• Events: the “bubble” that appeared on the right of the home page featured upcoming events and other notworthy items. You can now find them in the Upcoming Events area on the left of the home page, and other items will appear from time to time to the right of the Upcoming Events area (below our Premium Members).  You can also access our Event Calendar via the main menu.
• Event Registration: viewing a MassMEDIC event via the Upcoming Events or Event Calendar will display a Register button, assuming registration is still open. This will take you to the familiar registration page. We’ve made the process easier – just enter your email and we’ll figure out if you’re already in our system, and guide you through creating an account if you’re not.
• Event Connect: formerly known as our Events Application, this is where you can view and message other event attendees.
• Job Bank: can be found in the Resources section of the main menu.
• Program Presentations: also found in the Resources section of the main menu.  These presentations are now limited to members of the site. Registering for a MassMEDIC event automatically gives you access to these documents. Anyone else is welcome to access them by simply creating an account.
• Suppliers Directory: can be found in the Resources section as well.

We hope you appreciate the changes we’ve implemented and find the new site even more useful!

MedTech IGNITE, a medical device-focused business coaching program launched by the Massachusetts Medical Devices Industry Council (MassMedic), won a $50,000 grant from the Massachusetts Life Sciences Center (MLSC).

Read the full story on MassHighTech.com

BOSTON, MASS. – Nearly 350 medtech investors and medical device business leaders convened at UMass Boston today as 23 of the area’s emerging medtech companies presentedtheir cutting-edge technologies and business plans to an audience of start-up funders and venture capital firms. In addition to the 10-minute presentations by each company, the day-long programincluded a panel discussion and talks surrounding the state of medtech innovation and investment trends.

The 13th Annual Massachusetts Medical Device Industry Council (MassMEDIC) MedTech Investors Conference featured a range of new technologies such as a wearable deep pressure wearable vest tohelp people with autism, ADHD and anxiety disorders; a localized drug delivery device to prevent the recurrence of cancer post surgery; and an antibacterial tube coating process that reduces health care associated infections.

“The recent Tatum Economic Climate Survey showed a boost in activity in the medtech industry over the last year, including a 10 percent increase in capital expenditures and a nearly 20 percent increase in hires,” said Tom Sommer, President of MassMEDIC. “The number of companies that were looking to present today as well as the incredibly innovative technologies showcased, further validates the survey and the industry’s commitment to continue to develop treatments that can profoundly impact people’s quality of life.”

The MassMEDIC conference attendees also heard an analysis of the challenges facing medical devicecompanies seeking venture capital funds by John Westwood of L.E.K.Consulting. Westwood noted, “Both the proposed medical device tax and possible changes in FDA regulations could have a negative impact on VC activity in the sector.” Cam Neely, president of the Boston Bruins, also gave remarks on “Assembling a Winning Team.”

Massachusetts is home to the nation’s second largest concentration of medical device manufacturing and development, with more than 225 manufacturers, 50,000 employees in manufacturing, development and related industries, annual shipments of $5.5 billion, and exports totaling $2.4 billion.

Some of the technologies presented at the event included:

Deep pressure vest helps people with autism, ADHD and anxiety based disorders:
Developed by Amherst, Mass.-based Therapeutic Systems, LLC, the Vayu Deep Pressure Vest is a non-invasive, non-pharmacological wearable vest which discreetly provides personalized deep pressure to the wearer. Deep pressure, a form of sensory input – like a firm hug or swaddling a baby – is commonly used to help self soothe, ground, and facilitate self organization in people with autism, and can lead to the reduction of anxiety facilitating better focus, function and interaction.

Localized drug delivery device aims to prevent post-surgery cancer recurrence:
AcuityBio Corporation of Newton, Mass. has developed ABC Polymer™, a unique and simple to use drug-eluting implant that reduces the incidence of locoregional lung cancer recurrence post surgery by locally delivering therapeutic levels of drug to the site of disease over several months.

Antibacterial coating to reduce healthcare-associated infections:
Axena Technologies of Providence, Rhode Island, has developed SeCure™, an antibacterial coating for medical tubing six times more effective at reducing bacterial growth than the current industry standard for antibacterial coatings.

The following companies and organizations presented at the conference:

• AcuityBio Corporation (Newton, MA)
• Analogic Corporation (Peabody, MA)
• ARO Medical (North Andover, MA)
• Axena Technologies, Inc. (Providence, RI)
• Cambridge Temperature Concepts Ltd. (Cambridge, UK)
• Convergence Medical Devices (Woburn, MA)
• CoolSpine LLC (Woodbury, CT)
• Covidien (Mansfield, MA)
• Emovi inc. (Laval, QC, Canada)
• eSight Corporation (Ottawa, ON, Canada)
• Haemonetics Corporation (Braintree, MA)
• Ionu Biosystems (Somerville, MA)
• mobiLIFE Inc. (Boston, MA)
• Neotherix Ltd. (York, UK)
• NeuroMetrix, Inc. (Waltham, MA)
• Oxus Medical, Inc. (Worcester, MA)
• Philips Healthcare (Andover, MA)
• Reflectance Medical Inc. (Westborough, MA)
• Smith & Nephew (Andover, MA)
• Strohl Medical Technologies (Norwell, MA)
• Therapeutic Systems, LLC. (Amherst, MA)

MassMEDIC’s MedTech Investors Conference has become a seminal event for the industry, drawing more than 350attendees from the sector’s financing, consulting and manufacturing sectors. More than 250 innovative medical technology ideas have been presented at the Conference, with many presenting companies finding funding or acquisition opportunities at the event.

Medical device startups faced a more skeptical crowd than usual at this year’s venture-capital-focused MassMEDIC Investors Conference. Tougher U.S. FDA regulations on medical devices have raised the bar for medtech startups, investors and entrepreneurs said.

Read the full story on bizjournals.com

Medical device industry executives in Massachusetts are expecting business to improve in the coming months, and more than half of local companies in the sector grew head count over the past six months. Those are two of the findings of a survey commissioned by the state’s industry association, MassMedic. The survey included 42 C-level executives, and was conducted in the first two weeks of August.

Read the full story on bizjournals.com

BOSTON – July 11, 2011 – The head of the state’s medical device association today raised key issues of concern with the Commissioner of the Food and Drug Administration (FDA) during a forum in Boston with over 50 device executives.

In the forum arranged by Sen. John Kerry, Tom Sommer, the president of the Massachusetts Medical Device Industry Council (MassMEDIC), said he was concerned about “inconsistent guidance” from the FDA.

“Unfortunately, over the past several years, from the perspective of most in this industry, we have seen troubling signs that we believe will jeopardize our position as the world’s foremost medical device cluster,” Sommer told Dr. Margaret A. Hamburg, the FDA Commissioner and Dr. Jeffrey Shuren, Director of the agency’s Center for Devices and Radiological Health.

The Massachusetts medical device industry represents 12 percent of the state’s exports, and the exports are growing at double the rate as all other Massachusetts exports combined. Massachusetts has the second largest number of jobs in the medical device industry with over 82,500 direct and related positions behind only California.

Sommer discussed the frustration with the current regulatory environment, including the lack of consistent guidance, the inability of the agency to assess new technologies in a timely manner, and concern that the industry’s voice is not being fully considered in policy development and execution.

Sommer said the delays in product reviews due to changing requirements often brought up by FDA reviewers just before the “90 day 510(k)clock” is about to expire, and have reached a critical point where delays have:

• Forced device companies to place a primary focus on introducing products to market in Europe, where a predictable but no less rigorous product review process is in place. This growing trend provides European doctors and patients access to products developed in the US up to a year before our providers and patients.
• Stalled hiring of additional workers for new product lines – such as one MassMEDIC member start-up that has been waiting for over six months to hire up to 60 workers to manufacture and market its new product.
• Postponed investment for early-stage medtech companies – limiting access to the new technologies they develop and delaying additional hires.

“If you were to spend a few hours researching the corporate mission statements of US medical device companies, you would in the vast majority of cases find that improving patient outcomes is priority one. In order for us to continue to make these devices available in a timelier manner, we urge the agency to listen to testimonials and policy reactions and to work with us more effectively in the future,” Sommer said at the forum.

Sommer also cited the concern surrounding the proposed revisions to the 510(k) process last August that, if fully implemented, will likely lengthen review times and impose additional costs and process to a product review protocol that has become unreliable and inconsistent.

“The state’s medical device companies very much appreciate the efforts by Sen. John Kerry and his staff in arranging today’s forum and we hope it will lead to improvements in the relationship between the FDA and our device companies,” Sommer said.

“Our members are very concerned that the FDA is proposing drastic changes to a program that has served the patient and health-care delivery system for many years. While review of a 35-year-old program is to be applauded, some of the changes that they have proposed MassMedic members feel will stifle innovation,” said Tom Sommer, president of the industry group MassMEDIC.

Read the full story on MassHighTech.com

Massachusetts medical device exports are growing more rapidly than the state’s exports as a whole, according to a study commissioned by MassMedic, the state’s device industry association.

Read the full story on bizjournals.com

BOSTON (May 3, 2011) – A new economic analysis released today shows exports from the state’s medical device industry growing at twice the rate of all other sectors in the state combined. The study was released as over 300 medical device and medical technology leaders gathered for the Massachusetts Medical Industry Council’s (MassMEDIC) 15th Annual Conference held at UMass-Boston.

The report, “The Medical Device Industry in Massachusetts – An Updated Profile,” developed for MassMEDIC by Deloitte LLP, is a comprehensive review of the medical device sector and factors impacting it since MassMEDIC’s previous study released in 2007. The Deloitte LLP report highlights the current state of the medical device industry in Massachusetts, providing insight on exports and job creation. The new data show that Massachusetts medical devices represent a significant portion of total state exports at 12 percent and U.S. medical device exports at 10 percent. And, the Massachusetts industry’s exports are growing at double the rate as all other Massachusetts exports combined.

Further, the state is the country’s second largest employer of people in the medical device industry, behind only California. And, a 2008 report by AdvaMed, the nation’s largest medical device industry association, showed that the medical device industry’s impact on job creation in Massachusetts is over 82,500 direct and related positions.

“In spite of these economically challenging times, the medical device industry in Massachusetts has demonstrated continued growth with its commitment to research, political support, capital funding and extraordinary talent,” said Mike O’Hara, partner at Deloitte & Touche LLP and a director at MassMEDIC. “As a result, the state is uniquely positioned to be a significant player in the industry,” he added.

Other key findings from the report include:

• Massachusetts medical device firms received $286 million, or 12 percent of the national medical device venture capital funds in 2010
• Massachusetts leads the country in spin-outs from universities and other non-profits

“It is gratifying to see that in addition to our industry peers and academics, political leaders and venture capitalists recognize the value of investing resources into our industry,” said Tom Sommer, president of MassMEDIC. “Today’s report validates that, as will the future medical treatments and innovations that come out of our state.”

Other presentations included:

A Report from Edelman Lab, Harvard-MIT Biomedical Engineering Center
Elazer Edelman, M.D., Ph.D.

Status of Proposed Revisions to the 510(k) Program
Susan Alpert, M.D., Ph.D.
Senior Vice President & Chief Regulatory Officer, Medtronic

The New Faces of MedTech Innovation – Profiles of Device-Related Research at Area Research Institutions and Academic Health Centers
Randy J. Boudrieau, DVM – Cummings School, Tufts University
Augustine Choi, M.D. – Harvard Medical School
Utkan Demirci, Ph.D. – Brigham & Women’s Hospital
Ronald Dixon, M.D. M.A. – Massachusetts General Hospital
Jeffrey Karp, Ph.D. – MIT
Catherine Klapperich, Ph.D. – Boston University
Dale Larson, Draper Laboratory
Frank Menzler, Heinrich Hertz Institute, Fraunhofer Institute
W. Grant McGimpsey, Ph.D. – Worcester Polytechnic Institute

Exports of Massachusetts medical devices have grown more than twice… represent about 10 percent of all US medical equipment sold abroad, according to a report… conference of the Massachusetts Medical Device Council.

Read the full story on boston.com