Officers & Committee Chairs
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Officers |
President: Ed Berger
eberger@meddevgroup.org |
Ed Berger has been an active member of MDG for four years and currently serves as Vice President. He has taken a leadership role on association governance issues, and has been an active member of the programming committee.
Ed founded Larchmont Strategic Advisors in 2005 to help life sciences companies deal effectively with the challenges and opportunities posed by the coverage and reimbursement requirements of public and private payers and a rapidly evolving healthcare regulatory and policy environment. As a consultant, he has provided reimbursement analysis and strategy development consultation to a variety of clients developing new technologies in fields including neural monitoring and neuro-modulation, gastrointestinal surgery, severe pulmonary dysfunction, clinical laboratory testing, and personalized medicine.
Ed’s total of more than 25 years of experience in the health care industry includes service on the senior management teams of ABIOMED, Inc. (2001-2004), Thermo Cardiosystems, Inc. (2000), Navix Radiology Services, Inc. (1998-99), and Fresenius Medical Care – North America (1983-1997). He earned his Ph.D. in Political Science from Boston University, where he taught and held administrative positions from 1969-1980, and received his B.A. in government from Harvard College in 1966. |
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Vice President: John Wlassich
jwlassich@meddevgroup.com |
This past year, John Wlassich started and led the first SIG (Special Interest Group) within the MDG, the Product Development & Manufacturing Outsourcing SIG. This SIG organized a team charter and formalized a SIG committee structure. The SIG Committee produced a unique event for the MDG, the Business Matchmaking Event 2008, which drew 93 participants. John leads product development with Nomir Medical Technologies. Nomir is commercializing new, noninvasive medical devices to treat bacterial and fungal diseases that are poorly treated today. For 12 years prior to Nomir, John was with the Blade & Razor Division of The Gillette Company. At Gillette he held management positions in Process Equipment Engineering, Program Management, and R&D and led teams across nationalities and geographies. These teams contributed to the launch of the MACH3, M3Power, Activator 360, and Fusion products.
As a manager in R&D, John also led the clinical studies group for a medical device that has been the subject of press releases by Gillette. Prior to joining Gillette, John started a materials equipment company that successfully made parts for millions of Ford vehicles. He has been elected to membership in Phi Kappa Phi, Pi Tau Sigma, and Tau Beta Pi. John graduated with a BS in Mechanical Engineering, Summa Cum Laude, from the University of Rhode Island and he graduated with an MS and PhD from MIT, each in Mechanical Engineering. |
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| Secretary: Dick O'Brien |
Dick O’Brien has been an active member of the MDG organization since 2004. Since that time he has served on the Program Committee as an event Chair and/or event Co-Chair each year for at least one individual forum event. His focus has been to bring scientific and technical trends of interest to MDG members and to reach out to presenters who might not otherwise have come to the Programs. Dick regularly volunteers to support the physical set-up of the Forum, and, occasionally, the networking events, and frequently has attended Board functions when appropriate.
Dick has been involved in the life sciences and medical/biotech markets throughout his professional career primarily in development and management of new product development activities – in-house and out-house. His current position as Director, Business Development, Optimum Technologies, Inc., an optics driven product development company, dovetails nicely with work at MDG. He is also Founder, Nagog Hill Partners, a business development consulting group focused on assisting medical device and other service companies to grow their businesses, and continues to hold membership and Board positions in other medical and venture forum volunteer organizations. |
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Treasurer: Sulo Musyaju
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At-Large Board Members |
Barbara Bix
bbix@meddevgroup.org |
Barbara Bix is the Managing Principal of BB Marketing Plus (www.bbmarketingplus.com)—and has been an active member of MDG almost from its inception. Drawing on her demonstrated strengths in problem articulation, cost-effective marketing research, and market development, Barbara has helped more than 50 local health care and technology companies uncover desirable market opportunities, launch products, and attract profitable business
Key to her success has been identifying the product features and marketing programs required to encourage rapid product adoption by physicians and other clinicians. A seasoned marketing strategist, Barbara earned her stripes at EMC, Motorola, GE, and Wang. She has an MBA from The Wharton School and completed postgraduate work at the Harvard School of Public Health. Barbara has been quoted in the Wall Street Journal and her articles have appeared in Effective Clinical Practices, The Boston Business Journal, Mass High-Tech, Health Care Review, Massachusetts Lawyers Weekly, Women's Business, and online at www.marketingprofs.com and www.raintoday.com. |
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Joyce College
jcollege@meddevgroup.org |
A long time member of MDG, Joyce College served as Secretary from 2005 to 2008. In addition, she has lead MDG’s Strategic Planning efforts and has served on the Program and Marketing Committees. Joyce is currently working as a Clinical Marketing Consultant to medical device companies and is a Partner of Medical Development Partners, LLC, a medical product development and commercialization company.
Joyce has expertise in strategic planning, clinical marketing, program/product management, disease management, quality improvement and development of educational programs. For over 16 years, she was a product/program manager for Fresenius Medical Care North America, the world leader in the manufacture and delivery of dialysis products and services. Prior to Fresenius, Joyce was employed by Boston Medical Center, Massachusetts Osteopathic Hospital as well as by visiting nurse associations serving Nassau County, N.Y. and the South Shore of Massachusetts.
She is active with the Boston Haifa Life Sciences Initiative, an organization to help Israeli companies commercialize their products in the U.S. Joyce presented to a delegation of eight Israeli companies on Market Analysis in October 2006. She is serving on the Life Sciences Committee of the New England Israel Business Council and is a member of Women in Healthcare Management and the American Nephrology Nurses Association. Joyce holds a B.S. with a Major in Nursing and an M.B.A. in Healthcare Management, both from Boston University. |
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Laura Appleton
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Laura Appleton is the principal of LA Consulting. Her practice is focused on data mining, numerical/statistical analysis, determination of market & financial metrics, business case development and short/long term strategic planning.
She has had clients in the medical device, biotechnology, pharmaceutical, information technology, telecommunications, energy and academic/education industries. She has previously held roles as a sales representative (IT medical sales), product marketing manager (multiple IT companies), product manager (IT/telcom companies), analyst (oncology) and research director (in venture capital).
Laura attended BC (BA Economics/Statistics), BU (MBA Marketing/Finance), University of Denver (Masters Telcom), and the University of Colorado Health Sciences (as a PharmD candidate). She is on the Alumni Board for the School of Management at BU. |
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Alan Raider
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Alan is an Account Manager for Intertek's Medical Device and Laboratory testing group, an MDG sponsor. Alan regularly attends MDG networking and educational events, and has taken part in brainstorming to develop session topics for 2011.
As an Account Manager at Intertek since 2008 Alan has worked closely with manufacturers to identify their testing and certification requirements, and facilitates testing programs required for market access.
Intertek is a global leader in testing, inspection and certification services, focusing on providing rapid global market access for manufacturers. Intertek offers a range of analytical research, testing and certification services to support the global pharmaceutical and biotech industries. Intertek shortens the time-to-market for manufacturers of medicines, devices, and related healthcare products.
Before working with Intertek's Medical and Lab clients Alan was Intertek Account Manager supporting clients in the telecommunications and information technology industries.
Prior to joining Intertek, Alan was an Account Manager for Williams Communications Solutions providing telecommunications solutions to corporate clients and was a Trainer for Ring Medical, a provider of healthcare telecommunications and information systems. He holds a bachelor's degree in Speech Communications from Ithaca College. |
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Lisa Sasso
lsasso@meddevgroup.org |
Lisa Sasso has been an active MDG member for the past six years. She is currently serving her second term on the Board of Directors, and most recently served as President for the last two years. Other MDG volunteer positions held include President-Elect and Programs Co-Chair.
Lisa is co-founder and President of Medical Development Partners, LLC (MDP). Lisa’s expertise lies in helping medical “start-ups start up.” She also coaches individuals either interested or working in the medical technology sector helping them to reach their maximum potential. She is particularly skilled in Sales, Marketing and Customer Relations. With a focus on business planning and execution, she brings strategic thinking to the team. Her vision and values have been instrumental in helping international companies successfully market and sell products in the United States.
Prior to MDP, Lisa was the U.S. co-founder and past President/CEO of Radi Medical Systems, Inc., a high tech medical device distributor specializing in innovative cardiology products for an international company. During her six-year tenure, she grew the company from inception to revenues of $28M with profitability. Lisa’s vision and strategic direction were responsible for the company’s explosive annual triple digit growth.
Lisa’s strongest “skill” is her passion. Motivated by excitement for new technologies, Lisa built strong physician advisory boards and a seasoned clinical/sales team motivated by her excitement for new technologies that ultimately helped healthcare professionals make more informed treatment decisions. Lisa was recognized for her efforts and ranked #28 out of 100 Women Led Businesses in Massachusetts in 2004.
Lisa currently serves as a Board Member for SCITENT, a Medical Education Service company and is a Board Member and immediate past President of the Medical Development Group (MDG), a professional organization for educating and networking individuals in the medical device industry. She received both a B.B.A. degree in Marketing as well as a B.A. degree in Economics from the University of Massachusetts at Amherst. While working at USCI (the Cardiology Division of CR Bard), Lisa earned an M.B.A. in Management from Bentley College, Graduate School of Business and graduated with honors. |
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Jerry Shapiro
jshapiro@meddevgroup.org |
Great programs, discounts at other organizations' meetings and medical device company input to the Statehouse are some of what Jerry Shapiro and his colleagues on the committees he links to the MDG Board have brought you this year. In addition to serving on the Program Committee to select the 22 programs scheduled this past year, Jerry and Richard Halpern put together the December program on "Voice of the Customer" that was so well attended. Working with the Alliances Committee chaired by Alan Kivnik, Jerry arranged member discounts for you at several alliance partners' meetings. One year ago, he was asked by the CEO of a biotech company to get involved with the legislature to be sure there was a voice for small medical device companies in Governor Patrick's proposed billion-dollar ten-year Life Sciences Bill. Jerry recruited MDG founder Marty Sklar and MDG Vice-President-elect Ed Berger to work with him and twenty four other life science company CEOs to petition the Governor last July to this effect. Starting last November, a core group including Jerry began meeting with individual legislators in the House and Senate, culminating in the House including over forty million dollars in funding for small life sciences companies in the bill they passed. An active MDG member for six years, Jerry is well known for his efforts to help MDGers new to the industry connect and find jobs.
In the 39 years he has been in the medical device industry, Jerrold M. Shapiro, Ph.D. has been both an intrapreneur within larger organizations and an entrepreneur in small and startup companies. He developed more than a dozen surgical devices, invented and patented four diagnostic devices and specializes in fast-track development of concepts into products. After many years working as a laboratory director, senior scientist, program manager, director of engineering and director of operations for medical device companies and universities, he founded Fem-Medical LLC in 2003 to introduce into the U.S. market an unconventional integrated medical product from Finland called FemiScan, which trains incontinent women to become continent. He has also invented two devices to treat FSD, or female sexual dissatisfaction. |
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Marty Sklar
msklar@meddevgroup.org |
Marty Sklar was the first president of Medical Development Group (“MDG”) and one of its co-founders, doing so in 2001, and currently serves on the MDG Board. He is also a founder and CTO of Medical Development Partners (MDP). In 1992, he founded Automated Medical Instruments, Inc. to develop remote-controlled and automated surgical devices. In 2002, with MDG colleagues, he co-founded AlvaMed, LLC, a Quality and Regulatory consulting company. In 2004, also with MDG colleagues, he co-founded MDP.
Martin has over twenty five years of successful experience in business development, project management, invention, design/development engineering, analysis, quality, regulatory, manufacturing engineering and product introduction of various medical products. He has experience in surgical, image guidance, automated laboratory, implant and other medical devices and systems. These products have been utilized for diagnostic and therapeutic applications in cardiology, orthopedics, neurology, and other key areas.
Earlier commercial experience includes work with Corning Glass Works, Dade Behring, Hewlett Packard, Johnson & Johnson, Millipore Corporation, Orion Research, Visualization Technology, Inc. (now part of GE Medical). More recent work has included development of micro technologies for drug delivery and pain management devices. Martin’s work has led to approximately $800 million in revenues for employers and clients. He continues to search for and develop new business opportunities, product concepts, and intellectual property to satisfy unmet medical needs, which will also provide an optimal ROI. |
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Committee Chairs |
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Alliances
Alan Kivnik, Co-Chair
akivnik@meddevgroup.org |
Alan Kivnik is a serial
entrepreneur in the medical device arena and is currently the President and CEO of Corum
Medical which is developing an instrument for the non-invasive, diagnostic quality, real
time measurement of hemoglobin. |
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Alliances
Lee Jones, Co-Chair
2leej@comcast.net |
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Marketing Coordinator
Judy Isaacson
jisaacson@meddevgroup.org |
Judy Isaacson is the Director of Vital Now!, a medical marketing and event management company. She specializes in medical sales, marketing, communications, investor relations, and public relations and often works with start-up organizations. Judy is also an adjunct faculty member at five Boston-area colleges. Judy holds a Master’s of Science in Communications Management. |
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Membership
Brian Shoemaker
bshoemaker@meddevgroup.org |
Brian Shoemaker consults for FDA-regulated companies on software validation, software quality processes, and electronic records and signatures. He worked in clinical diagnostics for over fifteen years, and as quality assurance manager in clinical trial data management software. He holds a Ph.D. in chemistry from the University of Illinois. |
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Networking
Bob Ezzell
bezzell@meddevgroup.org |
Bob Ezzell is the Director of Project Management and Regulatory Consulting Services at Apelles Partners. Previously he held senior positions at RenaMed Biologics, Argose and Scient, helped co-found Molecular Geodesics (MGI), and served as an Assistant Professor at Harvard Medical School. Bob holds a Ph.D. in Molecular Biology from UC Berkeley, a MBA from Northeastern University, and has Regulatory Affairs Certification from the Regulatory Affairs Professional Society. |
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Operations
David Ennen
dennen@meddevgroup.org |
David Ennen has extensive design and development experience in systems and software for medical devices, imaging, analytical instruments, and robotic-based distributed process control. He has served diverse roles, including program manager, technical lead, software engineer, software architect, systems engineer, and real-time embedded system designer. Currently a Project Director at Foliage Software Systems, David has held engineering management positions with Boston Scientific, Hologic, Physiometrix, Waters, and Advanced NMR. He holds a B.S. in Physics from the University of Cincinnati and an M.S. in Biomedical engineering from the University of Michigan. |
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Programming
Olga Taylor
otaylor@meddevgroup.org |
Olga Taylor is a Vice President of Marketing and Business Development with Quartesian LLC, a clinical stage CRO serving small and mid-size biopharma and device companies. Prior to joining Quartesian, she worked in marketing, sales, finance, and project management roles in consulting, insurance and biotechnology sectors. Olga holds a BS in Mathematics and an MBA from the University of Michigan, Ann Arbor. |
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Sponsorship
David Kaufman
dkaufman@meddevgroup.org |
David Kaufman served Hemetrics Development
Corporation as VP Strategic Alliances & Development and has 25 years experience in
senior level sales, business development, and marketing positions in technology-focused
solutions companies in the medical technology, communications, and information technology
and software industries. |
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Sponsorship
Jeff Sprung, Co-Chair
jeffrey.sprung@yahoo.com |
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Entrepreneurial SIG
Marty Sklar
msklar@meddevgroup.org |
Marty Sklar was the first president of Medical Development Group (“MDG”) and one of its co-founders, doing so in 2001, and currently serves on the MDG Board. He is also a founder and CTO of Medical Development Partners (MDP). In 1992, he founded Automated Medical Instruments, Inc. to develop remote-controlled and automated surgical devices. In 2002, with MDG colleagues, he co-founded AlvaMed, LLC, a Quality and Regulatory consulting company. In 2004, also with MDG colleagues, he co-founded MDP.
Martin has over twenty five years of successful experience in business development, project management, invention, design/development engineering, analysis, quality, regulatory, manufacturing engineering and product introduction of various medical products. He has experience in surgical, image guidance, automated laboratory, implant and other medical devices and systems. These products have been utilized for diagnostic and therapeutic applications in cardiology, orthopedics, neurology, and other key areas.
Earlier commercial experience includes work with Corning Glass Works, Dade Behring, Hewlett Packard, Johnson & Johnson, Millipore Corporation, Orion Research, Visualization Technology, Inc. (now part of GE Medical). More recent work has included development of micro technologies for drug delivery and pain management devices. Martin’s work has led to approximately $800 million in revenues for employers and clients. He continues to search for and develop new business opportunities, product concepts, and intellectual property to satisfy unmet medical needs, which will also provide an optimal ROI. |
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| Marketing & Sales SIG
John Knott, Chair,
johnk@jdtechsales.com |
John Knott is founder / owner of JD Technologies LLC a field sales company that provides premium sales and marketing services to a group of high quality, complementary manufacturers of engineered services and products who serve the industrial, aerospace, military & defense and medical industries. JD Technologies, LLC develops long term relationships with key customers who value the consultative style of selling and who wish to interface with sales professionals of high integrity. Our approach is to use proven consultative selling techniques. Consultative selling is a collaborative process that leads customers/prospects through an analysis of their current situation to a resulting improvement.
John Knott has a Bachelor of Science in Mechanical Engineering from University of Connecticut, a Masters in Mechanical Engineering (with an Electrical Engineering Minor) from Northeastern University and a Masters in Business Administration from Rensselaer Polytechnic Institute. John started his career with GE in Lynn, Massachusetts as a product design engineer and graduated from their rigorous Engineering Career Development Program. This was followed by senior engineering/new product design responsibility with United Technologies Corporation where he transitioned into marketing and sales. With this experience, coupled with an MBA, he achieved assignments of increasing responsibilities with established high tech companies as well as start-ups. He has successfully represented manufacturers by selling products in the northeast region of the United States since 1989.
The common denominator with John's selling experience since 1989 has been "identifying and satisfying customer needs better than the competition can or will do" and selling technical products and/or services resulting in increased revenue and profit.
When John is not selling he enjoys his three labs, hiking, running competitively and triathlons. Of course sharing quality time with his wife now that they are empty nesters is wonderful. |
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| Marketing & Sales SIG
Sharon Herrman, Co-Chair,
shogan1@optonline.net |
Sharon Herrman is a classically trained, senior strategic brand and product marketer with 20 years of experience creating and managing marketing and sales strategies that drove profitability within global consumer product and professional services organizations, from start-ups to Fortune 100 companies, including Xerox Engineering, Playtex, Black & Decker and Georgia-Pacific. She has led technical marketing and sales experts in market research, branding, advertising, consumer and trade promotion, channel development, direct marketing, internet marketing and social media in the execution of marketing plans that accelerated the time to profitability with creativity, insight and market savvy.
Throughout her career, Sharon has been recognized for turning engineering innovation into products, teaming with R&D, engineering and manufacturing to identify and co-create highly unique and value-added customer and consumer solutions – to the extent of establishing new product categories, such as the Black & Decker SnakeLight, which won an Edison Award for innovation.
Other products created and launched into the B2B and B2C markets under Sharon's direction have been cited for innovation and featured in the national press, including CNN, Industrial Design Magazine, USAToday, Advertising Age and Brandweek. In addition, she has been a contributor to a national radio broadcast on the "Culture of Innovation" in companies.
Sharon holds an MBA in marketing from the University of Connecticut, and a BA in History and Russian Studies from Dickinson College, Carlisle, Pa., where she studied extensively in Italy and Russia. Most recently, Sharon pursued her interest in engineering with study in an AS degree program in Architectural Engineering – facilitating her ability to work with engineers on complex products.
Currently Sharon is a District Manager for JD Technologies, LLC, a company that provides premium sales and marketing services to a group of high quality manufacturers of engineered services and products who serve the industrial, aerospace, military and defense, and medical industries. Her responsibilities include working with engineers to find the right suppliers and components to bring innovative products to market. |
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Product Development & Manufacturing Outsourcing SIG
Michael Aprea, Chair
maprea-sdw@cox.net
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Michael Aprea, founder and President of Sakonnet DesignWorks, Inc., is an engineer, entrepreneur, and inventor designing consumer, industrial, accessory and medical products. His company’s success is founded on persistence, resourcefulness, and strategic relationships to solve product design, development, and manufacturing challenges.
Michael has over twenty years of experience in business development, project management, engineering design, development, analysis and manufacturing creating hundreds of innovative products for commercialization. At the Double E Company Michael was Engineering Manager responsible for technology and the engineering group. He was Project Manager at Alden Products working with a medical business team to develop advanced connector systems for the medical community; co-wrote and was awarded an SBIR (Small Business Innovation Research) proposal, and was notably involved with the implanted Left Ventricle Assist Device as an interim device for heart transplants candidates. At Separation Technologies he managed and technically supported cross-functional engineering teams in the design and fabrication of a variety of machines for use in dry based electrolytic separation. At Sippican he was a Project Engineer providing technical research, engineering concepts and SBIR proposal writing to develop new oceanographic environmental sensors.
Michael is an adjunct faculty member at UMASS Dartmouth and Bristol Community College where he enjoys teaching courses in mechanical engineering. |
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Kevin Pelletier, co-Chair
kpelletier@massmaterials.com |
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Software SIG
Tony Raymond
traymond@meddevgroup.org |
Tony Raymond, President and Sr. Consultant; is the founder of New Harbor SQA, LLC that provides consulting and management to help companies verify product design and test software at virtually every stage of the development lifecycle. From analyzing requirements and developing comprehensive test plans to code reviews, testing, compliance audits, and documentation. They cover the full spectrum of medical device product development and help their clients comply with
FDA / EU regulations.
Tony has lead efforts in software and hardware testing, program management, quality assurance, complex system integration, customer satisfaction, supplier management and software development. He holds a BSEE from Worcester Polytechnic Institute and has done post graduate study in business management and executive leadership at WPI, Northeastern University and Babson College. He is an ASQ Certified Manager of Quality and Organizational Excellence. In 2008 Mr. Raymond received The Boston Society Award from the Boston Section for Demonstrated Meritorious And Most Distinguished Achievement On Promoting The Quality Principles And In Exemplifying The Ideals Of The Quality Profession. |
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