Gold Sponsors

B. Braun Medical OEM

Donatelle

Eurofins

Eurofins

Providien

Steri-Tek

Supporting Organizations

Biocom

CLSA

MDMA

Octane

San Diego Regional EDC

Media Sponsors

Med Tech Directory

RTC Media

Silver Sponsors

5th Axis

AGR

Cadence

Cyient

EG Gilero

Eldon James

Forefront Medical

IQMS

Judson Smith

KP

MedBio

Medmarc

Parmatech

Micro Mold

MW Industries

PlasticsOne

Plastikos

Pryor Products

Qosina

Seisa

Sigmatron

Spectrum Plastics Group

Surgical Technologies, Inc./McLean Medical and Scientific, Inc

Tegra Medical

Trademark Plastics

WYTECH

Bronze Sponsors

Bihlermed

Bonifacio Consulting Service

Covington Associates

MedWorld Advisors

MICRO

PMCF

Teleflex Medical OEM

Linda Braddon

Linda Braddon, Ph.D., President, Secure BioMed Evaluations
Linda Braddon, Ph.D., works with both emerging and established companies to prove regulatory, quality, and technical support to both the medical device and biologics industry. Dr. Braddon holds a bachelor of science in engineering from Mercer University, School of Engineering along with a master of science and a Ph.D. in mechanical engineering with a specialization in bioengineering from Georgia Institute of Technology. She has served as a National Science Foundation fellow at both Duke University and Georgia Tech and won the 2009 Women in Technology Small Company “Woman of the Year” award. Additionally, Dr. Braddon is on several industry specific boards to keep abreast of changing currents. Dr. Braddon founded Secure BioMed Evaluations to provide strategic support to the medical device community.

Bryan Brosseau

Bryan Brosseau, Regulatory, Quality, & Technical Support, Secure BioMed Evaluations
Bryan Brosseau’s experience has been forged in over 15 years in the medical device and biologics industries under challenging circumstances and tight deadlines. With a varied and in-depth knowledge of quality and regulatory requirements, he has helped secure numerous domestic and international regulatory approvals for medical devices and biologics. Brosseau’s creative solutions have been effective in resolving FDA 483s and warning letters, addressing compliance and operations challenges, creating compliant and convincing technical marketing material, and getting medical devices and biologics to market quickly. He received his Bachelor’s Degree in Biology from the University of Georgia and maintains a Regulatory Affairs Certification (U.S.) from the Regulatory Affairs Professionals Society. Prior to joining SBME in 2015, Brosseau served in various operations, quality, and regulatory roles at several medical device and biologics companies.

Scott Covert

Scott Covert, Full Time Instructor/Journeyman Precision Grinder, Penn United Technologies
Scott Covert started his manufacturing career in 1979, building rail cars at Pullman Standard. He spent most of his time there on the “re-work” line repairing problems that occurred on the assembly line, such as welding and riveting errors. After the plant closed, Covert continued his manufacturing career building oil drill pipe at Spang and Company. During his time at Spang, he gained experience with NC lathes, heat treating, hardness testing, and copper plating. In 1984, Covert was offered an apprenticeship in precision tool grinding at Oberg Manufacturing. In 1990, two years after receiving his journeyman’s papers, Covert joined his current employer, Penn United Technologies Inc. At Penn United, he continued his career in tool and die, first as a journeyman contour and surface grinder, and later as a team leader in the grinding department. Soon after, he became a part-time instructor to support Penn United’s apprentice program. He later moved to teaching full time and is now in his current position as training coordinator for the Learning Institute for the Growth of High Technology. In addition to his manufacturing experience, Covert continued his formal education, earning a four-year journeyman’s’ certificate from the State of Pennsylvania and an Associate’s Degree in Computer-Aided Machining from Butler County Community College. His certifications also include machine tool programming, machine tool technology, and CNC programming technology. Having been an apprentice, a journeyman, a supervisor, a student, and a teacher, Covert uses his unique viewpoint to develop comprehensive programs and curriculum to support Penn United’s employees, customers, and the larger manufacturing community. Covert is passionate about his own learning, and training and teaching the next generation of precision manufacturing workers.

George Diamantoni

George Diamantoni, CEO, Manager, and Chairman of the Board, Hip Innovation Technology
George Diamantoni is the chief executive officer, manager, and chairman of the board at Hip Innovation Technology LLC. He is also the founder and chief executive officer of Joint Innovation Technology LLC, which is the holder of the majority of the Class A Membership Interests of the Company for which he provides executive leadership. Diamantoni has over 25 years of professional experience in the healthcare industry, including 20 years with The Upjohn Company, Pharmacia Corporation, Pfizer Inc., and Schering Plough Corporation, multinational pharmaceutical corporations, and five years with Allos Therapeutics Inc., an oncology company; and Bone Care International Inc., a specialty pharmaceutical company. Diamantoni has previously served as a consulting partner for Direkt Finance, a privately held international investment firm. In this position, he established and led a healthcare-focused investment division. He has held the offices of vice president for government affairs, strategic alliances, reimbursement and managed accounts, customer marketing, and sales with his previous employers. He obtained his Bachelor of Arts in Biology and Chemistry from Kalamazoo College in Kalamazoo, Michigan.

Bill Ellerkamp

Bill Ellerkamp, Operating Partner, Inverness Graham Investments
Bill Ellerkamp is a medical device industry executive and strategic advisor. He has more than 35 years operating experience, primarily in medtech contract manufacturing. He currently serves on several boards and consults with private equity firms, corporations, and independent business owners on strategy, market assessment, business development, operational planning, buy- and sell-side planning, and due diligence.

Bryan Hughes

Bryan Hughes, Director, P&M Corporate Finance
Bryan Hughes is a director of PMCF and leads the firm’s medical technology team. His practice focuses on assisting clients with mergers and acquisitions, leveraged buyouts, private placements, financings, valuation and strategic consulting. His clients have ranged from global medical technology companies to small, privately held businesses.

Jessica Lenhardt

Jessica Lenhardt, Sr. Director, Teleflex Medical OEM
Jessica Lenhardt is the senior director of Teleflex Medical OEM and a member of the Teleflex Incorporated global executive team. Since joining Teleflex Medical OEM in 2005, she has helped the company become a global leader for custom-engineered extrusions, interventional and diagnostic catheters, balloons and balloon catheters, and performance fibers. She has played a significant role in the development of innovative, medical product development capabilities, ensuring Teleflex Medical OEM maintains its leadership position in an ever-changing, increasing demanding medical marketplace. Lenhardt has more than 20 years of management and product development experience, including 12 years at Teleflex Medical OEM, as well as similar positions at Cardinal Health, Leica Microsystems, and Cole-Palmer. In addition, she is known through the OEM industry for her expertise in extrusion technologies and applications. Lenhardt holds a Bachelor’s Degree in Molecular Biology and Chemistry from Knox College, and a Master’s in Business Administration from Keller Graduate School of Business.

Patrick Lynch

Patrick Lynch, Supply Chain Director, Sonendo
Patrick Lynch brings 25 years of progressive device experience into this conference, performing in key roles during transition phases at companies such as Abbott Labs, Guidant, Illumina, and other medical device powerhouses. His experience spans NPI, sourcing strategies, supplier development, supplier quality, outsource management, contract manufacturing, project management, purchasing, supplier relationship management, and supply chain. Lynch views his outsource partners as an extension of his own operation and has developed innovative methods to develop, lead, and monitor outsource activity. He earned a bachelor’s degree in Materials and Logistics Management from Michigan State University. Along his journey, he has maintained certifications in Lean, Purchasing, Quality Auditing, Production Control, and Supply Chain, and was an instructor for APICS for several years. Through these efforts, he has helped companies proactively manage risk, and is the author of various published articles on that topic, through APICS, AME, and the ISM.

Nnamdi Njoku

Nnamdi Njoku, Senior Business Director, Pelvic Health Minimally Invasive Therapies, Medtronic
Nnamdi Njoku is the senior business director for Pelvic Health’s Minimally Invasive Therapies at Medtronic. In this role, he provides oversight and operational leadership for Minimally Invasive Therapies within the Pelvic Health & Gastric Therapies Division. Prior to his current role, Njoku held positions across various Medtronic Business Units and Corporate. Before joining Medtronic, he worked at Cigna Healthcare in a national accounts role, and UnitedHealth Group in a corporate planning role. Njoku began his career as a business analyst at Deloitte Consulting. He holds a Bachelor of Arts, Summa Cum Laude, from the University of St. Thomas and an MBA from Cornell University.

Chris Oleksy

Chris Oleksy, Founder and CEO, Oleksy Enterprises and Next Life Medical; CEO, Emergent Respiratory
Christopher Oleksy is co-founder and CEO of Next Life Medical, a firm co-founded with his son Ryan Oleksy in 2011. He is also currently CEO of Emergent Respiratory, an emergency CPAP company Next Life Medical acquired in July, 2016. Previously, Oleksy was president of Integra Biotechnical, now Providien Medical, as well as president of ATEK Medical (acquired by Vention Medical in 2011). Prior to ATEK, he held several executive supply chain management positions within Medtronic Inc. and Dow Corning Corporation. Oleksy is known as a supply chain pioneer and thought leader who has developed, authored, presented, and successfully implemented customer-focused value chain thinking for over 30 years. He was one of the founding authors of the global, industry ANSI standard, Supply Chain Operations Reference (SCOR) Model facilitated by PRTM and AMR; developed the proprietary OE-Tier5 models to help organizations align their business models across the supply/value/care chain; and regularly writes for Medical Product Outsourcing, for which he also serves on the Editorial Advisory Board.

Paul Orlando

Paul Orlando, Vice President of External Operations, Olympus Surgical Technologies America
Paul Orlando is a Boston, Mass., native who has over 32 years of manufacturing, operations, and engineering experience—27 of which have been specifically in the medical device industry. He has held various operations, plant, engineering, business unit, and product development leadership positions with Motorola, Johnson & Johnson, Vention Medical, and currently with Olympus Surgical Technologies of America. Over his career, Orlando has been exposed to and worked with world class manufacturing and new product development methodologies. He has an in-depth knowledge of medical device manufacturing from an OEM and supplier perspective. His work history has allowed him to build a deep and diverse professional network across the medical device industry and has a respected reputation as a valuable employee, leader, colleague, and partner.

Alex Porion

Alex Porion, Global Sourcing Senior Manager, Boston Scientific Corporation
Alex Porion is a senior global sourcing manager at Boston Scientific Corporation. He has over 17 years of experience in the medical device industry. After gaining a Master’s degree in Material and Polymer Science at the international Ecole d’ingenieur of Strasbourg in France, Porion worked at various medical device multinationals in Ireland. His experience spans across process engineering, project management, insourcing, outsourcing, plant network optimization, acquisition integration, new product launches, change management, and global sourcing. He spent a significant time working for Millipore (now Merck Medical) and Depuy, a Johnson & Johnson company, in addition to over 10 years at Boston Scientific. After supporting the change management of the sourcing organization at Boston Scientific from a local procurement to a global center led organization, Porion recently led the overhaul of the Make vs. Buy process at Boston Scientific for the Global Sourcing organization.

William Pratt

William Pratt, VP Operations and Director of Creative Design, Kinamed Inc.
William Pratt has worked in the medical device industry for over thirty years in a variety of manufacturing, operations, and design roles. He holds several U.S. and international patents related to surgical implants and instruments, many of which have been successfully commercialized. His design activities range from direct product development and collaboration, to manufacturing process and equipment development. Pratt’s board memberships include the Southern California Biomedical Council and Ventura County Workforce Development Board. He advises biotechnology programs at Ventura and Moorpark Colleges, and he is an industry advisor to the Community College Consortium for Bioscience Credentials and the Bioengineering Department of UC Riverside.

Bryce Rutter

Bryce G. Rutter Ph.D., Founder & CEO, Metaphase Design Group Inc.
Dr. Bryce Rutter is the founder and CEO of Metaphase Design Group Inc., a company that specializes in the research and ergonomic design of hand-intensive products for national and international consumer and business clients. He is a specialist in innovation and business strategy, as well as the integration of research, ergonomics, and design into new product development. Dr. Rutter is a member of the Human Factors & Ergonomics Society, the Design Management Institute, and IDSA. He serves on the Industrial Design Advisory Panel of the University of Illinois at Champaign-Urbana and the Advisory Council of the Design Management Institute. Dr. Rutter has served as an invited juror for international design award programs including the Consumer Electronics Show Awards, the Industrial Design Excellence ID Magazine, and Medical Design Excellence Awards. He received a BID (Bachelor of Industrial Design) from Carleton University, Ottawa, Canada, an MFA in Industrial Design, and a Ph.D. in Kinesiology from the University of Illinois at Urbana-Champaign. Founded in 1991 and based in St. Louis, Dr. Rutter’s company, Metaphase, has partnered with numerous global brands to drive innovation and create powerful brand experiences, receiving more than 75 international awards, with two designs selected by the Museum of Modern Art, and operating with more than 125 design patents.

David Sheppard

David Sheppard, Chief Operating Officer and Principal, MedWorld Advisors
David Sheppard has been a leader in the medical device industry for more than 30 years, with experience in positions such as GM and VP, as well as high impact sales and marketing leadership roles at major 500 corporations (Covidien, Bard, Cooper, and Ciba). His achievements also involve work at start-up organizations (including working pre-IPO on a successful IPO company). Sheppard has become an expert in delivering Organic Growth for companies of all sizes in global environments. He has also successfully obtained EBIT growth thru successful M&A activities. At MedWorld Advisors, Sheppard works with clients focused on growth, international channel development, and getting companies on the market. He collaborates as he leads the strategic development of client organizations and creates tactical execution plans that help exceed organizational objectives for short and long term growth.

John Somers

John F. Somers, President & CEO, Harmac Medical Products
John F. Somers is the president and CEO of Harmac Medical Products Inc., a contract engineering and manufacturing company of single-use medical devices that has served the global marketplace for more than 35 years. The privately held company, with headquarters in Buffalo, NY, provides innovative technical solutions and manufacturing services for companies of all sizes including leading Fortune 500 medtech companies. Somers, along with his executive team, have overseen the company’s growth including the addition of manufacturing locations in Ireland and Mexico to complement its U.S. operations. Today, Harmac has over 1,000 employees and has received numerous awards for operations excellence, sustainability, and community investment. Prior to his involvement with Harmac Medical Products, Somers lived in Boston for 10 years working in the technology industry with Computervision Corporation and Unitrode Corporation. He is a board member of Advamed Accel, Buffalo Renaissance Group, The Community Foundation for Greater Buffalo, and the Buffalo Urban League. Somers has a BA from Williams College, an MBA from Boston University, and is a graduate of the President’s Program in Leadership at Harvard Business School.

Tom Taylor

Randall Sword, Principal, RidgeRunner Advisors
Randall is a medical device executive with a 25-year track record of growing businesses, turning around poor performing organizations, and integrating acquisitions. He recently served as CEO of AdvancedCath, a private equity (Inverness Graham)-owned platform company that Sword built and sold to TE Connectivity in 2015. During his tenure, AdvancedCath grew rapidly, added two strategic acquisitions, and opened a manufacturing facility in Costa Rica. Post acquisition, Sword worked with TE Strategy and M&A, helping to refine their future acquisition strategy and advising TE on the successful acquisition of Creganna Medical. Previous positions included global sales for Creganna Medical, senior director of engineering services for MedSource Technologies, and director at Arthur D. Little. Currently, he is advising private equity firms executing transactions in medical device contract manufacturing and defining growth strategies for their portfolio companies.

Tom Taylor

Thomas F. Taylor, President & CEO, Foxx Life Sciences
Thomas Taylor is the president and CEO of Foxx Life Sciences, a privately owned manufacturer of laboratory, medical, biotech, and pharmaceutical products located 32 miles north of Boston in Salem, N.H. He has over 27 years of experience in plastics engineering and the medical device industry. Taylor co-founded the company in 2006 and formed a JV in 2008 with Roush Enterprises. In 2013, Taylor purchased 100 percent of Roush Life Sciences and renamed it Foxx Life Sciences. Prior to Foxx Life Sciences, Taylor was president of Nypro Life Sciences, a division of Nypro Inc.—a billion-dollar global manufacturer of custom plastic products. He also held several other senior management positions including vice president of global marketing and business development for Nypro’s $400M healthcare market segment, president of Nypro Medical Products Group, and vice president of business development.

Brian Weller

Brian Weller RAC, Partner, Business Value Group Intl.
Brian Weller is a quality and risk management expert who leads the Management Systems and Compliance practice at BVG. Much of his 30-year career has been dedicated to developing and implementing business strategies for EMS and contract design organizations focused in healthcare. He led a global process development team at Flextronics that supported the creation of a medical division within the organization. He also led a similar effort at Nypro Healthcare, implementing an operational model that integrated design and manufacturing services for drug delivery products. Weller has a Bachelor of Science degree in Electrical Engineering from San Diego State University and is Regulatory Affairs Certified by the Regulatory Affairs Professional Society (RAPS). He also serves as an expert advisor to the Advanced Studies Program in Medical Device Engineering at UC San Diego.

Brian Weller

Michael White, CTO, Fusion Biotec
Michael White is a product development executive with twenty-three years of product development and engineering experience, mainly in medical devices. Early in his career, he worked for General Motors designing and developing engines and electric vehicles. In 2000, he received the GM Fellowship to attend MIT Sloan. While studying business at Sloan, he developed a passion for medical technology, and founded Cambridge Medical Devices LLC, to develop and patent an orthopedic surgical navigation system. More recently, as director of product development at Beckman Coulter, he recruited and led a team of fifty engineers responsible for development of IVD instruments and reagents, life sciences instruments, electronics, and mechanical components and subassemblies. That team’s value engineering effort saved Beckman Coulter over $250 million. More recently, White has consulted on FDA design control compliance and DHF remediation for 510(k) and PMA instruments.

Christopher M. Yakacki

Christopher M. Yakacki, Ph.D., Associate Professor, The University of Colorado Denver
Dr. Christopher M. Yakacki received his BS, MS, and Ph.D. from the Department of Mechanical Engineering at the University of Colorado Boulder in 2004, 2004, and 2007, respectively. After graduating, he served as principal scientist for MedShape Inc. in Atlanta, Ga., a biomedical device company he helped co-found. He was awarded over $1 million in Small Business Innovation Research (SBIR) grants at MedShape, and helped clear the first shape-memory polymer biomedical devices through the United States Food and Drug Administration (FDA). Dr. Yakacki became an assistant professor in the Department of Mechanical Engineering at the University of Colorado Denver (CU Denver) in 2012. Since joining the department, he has been awarded an NSF CAREER award, NSF I-CORPS award, an NIH/NIAMS R21 award, and a State of Colorado Bioscience Discovery Evaluation Grant (BDEG), and Army Research Office award. Dr. Yakacki has published 39 peer-reviewed publications, 3 book chapters, and has been awarded over $1 million in research grants at CU Denver. Dr. Yakacki recently founded another university-based startup, Impressio Inc., to develop energy dissipating materials and medical devices and continually seeks to build relationships between academia and the biomedical industry.