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MassDevice Q&A: Cook Medical vice president Rob Lyles

July 26, 2010 by Brad Perriello

Rob Lyles, who heads up Cook Medical's peripheral intervention business, on the company's origins in a two-bedroom apartment, the impact of gift bans on the medical device industry and developments in treating diseased blood vessels in the legs.

MassDevice Q&A: Cook Medical vice president Rob Lyles

Cook Medical Group and Boston Scientific Corp. (NYSE:BSX) both got their start with catheter-based devices, but the medical device giants' similarities don't stop there. As Boston Scientific founder John Abele told MassDevice last month, his firm got its start in an unlikely place: the basement of a Catholic Church in Belmont, Mass.

MassDevice Q&A: Abiomed CEO Michael Minogue

July 9, 2010 by Christian Holland

Abiomed president and CEO Michael Minogue on his company's Impella heart pump and its prospects for gaining a larger share of the cardiac assist market.

MassDevice Q&A: Abiomed CEO Michael Minogue

Abiomed Inc. (NSDQ:ABMD) makes cardiac assist devices powerful enough to pump more than a gallon of blood through the heart each minute and small enough to be placed inside the heart via catheter. It's a highly specialized, highly competitive market that's difficult to break into.

At an investors meeting in Boston last week, the company sought to deliver the message that its devices offer a less invasive option than ventricular assist devices and don't need to be combined with inotropic drugs as is often the case with intra-aortic balloon pumps. It's been two years since Abiomed won 510(k) clearance from the Food & Drug Administration for its Impella 2.5 device; at the conference, CTO Dr. Thorsten Siess acknowledged that physicians have been slow to adopt the device.

MassDevice Q&A: LifeImage CEO Hamid Tabatabaie

June 30, 2010 by Christian Holland

MassDevice talks to LifeImage president and CEO Hamid Tabatabaie about his company's e-sharing application for medical imaging.

MassDevice Q&A: LifeImage CEO Hamid Tabatabaie

If you’ve ever had a CT scan, X-ray or MRI, you were likely given a CD to tote around in case you wanted a second opinion. That’s because there isn’t a universal network or database for medical image files, even in an industry that demands standardization.

MassDevice Q&A: John Abele, Part II

June 10, 2010 by Brad Perriello

Boston Scientific Corp. co-founder John Abele, in the second installment of a lengthy interview, on the early days with Peter Nicholas, his take on demands for increased transparency and his frustration with some of the company's recent low points.

MassDevice Q&A: John Abele, Part II

Boston Scientific Corp. (NYSE:BSX) co-founder John Abele told us about the origins of the medical device giant in the first installment of a lengthy chat with MassDevice, detailing its start in the basement of a famed Czech mystic's lab in a Catholic church rectory.

In the second installment, Abele touches on how he and co-founder Peter Nicholas engineered the Boston Scientific's launch, how his involvement with the Natick, Mass.-based company evolved over the years and how being a "cheap son of a bitch" helped drive creativity and innovation in the early days.

MassDevice Q&A: Boston Scientific co-founder John Abele

June 9, 2010 by Brad Perriello

Boston Scientific Corp. co-founder John Abele, in the first installment of a lengthy interview, on the company's origins in the basement of a church rectory, its connection to a famous Czech mystic and how it overcame doctors' early skepticism about its catheter-based technology.

MassDevice Q&A: Boston Scientific co-founder John Abele

There aren't many multi-billion-dollar companies that can say they got their start in the basement of a Catholic church rectory. Still fewer can claim a connection to a famous Czech mystic credited with pioneering research into human consciousness (and, not incidentally, with inventing the steerable catheter).

But according to co-founder John Abele, Boston Scientific Corp. (NYSE:BSX) can. The Natick, Mass.-based medical device maker got its start with the steerable catheter invented by Itzhak Bentov, leveraging the platform into a family of catheter-based products that changed the way medicine is practiced.

MassDevice Q&A: Practice Fusion founder and CEO Ryan Howard

June 9, 2010 by Christian Holland

Practice Fusion's founder and CEO on the electronic medical record provider's free, advertising-based EMR offering.

MassDevice Q&A: Practice Fusion founder and CEO Ryan Howard

To raise the seed money for Practice Fusion, founder Ryan Howard sold his house and car.

"I was really going all in," the 34-year-old CEO told MassDevice.

Howard might have made a smart bet. According to Practice Fusion, the company has the fastest-growing user base of any electronic medical record company in the country, at 40,000 members. Its offering is free for physicians, using a largely advertising-based business model.

MassDevice Q&A: OmniGuide chairman Yoel Fink

June 1, 2010 by Christian Holland

MassDevice talks to OmniGuide's Yoel Fink and Yair Schindel about their company’s business development strategy.

MassDevice Q&A: OmniGuide's Yoel Fink and Yair Schindel

When Yoel Fink began his groundbreaking work with mirrors at MIT in the late 1990’s, he didn't know he would be creating a material that would be used to carry lasers into areas as hard to reach as the inner ear or brain. He was working on a problem that the Defense Advanced Research Projects Agency, the research and development arm of the U.S. military, wanted solved. For reasons still unknown to Fink, DARPA wanted large-area, low-cost surfaces more reflective than a mirror that could reflect light from all angles. Eventually, his work led to a PhD thesis and OmniGuide, the company where he is currently chairman. OmniGuide, which employs 120 workers, just last week celebrated its 10th year of business.

MassDevice Q&A: Molecular Biometrics CEO Jim Posillico

May 3, 2010 by Brad Perriello

Molecular Biometrics co-founder, president and CEO Jim Posillico on how metabolomics can revolutionize in vitro fertilization — and lower healthcare costs along the way.

MassDevice Q&A: Molecular Biometrics CEO Jim Posillico

Jim Posillico has a long academic and commercial pedigree in reproductive medicine, having spent time as a researcher at Harvard Medical School, Serono Laboratories, the Ares-Serono Group, InterMune Life Sciences and SAGE BioPharma.

So when he learned of a metabolomics platform being developed at McGill University, he was quick to realize its applicability to a variety of potential conditions and disease states. The technology allows the comparison of biomarkers produced by cell metabolism monitor the progress of diseases like Parkinson's and Alzheimer's.

MassDevice Q&A: Levitronix CEO Kurt Dasse

April 7, 2010 by Brad Perriello

Levitronix CEO Kurt Dasse on the company's roots at Thermo Fisher Scientific, why its magnetic levitation technology is so well-suited to implantable cardiac assist devices and how the medical device excise tax could force consolidation in the medical device industry.

MassDevice Q&A: Levitronix CEO Kurt Dasse

Kurt Dasse, the CEO of Waltham, Mass.-based Levitronix, counts a stint as chief scientific office for Thermo Electron Corp., better known today as Thermo Fisher Scientific as key to his professional career. His tenure at Thermo proved fateful, as it was there that Dasse came under the wing of the legendary George Hatsopoulos and his fervent devotion to starting new companies.

MassDevice Q&A: GenomeQuest CEO Ron Ranauro

March 16, 2010 by Brad Perriello

CEO Ron Ranauro on GenomeQuest's customizable API, the falling cost of human genome sequencing and the ethical implications of widespread access to personal genome data.

MassDevice Q&A: GenomeQuest CEO Ron Ranauro

Ron Ranauro spent the better part of two decades in the computer industry, watching as the personal computer and the Internet transformed the business. It's growing maturity coincided with early efforts to sequence the human genome, leading Ranauro in the late 1990s to apply his computing chops to the life science scene.

MassDevice spoke with Ranauro as GenomeQuest launched an application programming interface that allows developers to customize apps for their labs' research programs. We asked him about the API, what sets his venture apart from other sequencing data management firms (hint: it's in the clouds) and got his take on the ethical implications of widespread access to genome sequencing technology.

MassDevice Q&A: BioBehavioral Diagnostics CEO Byron Hewett

March 8, 2010 by Brad Perriello

Byron Hewett, the CEO of Cambridge, Mass.-based BioBehavioral Diagnostics, on the importance of being able to quantify the symptoms of Attention Deficit Hyperactivity Disorder, helping families cope with an ADHD member and how the Food & Drug Administration let the horse out of the barn when it comes to regulating the diagnostics industry.

MassDevice Q&A: BioBehavioral Diagnostics CEO Byron Hewett

We first spoke with Byron Hewett, the CEO of Cambridge, Mass.-based BioBehavioral Diagnostics Co., late last summer, following a $2.5 million funding round that saw the company sell convertible debt securities to a trio of investors.

MassDevice Q&A: PatientKeeper CEO Paul Brient

February 4, 2010 by Brad Perriello

PatientKeeper Inc. president and CEO Paul Brient on why healthcare IT won't save the healthcare system, why it's still crucial to healthcare reform and how it could revolutionize the practice of medicine.

PatientKeeper CEO Paul Brient

Paul Brient, the president and CEO of PatientKeeper Inc., has spent 20 years in the healthcare IT trenches, first with the physician practice management software start-up he founded and ran, BCS Inc. After stints at McKesson Corp. (NYSE:MCK), HPR Inc. and The Boston Consulting Group, he joined PatientKeeper in 2002.

MassDevice Q&A: Myomo CEO Steve Kelly

January 28, 2010 by Brad Perriello

Myomo Inc. CEO Steve Kelly on his company's portable, robotic device for stroke rehabilitation and the coming wave that will revolutionize the medical device industry as we know it.

Myomo's e100 NeuroRobotic System

Steve Kelly's spent three decades watching new technology that originated in consumer electronics wreak havoc on well-established industries. The CEO of Myomo Inc. bore witness as new technologies redefined the home computing market in the 1980s, the telecom space in the 1990s and the changes voice-over-IP technology brought to telephony in the last decade.

Kelly sees a similar wave heading for the shores of the medical device industry. MassDevice spoke with him to hear his take on where the sector is headed and why.

MassDevice Q&A: CeQur CEO Jim Peterson

January 21, 2010 by Brad Perriello

CeQur CEO Jim Peterson on his personal ties to diabetes technologies and why his company is poised to be the leader in next-generation insulin delivery devices.

CeQur CEO Jim Peterson

Jim Peterson spent the better part of 20 years helping to improve the quality of the world's blood supply at Haemonetics Corp. (NYSE:HAE), where he was CEO from 1998 to 2003. And while he was passionate about the importance of that work, his new role as chief executive for CeQur Ltd. might be even closer to his heart.

Peterson spoke with MassDevice just before giving a presentation on the patch-like device CeQur is developing for insulin delivery at the OneMedPlace Finance Forum in San Francisco Jan. 13. He told us about the personal connection he feels to his current work, which stems from the fact that his daughter has diabetes, and why he sees Montreux, Switzerland-based CeQur's device as a potential market leader.

MassDevice Q&A: Covidien medical devices president José Almeida

January 11, 2010 by Brad Perriello

Covidien's medical devices division president on reviving the company after its spinout from Tyco Healthcare and how it turned around in a down economy.

MassDevice Q&A: Covidien medical devices president Joe Almeida

José Almeida knows what it takes to succeed. The native of Brazil, a mechanical engineer by training, put down roots in the U.S. 20 years ago and never looked back.

Since then he's worked his way up the corporate ladder at firms including Acufex Microsurgical, Johnson & Johnson (NYSE:JNJ), Greatbatch Technologies and Tyco Healthcare. When the latter spun out into Covidien in late June, 2007, Almeida had been in his current role for a year already after spending the better part of 12 years with the company.

Researchers take on the FDA

January 7, 2010 by Brian Johnson

Researchers Sanket Dhruva and Rita Redberg on the hornet's nest they stirred up with their study of the Food & Drug Administration's approval process for high-risk cardiovascular devices.

Researchers take on the FDA

It's not often that a few doctors ensconced in the ivy towers of academia can get a lumbering dinosaur like the Food & Drug Administration to turn on a dime, let alone during the week between Christmas and the new year.

But that's exactly what University of California at San Francisco researchers Sanket S. Dhruva, Lisa Bero and Rita Redberg did after the Journal of the American Medical Assn. published their paper "Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices."

MassDevice Q&A: Robert Creeden of Partners Innovation Fund

December 30, 2009 by Brian Johnson

Robert Creeden, managing director of Partners Innovation Fund, on reviewing business plans and the state of innovation.

Bob Creeden

Robert Creeden knows a little something about how to invest in early-stage companies. A former vice president at the Massachusetts Technology Development Corp. and a general partner at Egan-Managed Capital, Creeden has spent countless hours on due diligence for new ventures.

MassDevice Q&A: Serica Technologies CEO Greg Altman

December 28, 2009 by Brad Perriello

Serica Technologies Inc. president and CEO Greg Altman on leveraging a platform product and the importance of creating a "learning organization."

Serica Technologies CEO Greg Altman

Thirteen years ago Greg Altman, president and CEO of Serica Technologies Inc., blew out his knee playing football. After reconstructive surgery on his ruptured anterior cruciate ligament, the former All-American at Tufts University found the rehabilitation process so challenging that he set out to develop an alternative.

At Employ+Ability, work is good

December 24, 2009 by Joe Nowlan

Employ+Ability Inc., like many of its disabled employees, has been defying the odds for nearly 30 years.

At EmployAbility work is good

Like many of its 33 employees, for more than 27 years Employ+Ability Inc. has been defying the odds.

As with many American manufacturers, this small original equipment maker in Braintree, Mass., faced the brink when competition from China began prying away business in 2004. The company, which primarily makes hot and cold packs for companies like Covidien (NYSE:COV), Johnson & Johnson (NYSE:JNJ) and Inverness Medical Innovations (NYSE:IMA), lost a $10 million contract to the Far East and the future looked a little grim.

MassDevice Q&A: Advertising executive Bruce Lehman

December 23, 2009 by Brian Johnson

Advertising executive Bruce Lehman on the challenges and opportunities in marketing medical devices for the masses.

MassDevice Q&A: Advertising executive Bruce Lehman

Bruce Lehman's been in the advertising game since the late 1970s, but the principal at Lehman Millet, a Boston-based marketing and communications agency, has been focused on the medical device and diagnostics industry solely since the 1990s, making it a powerful player in the industry despite its relatively small size.

Today, Lehman Millet's client mix includes biotechnology, biomaterials and specialty pharmaceutical firms, along with its core medical device customers. MassDevice: spoke with Lehman, 59, about an ever-present question: "How, exactly, do you market a medical device?"

MassDevice Q&A: Thermo Fisher Scientific CEO Marc Casper

December 7, 2009 by Brad Perriello

Thermo Fisher Scientific's new CEO Marc Casper on taking the reins from Marijn Dekkers and his cautious optimism about 2010.

A MassDevice.com Q&A with Thermo Fisher Scientific CEO Marc Casper

To outside observers, Marijn Dekkers' departure from the corner office at Thermo Fisher Scientific (NYSE:TMO) might have seemed abrupt. After a seven-year run during which he led a profound re-shaping of the laboratory equipment and supplies manufacturer (and boosted revenues from the $2 billion range to about $10.5 billion a year), Dekkers resigned as CEO of the Waltham, Mass.-based firm to take the helm at German pharma giant Bayer AG.

Winning the arms race: The centuries-old quest to build a better prosthetic

November 25, 2009 by Alan Siegel

Advances have been few and far between since Ambroise Paré invented modern prosthetics in the 16th century. But the wars in Iraq and Afghanistan might just change that.

Winning the arms race: The centuries-old quest to build a better prosthetic

JUNE 22, 2008 WAS A GORGEOUS EARLY SUMMER DAY, with partly cloudy skies and 80-degree temperatures.

Taking advantage of the weather, Greg Reynolds, a muscular 24-year-old veteran of Operation Iraqi Freedom, hopped on his yellow Suzuki TL1000R racing bike to spend the morning at Colt State Park in Bristol, R.I., a swath of land on Narragansett Bay some 17 miles south of his house in Dighton, Mass.

The TL1000R is not a motorcycle for the casual rider. Its 996C, 4-stroke engine is capable of 9,500 RPM — or zero to 60 miles per hour in about 3.6 seconds — giving the rider the feeling of being strapped onto the nose of a rocket.

The rebuilding process begins

November 20, 2009 by Alan Siegel

Greg Reynolds had to rebuild himself, physically and mentally, to recover from his accident and from the post-traumatic stress disorder he brought back from Iraq.

It wasn't until after the accident that Greg Reynolds realized he was suffering from post-traumatic stress disorder. The cloud of invincibility that first came over him in Iraq lingered long after he returned to Massachusetts. He even worked as a guard for cash-handling company Loomis Armored – and didn't wear a bullet-proof vest.

And he just couldn't relax. He drove friends crazy with his strict daily schedule.

The prosthetic fitting process

November 20, 2009 by Alan Siegel

Fitting an amputee for a prosthetic takes advantage of the latest, cutting-edge design and manufacturing technologies.

The prosthetic fitting process

Prosthetist Luke Richards' small office is tucked deep inside the Jamaica Plain branch of the VA Boston Healthcare System. One morning this spring, a patient's carbon fiber leg rests by his desk. A chrome briefcase, with a picture of Greg Reynolds' new arm on it, sits on the window sill.

Here, in the E Wing of the hospital, veterans are fitted for prosthetic devices. It doesn't end with arms, legs, hands and feet, either. For example, Reynolds is itching to get back to regularly riding his ATV. So Richards suggested a sleeve that will fill out Reynolds' shirt while he's riding.

For Richards, the question is always the same.

"What do we need to do," he says, "to get [the patient] doing what he used to do?"

To Iraq and back

November 20, 2009 by Alan Siegel

Greg Reynolds survived more than a year in Iraq without a scratch. It was only after his return that an accident nearly killed him.

To Iraq and back

Somehow, amid the chaos of the ambush, Greg Reynolds felt invincible.

It happened on Nov. 9, 2003, near Balad, Iraq.

"We were rolling up on a couple of Humvees that were broken down," Reynolds writes in an e-mail. It didn't take long to see that his unit was under fire. "I get out of the truck tactically and realize, 'Holy shit.'"

Bullets whizzed by his head. Civilians hid nearby.

"We were about 50 yards behind the lead vehicle, taking hand signals from them," he recalls. "Then we start raking rounds around the civilians. The enemy was dug in the brush, scattered around a 30-40 yard area. We hit it with everything we had."

The Humvees kept moving. With two critically injured soldiers in tow, it was the only option.

MassDevice Q&A: GE Healthcare's David Freeman

November 17, 2009 by Brad Perriello

The general manager of parameters for GE Healthcare on the company's FCC petition for a dedicated wireless spectrum for medical devices and his vision for the hospital of the future.

MassDevice Q&A: GE Healthcare's David Freeman

It's no secret that wireless technology is in a growth spurt. From WiFi cars on commuter trains to the omnipresent Bluetooth and iPhone devices, as the saying goes, "There's an app for that."

The medical industry is no exception. Wireless medical devices are becoming more and more common, with innovations like pacemakers that can send data directly to physicians. GE Healthcare is looking to push the envelope even further, with a vision for wireless medical monitoring systems that would eliminate the rat's nest of cables that spring up around hospital patients.

MassDevice Q&A: American Well CEO Roy Schoenberg

November 11, 2009 by Brian Johnson

The web-enabled, on-demand healthcare service firm's chief on why 2009 will be a watershed year and the similarities between fundraising and warfare.

MassDevice Q&A: American Well CEO Roy Schoenberg

Roy Schoenberg seems to have the gift of good timing.

The 42-year-old is CEO of American Well, a Boston-based company that's developed a web-enabled, on-demand healthcare service so patients can speak directly to physicians at any time. The system could prove to be a low-cost solution to getting healthcare to the uninsured or under-insured — pretty fortuitous timing, when you consider Washington's struggle to figure out a way to control spiraling healthcare costs while increasing access to care.

MassDevice Q&A: Maggie Pax

October 23, 2009 by Brian Johnson

The business development VP for the implantable drug/device developer on innovation through diversity and her keynote address at the Medical Product Outsourcing Symposium.

MassDevice Q&A: Maggie Pax, MicroCHIPS business development VP

MicroCHIPS Inc. may have been the result of divine inspiration (as the story goes, MIT professor Robert Langer thought of the idea while watching PBS), but it took people like Maggie Pax to turn his vision into a suite of implantable devices that could one day revolutionize medicine.

MassDevice Q&A: Michael Frazzette

October 23, 2009 by Jim Montalto

The Smith & Nephew Endoscopy president on how arthroscopic techniques have evolved and the importance of staying focused on customers and core business.

MassDevice Q&A: Michael Frazzette

After 20 years in the medical device business, you might think Smith & Nephew Endoscopy president Mike Frazzette had grown jaded. But the industry innovations, ranging from the mechanical tissue shaver that started it all for Smith & Nephew Endoscopy to current work with bioabsorbable materials, continue to amaze and engage him.

MassDevice asked Frazzette about how his endoscopy business has evolved and the way Smith & Nephew leverages its developing technologies in adjacent business segments.

MassDevice: How did you get your start in medical devices?

MassDevice Q&A: Steve Atkinson & Scott Schorer

October 19, 2009 by Brad Perriello

The CEO and Americas president, respectively, of wound care giant Systagenix on the carve-out from Johnson & Johnson and putting together a multi-million dollar deal amid economic turmoil.

MassDevice Q&A: Steve Atkinson & Scott Schorer

When Systagenix Wound Management, the former professional wound care business of Johnson & Johnson's Ethicon subsidiary, was carved out late last year, the timing wasn't propitious. Credit markets were frozen and the global economy was staring into an abyss with another Great Depression at the bottom.

Nearly a year later, it's a different story. The credit crisis has eased, there are signals that the recession may be coming to an end and Systagenix is on a roll, having engineered the spinout with help from backers One Equity Partners and JP MorganChase.

MassDevice Q&A: Patrick O'Donnell

October 15, 2009 by Brad Perriello

The CEO of Prochon Biotech on moving the company from R&D to commercialization, other markets for its BioCart knee cartilage regeneration technology and potential pitfalls facing orthopedic device makers.

MassDevice Q&A: Prochon Biotech CEO Patrick O'Donnell

Prochon Biotech, the Woburn, Mass.-based company that's developing biologic knee repair technology, got its start in an unlikely sphere.

The company is leveraging its core technology, a patented fibroblast growth factor variant, grew out of research into achondroplasia, a skeletal condition that leads to so-called dwarfism.

MassDevice Q&A: William Rutan

October 14, 2009 by Brian Johnson

The CEO of Mederi Therapeutics on the challenges of increasing awareness of bowel incontinence and his company's minimally invasive alternative to colostomy surgery.

MassDevice Q&A: Mederi Therapeutics CEO William Rutan

How do you get people to talk to their doctors about something so embarrassing they'll barely admit it to themselves?

That's the challenge facing Greenwich, Conn.-based medical device startup Mederi Therapeutics and the minimally invasive treatment for fecal incontinence it says will eliminate the need for drastic colostomy procedures.

MassDevice Q&A: Campbell Rogers

October 9, 2009 by Brad Perriello

Cordis Corp.'s chief scientific officer on the move from bedside to boardroom, and what Cordis has in its development pipeline.

MassDevice Q&A: Campbell Rogers

Campbell Rogers, the chief scientific officer for Johnson & Johnson subsidiary Cordis Corp., knows interventional cardiology from both sides of the clinical trial.

As the former director Brigham & Women's Hospital's catheterization lab and principal investigator of the Brigham's interventional vascular biology laboratory, Rogers led multi-center device and pharmacologic trials before joining Cordis in July 2006.

There he finds himself on the other side of the process as head of Cordis' research and development team — a role the company created for him.

Mass Device Q&A: Dave Kroll

October 5, 2009 by Jim Montalto

The founder of Kroll Associates on why distance doesn’t matter and the role small, focused firms will play in the expansive and varied medial devices field.

Mass Device Q&A: Dave Kroll

Dave Kroll, the founder and principal of Kroll Associates, works out of his office in western Massachusetts, which, according to him, proves there is life in design and product development beyond Worcester and the Greater Boston area.

In fact, Kroll sees his distance from Boston as an advantage, since he can also tap New York, Vermont, Connecticut, New Hampshire and beyond for new work.

He has clients in and around Boston, sure — one of his biggest is in Waltham — but his ties to New England universities, contractors and manufacturers, and his persistence in maintaining a presence with clients, either virtually or through office visits, keeps him on top of the industry.

MassDevice Q&A: Charles Mathews

October 1, 2009 by Brad Perriello

The Boston Healthcare Associates reimbursement expert dishes on the healthcare reform push and how it will affect medical device makers, ahead of his keynote speech at the MassMEDIC 11th Annual Medtech Investors Conference.

MassDevice Q&A: Charles Mathews

Charles Mathews is no stranger to Capital Hill, having worked as a legislative aide to Reps. David Price (D-N.C.) and Rob Andrews (D-N.J) in the early years of the decade. That experience comes in handy in his role a director at Boston Healthcare Associates, where he's keeping tabs on the ever-evolving debate over healthcare reform in Washington.

MassDevice Q&A: Dave Bergstein

September 30, 2009 by Brad Perriello

The Zoíray Technologies founder and CEO on the next big thing in diagnostics, why his startup might be the company that delivers it and making his pitch at the MassMEDIC Investors Conference.

MassDevice Q&A: Dave Bergstein

Ask Dave Bergstein about the next big thing in diagnostics and his eyes light up. The Zoíray Technologies Inc. founder and CEO runs startup that's developing a next-generation multiplexed immunoassay platform Bergstein thinks will become the new state-of-the-art standard for studying proteins.

MassDevice Q&A: Richard Packer, CEO of Zoll Medical

September 27, 2009 by Brian Johnson

The CEO of Zoll Medical Corp. talks about healthcare reform and the Chelmsford, Mass.-based resuscitation products maker's future.

Zoll Medical CEO Richard Packer

Richard Packer probably doesn't get confused for Konosuke Matsushita very often (first off, Packer's a lot taller), but listening to the CEO of Zoll Medical Corp. speak about his vision for the company can conjure images of the legendary founder of Panasonic and his 250-year business plan.

MassDevice Q&A: Richard Schumacher

September 21, 2009 by Brad Perriello

The Pressure BioSciences founder, president and CEO on how it took seven college majors for him to find his niche, making it through the recession and why his firm's pressure cycling technology could revolutionize scientific research.

Pressure BioSciences CEO Ric Schumacher

Richard Schumacher is no stranger to successful start-ups. The Pressure BioSciences founder, president and CEO had a hand in five early-stage life science ventures, including Boston Biomedica.

MassDevice Q&A: Philipp Lang

August 27, 2009 by Brad Perriello

The ConforMIS Inc. founder and CEO on custom-made implants, how the company was able to raise $50 million in a difficult investment climate and why ConforMIS is a lot like Dell Computers.

Philipp Lang wears a lot of hats. Besides being the founder, president, chairman and CEO of ConforMIS Inc., he's a radiologist and former director of the Musculoskeletal Radiology and Distinguished Weissman Chair at Brigham and Women's Hospital in Boston and associate professor at Harvard Medical School.

But ConforMIS and its breakthrough custom knee implant technology aren't Lang's first forays into the startup medical device world. He also founded Imaging Therapeutics Inc. (where he remains chairman) and served on the board at ViOptix Inc.

MassDevice Q&A: John McDonough

August 4, 2009 by Joe Nowlan

The T2 Biosystems CEO on the company's innovative, miniaturized diagnostic tool, the importance of de-risking before you hit the fundraising trail and why the U.S. intelligence community is interested in T2's technology.

John McDonough, CEO of Cambridge, Mass.-based T2 Biosystems Inc., is an optimist.

Bullish on his 22-employee company's prospects (the estimated $40 billion diagnostics market might have something to do with that), McDonough (far left in the picture at right) spoke with MassDevice about the technology behind T2's diagnostic device, which uses a miniaturized version of a magnetic resonance imaging machine to deliver near-instant test results from just about any blood, urine or saliva sample.

MassDevice Q&A: Thomas Taylor

July 21, 2009 by Brian Johnson

The president of Roush Life Sciences and incoming MassMEDIC chairman on his deep ties to the Michigan auto industry and why you should always listen to your mother.

Tom Taylor grew up in Grand Blank, Mich., just a short drive from Flint and the belly of General Motors'manufacturing machine.

The son of an auto executive and a registered nurse, the president of
Roush Life Sciences
always felt the pull of the two industries.

While a plastics engineering student at Ferris State University, Taylor worked at the GM technology center. But the idea of spending a career locked in a cube as a "right panel guy" forced him reconsider his options, a decision that today looks positively prescient.

MassDevice Q&A: Jean-Marc Wismer

July 14, 2009 by Brian Johnson

The CEO of Switzerland's Sensimed looks to peel back the lid on glaucoma testing.

You literally cannot see glaucoma coming.

Although it's one of the leading causes of blindness in the world, frighteningly little is known about a disease group that affects 4 percent of the world's population over the age of 40. No cure is on the horizon. And due to the insidious nature of the disease, which stars gradually affecting sight from the periphery, most people don't even know they're suffering from glaucoma until it's too late.

Swiss diagnostics company Sensimed AG sees this mysterious disease as a real opportunity.

MassDevice Q&A: Dean Kamen

July 8, 2009 by Brian Johnson

The inventor of the DEKA arm, the iBOT, the Segway (and others) on healthcare reform, the contrast between the pace of innovation and its adoption by society and how he'd like to be remembered.

Dean Kamen is rarely at a loss for words. In fact, the man is rarely at a loss for anything.

At a recent conference at Boston University, Kamen, 58, took up more than triple his allotted time for a keynote speech as he worked the assembled tech-heads and computer geeks into a near-frenzied lather amid shouts of "Dean for President," and basked in the warm embrace of a nearly five-minute standing ovation. Definitely not your average conference fare.

MassDevice Q&A: Stuart Randle

July 7, 2009 by Brad Perriello

The GI Dynamics president and CEO on the importance of maintaining an even keel, finding the right people at just the right time and the next generation of bariatric products.

Stuart Randle, president and CEO of Lexington-based GI Dynamics, has a long career in medical devices under his belt. Originally a mechanical engineer with a degree from Cornell University, Randle got into the device world during his MBA studies at Northwestern University and never looked back.

MassDevice Q&A: Charles Remsberg

July 1, 2009 by Brian Johnson

The CEO of robotic rehab equipment maker Hocoma's U.S. division on how robotics will change rehabilitation and why thinking Swiss has helped the company weather the downturn.

Charles Remsberg literally learned the medical device business from the ground up.

The 47-year-old's first job in the industry was sweeping the floors in a warehouse. That's also where he learned that it's more important to be judged by your work than your alma mater's pedigree.

The Long Island native's resumé includes stints ranging from clam digger to his current role as CEO of the American division of Hocoma Inc. in Rockland. Switzerland-based Hocoma produces the Lokomat, a robotic rehabilitation system that helps people suffering from spinal cord injuries and brain trauma learn how to walk again by acting as their legs.

MassDevice Q&A: Shawna Gvazdauskas

June 30, 2009 by Brian Johnson

Medical device industry veteran and Isis Biopolymer's new chief commercial officer on why the company's drug patch platform is revolutionary and the keys to bringing medical devices to market.

Shawna Gvazdauskas has a knack for bringing medical devices to market. The 53-year-old is on the third start-up of her 30-year career. In March, she left insulin management maker Insulet, where she helped bring the company's flagship Omnipod to market, for a new challenge at Isis Biopolymer Inc., which is developing a new generation of non-invasive drug delivery patches.

MassDevice Q&A: Kevin Outterson

June 23, 2009 by Brian Johnson

The Boston University law professor and pharmaceutical industry monitor on the origins of the Massachusetts gift ban and how medical device makers came to fall under its rules.

Kevin Outterson, an associate law professor at Boston University, is an expert on patent law and intellectual property as it applies to the pharmaceutical industry. He works to balance the incentives behind innovation with making sure low-income people have access to life-saving therapies.

MassDevice spoke with Outterson about the background behind states' efforts to rein in industry, specifically "Big Pharma," and how medical device makers came to be folded into the strict Massachusetts regulations governing industry payments to physicians.

MassDevice: Can you give us a quick history of the roots of the gift ban in efforts to regulate the pharmaceutical industry?

MassDevice Q&A: Amar Sawhney

June 19, 2009 by Brian Johnson

The founder of six companies, including Waltham's I-Therapeutix, on market conditions and the future of medical devices.

Amar Sawhney has a knack for turning gel into gold.

Over the years, the serial entrepreneur managed to leverage his work in hydrogel technology at the University of Texas into the basis for six companies, including one snapped up by Genzyme early in the decade and another that Covidien predecessor Tyco Healthcare acquired in 2006.

MassDevice Q&A: Michael Phalen

June 10, 2009 by Brad Perriello

The president of Boston Scientific's endoscopy division on putting patients first and why he's worried about the medical device industry's ability to innovate.

Michael Phalen, president of Boston Scientific Corp.'s endoscopy division, began his long tenure at the Natick devices giant in 1988 as a sales rep. After several crossings between the outside sales world and inside marketing positions, he was named president of the endoscopy operation in 1991.

It was a good time to get into endoscopy, Phalen tells MassDevice, as physicians began using the technology to provide previously unheard of, minimally invasive views of the workings of the human body.

MassDevice Q&A: Jeff Burbank

June 10, 2009 by Jim Montalto

NxStage Medical founder and CEO Jeff Burbank on the importance of people, better home devices and improving on what works.

More than 20 years of developing, marketing and manufacturing products for end-stage renal disease patients led NxStage Medical Inc. founder, president and CEO Jeff Burbank to a realizations: The key to improving care is to look beyond the hospital and into the home.

The Lawrence-based company makes a home dialysis system that allows patients with kidney disease to better manage their own treatment. Burbank talked with MassDevice about how the success of the product hinges on improving patients' quality of life and how the success of the company relies on the timing of finding and keeping great employees.

MassDevice Q&A: Mark Tauscher

June 9, 2009 by Jim Montalto

The president and CEO of PLC Medical Systems on the FDA, the credit crunch and how his roots as a physiologist made him a great fit for the medical device industry.

Mark Tauscher joined PLC Medical Systems Inc. in January 2000 after more than 20 years in medical product sales, marketing and management. When he spoke with MassDevice, the company had just announced strong sales and narrowed losses for the first quarter, largely due to strong international sales.

Tauscher told us about the rocky road PLC traveled in getting FDA approval for its first device, a transmyocardial laser revascularization system, how it decided the RenalGuard device would be its follow-up and why he sees the global credit crunch as the industry's biggest challenge.

MassDevice Q&A: Paul Nickelsberg

June 9, 2009 by Jim Montalto

Orchid Technologies president and CTO Paul Nickelsberg on the conflict between getting devices to market fast and keeping the FDA satisfied, doing business in a down economy and what med-tech electronic breakthroughs are on the horizon.

Orchid Technologies Engineering & Consulting president and CTO Paul Nickelsberg is an electronics industry veteran, with experience ranging from high-end computing design to networking and telecommunications under his belt.

But it was his "try anything once" attitude that helped him break into the medical devices market.MassDevice caught up with Nickelsberg recently to get his ideas on coming challenges for the medical device market and his strategy for keeping clients happy during uncertain economic times.

MassDevice: How did your company get into medical devices?

MassDevice Q&A: Chris LaFarge

June 9, 2009 by Brad Perriello

The MedicaMetrix president and CEO on how its Prostaglove aims to revolutionize prostate care, looking to Europe for capital and why he wishes he'd stayed away from venture backing.

Chris LaFarge, president and CEO of MedicaMetrix, is betting on his firm's ProstaGlove device to change the way doctors track and treat the prostate. The product is essentially a disposable rubber glove armed with sensors LaFarge says will provide a quantitative method for tracking the volume and growth rate of the prostate — the only human organ that never stops growing.

Pumped up

June 3, 2009 by Alison Carter

Insulet Corp. aims to change the way diabetics treat their disease with its OmniPod insulin management system.

Insulet Corp.'s OmniPod insulin management system

The symptoms had started about three weeks before — feeling constantly tired and thirsty, going to the bathroom frequently and losing a drastic amount of weight.

My doctor told my parents to bring me to the Children's Hospital of Philadelphia, where I would learn how to adjust my diet and schedule, administer medication and deal with the illness.

Extra credit

May 27, 2009 by Robin Ellington

Medical device companies, especially early-stage start-ups, stand to save a bundle by taking advantage of a tax credit for research and development expenses.

For companies with a burn rate that's hot to the touch, there could be a little bit of relief from an unlikely source.

There's a little-known credit in the federal tax code for research and development expenses that could save early-stage companies a boat load of money.

But most firms either overlook the credit entirely, or find it too mystifying to bother with, meaning that this powerful accounting tool isn't getting the kind of play it should with the companies that need it most.

Letting in the light

May 19, 2009 by Jim Montalto

A pair of Andover sister companies, Amorphex Therapeutics and Vista Scientific, are hoping to advance the treatment of serious eye diseases like glaucoma using sophisticated contact lens technology.

There's a certain irony to Amorphex Therapeutics working in the dark basement of a 100-year-old Andover mill building.

"It’s atrocious, but classic," president and CEO Robert Thompson laughs, trying to explain the peculiarity of scientists working on cutting-edge ophthalmic technology in an antiquated former mill complex.

VasoTech gears up to go global

May 12, 2009 by Jim Montalto

The stent startup's founder, Tim Wu, may have started out in his garage, but he aims to take the lead in developing the next generation of drug-eluting stent.

VasoTech founder Tim Wu

It would have been easy for Tim Wu, cardiologist and founder of VasoTech Inc., to give up on his vision for the next generation of drug-eluting stent. He didn’t.

Instead, he invested $50,000 of his own money to set up shop in his garage and build a better stent, wrapping three state-of-the-art elements — a cobalt chromium stent, a biodegradable polymer and a potent combination of two anti-restenosis drugs — into a single device he calls the PowerStent. And he's counting on that power to take his fledgling company global.

The next generation

MassDevice Q&A: MassMEDIC president Tom Sommer

May 1, 2009 by Brad Perriello

The president of the nation's largest regional medical device council tells MassDevice why device makers are happy to toil in obscurity, the problem with the Massachusetts gift ban and what's in play now that there's a new administration in Washington.

Tom Sommer's been a major player on the Massachusetts medical device scene for more than a dozen years. As president of the Massachusetts Medical Device Industry Council (MassMEDIC), Sommer runs the nations largest regional medical device council, addressing the needs of more than 400 member companies.

With the council's May 5 annual conference on the horizon, MassDevice visited Sommer at MassMEDIC's offices at the Boston Medical Center (PDF) campus to find out what's on the minds of the device company executives he visits each week, how they're coping with a down economy and the challenges imposed by the Bay State's stringent gift ban.

Dr. Obama is in the house

April 21, 2009 by Katie Quackenbush

More than $1 billion from the American Recovery and Reinvestment Act is earmarked for comparative effectiveness research. What will that mean for the Commonwealth's medical device sector?

Apples and oranges

Suzanne Ryan has a bum knee. If she doesn’t spend most of the day sitting down, she ends up coping with a lot of pain.

Her doctors say there are two options for the semi-retired elementary school teacher: Knee replacement surgery, using state-of-the-art plastic implants, or periodic injections to reduce inflammation and pain and improve joint flexibility.

When MassDevice first speaks with Ryan, in March, she's unsure which offers the best chance of regaining mobility.

"I’m not sure which treatment I’ll choose,” Ryan says. "The device or the drugs."

President Barack Obama wants to help her decide.

Banned in Boston

April 6, 2009 by Chris Markuns

Massachusetts enacted the nation's strictest law governing industry payments to physicians. What does the so-called "gift ban" mean for the Commonwealth's medical devices sector?

Say goodbye to the promotional pen

Pharma is sexy. Big drugs, big money, big news. In the life sciences arena, perhaps only biotech commands a higher political and public profile.

So it isn’t surprising that the medical device industry’s groundbreaking inclusion in Massachusetts’ new code of conduct garnered relatively little attention.

But the new rules governing industry payments to physicians — the so-called "gift ban" — include provisions aimed at curbing what some call undue and improper influence by medical device manufacturers.

Medical devices: A safe harbor in the economic tsunami?

March 30, 2009 by Davin Wilfrid

Despite the worldwide recession, there's hope for the medical device manufacturing sector.

The conventional wisdom that healthcare companies are immune to economic turmoil has gone the way of subprime derivatives and credit default swaps, as reduced consumer spending and tight credit markets have squeezed even the most “recession-proof” industries.

But there are signs of hope for medical device and diagnostics companies, as nervous investors seek quicker returns than pharma or other life science firms can offer.

Experts say the local job market for medical device professionals remains comparatively strong, despite the downturn, and the New England device industry remains an attractive target for government grants and other efforts to stimulate innovative sectors of the economy.

The big picture

Smart Surfaces aims to put bedsores to rest

March 30, 2009 by Alan Siegel

The (literally) visionary "rolling diaphragms" in the Billerica, Mass., startup's mattress are designed to eliminate pressure ulcers.

Smart Surfaces founder Tim Moutafis. Photo by Kat Duncan.

Tim Moutafis has visions.

Sitting in his racing green Triumph TR7 convertible one summer afternoon in August 1993, the Smart Surfaces Inc. founder envisioned miniature robots roaming around the human body, fixing problems. A decade later, daydreaming at work, he saw a living, breathing blob.

“A blob that knows your body very well and listens to it,” Moutafis explains from his office at Science Research Laboratory in Somerville, Mass.

“It sends information, it sort of heals you, protects you, rejuvenates you.”

Thinking small to solve big problems

March 30, 2009 by Joe Nowlan

The Institute for Pediatric Innovation is on a mission to develop medical devices and drugs for children.

Dr. Timothy Tracy of Hasbro Children's Hospital. Photo by Jane Fox.

When it comes to little children, medical devices can be a very big problem.

Take Dr. Thomas Tracy, a professor of surgery and pediatrics at Brown University. Virtually every day, Tracy deals with the fallout from the lack of child-sized medical devices.

“It just impacts your life every day, when you turn around and there’s yet another [device] you can’t apply to a kid,” says Tracy, professor of surgery and pediatrics at Brown University and pediatric surgery chief at Hasbro Children’s Hospital in Providence, R.I.

Organic growth

March 30, 2009 by Brandie Jefferson

Canton’s Organogenesis hopes to stake its turf as the worldwide leader in tissue regeneration.

A worker readies an Apligraf sample. Photo by Connor Gleason.

It turns out the secrets of science aren't always on the tip of your nose.

At Organogenesis, a Canton-based tissue regeneration firm, the company’s signature product, Apligraf, is derived from the cells of foreskins donated by the mothers of newborn baby boys. A single donor can eventually generate up to two football fields’ worth of Apligraf, according to Dario Eklund, the company’s VP of bioengineering and bioaesthetics.

That’s because the newborn donors’ cells are "so young, so robust, so full of life, that they can divide and build cell banks," Eklund explains.

MassDevice Q&A: Susan Windham-Bannister, Part I

March 30, 2009 by Brian Johnson

The head of the Bay State's Life Sciences Center explains the difference between $1 billion and $33 million.

Susan Windham-Bannister. Photo by Kimberly Moa.

The Massachusetts Life Sciences Center cuts a high profile these days. Created by the state Legislature in June 2006 to foster research and economic development in the Commonwealth’s substantial life science sector, the center has money to burn, thanks to the Life Sciences Act the Bay State passed last year.

Led Susan Windham-Bannister, a former healthcare policy wonk turned business strategy consultant turned state life sciences czar, the quasi-public agency is charged with dispensing a mix of public and private funding to cultivate the state’s medical device, biotech and pharmaceutical sectors.

Running in place

March 30, 2009 by Brian Johnson

Cambridge's InVivo Therapeutics is charging toward a cure for paralysis. Will investors come along for the ride?

Frank Reynolds taught himself how to walk again after doctors said he couldn't. He made a monkey run two weeks after a traumatic spinal cord injury. In fact, Frank Reynolds might even hold the cure for paralysis in the palm of his hands.

Who knew that would be the easy part?

Just after an investors conference last fall, Reynolds, the founder and chief executive of Cambridge’s InVivo Therapeutics Corp., stood just outside the conference center at Umass Boston’s Campus Center looking slightly bewildered.

MassDevice Q&A: Susan Windham-Bannister, Part II

March 2, 2009 by Brian Johnson

The second installment of a long conversation with Susan Windham-Bannister, head of the Massachusetts Life Sciences Center.

Susan Windham-Bannister. Photo by Kimberly Moa.

The Massachusetts Life Sciences Center cuts a high profile these days. Created by the state Legislature in June 2006 to foster research and economic development in the Commonwealth’s substantial life science sector, the center has money to burn, thanks to the Life Sciences Act the Bay State passed last year.

Led by Susan Windham-Bannister, a former healthcare policy wonk turned business strategy consultant turned state life sciences czar, the quasi-public agency is charged with dispensing a mix of public and private funding to cultivate the state’s medical device, biotech and pharmaceutical sectors.

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