SharpMed is an inventor’s dream; an end-to-end medical product design and development company partnering with inventors to drive innovation from the inside out.
An Idea Without Action Is a Lost Opportunity
Mission
To be the medical device industry’s most trusted, widely recognized, ‘go-to’ design and development company for medical device inventors and strategics, looking to improve patient care through clinically superior, financially sound, ‘wickedly cool’ ideas.
SharpMed
Leadership Team
Chris Salvino, MD, FACS
President & CEO
Dr. Salvino is a trauma and critical care surgeon with thirty years of experience in medicine. In addition to having a strong, hands-on clinical background, Dr. Salvino is an accomplished inventor with a degree in Mechanical Engineering. Early on, he recognized a need for improvements in the medical device development process; improvements that would benefit both patients and clinicians.
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Dr. Salvino completed his Bachelor of Science in Biology at the University of Notre Dame and his Doctor of Medicine at Loyola Medical School. Dr. Salvino also holds Master’s degrees in Aerospace Medicine from Wright State University, Flight Test Engineering from the National Test Pilot School, Planetary Geology from Arizona State University, Engineering Mining from the University of Arizona, and Space Studies from the University of North Dakota.
Manny Montoya
Chief Strategy Officer
Manny Montoya has a proven track record of achievement in his twenty-two years working within the medical device industry. Previously, he has served in executive leadership roles at Aquyre Biosciences, Z-Medica, Mauna Kea Technologies, EndoGastric Solutions, Intuitive Surgical, and Ethicon Endo-Surgery – a Johnson & Johnson company.
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Mr. Montoya holds a Bachelor of Arts degree from the University of Arizona. He also has completed the Program on Negotiation at Harvard Law School and has earned a Certificate In Business Excellence (CIBE) from Columbia Business School. Mr. Montoya is also an Associate Member of the American Bar Association, Public Contract Law Section.
Ken Andresen
Chief Financial Officer
Ken spent 14 years with KRD Trucking, an industry leader in providing loading and transportation services for collection companies in the Waste Industry. During his tenure, Ken was influential in the company’s growth from $40 to $117 million in revenue, 680 employees and a 14-state operating footprint primarily throughout the Midwest and Southeast Regions of the United States.
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For 8 years, Ken served as the President, Treasurer and a Board of Director for KRD Trucking predominantly focused internally on overseeing the Financial, Operational, Mechanical, and Safety pillars of the company and externally on customer relations including negotiating and executing multi-year master service agreements.
Prior to becoming President, Ken served as the Chief Financial Officer of KRD Trucking. For 6 years, Ken accounted for 6 entities, created divisional budgets, built an information technology data management and KPI platform, managed a large deductible insurance program, closed a $36.6 million bank deal and successfully brought on a private equity partner through a $60 million recapitalization of the company.
Ken began his career in public accounting with KPMG in Chicago, IL after graduating with Bachelor of Science Degrees in Accountancy and Finance from The University of Illinois at Urbana-Champaign.
SHARPMED
Departmental Teams
Engineering/Manufacturing
SharpMed’s best-in-class biomedical engineering team are experts in medical device design and development, with capabilities that include: product conceptualization, analysis, verification testing, and design for manufacturability.
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With extensive experience in mechanical/biomedical engineering and project management, the team specializes in early-stage product development using analysis and advanced simulation to bring an idea to life. Equally important, we utilize an iterative, rapid prototyping process and market-ready manufacturing to respond quickly and efficiently to changing product requirements. Engineering is dedicated to delivering the best overall vision for a product and to ensuring a smooth transition to manufacturing through equipment validation and verification testing.
Regulatory/Quality
The SharpMed Regulatory and Quality team is responsible for operation and maintenance of the quality management system built specifically to encompass design, development, manufacturing, distribution, and marketing of novel medical devices.
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The Regulatory team evaluates new products for regulatory and quality compliance, researches new product regulatory strategies for worldwide markets, develops new product design and manufacturing requirements, and submits regulatory applications, such as Q-subs, 510(k)s, de novo applications, PMAs, CE marking technical documentation, and mediates all interactions with auditors, notified bodies, and regulatory authorities. SharpMed can do all this for you and more.
Legal
SharpMed’s Legal has a combined 40 years of experience with intellectual property law spanning procurement, licensing, representation, and enforcement. With advanced knowledge of the patent and trademark processes, this group is driven to develop sound IP strategies and protections that align with business goals.
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Their professional backgrounds include Founding an advanced R&D head/media group, publishing peer-reviewed technical papers in engineering, starting and managing an international product transfer failure analysis team, and a decade of manufacturing and process engineering expertise. This diverse and extensive legal and technical framework translates to effective leadership and quality-driven, results-oriented IP analyses and solutions.
We are an ISO Certified Medical Device Design, Development, and Manufacturer
SharpMed has the people, equipment, and technology needed to produce high-quality medical devices. In addition to ensuring the proper practices and standards within our organization, we have taken the steps necessary to become ISO 13485 certified. This is the main Quality Management System (QMS) standard in the United States and most of the world and ensures the consistent design, development, production/manufacturing, distribution, and marketing of medical devices so they are safe for their intended purpose. Moreover, it puts SharpMed in the best possible position to help address a wide range of innovative product ideas.
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Contact Us
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14350 North Frank Lloyd Wright Blvd.
Scottsdale, AZ 85260
+1 630.232.8002
ideas@sharpmed.com