Phoenix Ambulatory Blood Pressure Monitor Project
5/22/2005 Meeting Notes



Ralph Cardinal, Director of Hardware Engineering at Guidant, presented to us on testing in the design phase. He gave us permission to post his presentation and you can view it by clicking here. It is also posted on our Bibliography page. He tailored his presentation to address our questions:

Ralph asked if there is any evidence that BP cycle measurement improves healthcare. Germaine summarized the data and outcome studies.

He introduced design analysis testing (DAT). It addresses design intent, whitebox testing, not blackbox, and the testers must have intimate knowledge of the design detail.

Q: How do you decide what the intended use is, do you have to account that products may be used in unintended ways?
A: DAT is one level above the requirements, it is looser, with a broad view, not narrow view.

Design Verification Testing (DVT). Demonstrates that the specified requirements have been met. These groups of tests are sometimes called QA, blackbox testing, and the testers have no knowledge of the design.

Design validation demonstrates that the system conforms to user needs and intended uses. Here, you bring in customers and have them perform testing, use models and prototypes, learn how they are going to use it and their expectation. Often it is called systems testing, GMP (Good Manufacturing Practice), testing on real people, and can even be test by sales reps if formalized. It can be called design validation if it is done by the people who designed it, but not on the same spot.

These are the three types of testing. At a high level all forms of this testing are similar because FDA requires it, but at a lower level it differs by degree of automation. In Europe, one must assure it conforms to 13485.

As the design changes, the plans and protocols change. Then you test, and write the report. All tests are expected to pass 100% otherwise a justification must be written. The best way is to continually test.

A protocol is a scenario description to test, the how to test. The plan says what to test and the protocol is how to test.

Development testing is a looser version of that. DAT testing is the development testing.

Q: Given our Roadmap, when must we begin testing?
A: In your productization phase, when you make the product manufacturable. However, DAT would be beneficial during your prototyping to catch errors and to prototype your testing capability.

IEEE has a standard for Verification and Validation for Software testing. It is standard engineering for best practices.

IEEE Std 1012-1986, Software Verification and Validation Plans, Institute for Electrical and
Electronics Engineers, 1986.

IEEE Standards Collection, Software Engineering, Institute of Electrical and Electronics Engineers,
Inc., 1994. ISBN 1-55937-442-X.

See the references in General Principles of Software Validation, also posted on our Regulatory Requirements page.

Sometimes, companies develop and 'throw it over the wall'. They have different groups for design and crash testing. The rationale for testing is: If the defects are found earlier, it costs less to fix them.

He reviewed test approaches.

You must have requirements in order to test.

What looks bad to FDA is if you try something, it doesn't work, and you try to hide it. If you try it, it doesn't work, you report it, then try something else, and iterate until you find something that works, but report continually.

What to test: Hardware, Software, System,

Test at the interfaces, have good requirements around the interfaces.

Regulatory Expectations: Verification and Validation, and Documentation. For Class II, they still expect V&V, design history file, record decisions and why, justification, safe and reliable. Increasingly, Human Interface and Human Factors is being done, especially for software, and is highlighted by the AMI (American Association for Medical Instrumentation).

Q: Does FDA come to our site?
A: No, just reports.

Q: What about ISO?
A: A notified body, like TUV comes. Guidant uses the British standards.

Good Practices - continued ...

For Peer Reviews, an independent team from outside the organization is not required. If the team that validates is managed by the development team, this will be questioned by FDA.

Inspection is going through the code with another coder.

FDA wants a planned, methodical, and documented test process and execution. You can fail and explain, but you may wish not to send anything that says "failed", but explain that it was outside reasonable bounds, then you changed something, and it passed. Or the color requirement says it should be yellow, not red, it wasn't so you went with it anyway because it didn't affect safety or efficacy. If you change something, use Ripple Analysis, and test what it affects, e.g. another 20 screens. Finish the protocol as much as you can before you make changes. Don't justify it as "engineering judgment".

What does software need to create for testers? They need requirements. Only include those who are needed on reviewing requirements, eg. concept would include marketing, but software requirements would not, nor would it include electrical or mechanical, and vice-versa.

Analysis testing includes DAT/or scripted testing, united, integration, possibly automated. Include the plan, methodology, protocols, use cases, report.

It is commonly believed that IV&V is better, but this is not necessary.

What does it mean to the integrity of the test process if testers are part of the design process? Integrity isn't the issue, coverage is. Testers need to be testing the areas they have not participated in.

How do they remain separate and 'part of the loyal opposition'? You can use a separate team. Or with smaller teams, one team can test software module they haven't worked on and vice versa, the other team can test their module.
Inspection in the design phase yields many benefits.

Q: How do you find the unanticipated, especially biological, effects. For example, a change in a pacemaker case that created a 'hole' in the case led to growths in a hole in the embedded product.
A: This should be covered in the hazard analysis. Brainstorm about what could happen. Don't allow last minute changes without hazard analyses. Have someone identified as the safety person who anticipates what could affect hazards.

Labeling includes anything written, on the screen, anything that comes out as documentation to the public.
Requirements are not labeling, and design history file isn't either. Labeling includes the user manual and patient manual.

Q: What is most difficult, FDA or ISO?
A: For Class II, it is very similar. FDA is a little more difficult because it focuses on safety and efficacy. ISO focuses only on safety. For any Class III (drugs and implantables), they want efficacy, but typically not for class II. FDA wants to know if it really works.

Guidant has used agile methods, team programming, PSP, it worked quite well. They use a dedicated team and they make the choice, so it that hasn't been consistent. Typically, a team is formed, executes, and is broken up afterwards.

Q: When we do the hazard analysis, with dire effects, what do we do with it?
A: Mitigate it.

Q: What tools do you use? For example, do you use ADA?
A: ADA doesn't work well with embedded products.

For software: C is good, choose a methdology, agile if fine. Or divvy out the requirements and go for it. Use what you are familiar with. Use the same methodology for the entire project.

For hardware: Programmable parts, same as how you've been doing it for years.

There is nothing unique about medical other than regulatory requirements and good practices. Therap, Thiac4 (sp?), it had a software fault and delivered too much gamma radiation. After that it showed up again and again, and was never corrected in the field. It started FDA's focus on software.

For system: MS Word works fine, XML for tags works for traceability, you can tag a requirement. Stay away from big requirements analysis systems for this project.

Open source defect tracking systems, CVS has worked well.

Ralph concluded his presentation and said he would be happy to return to address additional questions. We thanked him for his excellent presentation.

Projects Status Review.

* Germaine: reviewed some data formats with Dennis. Dennis and Chris are trying to . Interval, length of record, (24 hrs, 48 hrs, new ones are 7 days, and longer), some have holes and gaps, age groups, centenarians, contained projects to find association with melatonin.

* Wayne: breadboarding a circuit, Asked for another Sensor team: evenings, not Monday. Weekend works well in the evening. Possibly 6/4-5.

* Tom: organizing his project for testing. He'll send El a project plan to post for his project page and El will send him a logon to his page.

* Gerry: working to get back into pediatrics, will have new scenarios for clinical practice, working with Dr. Milt Seifert on patient-care software, healthy business model for healthcare. Why healthcare is such a bizarre process to model, very applicable for mass customization, and why this is such a good fit.

* Dennis:, click on Public Pages, then scroll down and click on Phoenix Project. Here. It is another wiki, used by Breakthough Thinking, another study group he is participating in. he Set up a Phoenix table for blood pressure. Began a discussion of data forms.

* Larry: Looking for a software project to do this summer.

* Dave: Getting lab access at the UofM, got parts on order to reproduce what Wade has done with the Piezo Film Sensor.

Our next general Phoenix meeting occurs on June 12. El will schedule a sensor team meeting for Dave, Wayne, Tom and El during the 6/4-5 weekend.



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