BME 3801 - bioDesign I

Before deciding on a project and developing design requirements, the team must:

1. Define the problem 2. Define the need

Design process order:

1. User needs in user terms 2. Marketing requirements are measureable 3. Specifications provide the details to build 4. Prototype is built to specifications 5. Verification testing ensures prototype(specifications) meets requirements

Which of the following ISO standards applies to risk management?

14971

How many years does a utility patent last from the non-provisional patent filing date?

20

What is the duration (in years) of a patent from the earliest effective filing date in the United States of America?

20

Problems that need solutions

= OPPORTUNITIES

Research bibliography

Annotated bibliography showing all relevant literature with notes about implications

Define each of the following statements as a need, requirement, or specification:

Audible by someone with unimpaired hearing in a mixed frequency 80 dB environment - REQUIREMENT 1 W speaker driven at 3 V, 2000 Hz for 2 sec/1 sec intermittent - SPEC Audible in a noisy environment - NEED

In order of increasing electrical protection

BF B CF

Electrical shock may result from:

Conditions a-c must occur simultaneously a voltage source driving current through the body between those two points of contacts a different part of the same body being in contact with a second conductive surface one part of the body being in contact with a conductive surface

Risk index Graph

DIAGRAM Bottom: broadly acceptible region Middle: ALARP region Top: Intolerable region

What branch of the US government is responsible for the regulation of medical devices?

Department of Health and Human Services

Design Specification

Derived from marketing requirements Requirements are reduced to specific design specifications Requirements = Skeleton, Specifications = Flesh Addresses each subsystem Specification will include appropriate tolerances (used for acceptance criteria)

primary types of records in QSR

Design History File (DHF) Device Master Record (DMR) Device History Record (DHR) Technical Documentation File (TDF)

Pick all that apply. Which of the following are a type of patent

Design patent Plant patent Utility patent NOT: Copyright patent Trade secret patent

Design Input

Each manufacturer shall establish and maintain procedures to ensure that the DESIGN REQUIREMENTS relating to a device are appropriate and address the intended use of the device, including the NEEDS of the user and patient.

Are all Class I devices exempt from special controls that apply to Class II and III devices?

False

A design project does not have to contain the following?

Gantt charts DOES have to contain: A signature block for responsible parties An assignment of responsibilitiies Subprojects, tasks, milestones

Which of the following statements is true?

Leakage currents are measured during both normal and single fault conditions

Which of the following are considered to be the minimal requirements for general controls?

Manufacturing registration Device labeling Manufacturing per cGMP NOT: Human clinical trials Post market surveillance

Device History Record

Production records for a particular device Demonstrates the process, tests, rework, etc. of a device in its fabrication and distribution Should include the following: Date of manufacture Quantity manufactured Quantity released for distribution Acceptance records to match back to DMR Primary identification label and labeling used for each unit Any device identification and control numbers used

What's the purpose for conducting a risk analysis? (Choose all that apply)

Reduce probability of having a recall Required in PMA and 510(k) filings Required by law Reduce product liability and damage awards NOT: Decrease manufacturing cost Shorten time to market Decrease clinician malpractice insurance rates Reduce the cost of design and development

bioDesign "Design and Development Plans"

Required by regulations (FDA) Design Input Design Output Marketing Requirements Design development Specifications Prototype fabrication Verification Testing

What about Software???

Software can be a device on its own (standalone), or it can be included in another device, either as a component or part, or distributed separately for use as an accessory to another device.

True or False? A need statement should have a quantifiable metric associated with it.

True

True or False? Requirements are often measurable.

True

Design Verification

Verification test plan Traceability is demonstrated Provides list of specifications to be tested Appropriate acceptance criteria given Methodology on how tests are to be conducted Lists responsibilities and due dates Appropriate statistical rational

A specification consists of...

a metric and a value.

Choose all the apply. Class I devices are not intended to

be used in supporting or sustaining life present a potential unreasonable risk of illness or injury be of importance in preventing impairment to human life NOT: be ingested or inhaled be administed by a physician

The objectives of a design review include all of the following except: (choose all that apply)

evaluate individual team member contributions to the project educate or bring new employees or unprepared employees up-to-speed NOT: evaluate the return on investment (ROI) include individual(s) who does not have direct responsibility for the design stage being reviewed evaluate the adequacy of the design requirements confirm and assure that the device is safe and effective

The minimum requirements for obtaining a patent are that the invention must be:

novel non-obvious or include an inventive step useful or capable of industrial application

Devices are regulated by the FDA according to the:

risks posed by their use

Risk index (R) = __________ index x __________ index

severity probability/likelihood

If you want to know what is actually covered by a granted patent, what should you look at?

the claims

Leakage current is (choose all that apply)

the current that passes through the patient's body in the course of device operation the current that passes through the caregiver's body in the course of device operation NOT: the current that flows in the live conductor the current that flows in the neutral conductor the current consumed during device operation

Four Laws of Design Control

1. Document Everything DHF 2. Inputs = Outputs Acceptance criteria 3. Trust but Verify and Validate Everything Verify acceptance criteria and specifications Validate we are making what the customer asked for 4. Transfer is Inevitable Repeatedly manufacturing the product

FDA History

862 - President Lincoln - Dept. of Chemistry - precursor of FDA 1906 - Roosevelt - Pure Food and Drug Act - founding of FDA 1937 — Over 100 people died after consuming a raspberry-flavored sulfa elixir which consisted of 70 percent ethylene glycol... antifreeze The Food, Drug and Cosmetic Act of 1938 gave authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics The Medical Device Amendments, 1976 Safety and effectiveness of medical devices Manufacturer registration Develop processes for premarket notifications, approvals, predicate devices, and performance standards. Safe Medical Devices Act (SMDA), 1990 Requires hospitals to report incidents involving medical devices that are reasonably believed to have caused or contributed to the serious injury or death of a patient or employee Requires manufacturers to conduct post-market surveillance of implanted devices. Food and Drug Admin. Modernization Act (FDAMA), 1997 Increased efficiency of reviews, harmonized FDA and other regulatory Increased efficiency of reviews, harmonized FDA and other regulatory standards, QSR Medical Device Fee and Modernization Act, 2002 Allows FDA to collect fees to review medical device submissions

General Controls

All medical devices. Considered to be the minimum requirements. Manufacturing registration Label devices per regulations Submit a premarket notification [510(k)], unless exempt Manufacture devices per cGMP regulations (Current Good Manufacturing Practice)

How can properly implemented GD&T save money in the manufacturing process?

Better definition of the design requirements, increased availability of tolerances, better communication between design, manufacturing and inspection, fewer engineering changes.

What class of medical devices does an adhesive bandage belong to?

Class I General Controls Class I devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Devices in this category include tongue depressors, bedpans, elastic bandages, examination gloves, and hand-held surgical instruments and other similar types of common equipment. These devices are subject only to general controls. General controls cover such issues as manufacturer registration with the FDA, good manufacturing techniques, proper branding and labeling, notification of the FDA before marketing the device, and general reporting procedures. (Most Class I devices are exempt from the good manufacturing practices and/or the FDA notification regulations.) These controls are deemed sufficient to provide reasonable assurance of the safety and effectiveness of the device; or the device is not life-supporting or life-sustaining and does not present a reasonable source of injury through normal usage.

What class of medical devices does a surgical drape belong to?

Class II General Controls with Special Controls Class II devices are held to a higher level of assurance than Class I devices that they will perform as indicated and will not cause injury or harm to patient or user. Devices in this class are typically non-invasive and include x-ray machines, PACS, powered wheelchairs, infusion pumps, and surgical drapes. General controls alone are insufficient to assure safety and effectiveness, and additional existing methods are available to provide such assurances. Therefore, Class II devices are also subject to special controls in addition to the general controls of Class I devices. Special controls may include special labeling requirements, mandatory performance standards, and postmarket surveillance[2].

Special Controls

Class II devices. Assume that General Controls are not sufficient to ensure the safety and effectiveness of the device. Varies by product. May include: Special labeling requirements Conformance with certain FDA guidelines Mandatory performance standards Human clinical trials Post market surveillance

What class of medical devices does a replacement heart valve belong to?

Class III General Controls and Premarket Approval Class III device is one for which insufficient information exists to assure safety and effectiveness solely through the general or special controls sufficient for Class I or Class II devices. Examples of Class III devices which require a premarket approval include replacement heart valves, silicone gel -filled breast implants, implanted cerebellar stimulators, implantable pacemaker pulse generators and endosseous (intra-bone) implants (with the exception of root-form endosseous dental implants which were recently reclassified as Class II). Such a device needs premarket approval, a scientific review to ensure the device's safety and effectiveness, in addition to the general controls of Class I. Class III devices are described as those for which "insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness or that application of special controls ... would provide such assurance and if, in addition, the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury."[3]

Technical Documentation File

Contains relevant design data which demonstrates that essential safety requirements are satisfied File must be kept for 10 years after production stops in case of liability proceedings Allows assessment of the conformity of the product with requirements of the Medical Device Directives

Which of the following is NOT considered intellectual property?

Copyright Patent Trademark Trade Secret All are considered intellectual property

Why would you use design control in the development of a medical device? (Choose all that apply)

Customer focused Required by law Systematic approach Allows multidisciplinary input NOT: Reduce cost Will ensure you don't get sued Leads to a 100% risk-free device

Rules when Writing User Needs

Customer needs take the form of job statements Must not make mention of a technology, solution, or product It must not contain ambiguous terms Must be as specific as possible without sacrificing brevity Consistency in terminology Must have a consistent structure, content, and format

510(k) eligible or requires PMA

DIAGRAM!!

Design Output

Design output means the results of a design effort at each design phase and at the end of the total design effort Final product specifications Device prototype Included as part of the DHF under version control The finished design output is also the basis for the Device Master Record

The phrase the "voice of the customer" refers to what aspect of design and development:

Development of user needs

What does ANSI Y.14.5 (Now renamed to ASME Y14.5) relate to?

Dimensioning and tolerancing

Sections 201(g) and 201(h) of the FD&C Act provide definitions for the terms "drug" and "device". What is the main difference between the two?

Drugs achieve their effect through chemical action and is dependent upon being metabolized

DHF

Each manufacturer shall establish and maintain a DHF for each type of device QSR and SOPs User Needs and Industry Standards Compilation of records which describes the design history of a finished device Contains 'institutional' memory of previous design activities Contains verification and validation protocols

Match the following symbols and labels to an equipment type.

Earth/Protective Earth/Equipotential = CLASS I Double Square = CLASS II

What is design validation?

Ensuring that the developed medical device conforms to user needs and intended uses

Design Concerns

Excessive documentation Human patients, animal studies, permissions Design is often iterative Teamwork, finances, reality Design Considerations: economic, environmental, sustainability, ethical, health and safety, manufacturability, social, and political considerations

Flow Chart Diagram

FTA

__________ is used to identify a failure/safety hazard and all possible ways to create that hazard, while __________ assumes a basic defect on a component level, assesses the effect and identifies potential solutions.

FTA (Fault Tree Analysis) FMEA (Failure Mode Effects Analysis)

True or False? 510(k) submissions never require any data collected in clinical investigations.

False

True or False? A needs statement should have a conceptual solution embedded into it.

False

True or False? Class III devices are never eligible for 510(k) clearance.

False

True or False? Grounding is not required for Class I equipment.

False

True or False? It's OK for a requirement to be vague, ambiguous, or conflicting.

False

True or False? Over 90% of the devices placed on the market in the US are cleared by the FDA after the review of a PMA (pre-market approval).

False

True or False? Patents are automatically enforced by the USPTO.

False

True or False? Planning is not mandated by 21 CFR 820.30, but it will help you complete the project on time, within budget, and using the allocated resources.

False

True or False? Reproducibility and precision imply accuracy.

False

True or False? Software cannot be considered a medical device.

False

Marketing Requirements Document

First step in transforming product ideas into approved product development efforts Subject to version control Joint ownership among all concerned departments

What is a Medical Device?

Food Drug and Cosmetic Act (1938) section 201(h): ... an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized 1. in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, 2. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or 3. intended to affect the structure or any function of the body of man or the structure or any function of the body of man or.other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

Medical Device Industry

Global market for medical devices exceeds $390B US market ~ 40% of WW market US innovation drives the market (more US producers than rest of world combined) However.. it is increasingly difficult to commercialize Consumer & agency regulation Increasing control improves safety and effectiveness at the expense of commercial progress of commercial progress Overseas manufacturing and product launch

Executive Summary

Management level document covering entire project Covers all phases of process (typically one or two paragraphs per milestone)

Why do medical devices fail and therefore impose risk on the user? (Choose all that apply)

Misuse Quality assurance deficiencies Design deficiencies NOT: High cost Lack of coverage from insurance company Lack of FDA approval

What is Design?

NOT research or craftmanship Involves devices, processes, re-engineering, systems, optimization, regulations, finances, innovation, invention, entrepreneurship, etc. invent, intend, devise rawing, arrangement, pattern, plan, art of making designs

At what point during the medical device design process must risk management take place?

Ongoing during the entire process

Verification test results

Provides statement of pass or fail per acceptance criteria Explains path to remedy failures

What is the significance of a traceability matrix in medical device design? (Choose all that apply)

Required by the FDA Basic design control tool used to establish clear linkages between design inputs, ouputs, verifications, validations, and risk analyses NOT: Ensures that all customers will be happy with the product Useful only during design verification activities Keeps your boss off your back throughout the design process

All of the following are characteristic of a patent drawing:

Scale Shading Number, letters and reference characters Variety of views Black & White EXCEPT: Detailed annotation

Why Design Control?

Systematic Allows organizations to develop design processes that meet their needs. Team based Multidisciplinary teams are empowered to make decisions. Customer focused Requirements play a key role in driving specifications and validation. Robust Verification and validation ensure a higher quality design. Required by law

Design Master Record

The total finished design output consists of The device The device packaging and labeling The Device Master Record Final specs including process to build prototype Testing results Documentation handed to manufacturing and quality assurance

True or False? Accuracy is a measure of the total error.

True

True or False? After the patent terms expire, the invention becomes 'public domain' and may be made, used or sold by anyone without licensing.

True

True or False? All medical devices are subject to general controls.

True

True or False? Class II electrical instruments use "live" and "neutral" connections only.

True

Choose all that apply. Which of the following devices are not exempt from 510(k) notification?

Veterinary devices Custom devices (intended for use by a single patient) Finished devices not sold in the US Preamendment devices ALL ARE EXEMPT

A design review is an examination of a design or process that is: (choose all that apply)

documented an ongoing part of the entire design process used to bring a cross-functional team to the table to ensure the design team has not missed something overall NOT: recommended by 21 CFR 820.30(c) a discussion over dinner and/or drinks a means to get a meeting with your boss

Electrical safety must be tested: (Choose all that apply)

during routine planned preventative maintenance on newly acquired equipment prior to being accepted for use after repairs have been carried out on equipment NOT: before each use any time you feel like doing it

Choose all that apply. A device is considered substantially equivalent (SE) if it:

has the same intended use as the predicate and the same technological characteristics has the same intended use as the predicate but different technological charactersitcs and the information submitted to the FDA does not raise new questions about safety and efficacy and demonstrates the device is at least as safe and effective as the legally marketed device NOT: has the same intended use as the predicate but different technological characteristics has a different intended use as the predicate but the same technological characteristics has a different intended use as the predicate but the same technological characteristics and the information submitted to the FDA does not raise new questions about safety and efficacy and demonstrates the device is at least as safe and effective as the legally marketed device

Fill in the blank: Product design specifications must be specific in translating and interpreting __________ into engineering, quantifiable terms.

marketing requirements

Broadly acceptable level of risk determination is driven by:

societal values