Proa Medical’s management team has expertise in intellectual property, product development, quality systems, and FDA compliance. Its members have various professional certifications, education, and industry experience; and one member of the team is a former FDA officer.
Arman H. Nadershahi, JD, MS, MBS, MBA
Chief Executive Officer, President
Arman Nadershahi is a well-rounded entrepreneur with deep expertise in several critical aspects of medical device development and commercialization.
Arman is a registered patent attorney and expert in FDA regulatory affairs and, in addition to his role at Proa Medical, currently serves as Head of Legal Affairs and Intellectual Property at the Alfred Mann Institute for Biomedical Engineering at the University of Southern California. He formerly led the Regulatory & Quality Affairs functions at AMI. His expertise includes patent, trademark, and trade-secret protection and licensing; FDA and EU regulatory affairs; quality assurance; corporate compliance; competitive strategy and planning; and technology valuation and commercialization. Prior to joining AMI, Arman practiced intellectual property law at Knobbe, Martens, Olson & Bear, LLP, where he focused on patent prosecution, licensing, and intellectual property litigation in the fields of biotechnology, pharmaceuticals, and medical devices.
Mr. Nadershahi played a leading role in the development of AMI's FDA-compliant quality system. Furthermore, he played a key role in bringing a pediatric medical product to nation-wide distribution, including securing a patent, developing a regulatory and quality strategy, leading the development of a design history file, obtaining FDA 510(k) clearance, negotiating and drafting a license agreement, and updating the licensee's quality system for compliance with FDA regulations..
At the Institute, Arman also led the quality and regulatory planning for a cardiac output monitoring system. He led the early design history file development efforts, and initiated clinical trials (including IRB approval, study site initiation, training, and auditing pursuant to Good Clinical Practices). Arman has also played key roles in preclinical studies under Good Laboratory Practices, has trained staff in numerous quality and regulatory matters, and has extensive involvement with engineering teams in the development of numerous medical devices.
Arman graduated with honors from the University of Wisconsin-Madison with a BA in Zoology and English Literature. He holds a Juris Doctor from the University of Minnesota Law School, a Master’s in Biological Science from the University of Minnesota, an M.S. in Regulatory Science from the University of Southern California School of Pharmacy, and an MBA from the Marshall School of Business at the University of Southern California.
Arman has obtained US and EU Regulatory Affairs Certification, and is an ASQ Certified Biomedical Auditor (CBA) and a Certified Manager of Quality/Organizational Excellence (CMQ/OE). Mr. Nadershahi is a member of the State Bar of California and is registered to practice before the United States Patent and Trademark Office.
Afshin Nadershahi, MD, MBS, MBA
Chief Operating Officer, Chief Technical Officer
Dr. Afshin Nadershahi leads Proa Medical’s operations and the technical aspects of medical device design and development. He has expertise in project management, medical device development, FDA-regulated quality systems, and Good Manufacturing Practices.
Afshin is an MBA graduate from the MIT Sloan School of Management. He received his undergraduate degree in Molecular and Cell Biology from the University of California, Berkeley; a Masters in Biological Science from the University of Minnesota; and his medical doctorate from the Keck School of Medicine of the University of Southern California. While attending medical school, Afshin Nadershahi served as Market Intelligence Analyst and Medical Technology Consultant at the Alfred E. Mann Institute for Biomedical Engineering; he later served as Medical Advisor to the institute. Dr. Nadershahi has conducted vascular research at the University of California, San Francisco and performed vascular oncology research at Norris Cancer Center of Los Angeles, for which he received the Lifeline Student Fellowship Award of the American Vascular Association. His research has been published in the Journal of Vascular Surgery and BMC Bioinformatics.
Dr. Nadershahi has served as Co-founding Director of the Biotech Education Center, a 501(c)(3) nonprofit organization. At MIT Sloan, Dr. Nadershahi was Products and Services Track Winner of the MIT $100K Entrepreneurship Competition’s Business Plan Contest, and he was a finalist in the MassChallenge Global Startup Competition.
Afshin Nadershahi has been a guest lecturer on Health Sciences and Technology at the Keck School of Medicine and Viterbi School of Engineering of the University of Southern California. He is also a mentor to MedTech Venture Teams at the University of California, Los Angeles.
Sudeep Deshpande, MSME
Engineering and Production Manager
Sudeep Deshpande has over a decade of experience in the field of Industrial Design and biomedical product development and commercialization. Mr. Deshpande has served as Senior Engineer - Device Technologies at Amgen; and has headed Mechanical Engineering & key FDA related activities such as Risk Management, Design Controls and GMP at the Alfred Mann Institute for Biomedical Engineering at the University of Southern California (AMI). Prior to joining AMI, he worked in the automotive industry, developed software efficiency programs for structural analysis, and designed fuel filtration systems for GE and Siemens.
At AMI, Sudeep lead the mechanical and electronics integration activities for two products under clinical trials. He also has experience in designing clinical setups for device design verification & validation (V&V), performing vendor audits and contract manufacturing activities. Sudeep helped in the establishment of a Quality System and FDA Design Controls at AMI.
Sudeep graduated with distinction from Pune University, India, with a Bachelor's degree in Production Engineering in 2000, and then went on to attain his Master's in Mechanical Engineering from the University of Southern California.
Sudeep's expertise includes: Medical Device Risk Management, Design Controls, Device V&V Industrial Design, Electronics Packaging, Outsourcing and Product Life-cycle Management. He is an expert in creating mechanical drawings using ANSI and ISO standards. He has extensive experience in CAD (SolidWorks, Inventor) and CAM (MasterCam), CNC programming, Adobe Photoshop, Ansys, and MSC visualNastran.
Victoria Nadershahi, MS
Director of Regulatory Affairs & Quality Assurance
Victoria Nadershahi is a former FDA Investigator and has extensive industry experience at leading dental manufacturing and distribution companies. Victoria served for several years as an Investigator and Consumer Safety Officer at the United States Food and Drug Administration (FDA). At FDA, she was responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. Specifically, Ms. Nadershahi’s duties included, entry review, working closely with other regulatory agencies at customs bonded facilities (CES), special investigations, inspections and sample collections.
Prior to joining the US Food and Drug Administration, Ms. Nadershahi had numerous roles within the dental and medical device industries. For example, as a Regulatory Affairs Coordinator and Consultant, Ms. Nadershahi developed strategic regulatory pathways for US and EU market entry of Class I and II medical devices, prepared applications for FDA establishment and device listing, prepared 510(k) submissions and technical files for CE marking of medical devices, and audited and provided guidance for establishment of QSR and ISO 13485-compliant quality systems for the design and manufacturing of various dental products. She has also managed the procurement and analysis of preclinical and clinical data and literature in support of regulatory submissions, conducted quality assurance audits, managed post-market surveillance, and ensured compliance of product labeling.
As a Clinical Research and Education Specialist within the dental device industry, she played a key role in creating and implementing educational seminars for new dental products and procedures, conducting clinical research, and researching and developing strategic marketing plans for various dental products. In addition, she has developed and maintained a broad customer base and prospected new business, gathered and analyzed data on marketing trends, competitive products and pricing, and led in sales at a top dental manufacturer and distributor.
Ms. Nadershahi graduated from the University of California-Irvine with a Bachelor’s Degree in Biological Sciences and Certificates in Medical Product Development and Clinical Trial Management. She has also obtained a Master’s in Bioscience-Regulatory Affairs, from the Johns Hopkins University. She has also obtained Regulatory Affairs Certification and Pharmaceutical Sales Certification. Ms. Nadershahi is fluent in English and Russian.
Fikret Kirkbir, PhD
Project Manager, Patent Manager
Dr. Kirkbir is a project manager and advises on a wide array of intellectual property issues related to medical devices, analyzes patentability of inventions, works with inventors to guide their research for intellectual property generation and develops IP strategies. He coordinates IP matters with internal and external patent attorneys in drafting, filing and prosecution of patent applications.
Dr. Kirbir has more than 27 years experience in research and development in the fields of materials science, chemistry and chemical engineering. Dr. Kirbir is registered to practice before the United Patent and Trademark Office as a patent agent.
He obtained his B.Sc. and M.Sc. degrees in Chemical Engineering from METU (Ankara, Turkey) and his Ph.D. degree in Chemical Engineering from Tokyo University. He conducted his post-doctoral research at UCLA's Materials Science Department between 1988 and 1990.
Dr. Kirkbir joined Yazaki Corporation's research division, YTCA in Camarillo, California in 1990. He became responsible for intellectual property activities of the company in 2002.
His research experience includes nanotechnology (nanoparticles and carbon nanotubes), aerogels, optical fibers, optical coatings, sensors, bulk glass and ceramic materials, organic and inorganic polymers, sol-gel processing, chemical vapor deposition and high pressure chemical technology.