Sigi Caron, BS, MBA, RAC
President, BioMDg
Ms. Caron has over twenty-five years of progressive experience in basic research, regulatory affairs, clinical research and new business development in both the academic setting and in the medical device and pharmaceutical industry. Ms. Caron has successfully submitted multiple 510(k)’s, IDE’s, INDs, PMA’s, obtained an Orphan Designation for a gene therapy product and several medical devices, successfully submitted a COVID-19 EAU and is overseeing data collection, and has successfully submitted several fast track designations. She has over 20 years of experience in biologics submissions, including embryonic stem cell therapy, and multiple autologous stem cell therapies, and allogeneic therapeutics for cardiovascular diseases. Over the past five years of practice, she has successfully submitted 8 INDs for gene therapies in clinical areas such as critical limb ischemia, heart failure, diabetic neuropathy, and ALS, and 1 IND for an embryonic stem cell product. Over the last 5 years, Ms. Caron has also successfully negotiated and obtained approval for 20 IDEs spanning therapeutic areas such as stroke, cardiac arrhythmia treatment, cardiac implants, in vitro diagnostics, physical therapy devices, thrombectomy devices, and critical care devices.
Ms. Caron’s clients include both Fortune 500 companies and startups in the fundraising stages. Prior to consulting, Ms Caron was Vice President of Regulatory Affairs and Quality Assurance at TheraCardia, a venture-backed startup company developing a paradigm shift emergency cardiac assist system for treating patients in cardiac arrest. Ms. Caron negotiated a reduction of clinical trial requirements (endpoint & enrollment requirements) for the device by two thirds and helped shape FDA’s policy for CPR devices. Ms. Caron also negotiated an agreement for Medicare Coverage with the medical device coverage group at CMS (formerly HCFA).
Prior to joining TheraCardia, Inc., Ms. Caron held several management positions at medical device companies including Biosense Webster, a Johnson & Johnson Company, Smith & Nephew’s Endoscopy Division, Codman, a Johnson & Johnson company and Johnson & Johnson Orthopedics. Before working in the medical device and pharmaceutical industry, Ms. Caron worked as a basic researcher at the Woods Hole Oceanographic Institution where she obtained grants from government agencies to fund original research, managed and administering them, designed and built novel chemical analyzers, and published four papers in peer reviewed journals (two-first author papers). Ms. Caron holds a BS from UCLA in Biology (emphasis in mathematics) and an MBA from Northeastern University’s High Technology MBA program (emphasis in biotechnology management).
For more information, please contact Ms. Caron at sigi@biomdg.com
Tavi Cruz-Uribe, PhD
Product Development and Operations
Octavio (Tavi) Cruz-Uribe is both an Operations professional that has experience establishing small medical device companies and a Quality System expert in setting up 21 CFR 820 and ISO 13485 compliant quality management systems. He started in the industry over 14 years ago in large scale pharmaceutical manufacturing validation and compliance before moving over to medical devices. Since then he has worked with over 20 different medical device companies in fields ranging from active implantable devices to surgical guidance systems to disposable catheters. He has successfully submitted technical files, 510(k)s, and PMAs for new products and has successfully navigated multiple regulatory (ISO and FDA) audits for new companies. Presently he manages a small medical device company developing membrane technology to immobilize and deliver stem cells. He holds a PhD in Biochemical Engineering from Oregon State University and a B.S. in Chemical Engineering from University of Colorado. For more information, please contact Dr. Uribe at Tavi@biomdg.com
Dr. Eeke A. Romo
Clinical / Scientific Research & Medical Writing
Dr. Eeke Romo was born and raised in the Netherlands where she received her medical doctorate degree. In pursuit of required research activities, Dr. Romo worked as a research associate for California State Developmental Research Institute in Costa Mesa and for the Department of Psychiatry and Human Behavior at the University of California, Irvine (UCI).
While applying for a doctoral program at UCI, Dr. Romo was offered a postdoctoral position in Psychobiology. She spent the next 2 1/2 years laying her foundations of basic research, research methodologies and scientific writing including manuscript preparation. Concurrent coordination of drug trials at the Alzheimer’s Disease Diagnostic and Research Center peaked her interest of applied science in the medical device industry.
During the following four years, Dr. Romo was employed at the Clinical Affairs Department of Baxter Healthcare Corporation, Edwards CVS Division where she held several positions with increasing responsibilities.
The cumulating experience led to the position of Director of Clinical Affairs at TheraCardia Inc., a start-up company focused on a novel class III device used in Emergency Medicine. Here for the next 2 years, Dr. Romo established the Clinical Affairs department; developed clinical strategies, protocols and CRFs for all study phases; managed local and international CRAs and CROs was responsible for training and training materials; recruited investigators and performed pre-study, study initiation, and monitoring visits.
In August 2000, Dr. Romo became a full-time clinical/scientific research consultant and medical writer. Dr. Romo’s proficiencies include, but are not limited to, preparation of clinical, pre-clinical, annual, and clinical reports for numerous successful PMA submissions, IDE and IND submissions; preparation of briefing materials for advisory panels; protocol and CRF development for (novel) devices, pharmaceuticals, biologics and drug studies; development of training materials; preparation of Clinical Investigator Brochures; extensive literature reviews for regulatory submissions; preparation and submission of IRB/IBC/EC applications; preparation of manuscripts for submission to peer-reviewed journals. In her role as Medical Director with MedTech, Dr. Romo has overseen the conduct of three gene therapy studies, a cerebral vasospasm study, and an EUA study involving COVID-19 patients.
For more information, please contact Dr. Romo at eekeromo@cox.net or eeke@biomdg.com
Megan Lamberti
MTM
Megan Lamberti holds a Master of Translational Medicine degree jointly from the University of California, San Francisco (UCSF) and UC Berkeley, and a Bachelor of Science in Biomedical Engineering, concentrated in cell and tissue engineering, from Johns Hopkins University. Ms. Lamberti is a certified Clinical Research Associate (CRA) and has expertise in clinical affairs for both medical device and in vitro diagnostic products, including clinical study design and management in the E.U. and the U.S. for non-significant risk (NSR), investigational device exemption (IDE), and emergency use authorization (EUA) studies. She also has expertise in regulatory affairs, including the writing and compilation of 510(k), breakthrough device designation, orphan drug designation, investigational new drug (IND), CMS coverage requests, and Technical File submissions.
For more information, please contact Ms. Lamberti at Meg@biomdg.com.
Bryan Wong
Quality Systems and Product Development
Bryan Wong is a quality assurance and regulatory professional with over 20 years of experience in the regulated medical device industry where he has successfully implemented and improved 21 CFR 820, ISO 13485, and MDD compliant quality management systems for small to medium sized-start ups. He has played a key role in the effective implementation of design controls and risk management in the product development of Class II and III medical devices. Mr. Wong has also contributed to the preparation and submission of technical files and 510(k)s for new products and has successfully navigated multiple regulatory audits. He holds a B.S. in Electrical Engineering and Computer Science from UC Berkeley.
For more information, please contact Bryan at bryan@biomdg.com.
Heidi Ansorge
Regulatory Affairs Associate
Heidi Ansorge graduated from the University of Southern California with a BS in Neuroscience and an MS in Translational Biotechnology. While attending USC Heidi worked in multiple labs mapping the neural circuits of aggression and studying the effects of electrical fields on axonal growth in the optic nerve. The latter research opportunity lead to publications in the Journal of Neuro-Ophthalmology and Glaucoma Physician Magazine. In addition, she worked alongside a pediatric ophthalmologist and handled IRB submissions for a dyslexia study. During her final year at USC Heidi began an internship with Biologics and Medical Device Consulting Group. During this time she gained experience in regulatory affairs, clinical protocol writing, quality assurance, and grant writing (SBIR).
Diana Porter
RA/QA Specialist
Ms. Porter has 13 years experience in the medical device industry with her main expertise in document control. Much of her career has been devoted to the implementation and maintenance of quality systems of both class I and Class III devices. As an RA/QA Specialist, she is able to put her organization skills and eye for detail to good use. Ms. Porter holds a Bachelors of Science degree in Animal Science from California State Polytechnic University, Pomona (cum laude.)
Ms. Porter can be reached at Diana@biomdg.com
Yi-Jing Duh, PhD
Statistical Services
Yi Jing Duh, PhD has more than 20 years of experience as a biostatistician and manager of statistical services, including responsibility for clinical database development and validation, study CRF design and review, SAS programming and output in support of 510(K), PMA and NDA applications.
Yi-Jing directly interfaces with FDA clinical and statistical reviewers and has participated FDA panels. Yi-Jing’s projects cover many areas such as ophthalmics, dermatology, diabetes, breast cancer diagnosis, bone replacement, and COPD.
For more information, please contact Dr. Duh at yijingduh@statserv.info or at yi-jing@biomdg.com
Jesse Yang, MS, RAC
Database Manager
Jesse Yang, MS, RAC has worked on the CRF design, clinical database management, database design and validation, and SAS programming.
Jesse works with biostatisticians on preparing SAS programs for data analyses; with clinical teams on resolving data issues; with clinical database designer/programmers on designing database and data query programs, and validating database.
Alice Alonso, PhD.
Pathologist & Immunologist, Senior Clinical and Regulatory Consultant
Dr. Alonso received her doctorate in pathology from UMDNJ-NJ Medical School. Based in Warren, NJ, she has over 25 years of experience in pharmaceutical, biotech, medical device, and diagnostic arenas. Her technical background includes experimental and clinical pathology, immunology, neoplasia, retrovirology, virology, large-scale human cell culture, human monoclonal antibodies, immunoassay development, diagnostics, transfusion medicine, infectious diseases, gene therapy, angiogenesis, autologous stem cell therapy, cardiology, and cardiovascular medical devices.
Dr. Alonso has held positions of increasing responsibility in Sandoz Research Institute (Novartis), Ortho Clinical Diagnostics (J&J), Cordis Corporation (J&J), and Biologics Delivery Systems – Biosense Webster Inc. (J&J) where she last held the position of Research Fellow. Her experience base includes preclinical and clinical research and development, product development, technology transfer to operations, product validation, process improvements, clinical study design and management, as well as clinical and regulatory submissions. She has established strong scientific links and collaborative studies with opinion leaders around the world, and has led technical and multi-disciplinary teams on over a dozen products for US licensure and/or European registration.
Born in Newark, NJ of immigrant parents from Spain and raised trilingual (Spanish, Gallego/Portuguese, and English), Dr. Alonso has used her background to full advantage in operations, clinical studies, and regulatory submissions worldwide. She has a proven track record in developing preclinical and clinical strategies and protocols for phase I, II and III clinical trials; saving sponsor time and money through study design and management; managing multi-million dollar clinical studies worldwide; writing Clinical Investigator Brochures, Investigational Medicinal Product Dossiers, Pharmacy Manuals, training materials, and clinical study annual and final reports; working closely with CRAs, CROs, Clinical Supply Management and investigators worldwide; clinical trial treatment authorization; reviewing SAE reports and autopsy findings; data analysis; and participating in pre-study, study initiation, and monitoring visits. She has further experience in areas of technical writing that include literature reviews, technical marketing summaries for physicians, development of literature databases, as well as preparation and review of manuscripts.
For more information, please contact Dr. Alonso at alice@biomdg.com.
Markus Weber
Principal Software Safety Consultant and Owner, System Safety, Inc.
Mr. Weber specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding System Safety, Inc. He was a software safety engineer for the German approval agency, TUV. Since 1991, Mr. Weber has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices. In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. Mr. Weber has helped multiple companies, from startups to Fortune 500 firms. For more information contact Markus at markus@biomdg.com.