ODDS Company is particularly useful to medical device manufacturer organizations that either
must become auditably compliant with FDA 21 CFR 820, the Quality System Regulation, or remain
so through periods of change. Because all business organizations seeking to gain or improve
profitability via Continuous Improvement eventually find that the "low hanging fruit"
has been harvested (the law of diminishing returns has become apparent). Then,
cost-effective solutions to the problems of further improvement are required. However, with the
various regulatory constraints on medical devices development, such solutions generally are not
obvious to the improvement team members (who normally are thought most likely to find them).
Accordingly, to evaluate probable worth of ODDSCO Training and Consulting services with regard
to accomplishing their planned objectives, potential clients should comprehend FDA QSR Design
Controls provisions and the Integrated Product/Process Team (IPPT) approach sufficiently, plus
know a bit about classical Systems Engineering (such as it not being the same as engineering
systems). A few first-time visitors, such as classical Systems Engineers with experience in
both defense/aerospace systems and medical devices development, may already know over sixty
percent of the provided introductory tutorials content. Extremely rare, however, is
anyone who already knows over ninety percent of the provided information (at the
detail level). The integrated set of comprehensive tutorials is provided to address the
probable knowledge gaps for the majority of first-time site visitors.
Return to Top of the Tutorials List
ODDSCO was founded in 1991 as a sole proprietership modeled on the approach used by many
university professors who write and consult in a specialty, thus needing a means to keep
the income from products and services separate from their teaching salaries and to deduct
the legitimate business expenses. That is, ODDSCO was a side business at inception, allowing
only part-time writing, consulting, and teaching. Still, much was accomplished despite that
constraint, permitting increased proportion of time for developing training materials and
performing seminars.
A first product was to be a robust, but easily understood decision assisting PC based program
for automating much of the decision process presented in Tutorial 5. Even then, however, this
author was dissatisfied with software manuals that stated only what to do, without explaining
why to do it. Then, experimenting with a popular spreadsheet program led to the
key finding: Thomas Saaty's Analytic Hierarchy Process for priority weighting with consistency
feedback (an eigenvalue and eigenvector computation in matrix algebra) could be implemented
for up to nine decision criteria within the limit of cell formulas length. Because virtually
everyone with a personal computer could have a reasonably capable spreadsheet, this meant a
much larger potential audience for the decision process. The intended writing shifted toward
business related decision making and research expanded into new domains.
While working to comprehensively describe processes supported by related decision and risk
assessment methods, this author developed and presented the 1994 and 1995 National Council on
Systems Engineering (NCOSE) Symposia Proceedings Papers which are the essence of Tutorials
6 and 5. Then, a drop in Silicon Valley defense/aerospace work resulted in some extended
unemployment and redirection of effort toward renewal of a primary earnings source. That
employment was as a software tester with a medical device manufacturer, which led to the
observation that adapting some proven defense industry practices was more than appropriate.
However, Integrated Product/Process Team (IPPT) and classical Systems Engineering processes
simply were not understood by that organization (the latter was thought to simply mean
'engineering systems' by the engineering staff, which naturally occurs) and, therefore, such
labels were less than welcome.
Accordingly, stealthy implementation of many process improvements was required to obtain their
value. Pride of authorship was internalized as the product developments became smoother. This
author's experiences then, and continued later as a working Systems Engineering Manager with
another medical device developer, were convincing of need for an IPPT approach in the QSR
domain for more than just those two organizations. The training and consulting work expanded
and was reworked to provide a medical systems development emphasis to match the extensive
revisions to this website.
Featured ODDSCO Training reinforces and builds upon the primary tutorials provided knowledge.
Comprehensive training on using an Integrated Product/Process Team approach to implement
automatic compliance with FDA QSR Design Controls is the obvious primary seminar. Training is
offered for the supporting elements of the other tutorials as well, when specific gaps in the
requisite knowledge are recognized. Further, all the primary tutorials may be customized to
emphasize selected areas with expanded detail.
To view descriptions of the current set of in-house training seminars, click on ODDSCO Training
When you must compress the cycle to obtaining cost-effective solutions, ODDSCO Consulting
teaches the recommended processes while assisting in addressing specific identified
problems. The emphasis is on the adaptable proprietary knowledge within your organization,
because therein awaits the source of most rapid adoption. Usually, the experienced workers
soon recognize that application of specific methods to existing approaches is mostly just
targeted tailoring and thereby is acceptable. (Stubborn resistance usually arises from a
perception of radical change alng with the not invented here (NIH) factor.)
Proprietary knowledge remains with you, of course, because each client will develop unique
solutions based on differences from as well as similarities to general practices provided
in the training. Learning (beyond the free introductory tutorials content) while solving
your own problems on the job with the working consultant can transform you or some designated
person(s) into the local consultant(s) or process champions, which soon can make ODDSCO
Consulting assistance redundant. A reputation for quickly training competent replacements
while implementing the integrated processes is the goal of ODDSCO (unlike the major management
consultants that work to expand the perceived need for ever more consulting services).
To pursue this approach, click on ODDSCO Consulting.
ODDSCO Products complement the
tutorial provided knowledge with supporting tools (spreadsheet Weighting Template,
Documentation, and Example Decision Model Template) for the Decision Process described in
Tutorials 5 and 6 and in their pdf versions.
Tutorials Author: jonesjh@optants.com
Consulting/products: consult@optants.com
James H. Jones received his B.S. in Business Administration from College of Notre Dame at
Belmont, CA, and his M.S. in Industrial and Systems Engineering from San Jose State
University, CA. During an economic recession, he performed contract work in avionics System
Engineering for the ongoing application of experience gained during U.S. Navy and in both
major and minor aerospace corporation employment as industrial electronic technician,
industrial engineer, system test engineer, logistics specialist, and staff system engineer.
Subsequently, he performed embedded system medical devices R&D requirements management with
emphasis on formal verification and implementation of FDA QSR (cGMP requlation) design
controls compliance. Therefore, he teaches and writes from in-depth experience and exposure
as well as extensive research into the processes set forth in the above set of tutorials.
Associated Resources, other
useful links that are indirectly related to the tutorial subjects.