We are the happiest when we are creating.
Omnica is driven by a love for design, engineering, and creating new possibilities in the medical device industry. Our clients experience our commitment which is why Omnica gets 70% of its new business from direct referrals, underscoring our exceptional results and commitment to building lasting customer relationships.
We have been an asset to startups and some of the world’s largest medical device manufacturers for nearly four decades. Part of this success is attributed to the 17+ year average tenure of our staff. Not only does this result in an efficient approach to design and development, it also helps ensure that the specific knowledge and experience gained on each client is retained here for many years and multiple projects.
"The system looks very nice. You and your team did a really excellent job and the attention to detail really shows."
"Thank you for a great piece of equipment! As always, it has been a wonderful experience partnering for this project – and we look forward to future collaborative opportunities!"
"Everyone really likes the direction and had nothing but good things to say. Thank you and your team for all that you have done and will continue to do for us."
"This has been the best product launch that I have ever experienced. We could not imagine working with a better partner than Omnica."
Problem Solving Specialists
Advancing the Promise of Medicine
If you are facing a challenge in one of the following areas, we are uniquely prepared to solve your problem.
- Projects taking too long to complete?
- Lack the experience of an integrated team?
- Are you relying on slow supplier turnaround times for prototyping?
Design and engineering is fun for us. We tackle your project with creativity and care that comes from knowing that our work is saving and restoring lives.
Get to know our TEAM of highly qualified specialists.
Omnica has designed an integrated prototyping development process.
Omnica features a “fail-fast” approach that reduces risk in the development process. It also provides early manufacturability information. This helps prove early on, that we can make it work; and at an acceptable cost. We are able to do this because we have incorporated the capabilities of a service bureau within the design and engineering organization eliminating communication errors and delays.
Our Process Evolved Over Decades
We have seen countless processes over the years with fancy names and many books written about them, but we have learned that any of these processes will work well given an experienced team. We find the team more important than the process. What we have done is eliminate communication bottlenecks and unnecessary translations within the organization in order to reduce turnaround time and errors. In general, we follow a simple phased approach for a full development.
This phase is only necessary if the development is not well defined in advance. We use this phase to make sure that we have a clear understanding of the project, work with our customers on requirements, definitions, flow charts, cost targets, use cases, etc.
Our typical Phase I efforts result in a working system that proves the technology. We often refer to this as an Alpha prototype and is also called a proof of concept. We take the time to attack the difficult problems first to ensure that we can achieve the necessary performance parameters and cost. This Alpha prototype will be adequate for testing but may not look like the final system or have the same control system etc.
Based on the work from Phase I, we will have defined exactly what we are going to build and how we are going to design each sub system. Phase II will be the actual production design and will result in what we refer to as Beta prototypes. These units will look like and function like the finished product but may still have some components that are not from production tooling, etc. The Beta units can be utilized for pre-screening for electrical safety and other regulatory required tests.
We generally work with your manufacturing team or the chosen contact manufacturer to update the design documentation, coordinate work instructions, and provide assembly and testing training.
Primary Service Offerings
Our specific skill sets are too broad to list individually, but we meet or exceed industry expectations in the following areas. We invite you to explore more specific information about our DESIGN AND DEVELOPMENT.
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Omnica design engineers have been involved in the development of laboratory IVD instrumentation, including: photometric, amperometric, fluorescent and chemiluminescent clinical and immunoassay analyzers, immunoassay washers and liquid handling devices, microfluidic POC cartridges…More
Our free resource to you.
Sign up to receive a copy of the introduction to the Design Controls section of regulation 21 CFR 820.30. It will guide any medical device manufacturer working on a regulatory strategy for developing a new product. A list of references at the end of the e-book will point to additional information on development of a medical device, the Quality System Regulation, Design Controls, and interfaces to be managed along the way. While not a comprehensive list, it highlights the most basic elements needed to get you started.
So, grab a favorite beverage, sit back, and review this information at your own pace. Hopefully, you will benefit from its contents and it will confirm what you already know.