From Design to Commercialization

Claire Nippress

 Developing a medical product, from design to commercialization, can be a complex journey that demands expertise and perseverance. OMEC has 15 years of experience in medical device manufacturing, and our parent company, NovelBeam has 20 years of experience in healthcare, optics, and biometrics product development and commercialization.

In 2021, OMEC begin designing products for the life science market. OMEC designed and commercialized the first and only Laser Diode Gel Illuminator on the market, in partnership with Biotium. Using our optical expertise, we redesigned the Gel Illuminator to be the safest choice for microbiology labratory scientists who do not wish to expose themselves or their samples to UV Radiation. The Laser Diode Gel Illuminator is available now for DNA researchers, as a safer alternative to UV Gel Docs. 

How does OMEC find success in commercializing products?

Careful Planning: Before OMEC starts the design process, we ask ourselves the following questions:

  1. Does a need for the product exist?
  2. Is the window of opportunity open now, already past, or will it occur in the future?
  3. Is the IP (Intellectual Property) ours or does the IP need to be licensed?
  4. Do we have the budget and resources?
  5. How many devices can be sold?
  6. Which distribution channels should be used?
  7. What is the estimated return on investment?

After careful consideration of these questions for each product, OMEC either starts building prototypes or dismisses the idea in favor of allocating resources to more fruitful ventures.

 

Optimized Manufacturing: When OMEC is building prototypes, we are already designing for manufacture by asking ourselves the following questions:

  1. Can the product be easily assembled?
  2. Will the optical, mechanical, and electrical components work together?
  3. Is the product scalable, in terms of personnel, equipment and costs?
  4. Will the device pass FDA medical device requirements?
    • Is ISO 13485 certification needed?
    • Is a 510K required?
    • Are clinical trials necessary?
  5. What UL, CE, FC and other safety tests need to be carried out?
 

Check out this sneak peek into OMEC's Manufacturing facilities:

 

Forming Synergistic Partnerships

The largest medical companies take years to commercialize new medical devices and/or procedures. As a small medical life science manufacturer, OMEC collaborates with other local Silicon Valley Biotech expert companies to create a better product and share each expertise.

  1. Small and agile companies, like OMEC, work with select partners, like Biotium, to bring products to market faster.
  2. By forming a synergistic partnership with one or more hospitals, small companies can learn about the end user experience and improve desired end products.
  3. Any manufacturing and testing that is beyond the company core competency should be outsourced. For example, OMEC Medical is working with microbiologists and biochemists to test our life science products in development. 

If you have ideas you’d like to discuss with our team, please email us to get started at: support@omecmedical.com