Advances in healthcare technology and medical devices are reshaping how care is delivered, monitored, and managed. As hardware, software, and data-driven systems converge, companies face complex questions around regulatory expectations, product safety, intellectual property, and privacy across both traditional devices and digital health solutions.
DOAR represents healthcare technology experts and medical device expert witnesses who understand this environment from the device design, testing, and manufacturing to software integration, connectivity, and real-world clinical use. They bring practical insight into how products function, how data moves through connected systems, and how regulatory requirements apply throughout the product lifecycle.
Our network includes former regulators, industry leaders, and academics with deep experience in product development, quality systems, cybersecurity, and compliance, including matters involving HIPAA and data protection. In litigation and regulatory actions, they frequently serve as medical device expert witnesses, helping legal teams evaluate competing technical narratives, assess risk, and present complex healthcare technology issues with clarity and credibility.
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We represent experts who are world-class academics, industry executives, and former government regulators who were carefully selected for their knowledge, experience, and ability to communicate effectively.
Expertise in mechanical and systems design for medical and implantable devices, including performance, usability, and safety considerations.
Experience with mHealth applications, EHR systems, clinical software, and the integration of digital tools into patient care and provider workflows.
Focus on encryption, access control, and HIPAA compliance, including how patient data is protected, transmitted, and monitored within connected systems.
Knowledge of precision manufacturing, quality control, and compliance with FDA and ISO standards governing device production and testing.
Insight into FDA approval pathways, device classifications, and global regulatory requirements that shape product development and commercialization.
Background in minimally invasive tools and robotic surgical systems, including safety, performance, and human-factors considerations.
Experience with consumer and clinical wearables, remote monitoring technologies, and wireless connectivity features that link devices to broader health ecosystems.
Across 192 biologics PTAB proceedings, a small group of APJs and repeat innovator and biosimilar companies accounts for much of the activity.
The petitioner challenged the validity of several patents covering catheter-based delivery systems for heart valve replacement.
DOAR anticipates future litigation trends in emerging areas of life sciences and builds diverse teams of testifying experts who can best advise our clients.
We asked DOAR robotics expert and accomplished engineer to evaluate the sector with respect to ongoing trends and litigation challenges.
A global healthcare company sued a medical tech firm for allegedly infringing on its patents for a heart treatment device.
We asked DOAR biotechnology expert and accomplished academic, Dr. Brenda Wilson, to evaluate the industry with respect to ongoing trends.
Our client approached DOAR to provide an expert who possessed a general knowledge of injector devices and the mechanics behind their engineering.
At DOAR, we have built teams of biotechnology testifying experts that are prepared to handle all aspects of biotech litigation.