Areas of Practice

regulatory affairs

With specific expertise in medical device regulation, I provide regulatory affairs consulting services to the medical products industry. My particular areas of specialty are clinical-regulatory requirements and compliance, pre-market strategy development, submission support, CAPA, quality systems compliance, quality document preparation and remediation, recalls, post-market surveillance, analysis of complaint data and trending, and both written communication and direct engagement with regulatory authorities. I have direct experience with U.S. FDA, EU MDR, and Australia medical device regulations and requirements.

Medical product sponsors will realize more successful and efficient pre- and post-market regulatory activities, positive interactions with regulators, and greater regulatory compliance when they rely on my exceptional communication skills and in-depth knowledge of medical device regulations. Contact me to find out how I can help you successfully navigate medical device regulatory requirements and apply my diverse skill set to address your regulatory challenges.

Clinical evidence

patient engagement

With extensive training and experience in clinical and observational research, I provide expert leadership, direction, and clinical affairs consulting for the life sciences industry. My areas of specialty are prospective and retrospective cohort studies, case-control studies, medical device early feasibility study (EFS) and investigational device (IDE) pivotal study design, execution of clinical research, management of clinical operations, data, and biostatistics resources, CRO engagement, and clinical site relations. I have overseen large, multi-center studies to support regulatory requirements, directed the publication of results, and helped design and engage with regulators on the conduct of medical device RWE, premarket, and post-market research.

Clinical research sponsors will realize more efficient conduct of their clinical research, excellent compliance, positive regulatory engagement, and successful achievement of clinical-regulatory goals.

• Oversight of clinical affairs operations, data, and biostatistics

• Premarket and post-market medical device clinical research

• Observational and interventional study design and execution

• Prospective and retrospective study design and execution

• Clinical outcome measure identification

• Clinical evidence strategic planning and execution

Including the patient voice in medical product development and commercialization is a new area of focus for FDA, medical product sponsors, and patient advocacy groups. My patient engagement work is focused on how best to use patient experience data to influence regulatory policy and decision-making. I apply my knowledge and experience to designing qualitative and quantitative studies aimed at rigorously capturing patients’ preferences, treatment priorities and benefit-risk tolerance.

Medical product sponsors and patient advocacy groups will benefit from my unique training and experience in observational research, patient engagement, and patient-focused regulatory policy. Contact me to see how I can help you amplify the patient voice in your efforts to bring effective therapies to market.

Policy Advocacy

Patient advocacy groups, industry organizations, and the medical technology industry are increasingly focused on patient-centered policy development. My policy work is focused on the need to augment the patient’s voice in FDA regulatory decision-making. By participating on public-private and industry policy working groups, I have made significant contributions to patient engagement policy development and advocacy, including providing written comments on proposed regulatory policy, and development of patient-centric legislation. I am passionate about the development of rational regulatory policy that benefits patients by enabling the life sciences industry to incorporate patient input in a cost-effective and meaningful way while maintaining least burdensome principles of regulatory requirements.

Industry sponsors, patient advocacy groups, and public-private organizations will benefit from my passionate focus and deep knowledge of patient-centered regulatory policy. Contact me to develop your policy priorities and communicate your policy positions to ensure the patient voice continues to be heard by regulators and policy decision-makers.

Patient by Design

Patient by Design is a concept by which patient input is necessary across all phases of the medical product life-cycle. Patient experience is a critical and valuable input to the design and development of all medical products. Medical product sponsors will benefit from obtaining patient data during the design and development phase of product development. Sponsors need to establish authentic partnerships with patients and patient groups to improve the conduct of clinical trials and ensure trials better meet the needs of patients and caregivers. Assessing patient preference, patient risk tolerance, and patient experience can enhance the regulatory strategy for devices, drugs, and biologics. Engaging with patients to generate rigorous, scientific, and clinically meaningful data is at the core of Patient by Design.