Sep 18, 2015


by Grant Goad

According to an October, 2014 report, the global molecular diagnostics market will grow to nearly $8 billion by 2018. And with the boom in technologies such as digital PCR and DNA sequencing, this market will only get bigger.

At American Laboratory Trading, we strive to support life science entrepreneurs, and to provide you with information and educational resources that will help you launch a successful business. We spoke with Dr. Sylvia Norman, founder of Molecular Diagnostics Consulting, about some of the important things to consider when launching a molecular diagnostics product and business.

Dr. Norman, who earned a PhD specializing in molecular and developmental genetics at Arizona State University, has been working with diagnostics start-ups for the last fifteen years. She provides support on fundamentals ranging from assay design to regulatory compliance to new lab set up.

Many of her clients are biotech start-ups seeking to commercialize a product they’ve developed. Dr. Norman helps them navigate the world of business and keeps them on track to launch a profitable commercial venture.

Many factors can affect the business value of your product, from shipping stability to the thoroughness of your protocols. The following tips will help you get started.

1.) Marketing

Dr. Norman advises her clients to think about marketing early. As an entrepreneur you need to ask, Who will buy my product? And it’s important to do market research to help answer that question—preferably before you begin development.

Market research also helps ensure that your product will be eligible for reimbursement by programs such as Medicaid, as well as insurance companies.

Learn more about the importance of life science marketing in our recent interview with Erik Clausen of the Chempetitive Group. >>

2.) Regulatory Compliance—FDA?

If you are planning to commercially distribute your diagnostics product, you will need FDA approval or clearance. For a product that is substantially similar to an existing one, you’ll need to meet the same FDA requirements as that product.

If your product is unique, or for which a false positive or negative test would pose a significant risk to public health, you’ll need to submit a pre-market approval application, and will be subject to an in-depth scientific data evaluation and manufacturing facility inspection.

Other types of products subject to regulatory standards include:

  • Laboratory developed tests (LDTs), which are made for use in a single CMA (Centers for Medicare and Medicaid Services) approved lab, and must meet CLIA (Clinical Laboratory Improvement Amendments) standards; and
  • Research use only (RUO) products, which are not intended for diagnostic purposes and must be labeled as such.

You will need to determine where your product fits into the regulatory approval process and plan and budget accordingly. Solid project management is also extremely important as you develop your product, especially when it comes to the FDA.

3.) Patent Landscape Review

Money is tight at most start-ups, and spending it on an initial patent landscape review can seem like an expensive proposition. Dr. Norman, though, believes that it is money well spent.

A patent landscape review is an excellent way to find out if competitors hold patents for products similar to yours, as well as to identify opportunities for new products with low competition.

Although there are other ways to monetize un-patented products, such as licensing them to companies that already hold a patent for a similar product, a patent will help establish your product’s unique value and provide protection from intellectual property theft.

4.) Network for Success

Networking is essential to the success of any entrepreneur. It’s the best way to connect with your peers and gain access to precious resources. These include funding sources, legal help, educational opportunities, and access to affordable laboratory equipment and facilities.

Dr. Norman is dedicated to helping life science entrepreneurs and serves on the executive board of the San Diego Entrepreneurs Exchange. SDEE was founded by and supports local entrepreneurs in the fields of life science, mobile health, diagnostics, medical devices, clean tech, biofuels, and alternative energy.

The organization sponsors networking and educational events designed to promote the local start-up community and bring funding, business, and jobs to the San Diego area, the third-largest life science hub in the U.S.

One example of a valuable resource that Dr. Norman recommends to entrepreneurs is Lab Fellows, which helps local scientists access idle equipment in larger laboratories. She also encourages attendance at SDEE’s regularly scheduled free happy hours at the New English Brewing Company, where you can network with your peers and local service providers.

For more information on Dr. Sylvia Norman and Molecular Diagnostics Consulting, please visit the website here. >>