* Andrei Khodak, of Advanced Bionics, Inc, joined us. He has a research and development background in blood pressure, fluid interaction, and computation fluid dynamics.
* Max Cortner, Director of Testing at Guidant, will present to us at our next meeting on medical device testing. Chris wants to hear what testing we need to do as an open source community because we come from companies with cultures who have a tradition of testing. However, in open source organizations we can't afford that cost structure, but we still need to do testing. So, what should we do, how do we adapt and what can we avoid that is just culture.
Dennis: Looing at repository tools, doesn't like CVS, looking at TLA, Arch,subversion, in CVS he doesn't easily enable to reorganizing the code, doesn't allow you to create new directories, delete and rename old directories.
Gerry: Monitoring groups, need for medical vocabulary, interachinge information with medical personal, looking at open source projects. There have bween other attempts, UNMLS universial medial language system, meta thesaurus, may become open. For auditing records, just keep all of the old records, e.g. in medical records, you have to keep all of the records, never forgets all of the old records. FDA is using that culture, all of the old versions of the specifications.
Wade: suggested www.21cfrpart11.com, solution providers, electronic ocument management systems. We should look at these, they specialize in handling and storing these documents. Is there an open source product that will take our information and provide a 21CFR Part 11 compliant verision that is auditable. Also, look at their discussion group, it is a Yahoo Group. "21CFRPart11 mailing list". We need to capture data and the design history file. Gerry will look at this and let us know.
El: will add the link to the full 21CFR Part 11 to the medical
regulations webpage. www.access.gpo.gov/nara/cfr/waisidx_04/21cfr11_04.html
Start with scope.
Wade: Received a package from Conductive Technologies, Mike Flickinger, sent a blank with a square field that you can cut out the electrode, atttach three tails, then use a conductive epoxy. Wondered if you just use a glue, or their own proprietary adhesive. We are reluctant to go with a proporietary solution because we are trying to create an open marketplace for people to compete for best price and service. We are trying to create a marketplace for ABPM.
Bob: Asked where Franz' additions to the mission.
El: We changed the definitions of 'unobtrusive' and 'easy to use' which are linked on every use of it on the webpage. We don't want to change the mission statement, because that may require a restart of the Phoenix Project, but we structured it so that it is flexible enough to accommodate change through 'clarification' of the words used in its definition.
Bob: There is encouraging news of the last issue of EE Times of open source products for the 3rd world, eg. a bicycle powered computer.
Germaine: It is possible that Miguel Rebilla, a mathematician and webmaster of the Halberg Chronobiology Center, may be interested in participating in the Phoenix Project. He has worked on Cosignor function for Chronobiology, using Matlab.
Regarding the platform for developing software, between
Input example, VBA program, output example, statistics routine, enhancements that allow for handling infinite amout of data.
Chris Adams: Just accepted a position with United Health Group as a senior business analyst based in part on presentation of his work with Phoenix, where he will focus on systems requirements analysis. Questions include: do we want to do test driven development. He took us through his presentation. Today we will focus on User Roles and requirements. We envision the system comprising four parts, 1) the local wearable subsystem, 2) the remote data analysis workstation subsystem, 3) the physiologist's analysis system - the baseline manasgement workstation which uses a profile of the patient (e.g a 35 yr old male) and allows them to create new profiles and modify existing profils, and 4) a diary which includes information about each measurement to interpret each measurement. The diary is essential and will be unique to Phoenix, because no other ABPM incorporates a diary into it. It is a major issue in making sense of the blood measurements.
Germaine: The diary is most useful in determining what the patient's activity at the time of measurement. Currently, the data is the sum of all the data, with the diary, you can interrogate the data and categorize it based on activity, sleep, wake, exercise, and other activity, changing the time base and activity base.
Chris: We can separate out the work of the Daa Analysis Workstation: heavy data modeling, XML, some commuiniocation modules in both the data analysis (remote) and the blood collection (local) system. It will have a display, because the patient will need this information, their will be a keyboard to provide commands, a processor, and an applications layer to enable processing.
The Actor/Users: The scenarios we previously identified are more limited than we thought. A monitor wearer - we need another label which describes the user not what they do. Other class of user are administrators, who get the data out of the device and provide it to others, including physicians, technicians, pharmacuests or a self-care person. There are multiple kinds of clinicians: Primary Care physician,specialist, nurse. The last major role is the physiologist.
The stakeholders include: health insurance companies, inspector/auditors/regulatory agencies, and clinicians.
Actors includes: Patients (wearers), speicalist, clinicians, physician, nurse.
Summary Use Cases inlcude: 1) Rehabillitiation for clinical trial and clinical practice, and 2) Prehabilitation for self-care or education. We suggested others including 3) public health where a government or non-for-profit agency to gather information on the health of a population, 4) research - evidence-based medicine, 5) Insurance programs while implement illness preveniont discounts and wellnes programs.
Next step: we need story writing for each of these to capture the requirements. Example: A patient checks into a clinic, nurse collects a patient history, doctor looks at it and says to the patient that they are a candidate for a program, they patient agrees, they sign agreement forms, they give the patient the device, train them in their use, and create a schedule of use and visit to the clinic, the program is conducted and completed, the data is collected and analyzed, data submitted to the originating organiztaion and used in the following way. Gerry will write stories on primary care, nurses perspective, wearer/patient. Bob will write a narrative on the application in the hospital. Germaine will write a narrative form the chronomics analysis perspective - included as part of her document on blood pressure analysis including input - analysis method - output, or just give us references to such articles. El will write stories about public health and insurance. Dennis will write a story about Self-care.
Education: Germaine described how they used slumber parties to
discuss it and learn that there were blood pressure variations.
Our next meeting will occur on February 27th.
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