Consulting Specialties

  • Device, Drug, and Biologic Combination Product Safety, Cybersecurity Risk Management and Assurance Cases

  • Pre-Market Approval/Clearance Issue Resolution and Post-Market Issue Remediation

  • Risk vs Clinical Benefit Analysis for Drug, Device, Biologic, and Combination Products

  • Global Product Risk Management Compliance, Best Practices and Improvements

  • Digital Health, Mobile Medical Apps, Connected Devices, and Artificial Intelligence(AI) System Safety, Cybersecurity, and Compliance

Senior Consultants

Jessica Eisner, MD

 

Dr. Eisner spent 4 years as a Senior Medical Officer at the US FDA (both CDER and CDRH) where she provided medical leadership, expert scientific review, and science-based regulatory input for selected drug & device issues while meeting Congressionally-mandated deadlines for medical review of INDs, Q-subs, IDE, 510(k)s and “de novo” applications, as well as NDAs, protocols, clinical trial design, adverse event and periodic reporting submissions.

 

Dr. Eisner was a CDRH General Hospital Device Branch [GHDB] Medical liaison and Senior Medical Consultant to CDER Office of Combination Products Inter-Center Consults as well as and a policy analyst for various cross-Center projects and issues (e.g. FDASIA Health IT Policy Report, and the IMDR Software for Medical Devices Framework for Risk Categorization & Controls). She authored several GHDB Branch policy white papers on safety issues and software systems and worked with Compliance to pursue and halt fraudulent and inappropriate Sponsors. In addition, Dr. Eisner was appointed a core member of the General Hospital Safety Signal Review Team that investigated identified and potential medical device performance issues, recalls, and device-related adverse events.

In addition, Dr. Jessica Eisner has 20 years of international medical product development experience working in private industry as well as for the US government. As the Deputy Director for the US Department of Defense, Military Infectious Disease Research Program, she led, co-managed and executed a $400 million tri-service global health & infectious disease research and development program directed at discovering, translation & transition of innovative drugs, vaccines, diagnostic assays, and wound healing technologies for the treatment and prevention infectious diseases and wounds.

Dr. Eisner’s experience spans clinical development, regulation, pharmacovigilance, and policy issues for drugs in multiple therapeutic areas (e.g. analgesia, addiction, oncology, cardiology, sepsis, infectious diseases [including HIV/AIDS and vaccines], coagulation disorders) as well as medical devices, clinical decision support systems [CDS] software, and combination products.  Among many others, she has worked on auto-injectors, jet injectors, surgical spray devices, large volume infusion pumps & accessory software, pre-filled syringes, nuclear imaging devices, implantable pumps (e.g. intra-thecal), syringe pumps, micro-needle delivery systems, body-worn (patch) pumps for a variety of therapeutic areas ( e.g. rheumatology, neurology, oncology, anti-infectives, orthopedics, etc.) and high-priority, innovative technologies such as event markers and medical device software [e.g. clinical decision support systems [CDS] software, drug-dosing calculators, medication -reminders and software, etc.)

Dr. Eisner has experience working with regulatory authorities in the US, EU and member states, South Africa, Taiwan, Nigeria, Ghana, Liberia, Japan, and Canada.  She has also been an Institutional Biosafety Committee(IBC) member. Currently, Dr. Eisner sits on the Fellowship Advisory Committee for the American Association for the Advancement of Science (AAAS) and is also a member of the International Standards Organization (ISO) Pediatric Drug Delivery Device Working Group. 

Dr. Eisner hails from Chicago and received her BA from Cornell College in Iowa. She earned her medical degree from the University of California, San Diego and, after an internship at University of California, San Francisco, she completed her medical residency at the University of Washington in Seattle. 

She works in Boston in the pharmaceutical industry and has been a consultant for biotechnology, pharmaceutical, medical device, hedge-fund and investment companies as well as federal and non-profit organizations that develop or invest in therapeutics and/or global health.

Paul Jones

 

With 24 years’ experience at FDA/CDRH as a senior systems/software engineer and as FDA’s software systems safety engineering expert, Paul jones, has provided software, risk management, and cybersecurity premarket reviews (including 510(k). PMA, De Novo, Q-sub, IDE) for hundreds of devices including general hospital, cardiovascular, surgical, radiological (RTP, LINAC, PROTON), blood establishment, combination devices, and many other types. He has carried out inspections, investigations, and training for the FDA Office of Regulatory Affairs. He has also provided training to FDA staff on software quality, risk management, software engineering, and model-based engineering. He was also a member of the Digital Health Committee.

He was active in standards development including ISO/IEC 62304 (Medical Device Software Lifecycle), IEC 61508 (Functional Safety), UL 1998 (Software in Programmable Components), AAMI/UL 2800-1 (Interoperability), AAMI TIR38 (Assurance Cases), and co-chair of AAMI TIR32 (Software Risk Management). He was also active in the development of FDA/CDRH Guidance on 510k software submissions, OTS software, software validation, when to submit a 510k, cybersecurity, AI, and many others; and in the introduction of (Safety) Assurance Cases (structured arguments).

 

He established FDA’s software engineering lab, where he directed staff in advanced software engineering development techniques and technology research, and established research collaborations with other government agencies, academics, and manufacturers, for the development of high assurance safety critical cyberphysical systems. This work encompassed research in formal methods such as Cleanroom SE, MBE, open-source insulin pump models, software quality metrics, human-computer interfacing, and structured argumentation, resulting in more than 60 peer-reviewed and conference publications.

 

Prior to joining FDA, he worked 20 years in industry as a systems/software engineer for companies like Ford Motor, Electronic Data Systems, Honeywell, and SAIC.

 

Mr. Jones retired from FDA in April 2018. He received a MS in Computer Engineering from Loyola College in 1999 and a BSE in Naval Architecture and Marine Engineering from the University of Michigan in 1974. He also has CDP and CSQE certifications.

 

Interests:

Mr. Jones is interested in working with those who want to excel at building safe, secure, quality products. Work would include device software reviews, advise / guidance related to FDA software submissions (SaMD, SiMD, SoSMD), guidance on high assurance (cyber-physical system) software development techniques, software risk management, software safety and cybersecurity concerns, assurance cases, device interoperability, interdependence, AI, robotics, and training.

Consulting Partners

Fubin Wu

 

Co-founder and President of GessNet™, formerly Quality Director and Manager with  Hospira, Haemonetics and Medtronic. 16 years experience in Quality Engineering (Hardware and Software), Risk Management, QMS and FDA inspections.  Designed the TurboAC™ Risk Management and Assurance Case Software working with FDA CDRH OSEL and Industry  Subject Experts.

AAMI Instructor for Medical Device Safety Assurance Cases Course. PDA Instructor for Drug Delivery Device and Combination Product Risk Management, and Cybersecurity 

Harvey Rudolph

 

Over 25 years of experience with FDA, including FDA Deputy Director of the medical devices laboratory. Formerly Global Program Manager for Medical Devices at Underwriters Laboratories. A founding member of the ISO/IEC Joint Working Group on Risk Management and a primary author of ISO 14971 and ISO TR 24971.

 

Debra Csore

 

Formerly Head of Quality and Regulatory at Global Med Technology and Regulatory Affairs Manager with Haemonetics. Expert in 510(k) Submissions with extensive experience in Medical Devices Regulatory Compliance and Quality Management Systems.

Alan Kusinitz

 

Founder of SoftwareCPR, co-chair of AAMI TIR32 SW Risk Management, and Instructor for AAMI Software Regulation, Safety Case, and Quality System courses. Expert in FDA premarket submissions and enforcement action recovery.

 

Sherman Eagles

 

Medical Device Standards, Safety Case, Medical Device Network Risk Management expert. AAMI Instructor for Safety Case courses. Chairman of AAMI software committee and IEC 60601 PEMS and 62304 working groups.

 

Brian Pate

 

Member of AAMI TIR45 Agile Methods and TIR32 Medical Software Device Risk Management working groups. AAMI Agile Methods Compliance Instructor . Expert in software hazard analysis and use of severity for risk control effectiveness evaluation.

 

Stan Hamilton

 

Medical Device and Aerospace Risk Management expert. Member of AAMI TIR32 Software Risk Management working group. Expert in systems and software hazard analysis and FMEA. Lead Avionics and Software Safety Engineer Space Launch System.

 

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