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Supreme Court Expands Exhaustion Doctrine


Honeyman
Earlier this month, the U.S. Supreme Court issued its decision in Quanta Computer Inc. v. LG Electronics Inc., thereby limiting the ability of patent owners to demand downstream royalties from customers of licensees. Although Quanta involved manufacturers in the laptop computer industry, the ruling has implications for medical device manufacturers, many of whom routinely incorporate components purchased from outside vendors into their final products.

In this article, Jason Honeyman, a shareholder and chair of the medical device practice group at Wolf Greenfield (Boston), provides background on the Quanta ruling and an assessment of its implications for patent licensing agreements going forward. [More]  

AAMI Highlights Device Makers’ Shortcomings, Opportunities 


Gee
The hospital market’s demand for work flow automation at the point of care has prompted many medical device manufacturers to incorporate information technologies (IT) into their products. Yet the integration of these medical device systems into hospitals’ IT infrastructures—where they often coexist with other medical device systems—is a growing challenge for the healthcare industry as a whole. And wherever challenges for healthcare providers exist, opportunities abound for device manufacturers that seek to alleviate such burdens in subsequent product offerings.

Specific examples of how IT demands are affecting medical device manufacturers and healthcare providers were prominent at the recent Association for the Advancement of Medical Instrumentation (AAMI) annual conference and expo, held earlier this month in San Jose. In this article, Tim Gee, principal of Medical Connectivity Consulting (Beaverton, OR), identifies themes that emerged during this year's meeting, as well as the opportunities they present for savvy device manufacturers. [More]   


Heart-Assist Device Market Heats Up

Recent regulatory approvals and favorable reimbursement rulings are expected to provide a boost to the market for heart-assist devices. Such devices offer the promise of extending and enhancing the lives of 22 million people worldwide who suffer from heart failure, some of whom might eventually be candidates for a human heart transplant or an implanted heart-assist device. According to the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH; Bethesda, MD), heart failure affects 5 million people in the United States, with 550,000 new cases each year, resulting in 300,000 deaths, and annual healthcare costs of more than $30 billion.

As the number of clinically viable human heart transplants continues to fall far short of demand, technological advances continue to show promise as permanent replacements for defective hearts. As a result, industry consensus is that the heart-assist device market could reach between $8 billion and $10 billion worldwide within the next few years. In fact, more than a dozen medtech manufacturers are actively developing products for what could be the next hot-growth sector for the worldwide cardiovascular market. [More] 


Novel Collaborative Relationships Emerge on the Medtech Landscape


Cartwright 
Bringing a medical device from concept to commercialization has never been an easy task. The process typically requires an extensive and daunting assortment of skills, resources, and capabilities in product design, manufacturing, regulatory approval and compliance, reimbursement, marketing, and distribution. The medtech industry has a long and successful history of overcoming hurdles to market through strategic, collaborative efforts. This month’s MX: Issues Update looks at three such innovative arrangements.

For example, earlier this month, GE Healthcare, a unit of the General Electric Co. (Fairfield, CT), and the University of Pittsburgh Medical School (UPMC; Pittsburgh) announced the formation of a new company, known as Omnyx LLC (Pittsburgh), which will focus on developing products for the digital pathology market. According to Omnyx CEO Gene Cartwright, “Digitizing pathology will allow Omnyx to provide doctors with better tools for the full care continuum, enhancing their decision-making capabilities in key disease areas.” His remarks reinforced the linkage with GE’s molecular diagnostics business, where he previously served as the unit’s president. [More]


2008 BMEidea Competition Honors Collegiate Biomedical Engineering Innovations


BMEidea trophy
Student teams with innovative discoveries for surgical incision closure, premature baby care, and the delivery of local anesthesia have received top honors in the 2008 Biomedical Engineering Innovation, Design, and Entrepreneurship Award (BMEidea) competition—a national competition celebrating student biomedical innovation. The BMEidea winners were announced earlier this month, in conjunction with the Medical Design Excellence Awards ceremony at the Medical Design & Manufacturing East trade show, in New York City.

Honors went to three collegiate biomedical engineering teams, recognizing their outstanding work in the field. First prize—a cash award of $10,000—was awarded to Rapid Suture from Stanford University (Palo Alto, CA). The team developed a small, inexpensive device that enables quick, safe, and easy surgical tissue manipulation during laparoscopic procedures, leading to fewer surgical risks and faster patient recovery. [More]  

 Innovative Medical Products Showcased at MDEA Ceremony

The winning products in this year’s Medical Design Excellence Awards (MDEA) competition, sponsored by Canon Communications, received their gold or silver recognition at a ceremony held earlier this month during the Medical Design & Manufacturing East 2008 Conference and Exposition at the Jacob K. Javits Convention Center in New York City.

MDEA is the premier awards program for the medical technology community. It recognizes the achievements of medical device manufacturers, their suppliers, and the many people behind the scenes—engineers, scientists, designers, and clinicians—who are responsible for the groundbreaking innovations that are changing the face of healthcare. The 2008 jury selected 33 winners in 10 medical product categories. For additional coverage of this year’s ceremony and more information on the 2008 award winners, look for MX’s annual coverage of the event in the upcoming July/August issue. [More]  

JUNE 2008 CONTENTS

Supreme Court Expands Exhaustion Doctrine

AAMI Highlights Device Makers’ Shortcomings, Opportunities

Heart-Assist Device Market Heats Up
 
Novel Collaborative Relationships Emerge on the Medtech Landscape

2008 BMEidea Competition Honors Collegiate Biomedical Engineering Innovations

Innovative Medical Products Showcased at MDEA Ceremony

INDUSTRY IN BRIEF
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INDUSTRY IN BRIEF

The Southern California Biomedical Council (SoCalBio; Los Angeles), Biocom (San Diego), and BayBio (San Francisco), which together represent life sciences firms and research organizations across California, have announced an alliance to promote the state’s life sciences industry. Under the terms of the three-year agreement, the organizations will pool resources and work together to address a range of public policy and joint advocacy efforts at the state and federal levels. The organizations will also collaborate on life sciences industry conferences and joint purchasing group opportunities.

Boston Scientific Corp. (Natick, MA) expects to raise about $140 million by selling its investments in a portfolio of venture funds and companies to two investment firms. “The sale of these investments, which represent the vast majority of our private investment portfolio, is part of our previously announced plans to divest nonstrategic assets, while focusing on our core businesses and increasing shareholder value,” said Sam Leno, CFO of Boston Scientific.

Massachusetts Governor Deval Patrick signed into law a measure aimed at strengthening the state’s life sciences sector through tax incentives, research funding, and university-building projects. As part of the $1 billion, 10-year commitment, $10 million is being committed to fund the Massachusetts Medical Device Development Center at the University of Massachusetts–Lowell.

CALENDAR

July 7–8: Healthcare Unbound Conference and Exhibition, San Francisco.

July 10–11: Intellectual Property for Technology and Business Development, Pasadena, CA.

July 21–23: Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries, Costa Mesa, CA.

July 22–23: Competitive Technical Intelligence, Pasadena, CA.

July 22–23: Leadership Summit on the Road to Interoperability, Boston.

July 28–29: Growing Your Business in China, Pasadena, CA.

July 28–29: IT for the Non-IT Executive, Cambridge, MA.








 
  ABOUT MX  
 

MX: Issues Update is a monthly e-supplement prepared by the editors of MX: Business Strategies for Medical Technology Executives and sent to you as a benefit of your online registration with Canon Communications. To become a regular subscriber to this monthly medtech business update, click here.

The editors welcome your suggestions for future content in MX: Issues Update. Please feel free to contact us with your comments and ideas.Steve Halasey, Editor in Chief, MX

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