Healthcare Technology & Medical Device Experts

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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Software as a Medical Device (SaMD)

The rapid expansion of Software as a Medical Device (SaMD) has introduced new technical and regulatory challenges for manufacturers, digital health companies, and healthcare providers. These products blend clinical functionality with software, algorithms, connectivity, and continuous data flows—raising questions around validation, cybersecurity, interoperability, and regulatory classification. DOAR represents testifying experts who understand how SaMD products are designed, tested, deployed, and monitored in real-world settings, helping legal teams assess risk, evaluate contested claims, and present SaMD-related issues clearly and credibly in high-stakes disputes.

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Areas of Expertise

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.

Device Design

Expertise in mechanical and systems design for medical and implantable devices, including performance, usability, and safety considerations.

Digital Health

Experience with mHealth applications, EHR systems, clinical software, and the integration of digital tools into patient care and provider workflows.

Data Security & Privacy

Focus on encryption, access control, and HIPAA compliance, including how patient data is protected, transmitted, and monitored within connected systems.

Manufacturing & Quality Systems

Knowledge of precision manufacturing, quality control, and compliance with FDA and ISO standards governing device production and testing.

Regulatory Compliance

Insight into FDA approval pathways, device classifications, and global regulatory requirements that shape product development and commercialization.

Surgical & Robotics Devices

Background in minimally invasive tools and robotic surgical systems, including safety, performance, and human-factors considerations.

Wearables & Connected Devices

Experience with consumer and clinical wearables, remote monitoring technologies, and wireless connectivity features that link devices to broader health ecosystems.

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