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FAQS

Frequently Asked Design and Engineering Questions
Specializing in Product Development for the Medical and High-Technology Communities.

 

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What is your product development specialty

What is your product development specialty?

We mostly develop medical products, which constitutes over 80% of our business. Typical products are handheld, tabletop, or free-standing Class I, II, or III electro-mechanical devices that may or may not have a disposable component. A wide range of services, and the personnel and resources to conduct feasibility studies and R&D are more reasons we are a unique product development firm. The medical industry demands thoroughness and quality standards which are an excellent fit with our business model and the way we prefer to do business.

Will you design consumer or commercial products

Will you design consumer or 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 prefer are those that require robust designs, and high technology materials and development methods. The general consumer product requirements of "fast and cheap" are not a good fit with Omnica.

Are you a medical device manufacturer

Are you a medical device manufacturer?

We don't do any manufacturing, and consider R&D and manufacturing to be incompatible cultures. We 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.

Do you provide prototyping services

Do you provide prototyping services?

Yes. 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.

What size design project is a good fit for Omnica

What size design project is a good fit for Omnica?

With full-time people, we are equipped to handle 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.

Can you work with clients who have existing technical staff

Can you work with clients who have existing technical 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. 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.

Will you work with inventors and private individuals

Will you work with inventors and private individuals?

We rarely work with individuals unless they are affiliated with a company who markets or manufactures products in our area of expertise. Companies we work best with are venture-funded startups or existing medical device firms.

Do you offer fixed-price bids for your design and engineering services

Do you offer fixed-price bids for your design and engineering services?

We do not offer fixed-price bids. All of our estimates are based on time and materials. Since we are concept developers it is next to impossible to give a firm bid for a product that is not yet designed or engineered. It's a business reality: Contractors who offer fixed price bids must necessarily pad their estimates for unforeseen changes in the development process.

Will you work with medical device customers outside of California

Will you work with medical device customers outside of California?

We have customers in Canada, Western Europe, and throughout the U.S. and we're only 10 minutes from John Wayne Airport.

Do you perform Verification and Validation (V&V) at your facility

Do you perform Verification and Validation (V&V) at your facility?

For all medical devices, we recommend V&V be performed by an independent third party. It is good practice to have this performed by a firm not involved in the actual design process. We can recommend companies who can administer 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, and risk analysis.

Are you ISO 9001 or ISO 13485 registered

Are you ISO 9001 or ISO 13485 registered?

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, and 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. Read why we choose not to be ISO Registered.

Can you help with FDA Documentation

Can you help with FDA Documentation?

For ongoing projects only, we have a dedicated Regulatory Affairs Director, who 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.