Next Meeting: We will conduct our next meeting on November 7.
New Member: Chris Adams joined the Phoenix Project. He is a software engineer, applications programmer, systems programmer, migrates applications to new operating systems, builds tools for engineers, and has worked for Medtronic in their Cardiac Pacing division, with other medical device companies, and in product localization. He has a lot of process engineering experience, is a systems thinker, and is collaborative. Most recently, he worked as a terminologist in glossary development, specifically in electrophysiology. He has been in the business long enough that he has touched on most of the issues we are discussing, especially requirements development, specifically translating highly technical requirements into terms non-engineers can understand, e.g. from engineering to marketing.
Bob's Questions: We discussed Bob's questions, specifically the sphygmomanometer. Germaine suggested that we correlate the monitor to a known standard and publish the results in a journal in hypertension to be accepted by a community of physicians. We will need it for a clinical trial. We discussed how we get agreement from the medical community, and identified that we need to: 1) comply with the ANSI standard (ANSI/AAMI SP10-1992, see Phoenix Regulatory Approval Project, Requirements, non-invasive blood pressure monitors), we need a copy of this standard. (Bob will get a copy) and 2) develop a process for calibrating the monitor in the manufacturing process (and discussed whether we should also have one for calibrating it in the field. Issues of whether we a human arm or a test fixture, which pressures and are there known fixed pressures in the human body so that monitor could perform some of this as a automated self-calibration. We'll identify these issues to discuss at the next meeting.
Bob discussed other competitors (using ARM 7), e.g. is all of the electronics work done? Bob sent El the links to EE Times (El said he would forward them to Bob, Wade, Germaine and Mary Jo. Mary Jo will help document which sphygmomanometers use the ARM 7 as part of her literature search project. We agreed that prototypes can be in any form that works, which can be miniaturized later and made inexpensively. Bob told us that he knows of a company that makes electrodes that do not touch the skin. They have a patent and he will provide a patent file number by the next meeting.
During the next meeting we will discuss Bob's remaining questions: battery, user, other measurements, power, packaging and sphygmomanometer manufacturers.
Projects Status Review
El posted the Phoenix Product Introduction System under the Regulatory
Approval Project, Processes, as the center of our Quality System.
He will continue developing the Quality System. He and Bob went
to the MD&M conference, a medical device manufacturing design
conference.
Wade went to the MD&M conference in the Twin Cities. Also
looked at patent issues regarding assuring that our IP stays in
the public domain. When we are ready for patent registration,
we have a person witness it, then we will submit a "Invention
Registration Disclosure" to the USPO for $10. This will better
assure it is protected before it is posted and decrease the likelihood
that someone will challenge it. Also, we will look at the Manual
Patent Examining Procedure (MPEP).
Germaine discussed an article on Chronotheranostics which integrates timely monitoring and timed therapeutics, and diagnostics, and she will post it on the Analysis Methods project page. She expects to have a PowerPoint document of her analysis methods by next meeting.
Summary of our project goals by next meeting on 11/7:
During our next meeting we will discuss: Bob's remaining questions: * battery, * user, * other measurements, * sphygmomanometer manufacturers, * power, * packaging. Our working activity will be software requirements.
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