? •Engineering practices / perspectives, system or product devel • Careers, fields of study

Medical Imaging: X-ray

-an X-ray beam is passed through the body where a portion of the X-rays are either absorbed or scattered by the internal structures, and the remaining X-ray pattern is transmitted to a detector

Medical Imaging- Ultrasound

-uses high-frequency sound waves to view inside the body. Because ultrasound images are captured in real-time, they can also show movement of the body's internal organs as well as blood flowing through the blood vessels.

Fields of BME: Biomaterials

A biomaterial is a substance that has been engineered to take a form which, alone or as part of a complex system, is used to direct, by control of interactions with components of living systems, the course of any therapeutic or diagnostic procedure. -polymer synthesis and characterization -drug and gene vector design -biology of the host response -immunology and toxicology -self assembly at the nanoscale

What is a system?

A product, sum is more than the parts, result in operational capability

What is Biomedical Engineering?

All-encompassing field that includes such areas as: •Biomaterials •Biomechanics •Bioinstrumentation •Biosensors •Bio-signal processing •Biotechnology •Computational biology, genomics •Medical imaging •Optics and lasers •Radiation imaging •Tissue engineering •Moral and ethical issues

Rehabilitation Biomechanics

Analyses of gait, mechanics of prosthetics and orthotics.

The Power of Systems Engineering: Example

Assumptions: •There are approximately 5,000,000 people living in Chicago. •On average, there are two persons in each household in Chicago. •Roughly one household in twenty has a piano that is tuned regularly. •Pianos that are tuned regularly are tuned on average about once per year. •It takes a piano tuner about two hours to tune a piano, including travel time. •Each piano tuner works eight hours in a day, five days in a week, and 50 weeks in a year. -(5,000,000 persons in Chicago) / (2 persons/household) × (1 piano/20 households) × (1 piano tuning per piano per year) = 125,000 piano tunings per year in Chicago. -(50 weeks/year)×(5 days/week)×(8 hours/day)/(2 hours to tune a piano) = 1000 piano tunings per year per piano tuner. -(125,000 piano tunings per year in Chicago) / (1000 piano tunings per year per piano tuner) = 125 piano tuners in Chicago.

Bioinstrumentation

Basic instrumentation systems using sensors to measure a signal with data acquisition, storage, and display capabilities, along with control and feedback -transduction and measurement of physiological quantities

NULL HYPOTHESIS

By convention contains some form of equality statement.

ALTERNATIVE HYPOTHESIS

Contains a statement of inequality

variance

Is an unbiased estimator of the population variance. Units are squared.

Feasibility Definition

Is it feasible? Does the concept meet a given set of operational objectives? Functional design System Cost External constraints and interactions Compatibility with other systems Visualization of Subsystem Implementation Vs. current system With advanced technology Cost: models, maintenance records, inflation factors Definition of a Feasible Concept includes a discussion of the development process, anticipated risks, general development strategy, design approach, evaluation methods, production issues, and concept of operations, cost of system development and production Not highly detailed but should show that all major aspects of system feasibility have been addressed

Molecular Biomechanics

Mechanical analyses of biomolecules

Sports Biomechanics

Mechanical analyses of sports performance

Injury Biomechanics

Mechanics of impact and trauma, dynamics of man-machine interaction

Hypothesis Testing

Null Hypothesis •H0: Patient HIV Positive •H1: Patient HIV Negative Significance Level •Probability of Type I error = α •α is significance level •α is usually 0.01 or 0.05 •H0 and H1 •Select α •Sample size •Test and collect data •Compare result to α at 0.05 •Accept H0 if result is < α •Reject H0 if result is ³ α

Requirements Definition

Requirement: •Documented need of what a product should do •Attribute, capability, characteristic or quality •Inputs to design phase of product development •Inputs to verification and validation process (traceable) •Product (what) vs. Process (how) Requirements •Development cost à Sales Price •Functional (must be able to do) vs. Non-Functional (quality of service) •i.e. Enumerate PLT > 5000 vs. Operate > 1 year with no service call •Should not prescribe implementation methods except for constraints •Leave to design engineers •Can not have optional requirements

Risk Management

Risk: (Exposure to) the possibility of loss, injury, or other adverse or unwelcome circumstance; a chance or situation involving such a possibility, according to Oxford. Challenge to system engineering is to minimize risk while maximizing results Continual Process throughout life cycle: Needs Analysis phase reduces the risk of embarking on the development of a system that does not address vital operational needs Concept Exploration phase reduces the risk of deriving irrelevant or unrealistic system performance requirements System Definition phase selects a system concept that utilizes technical approaches that are neither excessively immature nor unaffordable, but rather one that has the best chance of meeting all system goals

State Machine vs. Flow Chart

Security Lamp Control

Managing System Development and Risks

Systems engineering is integral part of management of system development

Technology has had a major impact on medical care

Technology has had a major impact on medical care •Biomedical engineering integrates medicine and engineering •Provide tools for research, diagnosis, and treatment -Sensors, materials, image processing etc. -Resulting in better, more cost effective patient care •Biomedical engineering involves training essentially three types of individuals: -clinical engineer in health care -biomedical design engineer for industry -research scientist

Operational Test and Evaluation

Test and evaluation scope Trade-off between confidence in validity of the effort vs. cost How much is enough? - the sooner problems or defects are found the less you will have to pay and the length of the feedback cycle will be shorter

Range

Very sensitive to outliers, only uses two data values from data set. Is a biased estimator which overestimates the amount of variability in the population.

Waste in Product Development

Waste: "The work element that adds no value to the product or service in the eyes of the customer. Waste only adds cost and time." •The MIT Lean Advancement Institute (LAI) classifies waste into seven categories: -Over‐Processing - more than necessary to produce the desired output. -Waiting - for material or information, or information or material to be processed -Unnecessary Movement - Moving people (or people moving) to access or process material or information -Over‐Production - too much material or information -Transportation - moving material or information -Inventory - maintaining more material or information than is needed. -Defects - errors or mistakes causing the effort to be redone to correct the problem

Medical Imaging: Microscopy

Wide-field and confocal intensity distributions

ergonomics/human factors

a field that combines engineering and psychology and that focuses on understanding and enhancing the safety and efficiency of the human-machine interaction

Biomaterials - example

heart valve, hip replacement, knee replacement, intraocular lens, intravascular stent

"problem solver" type of BME

most likely the clinical engineer or biomedical design engineer) maintains the traditional service relationship with the life scientists who originate a problem that can be solved by applying the specific expertise of the engineer

Systems Engineering as a Profession

• •The following characteristics are commonly found in successful systems engineers -enjoy learning new things and solving problems -like challenges -are skeptical of unproven assertions (but think positively!) -are open-minded to new ideas -have a solid background in science and engineering -have demonstrated technical achievement in a specialty area -are knowledgeable in several engineering Fields -pick up new ideas and information quickly -have good interpersonal and communication skills

Systems Engineering Quotes

•"It is well to remember that any fool can design a complex system to do a simple job, but it is something else to design a simple system to perform a complex task" Dommasch, 1962 • •"The systems approach is dedicated to emphasizing the ideas which are common to the successful operation of somewhat independent parts in an integrated whole" Chestnut, 1965 • •"System engineering replaces a piecemeal approach to problem solving in organizations by a disciplined, overall approach" Jenkins, 1971

Model

•- A mathematical relationship between the input and output variables. -Example: Failure Rate = b0 + b1*Power + b2*Pressure + Error

Systems Engineering Through the System Lifecycle

•A typical major system development exhibits the following characteristics: -It is a complex effort. -It meets an important user need. -It usually requires several years to complete. -It is made up of many interrelated tasks. -It involves several different disciplines. -It is usually performed by several organizations. -It has a specific schedule and budget. •System Development occurs in a step-wise manner -Success needs to be demonstrated before moving on to next step -Business Decision Point

Systems Engineering Viewpoint

•Balanced System: "balance is a harmonious or satisfying arrangement or proportion of parts or elements, as in a design or a composition."

Population vs Sample

•Because the population and sample represent two different aspects of the data collected, they have different notation. mean : p- s- variance: p- s- standard deviation: p- s-

Cell Biomechanics

•Biomechanical analyses of cells, membranes and sub-cellular structures; the relationship of the mechanical environment to cell and tissue response.

Professional Status of Biomedical Engineering

•Biomedical engineers are professionals, sharing values and skills absorbed during a common course of intensive training. • •Professionals generally accept scientific standards in their work, restrict their work activities to Fields in which they are technically competent, avoid emotional involvement, cultivate objectivity in their work, and put their clients' interests before their own. • •PROFESSIONAL SOCIETIES -The American Institute for Medical and Biological Engineering -IEEE Engineering in Medicine and Biology Society -The Biomedical Engineering Society - student chapter at UM

Fields of BME: Biomaterials

•Clinical applications include the therapies of medical technology and regenerative medicine in all clinical disciplines, and diagnostic systems that reply on contrast and sensing agents. •Fields such as cancer diagnosis and therapy, implantable devices, drug delivery systems, gene vectors, bionanotechnology and tissue engineering.

Sample Correlation

•Correlation measures the strength of the (linear) relationship between two variables. •Correlation ranges between -1.0 and 1.0. A value of 1.0 indicates an absolute positive relationship. A correlation of 0 indicates no relationship.

What do System Engineers Worry About?

•Deal with complexity •Create effective solutions and manage process •Requirements from user to production •Track from user level to test cases to allow traceability

Key points - career wise of Systems Engineering

•Depth of experience is central to success •Become technically very good at "something", then broaden horizons •Problem solving •Through experience •Design optimization (DOE) and other tools •Understand the environment •Know your customers and business •System approach - "big picture" thinking

Labels

•Descriptive information about data

Dental Biomechanics

•Design and analysis of dental tissues and prostheses, mechanics of chewing.

Histograms

•Determine the Class Boundary or End Points •For simple determination of the class boundaries, take the smallest individual measurement in the data set and add the W value.

Systems Engineering Viewpoint

•Different way of thinking about engineering using a greater breadth of technical knowledge •Want to Build a Successful System -Meets Requirements by Understanding the User's Problems -Meets Development Objectives by Managing Risks -Successful Operation in the Field -Long, Useful Operating Life •Seek the "Best" System -"The best is the enemy of the good enough" -Performance, Cost, Time to Market, ASCOS, Project Schedule

Biosensors

•ECG, EMG, EEG, Thermistor etc. -Biomedical sensors -Linked to bioinstrumentation •Biosensor detects analyte combined with a biological component of a detector (bioreceptor) -Detecting devices that can detect specific substances in cells

Ethics Summary

•Ethics = "how to act" •Understand consequences and outcomes •Act ethically and responsibly - according to moral norms -Trustworthiness, compassionate •Practice ethical behavior continually -Like driving, easy most of the time but what do you do when something unexpected occurs?

Design of Experiments

•Factor •Level •Response •Trial •Combined Effect •Interaction •Confounding

Fields of BME: Biomechanics

•Fundamental Topics - Biomechanics of the musculoskeletal, cardiovascular, and respiratory systems, mechanics of hard and soft tissues, biofluid mechanics, mechanics of prostheses and implant-tissue interfaces, mechanics of cells. -Complex modeling with numerical methods, computer simulations

Biologic Drugs

•Humira - arthritis •Rituxan - lymphoma •Enbrel - arthritis •Herceptin - HER2+ breast cancer •Avastin - various cancers •Remicade - arthritis •Lantus - long acting insulin •Neulasta - neutropenia •Avonex - multiple sclerosis (interferon beta-1a) •Lucentis - macular degeneration

Perspectives: 3

•Industrial • -Products that address a particular problem - -System Development / Regulatory process - •Research • •Experience

Challenges in Systems Engineering

•Many considerations and interrelations •Many different and perhaps controversial value judgments •Knowledge from several disciplines •Knowledge at the levels of principles, practices and perspectives •Considerations involving product definition, development and deployment •Risks and uncertainties involving future events which are difficult to predict •A fragmented decision making structure

Measures of Location

•Mean ( ) - The average of all the data points. •Median(M50) - Value at which 50% of the observations are smaller and 50% are larger. -Odd number of observations - sort values by size, select middle observation. -Even number of observations - sort values by size, average middle two observations. •Mode - The most frequently occurring value(s) in a set of data.

Process Capability

•Measures how well centered the data are between the specification limits •Purpose is to establish X Bar and R charts •± 3 σ or 6 σ •Comparable to specification limits and control limits •Defined as UCL and LCL

Cardiovascular and Respiratory Biomechanics

•Mechanics of blood-flow, air-flow, mechanics of the soft tissues, flow-tissue or flow-prosthesis interactions.

Orthopedic Biomechanics

•Mechanics of fracture and fracture fixation, mechanics of implants and implant fixation, mechanics of bones and joints, wear of natural and artificial joints.

Technology has had a major impact on medical care

•Milestones in technology -Microscope -X-ray -Radioactivity -pH measurements -Electrocardiogram (ECG) -Electroencephalogram (EEG) -Ultrasound -Pacemakers -Heart valves -Dialysis -Joint Replacement

Biosignal Processing

•Noise reduction and signal enhancement •feature extraction •pattern recognition •diagnosis

Data Types: Non-ordered

•Nominal: color of cars, pass/fail All but continuous data can be referred to as categorical.

moral dilemmas

•Nonetheless, the general injunction "As to disease, make a habit of two things: (1) to help or, (2) at least, to do no harm" was accepted as a fundamental medical ethical norm -beneficence, which is the provision of benefits -nonmaleficence, which is the avoidance of doing harm.

Design for Reliability

•Normal PDF (probability density function) -two-parameter distribution, not often used for time-to-failure -Described by μ and σ. -MTTF = μ •Log-Normal PDF -two-parameter distribution, applicable to fatigue life of certain types of mechanical components -Described by • μ = (mean ln(time) or ln(life) •Σ = standard deviation of ln(time) or ln(life) •Exponential PDF -Used to describe constant failure rate. Described by parameter λ or failure rate. When t = MTTF, F(t) = 63.2%

Role Of Probability

•Our goal is to extract as much information as possible from data in order to make good business and engineering decisions • •Probability theory is the key tool used in statistics to -determine where to sample -determine how much to sample -find the models that BEST fit the data -test whether HYPOTHESIZED models are CONSISTENT with the data -guide decision making and quantify risk

Review of Probability

•Probability axioms and properties -The probability of an event, A, occurring is given as a real number between zero and one •P(A) [0, 1] -The probability of an event, A, NOT occurring is represented by several symbols including ~A, ¬A, and A′ (among others), and is expressed as •P(~A) = 1 - P(A) - The probability of the domain of events occurring (i.e., all possible events) is always •P(D) = 1.0 -The probability of the union of two events, A and B, is given

Random Phenomenon

•Random -If the outcome of a single repetition is uncertain. -However, there exists a regular distribution of relative frequencies given a large number of repetitions. -Unpredictable. -NOT uniformly distributed. •A random variable is a numerical outcome of a random phenomenon. •Mathematical study of randomness is called probability theory. •Probability as a branch of mathematics. •Sciences use probability to describe -The behavior of natural processes. -The genetic makeup of individuals. -The energy states of subatomic particles. -The rate of return on risky investments.

Design of Experiments

•State the problem •State desired results •Determine quality characteristics •Determine measurement methods •Select factors •Identify noise and control factors •Select orthogonal array •Select levels for factors •Select interactions •Design the matrix (assign F/L to columns) •Conduct trials •Analyze and interpret results •Confirm experiment

System Lifecycle

•Stepwise evolution of a new system from concept through development, production, operation and disposal •No single accepted model •All models subdivide the system life into basic steps that separate major decision milestones •Kossiakoff uses a derived model (hybrid) •"Systems Engineering Life Cycle" model is based on three different sources: -Department of Defense (DoD) Acquisition Management model (DoD 5000.2) -International model ISO/IEC 15288 •International Organization for Standardization (ISO) •International Electrotechnical Commission (IEC) •Six stages: concept, development, production, utilization, support, and retirement. -National Society of Professional Engineers (NSPE) model •Six stages: conceptual, technical feasibility, development, commercial validation and production preparation, full-scale production, and product support

Ethical Issues in Engineering

•Technology has provided us with the ability to -develop cardiovascular assist devices -perform organ transplants -maintain the breathing and heartbeat of terminally ill patients •Society has been forced to reexamine the meaning of such terms as death, quality of life, heroic efforts, and acts of mercy

Inter Quartile Range

•The 75th quantile minus the 25th quantile. Expresses the spread of the middle 50% of the data.

Hypothesis statements

•The analysis of test results is mainly concerned with summary statistics; typically either means or variances. •The two hypothesis statements must be phrased so they include all possible outcomes.

Average Moving Range

•The average distance of each data point to its neighbor. Moving Range computes ranges of two or more successive measurements. The default range span is 2. Because moving ranges are correlated, interpretation should be handled with care.

Range

•The distance from the smallest data value to the largest. max-min= range

What is Systems Engineering?

•The function of systems engineering is to guide the engineering of complex systems. • •"Guide" is defined as "to lead, manage, or direct, usually based on the superior experience in pursuing a given course" and "to show the way." -So system engineers select the path to follow (out of many) - •System: "a set of interrelated components working together toward some common objective." • •Engineering: "the application of scientific principles to practical ends; as the design, construction and operation of efficient and economical structures, equipment, and systems."

Functional Tissue Engineering

•The role of biomechanical factors in engineered tissue replacements and regenerative medicine.

Origin of ethics

•The term ethics comes from the Greek ethos, meaning "custom." •Latin word for custom is mos, and its plural, mores, is the equivalent of the Greek ethos -the root of the words moral and morality. •Ethics and morality are often used interchangeably, there is a distinction between them •Philosophers define ethics as a particular kind of study and use morality to refer to its subject matter. -examples of morals in our present society are telling the truth, paying one's debts, honoring one's parents, and respecting the rights and property of others

Modeling

•Thermometer's Mathematical Modeling •Thermistors are the most common semiconductor devices used to measure temperature in medical applications. Its behavior is described by a somewhat complex equation (the Steinhart-Hart equation), but can be approximated by a simple exponential, • R(v(s)(T)=R(v(0))(e)^(B((1/T)-(1/T0)) [Ω], (Eq. 1) •where Rs is the series resistance (in Ohms) of the thermistor, R0 is the reference resistance (10 kΩ), T is the temperature (in K), T0 is the reference temperature 293.15 K (25°C), and modeled material constant, β, is approximately 3920 (for the GE MA100 thermistor).

Ethics Cases

•Turing Pharmaceuticals -the CEO of Turing Pharmaceuticals, Martin Shkreli, bought a company that makes a life-saving pharmaceutical and promptly raising the price from $13.50 to $750 per tablet. •Merck -agreed to pay $671 million to settle claims that it overcharged Medicaid programs for four drugs, including Vioxx and Zocor, and to resolve allegations of improper marketing to doctors •Ford Pinto (1970s) -In a rear-end collision, the fuel filler neck could separate and puncture the fuel tank, spraying fuel into the passenger compartment and igniting. -it was revealed that Ford had known about the defect before the car even went to production, but decided it would be too expensive to fix -> 900 people died, hundreds of millions of dollars in civil suits •Takata Airbags -30 million cars worldwide, could create shrapnel when deployed -NYT alleged that Takata knew about the potentially fatal flaw as early as 2004 -failed to report their findings to the NHTSA -U.S. government fined Takata $14,000 for each day of not cooperating with the federal investigation. •Volkswagen -used software that allowed the car to pass emissions testing, then shutting off for normal driving •"defeat devices" detect steering, throttle, and other inputs used in the test to switch between two distinct operating modes -The diesel cars ended up polluting far more than any of their competitors. -VW tried to scapegoat its engineers -cost Volkswagen upwards of $14.7 billion in the U.S. alone •Theranos -Elizabeth Holmes, founder and chief executive of the blood-testing company Theranos, was charged by the Securities and Exchange Commission with an "elaborate, years-long fraud" in which she and former company president Ramesh "Sunny" Balwani allegedly "deceived investors into believing that its key product — a portable blood analyzer — could conduct comprehensive blood tests from finger drops of blood" -Holmes and Theranos created elaborate technology demonstrations in which they showcased their proprietary analyzers but actually processed the samples on machines made by other vendors. For example, Holmes allegedly led executives from a pharmacy company on a tour including a room full of miniLab analyzers, leaving the impression that samples could be clinically analyzed there, though the analyzers were not able to be used for testing -Theranos also projected that the company would generate more than $100 million in revenue in 2014; in fact, the company recorded $100,000, according to the SEC. Raised $700 million from investors.

Design of Experiments

•Two Types of Experiments -Classical (full factorial) -Fractional factorial

Biotechnology

•Use living systems and organisms to make products •Bioengineering •Biomanufacturing -insulin (Genentech) -vaccines -biologics - monoclonal antibodies •Genomics - computational biology •recombinant gene techniques - genetic engineering •pharmaceuticals •Diagnostics

Ohm's Law

•V = I · R -The voltage (V) across a resistor (R) is proportional to the current (I) -Similar to flowing water, current = movement of electrons •"Thermistor" -Resistor that changes in resistance value with temperature •∆R = k∆T •Semiconductor -Not metal, usually silicon -Conducts between metal and insulator -"doping" with impurities that carry electrical current •Boron (p-type) and phosphorous (n-type) •Voltage divider -Vout = Vin · Z2 / (Z1 + Z2)

Measures of Dispersion

•Variance - The average squared distance of each data point to the mean. •Standard Deviation - The square root of the variance.

The Power of Systems Engineering

•Vast Influence over system design •Success vs. Failure •Multidisciplinary -Accumulate a working knowledge to work effectively in a given field -Common principles •i.e. signal gain, transfer functions, detector sensitivity -Blood Cell Analyzer Example: contains Optics, Fluidics, Electronics, Computer Algorithm, Software, Firmware, LIMS, Automation •Process: Therac-25 case study -Radiation therapy machine -6 accidents between 1985 and 1987 giving patients massive overdoses of radiation -Thousands of times greater than intended, death and serious injury resulted -Bad design and development practices •Power of Approximate Calculation -How many piano tuners in Chicago?

Ethical Issues in Engineering

•We also have had to consider such moral issues as -the right of patients to refuse treatment (living wills) and to participate in experiments (informed consent). •As a result, these technological advances have made the moral dimensions of health care more complex

Ethics- goals

•While morality represents the codes of conduct of a society, ethics is the study of right and wrong, of good and evil in human conduct. •Ethics is not concerned with providing any judgments or specific rules for human behavior, but with providing an objective analysis about what individuals "ought to do." •Defined in this way, it represents the philosophical view of morals, and, therefore, is often referred to as moral philosophy

Prosthetics: Orthopedic

•a "replacement" limb . •must be comfortable, aesthetically pleasing, convenient, and simple in attachment.

Prosthetics: Neural

•may be powered by the human body— may operate from electrical signals sent via electrodes from an external source to the peripheral muscle neuron—or they may be powered externally. •"Brain Machine Interface" •Cochlear implant or used to guide assistive technologies, such as prosthetic arms