MassMEDIC

Donated Medical Devices Urgently Needed for Syrian Relief Effort

MassMEDIC — Wed, 16 May 2012 15:25:57 +0000

Device donations press release:

Solicitation on Crimson site:… Read the rest

Jobs, R&D Cuts are Likely Steps to Deal with Device Tax Survey of MedTech Execs Shows Anticipated Impact of Impending Medical Excise Tax

MassMEDIC — Wed, 14 Mar 2012 19:14:59 +0000

Jobs, R&D Cuts are Likely Steps to Deal with Device Tax

Survey of MedTech Execs Shows Anticipated Impact of Impending Medical Excise Tax

BOSTON, MASS. – March 14, 2012 – Job cuts and slashing of R&D budgets are two of the likely

options the state’s medical device companies will take to address the impending tax on their products,

according to a new survey of senior executives of the firms.

The Massachusetts Medical Device Industry Council (MassMEDIC) conducted a survey last month

among medical technology manufacturing companies in the region to gauge their plans and readiness

for the coming Medical Device Excise Tax (MDET) and its impact on company operations.

The MDET, which goes into effect January 1, 2013 and raises $20B over a 10-year period, was

established to help finance the Affordable Care Act that was signed into law in March of 2010. The

amount is based on a 2.3 percent excise tax that will be levied on the sale of most medical devices,

regardless of whether a company generates a profit.

“We warned two years ago that medical device companies would be forced to deal with this tax by

preparing for job cuts and reductions in R&D spending,” said Tom Sommer, President of

MassMEDIC. “The U.S. leads the world in developing and manufacturing medical products, it doesn’t

make sense that on one hand the government is promoting exports and manufacturing jobs, while on

the other hand it is implementing policies that will cut jobs in this sector and harm its competitive

advantage – the development of innovative medical technologies.”

Forty-two senior executives of medical device manufacturers were surveyed by MassMEDIC. Key

findings of the survey include:

• As of February 2012, 10 months before the tax goes into effect, only 25 percent of responding

companies have put systems into place to comply with the MDET.

• 44 percent of respondents stated that their companies would pass the cost of the new tax on to

end users such as hospitals, clinics, purchasing organizations and doctors. This would result in

higher costs for medical devices sold in this country.

• 39 percent of respondents stated that their companies would assume the cost of the MDET,

implementing internal cost reductions to meet revenue losses, taking the following actions:

− 50 percent will cut R&D operations

− 25 percent will implement workforce reductions

− 25 percentwill outsource manufacturing to lower cost areas

The survey also found that 49 percent of respondents said that the MDET would have a ‘significant

impact’ on their company’s operations, while 75 percent said it would ‘have an impact’.

Proponents of the health care reform law argued that medical device companies will experience a jump

in revenue as a result of millions of newly insured citizens. Industry representatives at the time said

that the overwhelming number of devices used by patients is already covered by private insurance

plans or through Medicare.

In Massachusetts, the state’s universal health care law has been in effect for six years. With nearly 100

percent of the population now covered by health insurance plans, the KPMG survey participants were

asked if their companies had experienced an increase in unit sales in Massachusetts since 2006. None

of the respondents reported an increase in unit sales in that time period.

The US Department of Treasury will be responsible for collecting and administering the MDET. The

department issued proposed regulations on the collection of the tax earlier this year. No timetable has

been set for the release of final regulations.

###

About MassMEDIC:

The Massachusetts Medical Device Industry Council, an organization of nearly 400 manufacturers,

suppliers, research institutions, and academic health centers, promotes the unique interests of the Bay

State’s growing and vibrant medical device sector. Through a variety of programs, informational

seminars, advocacy campaigns and other projects, MassMEDIC provides medical device

manufacturers and suppliers with information on industry trends and regulatory policies, and creates

forums that allow members to exchange ideas and information on issues affecting the industry. For

more information on MassMEDIC, please contact us at (617) 414-1340, or visit our web site at

www.massmedic.com.

New Site Launches

Tom Sommer — Fri, 09 Dec 2011 15:47:24 +0000

MassMEDIC is pleased to announce the launch of its new web site, featuring a fresh look and improved user experience. We’ve maintained all the features from the old site, though they might be in a different place or look a little different. Here’s a quick overview:

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!

MLSC Awards Grant to Support Med Device Entrepreneurs

MassMEDIC — Tue, 01 Nov 2011 02:22:30 +0000

By Michelle Lang in Mass. High Tech, October 31, 2011

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 … Read the rest

Deep Pressure Vest to Help Those with Autism Among Medical Innovations Presented to Investors

MassMEDIC — Fri, 21 Oct 2011 15:59:01 +0000

VC Audience Assesses Pitches at Annual MassMEDIC Investors Conference

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.

17 MedTech Startups Pitch at MassMEDIC Investors Conference

MassMEDIC — Fri, 21 Oct 2011 14:36:07 +0000

By Galen Moore in the Boston Business Journal, October 21, 2011

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

Survey: Most Mass. MedTech Firms Added Jobs in Past 6 Months

MassMEDIC — Thu, 22 Sep 2011 19:38:37 +0000

By Julie M. Donnelly in the Boston Business Journal, September 22, 2011

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

State’s Medical Device Sector Raises Issues with FDA

MassMEDIC — Mon, 11 Jul 2011 18:53:24 +0000

Impact of Policies Key Topic at Boston Forum With Agency Head

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.

FDA’s Proposed Changes in 510(k) Process Are Still in Their Own Process

MassMEDIC — Thu, 23 Jun 2011 02:29:16 +0000

By James M. Connolly in Mass. High Tech, June 22, 2011

“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

Mass. Medical Device Exports Growing

MassMEDIC — Wed, 04 May 2011 02:33:35 +0000

By Julie M. Donnelly in the Boston Business Journal, May 3, 2011

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 … Read the rest