RT-PCR kit to detect presence of 2019-nCoV or virus presence in clinical specimens

Plan Ahead to Get Your COVID-19 Diagnostic to Market Fast

In the current era of COVID-19, many diagnostic device developers are looking for ways to get their products to market fast. They are striving to fill one of today’s most important healthcare needs: new devices and technologies to help fight the pandemic.

Still, many developers operate under the mistaken assumption that once the technology is finalized, everything else will fall into place. This couldn’t be further from the truth. In fact, once the technology is done, a long road remains—one consisting of regulatory hurdles, manufacturing concerns, shipping, marketing, and more.

Bottom line: it benefits COVID-19 diagnostics developers— and in fact, medical device developers of all types—to plan ahead and start early.

One of the most beneficial steps diagnostic developers can take is get a manufacturer onboard early, preferably in the development phase. What if you’re not at that stage yet? Fortunately, the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) recently took actions to help get diagnostics to market faster.

The NIH RADx Program

The NIH, in collaboration with other organizations such as CDC and Biomedical Advanced Research and Development Authority (BARDA), recently launched the Rapid Acceleration of Diagnostics (RADx) program. This program is intended to accelerate innovation in the “development, commercialization, and implementation of technologies for COVID-19 testing.” One component of RADx is a funding opportunity to assist organizations developing COVID-19-related diagnostics. Another component provides assistance to developers in scaling up their technologies and increasing their performance. You can find more information about the RADx program here.

The FDA EUA

On February 4, 2020, the U.S. Department of Health and Human Services (HHS) determined that the coronavirus represents a “public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad.” Subsequently, FDA (an agency of the HHS) authorized the emergency use of in vitro diagnostics and other specifically defined medical products and devices for the detection and/or diagnosis of COVID-19. This Emergency Use Authorization (EUA) allows for the use of “unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives.”

In essence, an EUA officially expedites the process to quickly get medical products that fulfill urgent needs into the hands of professionals and the public during healthcare emergencies. It’s important to note that products approved under an EUA are only authorized for use in specific circumstances and during a particular emergency period. When those conditions end, so too does the EUA declaration, and as a result all the EUAs issued based on that declaration will be terminated. You can find more information on the EUA here.

NOTE: At the time of this article’s writing, developers may not be required to obtain premarket FDA review of their laboratory developed tests (LDT).

COVID-19 DIAGNOSTICS and MANUFACTURING PARTNERS

Say you have funding for your COVID-19 diagnostic device development program. Now what? Hopefully, you have planned ahead and have already begun working with a manufacturing partner. As stated before, getting a manufacturer onboard with your device early can help diagnostics programs be more successful, and make the ramp up to mass manufacturing faster and easier.

Ideally, developers should begin working with manufacturing partners in the development stage. Some designs, depending on subtle directions or locations of features, may not be mass manufacturable or may require complex methods with higher costs. This becomes a problem if the product is brought to the manufacturer after the designs are “locked in.” Your manufacturing partner can work with your engineering team on design development to make your designs manufacturable, and/or with a more efficient manufacturing method that could save costs. Addressing Design for Manufacturability (DFM) items upfront could save a lot of development time compared to finding (possibly expensive) work-arounds later with little room for adjustment.

The partner you select should have the expertise required to manufacture your device to your unique specifications. A manufacturing partner should also have knowledge and experience in quality assurance and regulatory requirements. They can help ensure that it complies with applicable standards. For medical products, the manufacturer should be well versed in process validation to ensure efficient production of your quality parts.

Choosing the right manufacturing partner is also critical to ensuring a continued supply of your devices with the high standards you need. Inexpensive molds and tools may be able to make good parts to specification at the beginning of their tool life, but we have heard many horror stories in which customers begin receiving defunct parts after working with a budget manufacturer, and being unable to get any improvement plans or accountability from it. Choosing a trusted manufacturing partner is the best thing you can do to save costs, time, and quality troubles in the long run.

CONCLUSION

Often, a failure of design is not the biggest challenge diagnostic device developers face. Rather, it is simply the failure to plan ahead. Successfully getting a new product into mass production, and doing it well—on time, at the correct volume, with high quality, and cost effectively—is not easy.

Getting it right the first time is important. COVID-19 diagnostic device developers that plan ahead and begin working with a manufacturing partner early will launch their products faster and more effectively. There’s an old adage that says, “Failing to plan is planning to fail.” By planning early, developers can put themselves on the path to success.

With over 20 years of satisfied customers, Enplas Life Tech is the leading single-source manufacturer of high-quality custom plastics parts for global OEMs in the medical, biotech, pharmaceutical, and life science industries. For more information about Enplas Life Tech and how we can help you with your COVID-19 diagnostics projection, click here.