New VP Named at Premier Research Group

New VP Named at Premier Research Group

Premier Research Group Limited has appointed Ronald Kershner, Ph.D., to the position of vice president, biostatistics and data operations for North America. He comes to Premier from Novella Clinical Inc., where he was global head of clinical data reporting.

“We are very pleased to welcome Ron to Premier Research to manage these key operational groups,” said Krista Armstrong, Ph.D., vice president, North America. “He has a significant track record with developing efficient and productive teams producing high-quality, on-time deliverables for sponsors as well as providing strategic consulting services for biostatistical study design and guidance for all phases of clinical trials.”

Kershner has more than 25 years of experience in clinical trial planning, execution and delivery within the pharmaceutical, biotechnology and contract research industries. He currently is a speaker on the faculty series for the Society of Clinical Research Associates. Kershner, who holds a Ph.D. from Cornell University in Ithaca, N.Y., also is a past member of the Regional Advisory Board of the Biometrics Society.

Premier Research Group is based in Philadelphia, Pa.

Micron Expands Quality Assurance Team

Micron Technology Inc. has made three staff changes in its Quality Assurance Group. Gary Buchholz has been promoted to director of quality; Terri J. Haskins has been hired as quality systems analyst and Dan M. Truong has been hired as quality assurance engineer.

Buchholz will be responsible for operational compliance and quality management systems policies, principles and objectives. He also will coordinate development and integration activities for existing product lines and new product opportunities, as well as identify post-product quality information for distributed devices. Buchholz was promoted from his position of quality assurance manager.

Haskins previously served as an engineering technician at Pexco LLC. She will handle quality system compliance as it applies to company objectives and International Organization for Standardization rules through document change control, internal auditing, preventative and corrective action management and certification processing.

Truong comes to Micron from Smiths Medical ASD, where he was a quality assurance engineer. He will provide technical support and guidance to Micron through equipment and test metrology, statistical analysis, process and product validation and product development activities.

Micron Technology is headquartered in Boise, Idaho.

MRPC Expands Sales Team, Announces Promotions

MRPC has appointed Don Durand as its East Coast territory sales manager.

Durand, a U.S. Air Force ReservesMaster Sergeant, joins MRPC with 20 years of materials processing and silicone plastics experience.

MRPC also promoted Joshua Meier and Marianne Elmer to controller anddirector of administration, respectively. Meier has been with the company for 11 years, and now will be responsible for the company’s financial and accounting functions. Elmer, who has been with MRPC for 30 years, will oversee internal information technology as director of administration, a newly created position.

MRPC is a provider of medical device components and assemblies, specializing in silicone molding, two-material molding and micro-molding. The company is based in Butler, Wis.

NovoStent Appoints New Board Chairman

NovoStent Corporation has appointed Rick Randall as board chairman. Randall currently is chairman and CEO of Sunnyvale, Calif.-based Avantis Medical Systems Inc. and chairman of Wilmington, N.C.-headquartered TranS1 Inc. He also served as CEO of TranS1 from 2002 to 2011, resigning in January.

“We are delighted to have Rick join NovoStent as chairman,” said G. Ray Martin, Ph.D., president and CEO of NovoStent. “With his wealth of experience in the medical device industry, particularly with development stage companies, Rick is truly an asset to NovoStent.”

Randall’s medical device industry experience also includes a stint as president and CEO of Innovasive Devices Inc. until it was sold to Johnson & Johnson in 2000.

Mountain View, Calif.-based NovoStent manufactures products with an ultra-thin macro structure along with a micro cell structure that can be tailored for different vascular anatomies to enable easy deployment and accurate delivery of medication.

Electromed Fills Chief Operating Officer Role

Electromed Inc. has named James J. Cassidy, Ph.D., as its chief operating officer. Cassidy’s focus will be in engineering, product development, regulatory and manufacturing.

“Jim will make a very important contribution as a new resource to all of us at Electromed,” said Robert Hansen, chairman and CEO. “He will be a strong contributor toward making Electromed a larger and stronger company, but he will also help fortify the values and history upon which its foundations rest.”

Cassidy’s experience includes 20 years of international management in the medical device industry.
He also has served as CEO for U.S.- and Europe-based start-up companies, and as vice president of development for ApaTech Ltd. (which is part of Baxter Healthcare Corporation). In addition, he was chief operating officer ofMinnetonka, Minn.-based spinal implant manufacturer Vertebral Technologies Inc. In 2010, Cassidy founded TransAtlantic Medical Device Consulting, LLC, a business development and technology consulting services firm.

Electromed is headquartered in New Prague, Minn.

MMD Names Vice President of Regulatory Affairs

Medpace Inc. has named Mike Winegar vice president of regulatory affairs for subsidiary Medpace Medical Device (MMD).

Winegar brings 25 years of experience to the role. His focuses have been global regulatory affairs, regulatory compliance, quality assurance and clinical research, with a particular emphasis on cardiovascular, neurovascular, and peripheral vascular technologies. He also has held senior leadership positions with several large and small medical device companies.

“Mike Winegar is a highly valued research professional and seasoned industry expert in regulatory affairs, clinical research, and quality assurance,” said Ryan Wilson, general manager, MMD. “His extensive experience in the regulatory and clinical aspects of conducting medical device trials both within and outside of the United States, especially within the cardiac and vascular device arenas, further strengthens MMD’s position as a top tier clinical research organization for the medical device industry. The addition of Mike to the MMD team will allow us to offer deeper strategic solutions for global premarket and post-market clinical and regulatory challenges, including leading clients through changing European and U.S. regulatory approval requirements.”

Medpace and MMD are headquartered in Cincinnati, Ohio, and Minneapolis, Minn., respectively. MMD is a full service medical device contract research organization that offers trial design, project management, site management, monitoring, biostatistics, regulatory support, and data management to customers.

Systagenix Names New CEO

Systagenix Wound Management has named Earnest Waaser CEO and member of the company’s board of directors. Waaser will be based at the firm’s global headquarters in Gatwick, United Kingdom. He replaces Steve Atkinson, who has led the firm since it was spun out of Johnson & Johnson’s advanced wound care business in 2008.

“We thank Steve Atkinson for his service over the last three years, and are delighted to have an executive of Ernest’s caliber now joining Systagenix as CEO,” said board member Chris Ahrens. “His strong track record of growing companies organically and through acquisition, extensive global experience, and broad medical device background is an excellent fit and we look forward to his leadership.”

Most recently, Waaser served as president of Teleflex Medical, based in Research Triangle Park, N.C., and as president and chief executive officer of Batesville, Ind.-based Hill-Rom Services Inc., a supplier of beds and stretchers.

Hansen Medical Hires Former Guidant Executive as CFO

Hansen Medical Inc. has named former Guidant Corp. executive Peter J. Mariani as chief financial officer. Mariani replaces interim Chief Financial Officer PeterOsbourne, who has held the role sinceJanuary 2010.

“It’s exciting to be joining the management team at Hansen Medical and to have the opportunity to help the company fully realize the value of its flexible robotics technology,” Mariani said.

In his 12 years at Guidant, Mariani served in a number of financial leadership positions, including controller and chief accounting officer. He also spent four years at Guidant-Japan, primarily as vice president, finance and administration, where he helped facilitate the conversion of Guidant’s business in Japan from a distributor network to a direct sales and marketing organization. Previously, he led the advancement of Guidant’s consolidated customer billing and collection services prior to several significant product launches for the company’s vascular subsidiary.

“Pete has a strong financial background and a proven track record of results while working for a global, publicly-traded medical device business,” said Bruce J. Barclay, president and CEO of the Mountain View, Calif.-based firm. ”He also has shown an expertise for building and managing professional, high performing teams focused on high quality execution.”

Phillips Plastics Names New VP of Sales and Marketing

Daniel J. Kunst has joined Hudson, Wis.-based Phillips Plastics Corporation as vice president of sales and marketing for the medical division.

Kunst previously served as vice president of business development for Flextronics’ medical division and executive vice president and board member at Horizon Medical Outsourcing, where he doubled business in 18 months. After Horizon was acquired by Avail Medical Products Inc. in June 2002, Kunst stayed on and grew business by 150 percent; Avail was acquired by Flextronics in March 2008.

“We are pleased to have Dan join our organization,” said Matt Jennings, president and CEO of Phillips Plastics. “His experience level and personal drive will be valuable assets as we continue to grow Phillips Plastics’ medical business.”

Kunst will foster the development of the medical division and new medical technology investments, which include multi-shot, multi-shot liquid silicone rubber and metal injection molding.