From mboxrd@z Thu Jan 1 00:00:00 1970 X-Spam-Checker-Version: SpamAssassin 3.4.4 (2020-01-24) on polar.synack.me X-Spam-Level: X-Spam-Status: No, score=-1.9 required=5.0 tests=BAYES_00 autolearn=ham autolearn_force=no version=3.4.4 X-Google-Language: ENGLISH,ASCII-7-bit X-Google-Thread: 103376,72bc4f824cc8affc X-Google-Attributes: gid103376,public X-Google-ArrivalTime: 2001-10-13 08:35:23 PST Path: archiver1.google.com!news1.google.com!newsfeed.stanford.edu!logbridge.uoregon.edu!feed2.news.rcn.net!rcn!chnws02.mediaone.net!chnws06.ne.mediaone.net!24.128.8.70!typhoon.ne.mediaone.net.POSTED!not-for-mail From: "John Cupak" Newsgroups: comp.lang.ada References: <9q8ii6$at1$1@suaar1aa.prod.compuserve.com> Subject: Re: Ada in Medical Devices: was RE: Inexpensive Developer Level Commercial ADA compile X-Priority: 3 X-MSMail-Priority: Normal X-Newsreader: Microsoft Outlook Express 5.00.2615.200 X-MimeOLE: Produced By Microsoft MimeOLE V5.00.2615.200 Message-ID: Date: Sat, 13 Oct 2001 15:32:40 GMT NNTP-Posting-Host: 66.31.64.136 X-Complaints-To: abuse@mediaone.net X-Trace: typhoon.ne.mediaone.net 1002987160 66.31.64.136 (Sat, 13 Oct 2001 11:32:40 EDT) NNTP-Posting-Date: Sat, 13 Oct 2001 11:32:40 EDT Organization: Road Runner Xref: archiver1.google.com comp.lang.ada:14455 Date: 2001-10-13T15:32:40+00:00 List-Id: Time for my $0.02! As a software professional, I have been teaching software engineering, process, language, and tool courses for a major defense company for the last 4 years. Previously, I was a software developer and occasionally taught Ada. I have over 30 years experience, and have a MS/CS. I'm not a novice. I have seen the shift to Ada only because it was mandated by the customer, then a rapid departure to C++ and Java once the mandate disappeared. Languages are NOT selected based on their reliability, etc, but (apparently) how much it will cost to hire / train programmers. "Penny wise, but pound foolish" philosophy. A few years ago, when I was looking to change my employer, I seriously considered employment with a well-known medical instruments company. After a bit of research, however, I was apalled at the lack of standards, reliability, and programming language knowledge! "Ada" was an acronym - NOT a programming language! Not even the FDA had appropriate software standards for medical companies! As a result, rather than be put in a position where my software engineering and language expertise would put the patient at risk, I choose to stay in the defense industry. I doubt the medical instruments industry has changed much in the last few years. An interesting sidelight - in a Software Testing Overview course that I teach, I present the story of the Therac-25 (garnered from the internet) to impress upon the attendees how the medical industry ignores standard testing techniques, places the patient at risk, and "protects" the software developers! Inspection and testing techniques which are REQUIRED by CMM, ISO, etc., etc. I'd love for the FDA to mandate Ada, but I doubt they're going to find anyone to support them. In fact, I'm SURE the medical instrument companies would lobby against such a mandate! Too bad - for all of us. John Cupak P.S. My opinions stated above DO NOT reflect those of my current or any past employers. Michael Garrett wrote in message news:9q8ii6$at1$1@suaar1aa.prod.compuserve.com... > --From: Bob Leif > --To: Michael Garrett, Ann Brandon et al. > --Although to most of us the utility of Ada for medical devices is obvious, > --the FDA has not been educated to this fact. > --As a former professor of Biomedical Engineering, I have always been upset > --about the lack of instruction in the regulatory aspect of the profession. > --This is in spite of about one fourth of the students becoming involved in > --satisfying the FDA, who is the first customer for the device. > > I would definitely agree about the lack of training on the regulatory > aspects > of medical device development. Not only on the part of students training for > careers in the field but also the training of the regulators > themselves.....As you stated. > > I am currently working with a major university in the area on developing a > bio computing > curriculum. We have delivered the first in a series of three new classes > that include > lectures on the complete software lifecycle including validation > verification procedures and documents, > 510K filing and follow-up GMP inspections. We will be showing examples of > documents > and procedures that meet the regulations. The courses are currently > "language independent" > with students having exposure to assembly and C. > > The class involves a lab where students take a project through the entire > lifecycle, including > mock review of documents and functional testing. > > Now here is an interesting dilemma. There is not enough time in the classes > to teach a new language > nor is the hardware available to run Ada. ( Current hardware is MOT HC12 ). > But I would like to convey > the feeling that I had before and after learning Ada writing statements such > as: > > unsigned int selected_energy; /* range checking up to anyone who decides to > set the energy !!!!! */ > > or > > void deliver_pulse_to_patient( unsigned int selected_energy ).......... > you get the picture }; > > My experience of such coding was drastically changed after learning Ada, > even though I paid lip > service to process process etc. I might note that the experience resulted > in process changes > at the company that I was with. > > Your statement about one fourth of the students choosing a career path of > "Satisfying the FDA" > is an interesting one. I have found that in many companies the process of > regulation has become > one of satisfying regulators with a show of documents, rather than > developing a process that > continuously improves quality, safety and reliability. ( The razors edge > ....... ). > > --I might also suggest, that if one has an installed, well tested code base > in > --C, it is quite reasonable to reuse this code. However, this can be done by > --encapsulating the C into the bodies of Ada packages. > > Long Story....... > > Michael C. Garrett > Garrett Technologies Inc. > michaelgarrett@csi.com > > > > >