Daniel L. (Dan) Mooradian, Ph.D. Email and Phone Number
Senior Lecturer - Medical Industry MBA (MIMBA) Program (Shanghai, China) at
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University of Minnesota - Carlson School of Management
Saint Paul, MN, US
Daniel L. (Dan) Mooradian, Ph.D.'s Location
St Paul, Minnesota, United States, United States
Daniel L. (Dan) Mooradian, Ph.D.'s Contact Details
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About Daniel L. (Dan) Mooradian, Ph.D.
I am a experienced and accomplished scientist, business executive, entrepreneur and educator with more than 20 years experience in the successful commercialization of medical products including polymeric and tissue-based implants, medical instrumentation/surgical tools/diagnostics, and combination devices.Areas of scientific expertise: Pathology (I.e., the causes and effects of disease) with emphasis on cancer, wound healing and vascular disease. Extracellular matrix biology, Growth factors/cytokines.Clinical Disciplines: General Surgery (e.g., instruments, sealants, fixation devices) for open, laproscopic and robotic-assisted surgery. Abdominal Wall (hernia) repair (meshes, fixation devices). Pelvis floor (Urogynecology). Cardiothoracic surgery (Chest wall, heart, valves, coronary artery bypass grafts). Electrophysiology and Cardiac Rhythm Management. Reconstructive microsurgery (vascular closure, wound closure). Neurology, dural repair, peripheral nerve repair/regeneration, neurostimulation (Vagus, DBS, pain management (SNS, TENS). Pathology (Gross and microscopic) including but not limited to evaluations of the host implant response to implanted materials. Technology Development: Biomaterials (ISO 10993 Biocompatibility, Mechanics, degradation, packaging, sterilization (e.g., Engineered tissues, Animal-derived tissue, synthetic polymers). Bioactive and drug-eluting coatings. Surgical Staplers and Buttresses (design/performance). Suture-less anastomotic devices (coronary bypass and peripheral “free flap” surgery use). Wound-closure devices . Small-scale implantable sensors (e.g. 0.5mm ultrasound sensor and lead). Neurostimulators (TENS, ICD, DBS). Skills/Experience: Bench, preclinical and clinical study design, execution and reporting. Animal model development. IP Strategy and Management. Regulatory strategy development. Reimbursement strategy development. Portfolio Analysis/Review. Strategic Market analysis. Product Development Process development/Management. Technology evaluation. M&A due diligence/Integration management. Litigation Support (Patent validity/Infringement as well as medical product liability). Clinical Education. KOL relationship development. Grant writing/Review. Governance (External/C-Suite/Corporate Board).
Daniel L. (Dan) Mooradian, Ph.D.'s Current Company Details
University Of Minnesota - Carlson School Of Management
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Senior Lecturer - Medical Industry MBA (MIMBA) Program (Shanghai, China)
Saint Paul, MN, US
Daniel L. (Dan) Mooradian, Ph.D. Work Experience Details
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Senior Lecturer - Medical Industry Mba (Mimba) Program (Shanghai, China)University Of Minnesota - Carlson School Of ManagementSaint Paul, Mn, Us
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Chief Technology AdvisorKerecis Apr 2024 - PresentIsafjordur, Vestfirdir, IsAs Chief Technology Advisor at Kerecis, LLC my mission is to build a pipeline of innovative products based on the company's disruptive fish-skin technology that address the needs of patients and healthcare professionals around the world and do so in a sustainable manner. -
Senior Vice President - Product Life Cycle ManagmentKerecis Sep 2023 - Apr 2024Isafjordur, Vestfirdir, IsI lead a remarkable and diverse group of Medtech professionals who manage the company's Global Product Life Cycle Management division that includes; Upstream Product Management, Research & Product Development, Regulatory Affairs, Quality Assurance and Clinical Affairs.
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Senior Vice President - Research & Product DevelopmentKerecis Sep 2022 - Sep 2023Isafjordur, Vestfirdir, IsLeading a talented team of scientists and engineers responsible for the company's Research & Product Development. They have helped make Kerecis the fastest growing medical device company in Iceland. I am committed to helping them achieve even greater success in the future.
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Senior Lecturer - Medical Industry Mba (Mimba) Program (Shanghai, China)University Of Minnesota - Carlson School Of Management Jun 2022 - PresentMinneapolis, Mn, UsIn my role as Senior Lecturer, I teach MIMB6888: Medical Technology Research & Development to MBA students in the Medical Industry MBA (MIMBA) program. This program, a partnership between the Carlson School of Management & Tongji University School of Economics & Management, is designed to prepare current and aspiring managers to excel in China's Medical industry.
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Strategic AdvisorTearrestore Sep 2018 - PresentMinneapolis, Minnesota, Us -
Strategic AdvisorRemastered Sleep Nov 2019 - PresentEagan, Mn, Us -
Chief Science OfficerInnova Medical Design, Inc. 2011 - PresentInnova Medical Design is a Twin Cities-based early-stage Medical Device Company focusing on the development of novel devices to treat needle pain which remains a challenge to patient compliance in chronic conditions such as diabetes and hospital procedures that include IV set-up, blood draw or injection. Led development of a functional prototype, including purpose built electronics and microprocessor-controlled signal generator. Currently seeking investment from interested angel investors and strategic partners.
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Adjunct Associate Professor - Department Of SurgeryUniversity Of Minnesota Medical School Sep 2020 - PresentMinneapolis, Minnesota, UsI've spent the greater part of my professional career supporting the life-saving work of surgeon's across the globe. I've had an opportunity to invent, develop and/or commercialize products in a variety of surgical specialties (General, Bariatric, Cardiothoracic, Reconstructive microsurgery, etc.). I've had the privilege of learning from several pioneering surgeons in these fields as well. What an honor it is to have an opportunity to continue that service as a member of the adjunct faculty in one of the greatest departments of surgery in the world. -
Visiting Professor - Ms In Medical Device EngineeringTecnológico De Costa Rica Apr 2014 - PresentCartago, Cartago, CrI've had the pleasure of working with the Cost Rica Investment Promotion Agency (CINDE), colleagues at Boston Scientific Corporation, and a remarkable group of faculty at TEC over the past 6 years. I served as an advisor to TEC faculty on the design of their Medical Device Engineering program and recruited a team of instructors from my home Institute - the Technological Leadership Institute - to teach critical subjects in the program. I have taught a course on Entrepreneurship and Strategic Analysis in the program since 2014. I am enormously proud of the TEC program, its faculty and its students who are fueling growth in Costa Rica's Medical Device Manufacturing. -
Medical Consultant & Expert WitnessMooradian Medical Consulting & Expert Witness Services Apr 2022 - Sep 2022
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Honeywell - James J. Renier Chair In Technology ManagementTechnological Leadership Institute, University Of Minnesota Nov 2013 - Apr 2022Minneapolis, Mn - Minnesota, UsAs Honeywell - James J. Renier Chair in Technology Management I helped shape the academic direction of the Institute in collaboration with the Director, faculty and advisory board. I served as the Director of Graduate Studies for the MD in Medical Device Innovation since its launch in the summer of 2014 through the spring of 2022. During my tenure as DGS, I've been responsible for recruiting our outstanding faculty, shaping the curriculum to prepare more than 100 program alumni in the medical device industry become effective leaders of innovation and drive business growth. I've mentored entrepreneurs across the University and connected them with sources of capital and support. I've build partnerships across the University and with organizations in Minnesota and elsewhere to create shared value. Over the past year, I played a central role on behalf of TLI in developing the educational curriculum for the University's new Center for Medical Device Cybersecurity. Along with my colleagues Micheal Johnson and Bill Aerts, I designed, developed and successfully launched the CMDC's inaugural course in Medical Device Cybersecurity. -
Founder & PresidentThe Simpatico Group Llc Nov 2012 - Apr 2022The Simpatico Group LLC is a twin cities-based consulting firm offering guidance on the design, development and commercialization of structural biologics (i.e., allografts, xenografts and other engineered tissues) in global markets. We are uniquely positioned to help clients achieve their commercial objectives based on our knowledge of markets, products, regulatory requirements and relationships with key thought-leaders.
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Member Board Of DirectorsAxonia Medical Inc. Sep 2014 - Sep 2016Axonia Medical is pioneering a revolutionary and proprietary approach to repair and restore damaged peripheral or central nervous systems using tissue-engineered nerve grafts (TENGs). By recapitulating the anatomy of the nervous system, TENGs are expected to bridge lost nervous tissue and jump-start regenerative mechanisms to achieve levels of functional recovery not possible with current technologies. As a result, TENGs may not only change the way nervous system injuries are treated, but also clinical expectations for restoration or recovery of sensory, motor and/or cognitive deficits.
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Vice President Of Research & DevelopmentSynovs Life Technologies, Inc. (Baxter International) Dec 2008 - Oct 2012Deerfield, Illinois, UsResponsible for Research and Development in support of the company’s Surgical, Microsurgical, Orthopedic and Wound Care businesses. Managed the company’s IP portfolio, developed a scientific foundation for the clinical use of the Company’s products, managed the planning and execution of the Company’s product development pipeline leading to timely commercialization of innovative products across Synovis business units.- Created integrated Life Science/Engineering/Process & Product Management organization clearly aligned on product development and with the skill-sets necessary to be successful.- Developed and launched products such as Veritas(R) Collagen matrix, Peri-Strips Dry(R) with Veritas(R); Circular PSD with Veritas(R) and the Flow COUPLER(R) that have generated more than $140M in revenue for Synovis Life Technologies, Inc. and constitutes a large part of the companies current product offerings.- Key member of an executive Management team that traveled to Beijing, China and successfully sought licensure of Neurotube(R) peripheral nerve conduit with an SFDA review panel. The Neurotube(R) is the first peripheral nerve conduit approved for sale in China.- Inventor on a number of key patents in the Synovis Portfolio (see patents listed below).- Member of the Synovis/Baxter Due Diligence team pre-acquisition and a member of the Baxter Integration Core Team post-acquisition (February 2012 - October 2012). -
Director - The Research & Technology CenterBoston Scientific Corporation Nov 2007 - Nov 2008Marlborough, Ma, UsP&L responsibility for a staff of 35 including scientist, veterinarians and technicians in BSC’s State-of-the-art GLP preclinical research facility with an annual operating budget of $5M US. with direct-line reporting to the VP of Preclinical Sciences within the Clinical Department of Boston Scientific and the VP of New Technology within the R&D organization of Guidant post-acquisition- Managed all aspects of operations of this 50,000 square-foot facility in the northern suburbs of St. Paul- Expanded services to include the global BSC businesses including Cardiovascular, Neurovascular and neuromodulation businesses in addition to the facilities core support for cardiac rhythm management division- Integrated anatomic/microscopic pathology into on-site services to facilitate model and study development and execution- Established veterinary interventional cardiology core on-site to improve the efficiency, standardization and quality of preclinical Drug-eluting Stent studies carried out internally in support of regulatory submissions- Resigned position to return to Synovis as VP of Research & Development -
Director - Preclinical Sciences (Ic/Pi/Vs)Boston Scientific Corporation May 2006 - Nov 2007Marlborough, Ma, UsResponsible for developing and implementing preclinical research strategy in support of worldwide product approvals for the BSC Interventional Cardiology, Peripheral Interventions and Vascular Surgery businesses. Led the execution of multiple preclinical programs, and collaborated with a variety of internal and external stakeholders to accomplish business goals. Facilitated the establishment of systems to ensure compliance with governmental regulations related to preclinical research in support of domestic and international regulatory submission.- Provided effective local leadership to a preclinical team of ~20 scientists in Maple Grove while reporting to VP of Preclinical Sciences in Natick, MA.- Member of the Peripheral Interventions Management Team - ensuring functional alignment with business unit objectives.- Developed successful strategy to address issues related to stent fracture with regulatory agencies - effectively reducing the testing/reporting requirements associated with post-market surveillance. - Successfully supported regulatory submissions of DES platforms in the US, Canada, Europe and Japan.- Left position to gain Operations experience as Director of preclinical facility with direct P&L responsibility.
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Strategic Advisor - Design/Manufacturing/Regulatory & Clinical StrategyWound Care Technologies, Inc. (Synovis Mca/Baxter International) 2006 - 2007Served as a strategic adviser to the CEO and VP of Regulatory/Clinical Affairs on product design/manufacturing as well as regulatory and clinical trial strategy in preparation for the US launch of DermaClose - a Continuous External Tissue Expander. The Company was acquired by Synovis MCA in 2017 and is now a part of Baxter International.
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Strategic AdvisorMedtech Development, Inc. Sep 2005 - Apr 2006Served as an advisor on a MedTech start-up with novel technology to treat asthma and CPOD. Subject matter expert on physiology of sympathetic/neurosympathetic control of pulmonary resistance and preclinical model selection, study design, data analysis. Participant in VC fundraising effort.
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Vice President - Research & DevelopmentQueststar Medical, Inc. Jan 2005 - Apr 2006Management of Research & Development/Product Development of start-up company’s pipeline of point-of-care and home-based diagnostics. - Completed development of a low-cost, reliable blood glucose monitoring system (BGMS) for the international markets, a second generation BGMS which offers significantly reduced sample volume (1 μL) and test time (5 sec) while offering a very competitive cost per test strip that was abandoned for business reasons during clinical testing.- Demonstrated Feasibility of a revolutionary optical fiber-based BGMS in collaboration with NASA with sub-milliliter blood volumes, very rapid test times (< 2 sec) and test strip costs that were to be well below those of available devices. The core optical fiber technology was also being used to develop POC diagnostics for cardiac care (i.e., early markers of platelet activation such as p-selectin, sCD40L).- Resigned position and day-to-day responsibilities to company but retained equity in spin-off of the NASA-based technology (LightPointe Medical).
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Director - Research & DevelopmentSynovis Life Technologies, Inc. Jan 2003 - Dec 2004St Paul, Mn, UsResponsible for managing the R&D pipeline in the company's Surgical Products Division. - Developed and implemented the company's "Stage-gate" style technology/product development process- Co-inventor on several key patents in the company's portfolio -
Principal ScientistSynovis Life Technologies, Inc. Jan 2001 - Dec 2002St Paul, Mn, UsSynovis Surgical is where I made the transition from academic scientist to corporate scientist. The Company - then called Biovascular, Inc. - was a consulting client and I was very interested in the technology they were developing, i.e., a remodelable tissue implant material called Veritas, When offered an opportunity to help rebuild the R&D department and find new applications for this novel material, I seized it. The outcome was good for the company and for me.
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Scientific Advisory Board MemberComedicus, Inc. 1999 - 2004Served as a member of the Scientific Advisory Board for this Medical Device Start-up focusing on Intrapericardial Therapeutics and Diagnostics. Key technologies being developed were the Perducer intrapericardial access catheter and a family of compounds licensed from the National Cancer Institute (Dr. Larry Keefer) called the "NONOates". Among my most interesting scientific and business collaborations...promising compounds still searching for the right application!
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Assistant ProfessorUniversity Of Minnesota Sep 1993 - Dec 2000Minneapolis And St. Paul, Minnesota, UsI held faculty appointments in Laboratory Medicine and Pathology, Biomedical Engineering and DentistryI was a founding member of the Biomedical Engineering Center, Biomedical Engineering Institute, and the Department of Biomedical Engineering.I developed and taught "Biology for Biomedical Engineers" (1998 - 2000) and "Pathobiology of Medical Devices" (1999 - 2000).My research focused on cardiovascular disease and vascular pathology with emphasis on the role of vascular endothelial and smooth muscle cells in vascular injury and repair, restenosis. The practical aspects of my work focused on the development of bioactive coatings for vascular implants, drug-eluting polymers (e.g., drug-eluting stents) and engineered vascular tissues. -
Associate Director - External Relations In The Biomedical Engineering Institute (Bmei)University Of Minnesota 1998 - 2000Minneapolis And St. Paul, Minnesota, UsServed as Associate Director of External Relations for the Biomedical Engineering Institute and played a key role along with my colleague, Dr. Art Erdman, in the Institute's successful Endowment campaign which raised more than $8M. A tremendously enriching experience that taught me much about the Medical Device industry, its leaders and their perception of the relationship between academic and industry research.These lessons continue to inform my work every day! Read about this effort at: http://www.it.umn.edu/news/inventing/1998_Spring/bio_bmei.html
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Microfabrication Faculty Advisory CommitteeUniversity Of Minnesota 1998 - 2000Minneapolis And St. Paul, Minnesota, UsAs a member of the faculty in the Biomedical Engineering Institute, I was involved in research focusing on the characterization of materials used in BioMEMS devices. As an extension of this work, I was a member of this committee. The Microfabrication Center is now the Nanofabrication Center and continues to be a focal-point for cutting edge research in this important field.
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Founder And Director Of The Blood & Biocompatibility Research Laboratory (Bbrl)University Of Minnesota 1996 - 2000Minneapolis And St. Paul, Minnesota, UsWhile a member of the faculty in the Biomedical Engineering Program at the University of Minnesota, I founded the BBRL with my colleague, Dr. Gundu Rao and served as its first Director, a contract research laboratory offering services in biocompatibility and hemocompatibility testing to the medical device industry. Partnered with both large and small medical device companies in support of their R&D efforts. I am very proud of the work we did to help companies achieve their R&D objectives while mainaining a facility where students & Faculty could carry out cutting-edge research using methods/instrumentation not widely available at the U of MN.
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Co-Founder & PartnerKnowledge Frontiers, Llc 1997 - 1999I and my long-time friend, Dr. Bruce Lester founded Knowledge Frontiers as a consulting partnership with our colleagues Dr. Gundu Rao (Internationally known Platelet biochemist) and Bill Hoffman (Biotechnology author and creator of MBBNET.COM). With complimentary expertise in a wide range of Biotech and medical device-related fields, our emphasis was on "Scientific Due Diligence" to support investment, acquisition of technologies and businesses.
Daniel L. (Dan) Mooradian, Ph.D. Skills
Medical Devices
Biotechnology
Biomedical Engineering
R&d
Product Development
Commercialization
Lifesciences
Cross Functional Team Leadership
Life Sciences
Strategic Planning
Clinical Trials
Fda
Start Ups
Clinical Development
Glp
Technology Transfer
Strategy
Clinical Research
Medical Research
Tissue Engineering
Management
Leadership
Hardware Diagnostics
Surgery
Intellectual Property
Technology Evaluation
Healthcare
Regulatory Submissions
Vascular
Design Control
Product Management
Product Launch
Statistics
Due Diligence
Quality System
Validation
Technology Assessment
Cardiology
Iso 13485
Design Of Experiments
Regulatory Affairs
V&v
Capa
Patents
Higher Education
Gmp
Mergers And Acquisitions
Drug Delivery
Innovation Management
Kol Development
Daniel L. (Dan) Mooradian, Ph.D. Education Details
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Wayne State UniversityExperimental Pathology -
University Of MinnesotaVascular Pathology
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University Of Michigan-DearbornBiological Sciences
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Daniel L. (Dan) Mooradian, Ph.D. works for University Of Minnesota - Carlson School Of Management
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Daniel L. (Dan) Mooradian, Ph.D.'s current role is Senior Lecturer - Medical Industry MBA (MIMBA) Program (Shanghai, China).
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Daniel L. (Dan) Mooradian, Ph.D. attended Wayne State University, University Of Minnesota, University Of Michigan-Dearborn.
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Daniel L. (Dan) Mooradian, Ph.D. has skills like Medical Devices, Biotechnology, Biomedical Engineering, R&d, Product Development, Commercialization, Lifesciences, Cross Functional Team Leadership, Life Sciences, Strategic Planning, Clinical Trials, Fda.
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