NJK & Associates, Inc.

Helping you jump your highest regulatory hurdles

NJK's Associates

Clinical Input

Omnica

Who or what are NJK's Associates?

The people and companies listed here are our trusted colleagues, having collaborated with us on a multitude of projects over the years.

Between us we provide expertise in virtually every aspect of the medical device industry. We've worked with two-person start-ups and multi-national giants, always providing concrete value to our clients.

 

 

Clinical Input is the ultimate team of medical device clinicians. We have the experience and knowledge base to guide your products from concept to consumer, applying clinical input to product development and human factors.

Sandra is on AAMI's HTSI infusion systems and clinical alarm systems steering committees working with a community of leaders committed to patient safety initiatives with medical technology.  Sandra’s expertise includes smart IV pumps, patient monitoring equipment, healthcare information system connectivity, continuous glucose monitoring, cooling systems, data reporting, configuration tools and more.

Omnica was founded in 1984 by Rex Bare and Earl Robinson. Their goal was to create a design and engineering firm which offered all the core services necessary to develop medical products at one location – a comprehensive design and engineering resource. Today, they are one of the premier product development firms on the West coast, specializing in medical device design, product engineering, and product development of Class I, II, and III medical devices, with the resources and personnel to develop products of any complexity.

Most of their business originates from referrals and returning customers. A number of firms rely on Omnica as their design and engineering "hired guns". Some of these relationships span multiple product generations over many years. Returning customers from all-sized companies, venture-funded start-ups to large multi-national organizations, repeatedly state that their projects could not have been completed without their involvement.

 When you visit Omnica's 25,000 SF facility in Irvine, California, you will see clean and organized workspaces, an impressive collection of high-tech tools, and equipment generally found only in specialized service bureaus or high-end shops. Tools and assets give them the ability to move quickly and build prototypes of everything they design, but it's the people who make Omnica a unique product development resource.

 

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