Architecture & Engineering - Process Optimization - Culture & Change Management -Regulatory StrategyLearn more
From top device manufacturers to startups, we work with medical device manufacturers of all sizes to help secure their products.
“As a startup medical device company with a new product under development, including a cloud-based component, we needed to improve cybersecurity in order to protect our business and get IVDR CE-mark and FDA 510(k) clearance. MedCrypt helped us develop our threat model, which guided us to a more secure design and improvements to our solution architecture. MedCrypt has also been deeply involved in creating our cybersecurity risks and meet future regulatory expectations. We are extremely satisfied with the support we received from MedCrypt and recommend MedCrypt if you are looking for a partner to help with your medical device cybersecurity program and design.”
“In the course of filing for a 510(k) clearance we needed to establish a threat model that meets regulators' expectations. MedCrypt not only helped us with their deep expertise but even more with the excellent understanding of our company specific needs. If you are looking for a tailor-made solutions, provided by people who really care, MedCrypt are the folks to turn to!”
“MedCrypt’s support increased our confidence in our cryptography architecture, helped us better document its strengths, and provided feedback on gaps in other areas. From our work with MedCrypt, we expect a faster and smoother regulatory review, as well as faster development of our roadmap.”
MedCrypt is obsessed with medical device cybersecurity, and that's reflected by the team we have put together.Join UsJoin Us
Mike is passionate about new advances in the intersection of internet technology and healthcare. Prior to starting MedCrypt, he was the founder of Gamma Basics, a radiation oncology focused software startup. Gamma Basics was acquired by Varian Medical Systems in 2013. Mike holds an MBA from the Wharton School, and a Master of Medical Physics from the University of Pennsylvania.
Eric Pancoast, MedCrypt's CTO, was a co-founder of Gamma Basics, a radiation oncology focused software startup that was acquired by Varian Medical Systems in 2013. Prior to Gamma Basics Eric served as the Lead Architect and software engineer at Mimeya Technology, building Cloud-based Big Data SaaS applications. Eric has experience with a wide variety of cybersecurity engineering. Eric holds a BS in Computer Science from Drexel University.
Vidya has worked in security for 15 years, with emphasis on healthcare and medical devices for the last 8. Vidya began her career in consulting, she realized a passion for healthcare and worked for global medical device manufacturer Becton Dickinson. She has since joined MedCrypt, a company focused on bringing cybersecurity leading practices to medical device manufacturers, as the Vice President of Operations. Vidya holds an MBA from the Wharton School.
As Chief Security Strategist, Axel Wirth provides strategic vision and industry leadership to MedCrypt and its customers. In this role, he helps guide the company in critical security strategy decisions and supports the adoption of leading security technologies by the healthcare industry. He’s an advocate for compliance, privacy, and security - and ultimately patient safety - in healthcare. Wirth draws from over 30 years of international experience in the industry.
Clayton McNeil, our VP of Engineering, has spent his career developing products in a wide range of fields including robotics, fiber optics, virtual reality and medical devices. His development role has primarily been focused on embedded devices and their security. At MedCrypt, he has reviewed the architecture of over 40 systems, advising customers on cryptographic infrastructure. He holds a BS in Computer Engineering from Drexel University and an MBA from West Chester University.
Supports clients in identifying cybersecurity ROI, measuring success, adopting and embedding threat modeling, vulnerability process optimization, and more. Previously, she co-founded Booz Allen’s Secure Connected Health practice on cybersecurity, digital health, and patient safety. Shannon holds a PhD in Business with a focus on decision-making under uncertainty, a Masters in Information Management, and a BA in Mathematics and Philosophy, from the University of Maryland, College Park.
Naomi has 20+ years of systems engineering experience, including 6+ years of medical device evaluation and postmarket event response while at FDA. At MedCrypt, Naomi engages with medical device manufacturers to optimize their cybersecurity framework to meet regulatory requirements and guidelines. Naomi holds an MS in Electrical and Computer Engineering from Carnegie Mellon University and is a Certified Quality Auditor.
William, our VP of DevOps, has developed large, enterprise, cloud-native systems for over 20 years. As an early cloud adopter, he aggressively advocated for and led transitions and initial deployments to AWS since its inception in 2006. William co-founded Gamma Basics, a radiation oncology focused CAD software startup that was successfully sold to Varian Medical Systems in 2013. William holds a BS in Computer Science from The College of New Jersey.
Om leads Product at MedCrypt, helping build innovative cybersecurity products for healthcare. He enjoys speaking at conferences about the latest trends in cybersecurity and how they impact healthcare and patient safety. His interests in privacy and technology led him to join a cybersecurity startup after studying Computer Engineering at Drexel.