Medical Devices Consultants: 10

Peter Crosby has over 45 years experience in the medical device industry. He has served as CEO of six medical device companies in four countries (public and private), and brought many products to the world market through clinical trials and regulatory approval.

Through Biomedical Business Resources LLC, he provides many services including:

• Advisory - helping clients with strategy, operations, execution, and business building\
• Mentoring, especially first time CEOs
• Expert Witness - assisting attorneys with multiple expert reports, depositions, and testimony at trial and arbitration. Cases include disputes about intellectual property , product liability, and commercial contracts
• Board Services - offering Independent Board Member services for companies, public or private, with experience in building companies, and helping management teams in times of high growth and rapid change

Mr. Crosby's product experience includes implantable devices (cochlear implants, cardiac pacemakers, implantable defibrillators, artificial heart, neurostimulation), in vitro diagnostics, imaging (ultrasound and X-ray), software, AEDs, and patient monitoring. His clinical domain experience includes ophthalmology, otolaryngology, cardiac surgery, cardiology, orthopedics, pain management, anesthesia and intensive care.

View Peter Crosby's Expert Witness Profile.

Dr. Divya Chander, MD, PhD,  is a physician, neuroscientist, and futurist who trained at Harvard, UCSF, UCSD, and the Salk Institute. She is currently the Chair of Neuroscience and Faculty in Medicine at Singularity University. She is also a Visiting Scholar in the Stanford Department of Medicine, Biomedical Informatics, and was a member of the Stanford Anesthesiology Faculty for 8 years.

In the operating room, Dr. Chander applies EEG technology to understand what human brains and the underlying networks look like when they lose and regain consciousness. She also has a precision medicine initiative focused on understanding genetic variability in responses to anesthetic drugs and brain oscillations. Her goal is to understand neural mechanisms of consciousness, as well as the evolution of human consciousness secondary to human augmentation. She is working on devices that read and write the brain (brain mapping, neuromodulation) and link to brain machine interfaces for diagnostic and therapeutic purposes.

Keynote Speaking:

• Neuroscience is on the cutting edge of decoding brains, making it possible like never before to peer into brains and hijack their circuitry. In this talk, Dr. Chander explores how old and new technologies make it possible to read visions and dreams, hack thoughts, and plant false memories. She also addresses how modern medicine and science make it possible to restore and enhance function to people who are paralyzed, opening the door to digital and robotic control with the human mind.
• Medicine / Healthcare is being transformed by exponential technologies that often are developed in the non-healthcare space. Dr. Chander explores how breakthroughs in 3D printing, robotics, artificial intelligence, stem cells, augmented and virtual reality, microfluidics, nanotechnology, and brain machine interfaces are pushing medicine into the realm of science fiction. New diagnostics, therapies, and even augmentation are considered, as well as their ethical implications. 

Video: Can You Read My Mind? The Promises & Perils of AI Decoding the Brain: Divya Chander at NextMed Health

• Bioethics has both the near and long-term implications for humanity and the biosphere. This has never been more true as we have gained the ability to rewrite both the genetic and the neural code, fundamentally changing what it means to be human. The ability to implant, read and write functions to humans leaves us vulnerable to losing our privacy, or even being hacked and manipulated. This talk explores the ethical implications of the technology we have developed, which is exploding at an exponential rate, and considers some new solutions.

View Dr. Divya Chander's Expert Witness Profile.

Elite Medical Experts works with attorneys to provide 100% Board-Certified physicians and surgeons practicing at the professorial level at the nation's leading universities. From Stanford to Yale, and from every medical and surgical specialty, Elite secures full-time practicing high-level experts from the nation’s most respected medical institutions. Each specialist is truly unique – a Board Certified professor with a dedicated clinical practice, extensive publications, and top-tier credentials from a major U.S. medical center. 

Complex Consulting at the Intersection of Medicine & Business
Elite Medical Experts also consults on complex strategic and tactical issues for enterprises of any size, and has extensive experience securing top-tier Professors of Medicine and Surgery for a range of complex consulting engagements. Elite Medical Experts is mission-critical to:

Corporate Consulting Occupational Health Special Projects Product Development Legislative Issues FDA Navigation Television, Film, Print News, and Other Media

FTC Rules and Regulations Lobbying Intellectual Property Focus Groups and Due Diligence Keynote Addresses, Endorsements Executive Search for Strategic Advisors, Directors, and Board Members Device & Drug Insight for Hedge Funds and Private Equity

To learn how you can align with nationally recognized thought leaders from myriad areas of expertise, call Elite today and ask for our Director of Complex Consulting:

Dr. Burton Bentley II, M.D., FAAEM
CEO, Elite Medical Experts, LLC.

View Elite Medical Experts' Expert Witness Profile.

Finity Engineering, LLC comprises highly-accomplished engineers and industrial practitioners that work alongside leading researchers to provide design, analysis, consulting, and litigation support services. Associates are subject-matter experts in the areas of Automation, Mechatronics, Robotics, and Consumer Products.

Finity Engineering professionals have served scores of industry-leading companies and research institutes, and have developed and provided technical oversight for the implementation of hundreds of robotic, automation, and controls systems deployed within the facilities of high-profile end users. Collectively, Finity Engineering professionals are named inventors on over 60 patents and have founded dozens of successful entrepreneurial ventures, demonstrating pragmatic and marketable engineering innovation.

Clients Include: Alcoa, Apple, BMW, Boeing, Cargill, Caterpillar, Chernobyl, Cummins, Ford Motors, Fukushima, General Motors, Gestamp, Google, Honda, Hundai, Jet Propulsion Laboratory, Johnson Controls, Kia Motors, Lockheed Martin, and many more.

Design, Analysis & Business Consulting Specialties:

Additive Manufacturing Aerospace Engineering Biomedical Engineering Consumer Product Design Control Systems Cranes Design Methodology Dynamics Electrical Engineering Failure Analysis Fluid Power / Hydraulics Haptics Hazard Analysis Image Processing Industrial Control Systems Industrial Design

Machine Design Machine Learning Machine Vision Manufacturing Mechanical Engineering Mechatronics Motion Control Optics Photogrammetry Product Design Rapid Prototyping Robotics Signal Processing Traction Control & Wheel Slip Vibrations Warnings

 Founder, Khalid Sorensen, PhD, is a highly accomplished technology leader in Automation, Mechatronics, Motion Control, Manufacturing, Machine Vision, and Human-Machine Interaction. He has over 20 years of experience developing and deploying world class, mechatronic, motion control, and automation solutions.

Dr. Sorensen has directed the development and implementation of 100s of complex, multi-disciplinary mechatronic systems for high-profile industry leaders including Toyota, Ford, Alcoa, Caterpillar, Boeing, NuScale, and many others, and high-profile facilities including Fukushima and Chernobyl.

Previously, Dr. Sorensen Founded a technology company where he invented and was the Chief Architect of Expertoperator^TM, Safemove^TM, Automove^TM, and Cranevision^TM – technology known within the primary metals, automotive, and heavy-equipment sectors for enhancing crane safety, productivity, and ease-of-use; Developed state-of-the-art, on-line, time-optimal trajectory synthesis software for Cartesian machines - key drivers in the acquisition of his company 5 years after inception by a global leader in automation.

View Dr. Khalid Sorensen's Expert Witness Profile.

Rouzbeh R. Taghizadeh, PhD, has been researching, developing, and bringing to market Cellular and Tissue based Products and Medical Devices for clinical use – as a researcher, scientist, entrepreneur, innovator, and key opinion leader. Dr Taghizadeh is a Scientist, Entrepreneur, Innovator and Subject Matter Expert offering Business Consultant services in the following areas:

Regenerative Medicine Blood and Tissue Banks Blood and Tissue Manufacturing Cellular and Tissue Based Therapeutics Umbilical Cord Blood / Bone Marrow

Stem Cell Bioengineering Longevity Cellular & Tissue Engineering Biotechnology Medical Devices

Dr. Taghizadeh's research has focused on developing aand patenting a new method to increase the number of hematopoietic (blood forming) stem cells (master cells that produce working cells for the lifespan of an organism) ex vivo (outside the body) for treatment of patients afflicted with blood disorders and cancers. He has investigated various sources containing blood-forming stem cells, including umbilical cord blood, bone marrow, and mobilized peripheral blood.

Dr. Taghizadeh also co-founded a biotechnology company that pioneered the processing and banking of umbilical cord tissue for clinical use. He's worked with various groups including umbilical cord blood & tissue banks, organ procurement organizations (OPO), academic, biotechnology, pharmaceutical, contract manufacturing and medical device groups. Due to the diverse nature of the groups that he has worked with, he has experience in developing, manufacturing and innovating cellular therapeutics, regenerative medicine, allografts (tissue products developed from different donors & recipients), bioengineering, cellular and  tissue engineering products.

View Dr. Rouzbeh R. Taghizadeh's Expert Witness Profile.

Dr. Mayer is an independent consultant and scholar that (for identification only) holds the position of Visiting Fellow in Human Flourishing,  Harvard University. He has been a full-time tenured professor with recent appoints in statistics, biostatistics, epidemiology, biomedical informatics, public health and medicine (psychiatry). He held various titles including, Professor (Part-time), Bloomberg School of Public Health and School of Medicine, Johns Hopkins University, Affiliated Professor, Mayo Clinic/ASU joint program in Biomedical Informatics, a member of the Research Staff at Mayo Clinic, and Professor at Arizona State University. 

Dr. Mayer continues to do research and mentor young physicians and medical students while doing a limited amount of consulting in epidemiology, biostatistics, statistics, observation studies and clinical trials. His consulting projects often focus on model development, execution and inferences. He is one of the few MD/PhD epidemiologists. He led a  group of 6000 physicians and epidemiologists that reviewed the science of COVID-19 

mdi Consultants, Inc - Experts in FDA regulatory affairs, quality assurance and ISO 9000 certification. With 6 years in the FDA and 26 years consulting to the industry, mdi Consultants, Inc. has been an invited Speaker worldwide on FDA regulations and policies and has obtained FDA expert status as third party auditors.

OUR APPROACH

We utilize the following three part approach to providing high quality services to our clients:

Unsurpassed consultant experience – we identify and recruit only top quality consultants with deep industry knowledge to provide the most complete and insightful advice to our clients

Up-to-date systems and processes – we have highly defined systems (e.g. manuals, training programs, technical files) and processes (e.g. audit methodologies, 510(k) submission, validations) that are constantly refined and kept current across the ever changing regulatory environment

Involvement in regulation development – we stay ahead of policies by participating in the development of regulation (e.g. HACCP, Scientific Advisor to U.S. Congressmen)

OrthoBioMech LLC provides Medical Device Development and Injury Biomechanics Analysis services to the orthopedic and legal fields. The founder, Mari S. Truman, PE, has more than 37 years of experience in Orthopedic Product Design and Development. As Principal Engineer, she acts as an R&D design and development consultant to the orthopaedic industry and an injury biomechanics and medical device forensic expert.

While working for and with the major US Orthopaedic companies, she designed numerous instruments and implants for repair of skeletal injury. Ms. Truman is named on 12 Orthopaedic Patents and frequently gives talks on implant design and injury biomechanics on topics such as: knee and thumb-based joint surfaces and kinematics, joint design, rapid prototyping, medical device design control, and injury biomechanics.

Ms. Truman founded and ran ArthroMotion (1993-1997) and Seabrook International LLC's Midwest Design Center (1999-2002). Her project experience (non-inclusive):

• Total and Hemi Joint Resurfacing Systems: Hip, Knee, Wrist, Ankle, Hand/Toe, CMC, PIP, DIP, Shoulder
  
• Trauma Systems: Plates, specialty screws, intramedullary nails, wires, cables, external fixation systems, spinal fusion systems
  
• Soft Tissue Reattachment Systems

Speaking Venues: ASME Congress, North American Spine Society, Southern Biomedical Engineering Conference, International Society of Biomechanics, National Manufacturing Week Conference, American Society for Surgery of the Hand, International Hand and Wrist Biomechanics Symposium, International Federation of the of the Societies for Surgery of the Hand, Vth International Symposium on Computer Simulation in Biomechanics, Indiana Medical Device Manufacturer’s Council, Ohio Bar Association and the Ohio Trial Lawyer’s Association.

View Mari S. Truman's Expert Witness Profile.

Award winning, Oxford Educated scientist whose areas of expertise include medical imaging, electronics, semiconductors, medical devices, sensors, MEMS, signal processing and image processing. Dr Daft has deposition and trial testimony experience. Extensive Intellectual Property experience including patent development, analysis, licensing, and litigation. Serial inventor who holds 23 U.S. Patents with several pending. Completed more than 98 hours of SEAK Expert Witness Seminars, including patent-specific training. Diverse industry experience including multi-nationals such as GE, Medtronic, Fujifilm, Samsung and Siemens as well as several start-ups. Well published. Winner of grants from National Institute of Health. Extensive international consulting experience. IEEE (Institute of Electrical and Electronic Engineers) Senior Member since 2004. Three years’ experience teaching electrical and computer engineering at the University of Illinois. Holds BA and MA in Physics from Oxford University as well as Doctorate from Oxford in Materials Science.

View Dr. Christopher Daft's Expert Witness Profile.

Timothy A. Anderson, MS, MBA, is a former FDA Review Chemist, with over 43 years of career experience in Pharmaceutical R&D, Quality Operations, and Regulatory Affairs. A uniquely interdisciplined individual, he melds comprehensive pharmaceutical industrial R&D, business development, QA/QC, and consultancy experiences with formal FDA-tenured regulatory credentials. 

As a consultant in his own pharmaceutical development advisory firm for over 29 years, Mr. Anderson has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls (CMC), to current Good Manufacturing Practice (cGMP), quality system regulation (QSR) audits for finished dosage, and active pharmaceutical ingredient (API) manufacturing, as well as for device, drug-device combination, and biologic products.  Technical and regulatory compliance due diligence services are furnished to institutional investors.  

Mr. Anderson has contributed to regulatory approvals for over 50 drug and drug / device applications, spanning generic (ANDA) and innovator NDA, BLA, 510(k), PMA, and 505(b)(2) applications, and has provided regulatory compliance remediation services to resolve Form 483, Warning Letter, and Consent Decree issues. 

Clients have included Medtronic Ave., Allergan, Memorial Sloan-Kettering Cancer Center, Mass Biologics, MDS Pharma, US Pharmacopieia, Boehringer Ingelheim, BristolMyers Squibb, Genzyme, Intelliject/Sanofi, Church & Dwight, CR Bard/Davol, Ximedica, Fresenius-Kabi (Austria), KRS Biotechnology Ajanta, and many more

Consulting Services: 

Global Regulatory Filing Review / Writing Agency Negotiation Strategic Advisories

Contracted Management Services Current Good Manufacturing Practices Compliance Quality Systems

View Timothy Anderson's Expert Witness Profile.