EKG Life Science Solutions: Medical Device and Pharmaceutical Product Development Made Easy
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Katie Grayson, CEO, Director of Sales and Marketing, and Founding Member
When it comes to the development of a new product, the goal for every medical device and pharmaceutical company is to bring their product to market in rapid time. However, given the complexity of regulatory requirements today, this has invariably become a struggle, especially for small and mid-sized companies. Taking into consideration their limited internal resources, these companies need an expert for technical and regulatory guidance. EKG Life Science Solutions (EKG Labs) is perfectly poised to address these challenges. The company is an analytical and regulatory service provider that supports the development of medical devices, drug-device combination products, and pharmaceuticals. Founded in 2013, EKG Labs assists medical device and pharmaceutical companies in fulfilling complex regulatory testing requirements and ultimately helps them fast-track product development cycles. “Our company really focuses on becoming an extension of our client’s business from a regulatory and scientific basis in their analytical testing,” asserts Katie Grayson, CEO, Director of Sales and Marketing, and Founding Member of EKG Labs.
As a certified woman-owned business, operating within facilities that are FDA audited and DEA approved for substances scheduled I-V, the company’s analytical expertise includes extractables and leachables programs, impurity identification, material compatibility, chemical characterization, and method development, optimization, and/or validation. EKG Labs is an industry expert in offering medical device development support services to support 510(k) and PMA filings. EKG Labs’ team also has extensive experience in drug-device testing (combination product testing). “We focus on the client’s specific product. Whether it’s drug-device interaction, chemical characterization of the device—including ISO 10993-18 chemical characterization, scientific and regulatory consultation, FDA remediation, or program management and execution—we successfully support our clients in navigating all hurdles,” states Katie.
Providing insight into the company's approach to the execution of the services, Katie explains that the standard at EKG Labs is to think outside the box. As an industry veteran with 24 years of experience up her sleeves, Katie believes in helping her clients through trusted relationships built on quality, knowledge, and integrity. She meets with clients face-to-face whenever possible, in order to understand their culture and business through deeper conversations about product, strategies, and regulatory risk.
As every drug-device combination product requires a unique approach, the company develops a customized plan for each client. Katie explains, “after having built the business relationship, our partners get to interact directly with the scientists and chemists that do the testing for them, without the involvement of any middleman. This helps build trust and transparency, which is what we are renowned for and something we strive for in everything we do.”
Our company focuses on becoming an extension of our client's business from a regulatory and scientific basis in their analytical testing
EKG Labs has garnered massive traction in the market due to its quality of services. For instance, a company in the midst of developing a drug delivery device approached EKG Labs to assess the drug-device interaction. The company claimed that they weren't expecting any issues as both the drug and the device were known. However, being a combination of these two, the new product had to go through the regulatory process. EKG Labs' expert team discovered some incompatibilities during the testing. They were able to explore optional materials with the client and then proposed and executed some R&D work. The aim was to ensure that their new selected material was compatible with the drug, before them going through a complete change in design and change in material, only to find out again that it's not compatible. "As a result, we were able to take the client from what they originally thought was a complete drug-device compatible mix, but was not, to a final product that was," explains Katie.
The company's most significant focus in the next couple of years, due to a staggering response from clients, is to continue to build its infrastructure and expand to a new facility in mid-2020. With the increasing growth, EKG Labs will triple its facility size, which will allow them to continue adding state of the art equipment to stay on the top of their game, scientifically and technologically. EKG Labs' aim is to have the right equipment to solve problems and continue to address changing regulatory requirements. For example, following the recent 2020 revision and expansion of the ISO 10993-18 chemical characterization document, the company plans to connect with the broader pharmaceutical and medical devices communities through conferences, e-classes, and white papers. Through this endeavor, EKG Labs' focus is on educating the companies with respect to the changing industry standards in extractable and leachable testing, challenges of new drug delivery platforms such as microneedles and wearable injectors, and the ongoing development of inhalation drug delivery systems. "We're constantly evaluating new opportunities as well as getting feedback from our clients in areas that they need help with. We'll bring everything that makes sense from a business point into our portfolio of services, with a mission to continue growing in a way that we are the extension team to our clients," concludes Katie.
Management Katie Grayson, CEO, Director of Sales and Marketing, and Founding Member and Dr. Allen Kesselring, CSO and Founding Member; Jennifer Eagan, Director of Quality and Regulatory and Founding Member
Description The company is an analytical laboratory that supports medical device and pharmaceutical companies seeking to fast-track their product development. As a certified woman-owned business, operating within facilities that are FDA audited and DEA approved for substances scheduled I-V, the company’s analytical expertise includes extractables and leachables programs, impurity identification, material compatibility, chemical characterization, and method development, optimization, and/or validation. EKG Labs is an industry expert in offering medical device development support services to support 510(k) and PMA filings. EKG Labs’ team also has extensive experience in drug-device testing (combination product testing).
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