bioe 4420 – senior design

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BIOE 4420 – Senior DesignPre-Market Testingand Validation

K. LangA. Pinkie18 Feb 2014

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•Verification and Validation

•Standard Testing

•Testing Equipment

•Biocompatibility Testing

•Software Verification and

Validation

•Drug Development

•Clinical Trials

Overview

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Verification Ensures design outputs = design inputs

ValidationEnsures user needs are met

Specific tests depend on the function of the device

Verification and Validation

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∙ The verification process requires a stable and defined life cycle.

∙ To create a cohesive and efficient verification and validation effort, a definition of the “cradle to grave” development of the software must be produced.

∙ Setbacks should be handled but should not change the defined process unless absolutely necessary, otherwise inconsistency will place doubt in the users and erodes your confidence in the process.

∙ Validation requires that verification is working.

Verification and ValidationTest Method Commonalities

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∙ Creating an efficient verification and validation organization is done by producing salient results during the validation effort and permeating a common test approach.

1. Perform a survey of each product line and test equipment that the verification and validation group will support.

2. Implement a Common Test Set with a suit of static and dynamic test tools to run on the products and equipment using verification and validation.

Verification and ValidationTest Method Commonalities

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Test approaches should be selected based on categorization of the life cycle of the product/equipment.

• Full development life cycle – ▫ Is applied when new products = high level of concern.

• Accelerated enhancement development life cycle –▫ If the product is based on existing products then

majority of the faults are already taken care of.

Techniques, Methodologies and test approach

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The test approach to any product/equipment should be a combination of requirements testing and safety testing.

∙ Requirements testing:• Consists of development efforts that include a

production of requirements design specifications.∙ Safety testing:

• Validation in the focus consists of preventing harm to the user. hazard analysis – i.e. medical products surveying of the environment

Techniques, Methodologies and test approach

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∙ Test documentation that is generated for a particular product/equipment also depends on life cycle and level of concern.

∙ The verification and validation report summarizes the results of verification and validation activity.

∙ The reports should contain:

Verification and Validation Reporting

› Purpose› Scope

› Background› Worst case rationale

› References› Definitions› Responsibilities› Materials› Equipment

› Deviations› Including justifications for

any deviations› Results› Discussion› Acceptance Criteria› Conclusion› Appendices (as necessary)

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•Standard tests are conducted at room temperature with no acceleration of any parameters.

•Examples include:▫Cycle testing▫Typical use testing▫10 x 10 testing

Standard Testing

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•Conducts tests on individual components•Passing the state of operation and non-

operation of a component or device.

•Example: A power supply could be cycled on for 8 hours and off for 16 hours.

Standard TestingCycle Testing

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•Testing the device as it will be operated in its typical environment▫Helps show product reliability▫Also used to calculate a long-term mean

time between failures value (product lifetime)

Standard TestingTypical Use Testing

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•Ten samples tested for a particular parameter, ten different times. ▫The mean and standard deviation values

are then calculated for each of the ten recordings and ten units.

Standard Testing10 x 10 Testing

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•Instron/MTS▫Mechanical or hydraulic testing machines

Tensile Tear Shear Compression Peel Flexure

•Scales/calipers Length Diameter Width

•HALT Chamber Accelerated Aging

Testing Equipment

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•For devices which are to come in contact with the body

Biocompatibility Testing

“Biocompatibility is the capability of a material

implanted in the body to exist in harmony with tissue without causing deleterious changes”

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Software verification and validation must be performed when the quality or effectiveness of the product cannot be adequately tested or evaluated in the final product

▫ Ex: design testing through FEA

• Software verification is performed during product development to make sure that the development process, methodology and design have been met. ▫ Software developed according to procedure

• Software validation is the end activity to development and demonstrates that the software satisfies its goals. ▫ Product and software requirements satisfied

Software Verification & Validation

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• Testing final products is no longer adequate, one must assure quality during the design and development phase

• Verification and Validation ▫ Maximize assurance of quality▫ Minimize testing necessary

Software Verification & Validation

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∙ In order to satisfy the requirements of regulatory agencies, international communities, and corporate commitments, an effective systematic approach to medical product software is necessary.

∙ A software quality assurance program will minimize redundancy, assure access to information and integrate information.

Medical Product Software Development

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•Software Designers should:▫Record design activities and store resultant

design▫Generate tests to specify the testing to be

conducted to validate the design

•The tests should target:▫Integrated software components▫Interfaces between integrated

tasks/functions▫Path testing between tasks/functions

Steps of Software Testing

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∙ Design given to programmers to generate the code and create the tests. Results are reviewed, signed, and archived according to GDP

∙ Test priority:▫Safety▫Reliability▫Effectiveness or performance▫Any other relevant criteria

Steps of Software Testing

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Testing team tests

Results reviewed for adequacy

Sign/archive results

Software Testing Process

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Medical companies are faced with validating both products and test/manufacturing equipment.

Phases of Software Development• Code and Test – development of the code and debugging the

implemented code by the software developers. • Integrate and Test – integration of the software

components and the testing of the integrated parts.• Software System Testing – verification and validation

testing that is performed by the engineers on the fully integrated software and hardware.

Validation and Test Overview

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• Edward Kit is founder and president of Software Development Technologies (SDT).

• He is well known as an industry leader, test expert, author, and keynote speaker at testing conferences.

• His best-selling book, Software Testing in the Real World: Improving the Process, has been adopted as a standard by companies around the world such as Sun Microsystems, Exxon, Chase Manhattan Bank and Cadence Design Systems.

Edward Kit

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1. The quality of the test process determines the success of the test effort.

2. Prevent defect migration by using early life-cycle testing techniques.

3. The time for software tools is NOW!4. A real person must take responsibility for

improving the test process.5. Testing is a professional discipline requiring

trained, skilled people.6. Cultivate a positive team attitude of creative

destruction.

Edward Kit’s Six Essentials for Software Testing

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Drugs are created in one of three ways: 1. Trial and error2. Computer modeling of the chemical

structure3. Acquiring/testing unusual fungi, viruses,

and molds.

∙ After a drug has made it past test tube stages, tests are done on two relevant animal models. › Primarily rats, mice and other rodents are

used.

Drug Development

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Testing facility must follow government regulations for good laboratory practice in order to run properly and for accurate results

For example: animal care and testing procedures test and reporting procedures requirement for quality assurance

Drug Development

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∙ If effective in animal studies, the FDA can approve a drug to move to clinical trials

▫A committee of medical and lay personnel study the proposed drug’s test and protocol.

▫Committee approval allows for Phase 1 clinical trials to begin

Drug Development Clinical Trial

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∙ Phase 1 of a clinical trial involves 20-100 people, typically healthy volunteers or patients. › This phase is designed to assess the drug for acute adverse

effects and examine the size of doses that patients can take safely without a high incidence of side effects.

› Phase 1 lasts a few months

› ~70% of drugs pass this first test.

∙ Phase 2 of a clinical trial tests several hundred patients to determine short term safety and effectiveness.› Phase 2 takes months to years to perform

› ~ 50% of the drugs fail here.


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∙ Phase 3 tests the drug on several thousand patients with primary questions about drug safety, dosage, and effectiveness are being addressed.› Large samples are usually performed in order to obtain

good statistics which will be used in the literature that accompanies the prescription.

› About 60-70% of drugs pass this phase.

∙ After phase 3, the FDA is petitioned for a new drug approval.› Which takes an additional two years.

∙ Phase 4 investigates the continued efficacy and long term effects of the drug in use.


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Thank You

Presented by:Kacie LangAlex Pinkie