Simple HealthKit’s Head of Quality and Regulatory, Michael Gomez, unpacked why all companies, especially startups need to prioritize the quality and regulatory of laboratory-developed tests (LDTs) in a recent MedCityNews article


Today, most at-home lab tests on the store shelf or e-commerce sites for diabetes, cancer, STDs/ STIs, food sensitivities, metabolism, thyroid, testosterone, cholesterol, and others are laboratory-developed tests, otherwise known as LDTs. Any company that develops laboratory-developed tests must prioritize quality at every step in the process. History has shown that those who don’t prioritize quality at the forefront of product design, R&D development, go-to-market, and sales have a similar critical point of failure.

There is a heavy indication via recent potential rulemaking that the FDA will bring LDTs into stronger focus across the regulatory industry. While we can’t predict the future, here are three key considerations your organization should keep in mind if you’re developing LDTs or selecting an at-home diagnostics partner.

  1. The foundation of any medical device company’s Quality Management System (QMS) starts and ends with strong documentation. Documentation isn’t just for the final stages of product development; it extends to laboratory & production line feedback. Those working on your product daily have valuable information and suggestions for improvements. A continuous quality process ensures a quality product for its entire lifecycle. When evaluating a potential at-home diagnostic vendor, ask to speak to their quality and regulatory leaders. Any company with robust quality and regulatory processes will not shy away from involving its Head of Quality or Regulatory during the information-gathering process.
  2. quality of your suppliers impacts the quality of your products or the products you purchase. Ensure you know the quality and consistency of all parts of your product and prioritize mitigating any quality issues that arise. Supplier management will form the basis of the QMS.
  3. Quality is a continuous effort and extends through customer relations and post-production monitoring. Always document any customer feedback regarding the quality of your product according to the QMS and promptly notify the appropriate parties within your organization. Pro-tip: when selecting an at-home diagnostic partner, ask them how they document and respond to customer complaints.

Simple HealthKit’s digital health platform and at-home diagnostics for sexual health, chronic conditions, and respiratory health prioritize quality at every step. Ready to learn more? Reach out to the Simple HealthKit team today!