Ada in Medical Devices: was RE: Inexpensive Developer Level Commercial ADA compile

["Michael Garrett" <michaelgarrett@csi.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