Patient-Centric Regulatory Affairs & Policy
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Areas of Practice

Patient Engagement Regulatory Affairs Policy Advocacy


FDA regulatory affairs

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With specific expertise in medical device regulation, I provide FDA regulatory affairs consulting services to the medical products industry. My particular areas of specialty are compliance, CAPA, quality systems, post-market surveillance, analysis of complaint data and trending, pre-market strategy development, FDA submission support, and both written communication and direct engagement with FDA.

Medical product sponsors will realize more successful and efficient interactions with FDA when they rely on my exceptional communication skills and in-depth knowledge of FDA regulations. Contact me to find out how I can help you successfully navigate FDA requirements and apply my diverse skill set to address your FDA regulatory challenges.

Specific services

  • Navigation of FDA regulatory requirements

  • Development of FDA regulatory strategy and pre-market review pathway

  • Pre-submission communications (Q-sub)

  • Pre-market regulatory submissions

  • Clinical strategy development

  • Quality system development, review, and compliance

  • CAPA review and implementation

  • Post-market data collection, analysis, and trending

  • Recall review, documentation, and implementation (HHE and HRA)

  • Surveillance data synthesis and communication

  • Inspection and warning letter response

  • FDA engagement and communication


patient engagement

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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.

Specific services

  • Identification of preference-sensitive issues to support total product life-cycle

  • Design and implementation of patient preference studies

  • Conduct of patient interviews and focus groups

  • Design and administration of patient experience/preference survey studies

  • Collection and analysis of observational data

  • Protocol development

  • Recruitment strategy and implementation

  • IRB submissions

  • FDA engagement and communication

  • Literature review and synthesis

  • Manuscript and report writing

  • Dissemination of study results by means of conference abstracts, presentations, and panel discussions


Policy Advocacy

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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.

Industry sponsors, patient advocacy groups, and public-private organizations will benefit from my deep knowledge ad expertise in 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.

Specific services

  • Review of existing law and policy

  • Policy position development and writing

  • Written commentary on proposed FDA rules, guidance, and policy

  • Coordination and organization of policy stakeholders

  • FDA engagement and communication

  • Participation on advocacy working groups

  • Literature review and synthesis

  • Manuscript and report writing

  • Dissemination of policy development and outcomes by means of conference abstracts, presentations, and panel discussions


Patient X Design

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Patient x 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 x Design.

Specific Services

  • Understand natural history and patient burden of disease

  • Identify and quantify patients’ treatment outcome priorities, importance of symptoms, and most desired quality of life improvements

  • Prioritize product pipeline with patient input

  • Establish relationships with patients and patient groups to support trial enrollment

  • Collect patient experience data and clinical outcome assessments

  • Conduct patient-centered benefit risk studies to assess patients’ tolerance for risks given potential benefits

  • Provide education and support to patient groups while maintaining transparency

  • Collect patient and care giver experience data to characterize symptom burden, and effect on patient quality of life

  • Engage patients to support each other before, during, and after treatment

  • Quantify preference heterogeneity to identify potential patient groups for expanded indications


Litigation Support

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Medical device litigation can be complex and require review of large volumes of historical documentation. I have extensive experience supporting discovery and case strategy for medical device-related litigation with a focus on FDA required medical product documentation. My litigation support work has included both consulting and testifying expertise in state and federal court as a FDA regulatory expert. Prior case work has included tort, insurance, and fiduciary duty cases.

Medical device industry counsel will achieve a thorough understanding of their client’s regulatory compliance situation, and experience a more efficient discovery process and clearer context within which to develop a defense strategy. Contact me for pre-litigation evaluation of your regulatory documentation, discovery support, or regulatory expertise for your medical device litigation cases.

Specific services

  • Pre-litigation regulatory review and compliance analysis

  • Discovery support to determine relevant and responsive documentation

  • Litigation strategy development

  • Consulting expertise on FDA regulatory affairs

  • Deposition and trial preparation for regulatory and engineering experts

  • Testifying expertise in FDA regulatory affairs

  • Preparation of expert reports, declarations, and affidavits

  • Deposition and trial testimony