Advising investors and innovators on accelerated, more effective medical device pathways.
Leveraging her years of reviewer experience, broad FDA exposure, and strong network, Allison Kumar, founder of Arina Consulting develops actionable premarket strategies to guide medical device development programs through successful submission. She is also uniquely positioned to assist the investor community in due diligence of potential investment targets and her network is comprised of industry experts that serve a multitude of complementary services.
Our Services
Support Due Diligence
- Startups
- Angel Investors
- Venture Capitalists
- Private Equity Firms
- Strategic Acquirers
- Board of Directors
Strategic Advisory
- Submission Review (US or EU)
- Refuse to Accept or Hold Letter Remediation
- Deficiency letter response
- Investor pitch deck review
- Time to market planning
- Device registration and listing
- Marketing material compliance reviews
- Expert witness testimony
Regulatory Submissions
- Pre-Submissions (Q-Sub) for FDA feedback
- 510(k) Premarket Notifications
- De Novo Applications
- Premarket Approvals (PMAs) for Class III devices
- Request for Designations (RFDs)
- Humanitarian Device Exemptions (HDEs)
- Investigational Device Exemptions (IDEs)
Pre-Clinical and Clinical Strategy
- Pre-Clinical strategy
- Performance Testing
- Biocompatibility Testing
- Clinical strategy
- Clinical readiness of product
- U.S. and/or OUS Studies
- FDA Early Feasibility IDE opportunity
- Pre-market and post-market Study design/ clinical synoposis
Quality Management Systems
- Software Life Cycle Management
- Software Validation
- Design History File
- Device Master Test Plan
- Design Control
- Risk Management
- QMS Implementation
Meet Allison Kumar,
Executive Regulatory Affairs Advisor
Allison Kumar founded Arina Consulting in 2018 after working 10 years at FDA’s Center for Devices and Radiological Health (CDRH). Combining her FDA tenure with almost a decade of prior experience in the IVD and biotechnology industry has provided a comprehensive knowledge base for companies and investors that engage with Arina Consulting to leverage.
During her time at FDA, she spent five years as a Senior Program Manager in the Center Director’s Office and five years as a Senior Pre-market Reviewer in the Office of Device Evaluation. In her Senior Program Manager role, Ms. Kumar developed collaborations and worked as a liaison between medical device developers working in government agencies, DoD, academia, and industry and the CDRH review divisions to reduce the regulatory hurdles that often accompany bringing novel, high-risk, high-benefit innovative technology to market. She held positions on government steering committees for various high-level, high priority development efforts including traumatic brain injury, combat casualty care, medical countermeasures, and emergency response to emerging infection, diseases and natural disasters. As a Senior Pre-Market Reviewer, Allison provided primary contributions to regulatory management of 510(k), de novo, IDE, and PMA devices in the Division of Cardiovascular Devices, including review and collaborative development of pre-clinical testing and clinical trial design.
Her time in industry has provided management experience in quality systems, regulatory affairs, in vitro diagnostics, biorepository operations, laboratory automation, verification and validation activities, and regulatory audits. Allison’s passion is in using her deep institutional knowledge to develop innovative
approaches that help companies successfully communicate product information to investors and FDA throughout the total product life cycle. Leveraging her years of reviewer experience, broad FDA exposure, and strong network, she develops actionable premarket strategies to guide medical device development programs through successful submission. She is also uniquely positioned to assist the investor community in due diligence of potential investment targets.
Ms. Kumar holds a bachelor’s degree in Biomedical Engineering from Virginia Tech, a graduate certificate in Biohazardous Threat Agents and Emerging Infectious Diseases from Georgetown University, and is a graduate of the Harvard T.H. Chan School of Public Health’s National Preparedness Leadership Institute.