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Taking a Medical Product from Design to Commercialization

Updated: Feb 16, 2023

Taking a medical product from Design to Commercialization can be a complex process that requires experience and patience to navigate. OMEC has over 15 years of experience in developing medical products. OMEC’s parent company NovelBeam has 20 years of experience in developing products for healthcare, optics, and biometrics.

Recently, OMEC started 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.

How does OMEC find success in commercializing novel 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?

    1. Is ISO 13485 certification needed?

    2. Is a 510K required?

    3. 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 company, OMEC collaborates with other companies to create a better product, by sharing each other’s expertise.

  1. Smaller, agile, and nimble companies (like OMEC Medical) can work together with select partners (like Biotium) to bring products to market faster.

  2. By partnering with a medical company that has a good relationship with one or more hospitals, small companies can learn about the end user experience and desired product improvements.

  3. Any manufacturing and testing that is beyond the company core competency should be outsourced. For example, OMEC Medical is working with biologists and biochemists to test their life science products.

Commercialization of a medical or life science product can be a long and complex process, but the time to market can be shortened with careful planning, optimized manufacturing, and forming strategic and synergistic partnerships. If you have ideas you’d like to discuss with our team, please email us to get started at:

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About OMEC

OMEC Medical Technology of Qingdao has been manufacturing products for the medical field since 2007, and has a successful track record of designing and commercializing light sources, endoscopes, and laparoscopes. For many of these products, OMEC partners with industry leaders and these partnerships have proven to be lucrative for all companies involved. In 2022, OMEC Medical Technology opened a new manufacturing plant, in Reno, NV.

OMEC Medical is a USA subdivision of OMEC Medical Technology, based in San Jose, CA, and is focused on the development and manufacturing of life science instrumentation. Currently, OMEC Medical is developing fluorometer and PCR products for launch in 2023.

OMEC Medical Technology and OMEC Medical Inc. are wholly owned by NovelBeam Technology Co. Ltd, which is listed on the Shanghai Stock Exchange.

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