our President, Earl Robinson:
"Omnica is relatively unique compared to most other
design/engineering companies, despite the outwardly similar claims that
many competitors now make. We have always functioned as a true
“full-service” design/engineering company, placing equal emphasis on
(1) industrial design and human factors, (2) mechanical engineering, (3)
electronics and software development, (4) regulatory oversight, and (5)
scientific and technical services. We give each of these areas
approximately equal emphasis, and look for projects that require high
levels of design integration, since that is how we approach the
||28 years in Southern California as Omnica Corporation. Our president, Earl
Robinson has been working in the product
development industry since the early 1970s. Most of our employees have been in the industry between 10 and 30 years.
are a full-service
product developer. We are best at developing products that are
challenging - those that are technical in nature and will define the new
Our services include scientific
engineering (R&D, failure mode analysis, system development,
process design), industrial design,
mechanical engineering, electronics
documentation (for ongoing projects only), and prototyping/modelmaking.
System Level Development
Our approach is to view projects holistically. We believe that technical
product development requires a system level perspective, one that
combines the efforts of necessary resources from the start. At Omnica,
feasibility, engineering, design, and implementation are coordinated by
our project managers as integrated processes, not stand-alone
Why are we unique in the product
and private individuals
We prefer to work with venture-funded startups and existing medical device companies. We will consider working
with private individuals if: 1) The project is a good fit (probably a medical product), 2) The project is adequately funded and satisfies a market need, 3) There exists a business plan
which includes a marketing program, yearly unit production/sales projections, target costs (development, manufacturing, production, end-user), and distribution methods, 4) The acting project manager has developed
and taken other products to market in the past, and is familiar with the product development process, 5) Development of the product is a fulltime endeavor for the project manager, and not an "after hours" job. See
this article on the importance of a business plan.
|Customers in other states and countries.
only 10 minutes from John Wayne
Airport, and we have customers throughout the U.S., and in the UK. We
believe Omnica offers the most experienced and complete design and
services available anywhere.
not like the old days when you visited weekly to assure yourself that
we were both "on the same page". Today we conduct remote meetings online, with
With GoToMeeting we can hold on-the-fly SolidWorks presentations, and discuss and view documents
with customers anywhere- in real time. Clients can see on their
monitors any applications running on our multimedia screen. It's
secure, and easy. All you need is a broadband Internet connection.
When we produce a prototype or model,
it's easy to overnight ship to your facility.
distance is no longer a reason not to do business together, and considering the importance of what
you're trying to accomplish, can you afford to use anyone but the best?
generally stay involved by working with tooling
vendors through completion of the tooling phase by selecting materials
and approving first articles, etc. Depending on your needs, we will
participate in the fabrication and evaluation of a small quantity of
pre-production prototypes to be sure all of the design objectives are
met. We frequently superintend a first-article run (10 to 25
parts) for the projects we develop.
We are not a manufacturer.
will assist with production tooling, vendor coordination, manufacturer
sourcing and transfer to manufacturing. If you are developing a
medical device, we can help you identify and qualify an FDA registered
manufacturer that can build your product in quantity for you.
and validation (v&v) of the design
all medical devices, we recommend that V&V be done by an independent
third party. This provides an unbiased confirmation that the design
(including software and firmware) functions as intended. It is good
practice to have this done by someone that was not involved in the
actual design process. We can recommend companies that can perform this
important service for you, and we can help coordinate the process.
Throughout the design process Omnica
follows the directives set forth by the manufacturer/client as they
pertain to verification activities such as product testing, mechanical
testing, electrical safety testing, risk analysis, etc.
||Our expertise is in highly accurate machined parts fabricated with the materials to be used in final
production. When a client needs a hand-model or close tolerances are not required, we send the appropriate files to our preferred stereolithography service bureau and they make the parts. We have FIVE
(5) 3D printers, which we use as value-added tools for ongoing
projects when a rapid model is needed.
The 3D printers we use are not SLA rapid prototyping machines.
We are not a stereolithography service bureau.
Are you ISO 9001 certified or registered? NO
we are not a manufacturer, ISO Certification and
registration does not apply to our organization. Anyone who contracts
with us is responsible for maintaining records that demonstrate design
control. Our design and documentation process gives us the
flexibility to adapt to each of our client's internal system
requirements. It allows us to respond swiftly during all phases
of development. Our Quality System follows the model of the
International Standards Organization (ISO) 9001, the EN 46001, and the
U.S. Food and drug Quality System Regulation (QSR). Based on our
client's requirements, we can reference our Quality Manual and relevant procedures that will inform them about specific controls assuring our quality of service. See
our informative newsletter article regarding ISO Certified contractors.
Can you help with
design control documentation? YES
have a dedicated "Regulatory
Affairs Director", and we will work with each client company to
provide necessary documentation (at appropriate points in the
development process) to be sure that the requisite design controls are
being exercised and adequately documented. Formal design control is not
required for feasibility studies, but we would like to work with
you early in the project to define the requirements of your Design
Omnica terms, a prototype is a working version of a product or device.
Our prototyping services are value-added,
meaning we perform prototyping only for projects in development. We can build almost anything we've designed, but we reserve our
machining, modelmaking and fabrication resources to supplement the needs
of ongoing projects.
Omnica's focus is to offer prototyping
and modelmaking to existing clients who have hired us to
contribute to the design and engineering of their product concept.
We do not offer prototyping as a stand-alone service.
design or engineering services.
new projects employ us as only a mechanical engineering or a industrial
design resource. Historically, the best fit is a project that makes use
of all of our services, but most of our customers with an existing staff
want to keep them busy. One of our strengths is the flexibility to
integrate our resources with yours, and to supply critical amount
of manpower and talent you need.
have a complete molding shop, and experienced, dedicated model
makers. We build silicone molds
for urethane casting. The process is a way to inexpensively produce
parts that have the look of the final product. We generally offer
silicone mold making and urethane casting as value-added services.
We are not a service bureau for silicone and urethane molding.
consider medical product development our specialty. The medical
industry demands thoroughness and quality standards that are an
excellent fit with the way we like to do business. 75% - 80% of our
business involves medical products ranging from high-volume Class I and
II single use disposables, high-value electronic products to Class III
devices. See our Projects list.
and Commercial products
will develop consumer or commercial (and military) products if they
are a "good fit" with our resources and the needs of the
client. The projects we are interested in are those that require medium
and high technology materials and development methods.
do not offer fixed-price bids. Since we are concept developers it is
next to impossible to give a firm bid for a product that hasn't been
designed or engineered. It's a business
reality, that in order to offer a fixed price bid, contractors who have
their client's best interest in mind must necessarily pad their
estimates for unforeseen changes in the development process. See
our article on fixed-cost vs. time and materials bids.
and materials bids
of our estimates are based on time and materials. During the
development process we often show clients opportunities for improvement.
As a result they frequently ask us to take their projects in directions
they had not imagined. See
our article on evaluating bids.
Most of our customers speak with us or
visit the Omnica facility at least once or
twice a week, and want their product developed as quickly as possible.
We are involved in 10 to 20 projects at any given time, and can't afford
the time to make a job last any longer than necessary. Our clients don't
have the luxury of extra time, and by extension, neither do we.
you work with businesses that have their own in-house staff? YES
We prefer clients who are involved in the
process, and we welcome working with professionals who understand what
we are doing. We see ourselves as an
off-site extension of your in-house staff.
size project is a good fit for Omnica?
28 full-time people, we
are a good fit for small to medium-sized projects; those that will
cost from $30,000 - $2,000,000 with a development schedule from 3
months to a year-and-a-half. We're large enough to have the right
manpower and equipment, and small enough to avoid the red tape of a
company with middle management and bureaucratic procedures.