Frequently asked product design and engineering questions

Years in business	Twenty-three years in Southern California as Omnica Corporation. The principals, Earl Robinson and Rex Bare, have been working together in the product development industry since the early nineteen seventies.
Services we provide	We 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 state-of-the-art. Our services include scientific engineering (R&D, failure mode analysis, system development, process design), industrial design, mechanical engineering, electronics engineering, regulatory documentation (for ongoing projects), 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 services.
Inventors and private individuals	Generally we decline to work with inventors or private individuals unless: 1) The project is a good fit (probably a medical product), 2) The project is adequately funded, 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 other products 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.
Manufacturing	We 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.
Manufacturer sourcing	We will assist with production tooling, vendor coordination, manufacturer sourcing and hand-off 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.
verification and validation (v&v) of the design	For 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.
Stereolithography	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 three 3D (FDM) printers, which we use as value-added tools for ongoing projects when an ABS model is needed. We are not a stereolithography service bureau.
ISO 9001 Are you ISO 9001 certified or registered? NO	Since 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 operating procedures that will inform them about the specific controls that are implemented to assure our quality of service. See our informative newsletter article regarding ISO Certified contractors.
FDA documentation Can you help with design control documentation? YES	We 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 Control Process.
Prototyping	In 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.
Stand-alone design or engineering services.	Many 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 or our strengths is the flexibility to integrate our resources with yours, and to supply critical amount of manpower and talent you need.
Silicone Molds	We 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.
Medical products	We 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.
Consumer and Commercial products	We 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.
Fixed-price bids	We 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.
Time and materials bids	All 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 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.
Customers in other states.	We're only 10 minutes from John Wayne Airport, and we have customers throughout the U.S. We feel that Omnica offers the most experienced and most complete design and services available anywhere. We conduct online meetings with GoToMeeting™. With that application customers can hold on-the-fly presentations, discuss and view documents in real time concurrently with us at their facility. Considering the importance of what you're trying to accomplish, can your afford to use anyone but the best?
Will you work with businesses that have their own in-house staff? YES	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.
What size project is a good fit for Omnica?	With 29 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.
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