Contributor: Mike Phung

Last week at the Society for Imaging Informatics in Medicine (SIIM) 2013, a session was given on vendor neutral archives (VNAs) and picture archiving and communication systems (PACS) vendors with neutral systems, which can integrate with any current archiving solution. While there is a significant difference between the two, it all comes down to providing the end-user health care facility an open architecture for their systems to integrate with other systems.

Contributor: Mike Phung

Mobile applications and mHealth in general was a huge topic at the Society for Imaging Informatics in Medicine (SIIM) meeting this year, in line with the increasing usage of smartphones and tablets for both consumers and medical professionals.

Contributor: Karen Gierszewski

I haven’t posted anything on the ‘innovation crisis’ in the US in awhile but rest assured—it’s still kicking.

Contributor: Julie McLaughlin

Although the sun was slow to make an appearance during this EuroPCR, Paris in the rain is still a great place to be. From the Eiffel tower to my daily breakfast at the Boulangerie down the street (pain au chocolat et croissant pour moi), Paris is one of my favourite cities and this visit was no exception.

Contributor: Julie McLaughlin

In the city of love, hearts were “a-flutter” with news of recent trial results and updates on the transcatheter aortic valve replacement (TAVR) device market.

Contributor: Kyle Verleyen

Day 1 at EuroPCR was all about bioresorbable vascular scaffolds (BVS) in the interventional cardiology space as Elixir Medical rolled out the clinical results of the DESolve trial. Receiving CE mark approval last week, Elixir Medical's entrance into the BVS market surely signifies a changing of the guard in how we view stents and stent technology going forward. Or does it?

Contributor: Jeremy Seath

Here’s an angle to the Affordable Care Act (ACA) you don’t often hear: the effect of the legislation on oral health. There is little doubt that the implementation of the ACA will positively affect children, with an estimated 5.3 million children expected to receive dental coverage in 2014. This will help to provide children with access to dental care and improve oral health among the nation’s youth. However, there is concern that this could have a negative impact among the oral health of adults in the US.

Contributors: Michelle Chan and Kristina Vidug

The internet has been abuzz since yesterday morning, when activist and celebrity extraordinaire Angelina Jolie released an op-ed revealing that she had undergone an elective double-mastectomy, after finding out that she carries the BRCA1 gene mutation, which puts her at a vastly increased risk of developing breast cancer. By removing both of her breasts, she has reduced her risk to a mere 5% chance of developing the disease, down from 87%.

Contributor: Julie McLaughlin

The gloves were off at the 34th annual Heart Rhythm Society (HRS) conference this year in Denver. I attended several debates this year, including the new “Battle of the Titans” debate sessions, complete with boxing gloves for the debate participants.

Contributor: Julie McLaughlin

The 34th Heart Rhythm Society (HRS) conference was held in Denver this year, bringing physicians and industry from across the globe to the mile high city. One thing I really enjoyed about this conference was the reunion feel to it; it seemed that everywhere I turned old friends were meeting up, exchanging hugs and catching up.

Contributors: Laura Beerman and Ed Park

A recent survey by consultants L.E.K. of more than 200 hospital executives paints the picture: the next five years will likely see spending decreases for large device med tech spending. With 80 percent of those respondents already members of or planning to join accountable care organizations (ACOs), there are three things medtech should put on its radar.

Contributor: Karen Gierszewski

Earlier this year, our VP Adrienne Lovink presented the top ten trends to look out for in 2013. To no one’s surprise, a focus on health economic outcomes was listed as our top trend. We all know the story: even though medtech markets in countries like China and India are fast-growing, the large US and European markets still represent the bulk of revenues for most global companies. As a result, companies are having to adapt to a shifting view of health care in these countries as governments and regulatory bodies clamp down on unnecessary spending.

Contributors: Jennifer Smith and Canny Ho

The American Urological Association (AUA) annual meeting is the world’s largest gathering of urologists, and is in its impressive 108th year. Offering quality urologic education for urologists and urologic health care professionals, this year AUA is located in exciting San Diego, California!

Contributors: Karen Gierszewski, Ian Swanson, and Jeremy Seath

In Toronto, the weather is getting warmer but all eyes are on our favourite winter sport: hockey. Although everyone in Toronto has their own loyalties, the big news is that this year, the Toronto Maple Leafs are in the playoffs after an almost decade-long drought. As you may or may not know, as a team that hasn’t won the Stanley Cup since 1967, the Toronto team still has legions of devoted fans and manages to consistently pack the Air Canada Centre. 

As with all sports, there is an inherent risk of injury with hockey. Participating in a contact sport, hockey players are no stranger to contact from opponents, hockey sticks, and pucks. While their bodies and heads are covered in equipment to protect from these blows, hockey players have historically worn little protection for their mouths.

Contributors: Karen Gierszewski and Louise Murphy

Last week, the news broke that Cook Medical is recalling its Zilver PTX drug-eluting stents (DES), which had been so eagerly anticipated by US physicians following an incredibly arduous FDA approval process. Even at the time of the recall, it was only available in 85 US hospitals, leaving many physicians awaiting more widespread release. At the recent Society for Interventional Radiology (SIR) meeting, a couple of interventional radiologists were lamenting still not being able to get their hands on the device.

Contributors: Charlotte ChanLee and Milad Alizadeh-Meghrazi

We are back again in New Orleans for another conference! After attending both HIMSS and SIR 2013, we are back for a third time to attend AANS 2013.

Contributor: Karen Gierszewski

Hopefully we’ve all spent at least a bit of time thinking about the environment as we wrap up volunteer week, which started on Earth Day on Monday.

Contributor: Kristina Vidug

Jean-Claude Mas, the egregious owner of the now defunct PIP Implants, is currently on trial for fraud charges resulting from the use of industrial (as opposed to medical) grade silicone in the company’s breast implants. By some accounts, upwards of 300,000 women in 65 countries have been affected by the faulty implants. In France alone, some 5,000 women have registered as plaintiffs in the case, making it one of the country’s biggest trials.

Contributor: Chantal Dougan

Saturday was my last day at Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 2013 conference. The day started off bright and early with a series of presentations focusing on advancements in military surgery. I was particularly excited for this presentation, knowing that the US military has played a role in the development of many examples of cutting edge technology.

Contributor: Louise Murphy

Overall, the Society for Interventional Radiology (SIR) 2013 meeting was an excellent conference. I loved the innovative spirit of the interventional radiologists, their excitement about new procedures and devices, and their dedication to taking their profession to the next level by focusing on economic outcomes-based research. Host city New Orleans was also a fantastic time.

Contributor: Chantal Dougan

On my second day at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) annual meeting, the highlight of the day was definitely the Presidential Debates session. Having just written MRG’s US Markets for Laparoscopic Devices 2013 report in December, I was quite interested to listen to one debate in particular: “Be it Resolved That It Is Time to Play “Taps” for Single Incision Laparoscopy.” Or, in other words, it’s time to give up on single-site surgery.

Contributor: Louise Murphy

Here are the two trials you need to know about from the Society of Interventional Radiology (SIR) 2013 meeting. The buzz these days is around stent grafts for dialysis access, and embolization as a treatment for benign prostatic hyperplasia (BPH).

Contributor: Chantal Dougan

At the end of my first day at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) conference in Baltimore, Maryland, it was easy to see that the hot topic among endoscopic and gastrointestinal surgeons is reducing the invasiveness of the (already minimally invasive) procedures they offer their patients. Fortunately for those in the medtech industry, much of the talk involved managing diseases with implantable or endoscopically deployed medical devices, rather than simply changing techniques or instituting procedures with limited device usage.

Contributor: Louise Murphy

The final day at the Society of Interventional Radiology (SIR) 2013 meeting was marked by a series of lively and (mostly) good-spirited debates. The gloves came off as notable members of the interventional radiology community—including several past-presidents—duked it out over assigned topics. While the debate about centers of excellence vs community care and the debate about the need for diagnostic radiologists were thoroughly entertaining and had the crowd in stitches, I particularly enjoyed the subject matter in the FDA vs CE approval debate.

Contributor: Louise Murphy

A key theme that I’ve noticed at the Society of Interventional Radiology (SIR) 2013 meeting is an ongoing attempt to define the interventional radiologist (IR) specialty. What does the future hold for IRs?

Contributors: Karen Gierszewski and Kyle Verleyen

Lately, the intravascular imaging catheter and pressure guidewire markets have been attracting the majority of attention in the interventional cardiology (IC) device world. As concerns about overstenting plague the market, these catheters and guidewires represent one of the few remaining areas of growth. But there might be one more area worth considering: chronic total occlusion (CTO) treatment.

Contributor: Karen Gierszewski

So apparently it’s spring in Toronto now, although you wouldn’t know from the horrible, horrible cold wind that’s been whipping around the city the last few days. I’m probably a bigger fan of winter than a lot of people, but I’m feeling pretty ready for warmer weather now…come on, Spring!

Anyway, here’s this season’s edition of random medtech articles. Check out the links below for information on worldwide obesity, the medtech companies with the happiest employees, and the latest updates on the medical device excise tax.

Contributors: Karen Gierszewski and Louise Murphy

From a patient and clinician perspective, intravascular imaging catheters and pressure guidewires only mean good things for coronary stent procedures. You can more accurately identify stenting candidates? Great. You can better select the correct size and length of stent to use, and you’ll have a better idea of exactly where to put it? Wonderful. You can easily find out if the stent has been correctly placed? Fantastic. Nonetheless, from an industry standpoint, things are less obviously rosy.

Contributor: René Azeez

When first tasked with undertaking the market analysis for the veterinary orthopedic device market, I was slightly amused. The competitive human orthopedic device market is a battle field, with surprises and controversies around every corner, but I asked myself, does anyone really care about what is going on in the veterinary orthopedics world? Is strategic planning even a thought to manufacturers in that space? After all, to me any competitor in that space was always going to be labeled as little brother to the Medtronics and the Strykers of this world. Two months later, I can vehemently say, I was wrong for entertaining such a thought. This market is serious business.

Contributor: Melissa Hussey

Over the last 10 years, shoulder surgery has been gaining interest among both surgeons and the medtech manufacturers. The suite of products available has expanded to include several new technologies, including shoulder resurfacing and reverse shoulder implants, which have provided surgeons with a toolkit to treat patients who would have been previously ineligible for surgery. As product options and patient demand expands, the total procedure volume for shoulder arthroplasty surgery has expanded to about 110,000 annual surgeries in the US in 2012.

Contributor: Dan Brown

Day two of the annual American Academy of Orthopaedic Surgeons (AAOS) conference in Chicago has wrapped up with political advocacy being the theme of the day—only there were two very different stances on how that should play out.

Contributors: Brian Lipp and Karene Dumoulin

Welcome to a snowy and chilly China Interventional Therapeutics (CIT) conference in Beijing, China. Here are some notable highlights from today.

Contributor: Dan Brown

It was a busy Day One of the annual American Academy of Orthopaedic Surgeons (AAOS) conference in Chicago, and large-joint arthroplasty was the predominant theme.

Contributor: Ian Swanson

While this year’s American College of Cardiology (ACC) conference didn’t pack the late breaking clinical trial firepower of years past, the expectation was that the PREVAIL trial results of Boston Scientific’s Watchman endovascular left atrial appendage (LAA) closure device were going to be the one late breaker to watch, and it definitely was.

Contributor: Carmen Chan

Over the course of three days, MRG successfully toured all 5 halls (a total of 10 floors!) of the International Dental Show (IDS). Despite the sore feet and broken backs (that’s what it felt like, anyway), I’ve learned so much and met many of our clients. While we introduced ourselves to various companies, I was also happy to know that others recognized us and praised our reports. Here are some of my final thoughts looking back at IDS 2013.

Contributor: Dan Brown

We’re just one day away from the launch of the annual meeting of the American Association of Orthopaedic Surgeons (AAOS) happening this year at McCormick Place in windy Chicago…and MRG is going to be there.

Contributor: Ian Swanson

If there was one theme presented at the recent American College of Cardiology (ACC) conference, it was ever increasing role of data of all kinds.

Contributor: Carmen Chan

On the second day of the International Dental Show (IDS), it only got busier as both exhibitors and dental personnel filled up the conference halls, restaurants, and outer courtyard. Wandering the halls and speaking with multiple manufacturers, I’ve noticed that many companies share similar goals for what they want to achieve at the congress.

Contributor: Carmen Chan

On a rather cold and slushy March day in Cologne, Germany, the bi-annual International Dental Show (IDS) kicked off for a full week of everything dental. With over 2,000 exhibitors, the IDS is the only international conference for all products dental. And despite the major snowstorm that hit the northern parts of Europe (including Germany), there is huge attendance from both the manufacturers and dentist visitors.

Contributor: Ian Swanson

Innovations in drug-eluting stents, beating heart surgeries, and endovascular approaches to repairing a damaged heart will all be on the agenda this weekend at the American College of Cardiology (ACC) conference as physicians look to advance cardiovascular medicine, but one of the biggest changes might be in their pockets.

Contributor: Karen Gierszewski

As we’ve discussed, 2012 was a difficult year for medtech. The future of Obamacare was up in the air, the American and the European economies hung in the balance, and growth in the BRIC countries didn’t live up to expectations. Nonetheless, we made it through…and medtech companies, somewhat surprisingly, seem to be feeling good about their prospects for 2013.

Contributors: Karen Gierszewski, Michelle Chan, and Chantal Dougan

When I first came across the controversy surrounding the frequency of screening for a variety of conditions, including breast and prostate cancer, my first thought was that more and earlier screening is obviously better. It’s just common sense—we know that catching cancer earlier can increase the chance of curing it. It turns out that it’s not quite so simple though.

Contributors: Karen Gierszewski and Mashkur Reza

Orthopedic stem cell products are a relatively new form of bone graft substitute (BGS) and have generated considerable hype in the industry. After all, these products are perceived to be one of the better alternatives to autografts (which are harvested from the patient’s own body) among many surgeons. But there are still a lot of questions around the effectiveness of these products.

Contributor: Karen Gierszewski

Ok, so we know that a lot of companies were loudly complaining about the effects of the medical device excise tax on their profits. Although some dismissed these complaints as unfounded, it seems to be a fact that a lot of layoffs happened in 2012.

Contributors: Karen Gierszewski, Ian Swanson, and Sean Messenger

It's easy to feel like past relationships have left an emotional scar on your heart (as cheesy as that sounds, we all know it's true).  Unfortunately, there's no real way to avoid that, although time is certainly helpful. Now, if your heart is clinically “broken”, there might yet be hope. As a Valentine’s Day special, here are a few technologies that are being developed that will literally leave less scarring if your heart is “broken”.

Contributors: Karen Gierszewski and Dan Brown

Robotic surgery remains a topic of high interest in medtech. The first surgical robot to gain notoriety, the da Vinci, was designed for urogynecological procedures and has enjoyed rapid adoption since its release, despite the fact that its clinical merits remain debatable. In orthopedics, MAKO Surgical was the first company to make real headway in this space, initially enjoying rapid uptake of its robotic systems for use in unicondylar knee replacements. In 2012 though, this company struggled mightily.

Contributor: Karen Gierszewski

In a lot of ways, it felt like 2012 was the year of “watchful waiting”. Would the European economy tank? Would it bring down the US economy with it? Would Obamacare and the much-hated 2.3% medical device excise tax last through a Supreme Court hearing, and an election? Overall, things remained relatively status quo: Both the US and European economies avoided a full-scale meltdown, and Obamacare remained in place. Nonetheless, a few things changed...and as usual, medtech has to adapt.

Contributors: Karen Gierszewski and Dan Brown

Metal-on-metal (MOM) hip implants have had a rough go lately. In the last few years, this market has been largely decimated due to a number of complaints of implant failure and complications. Now, in January 2013, the industry was dealt another blow as the FDA requested that all manufacturers selling MOM hip implants go through a lengthy, expensive, PMA process—even those already selling these products. But how much of an impact will this have in an already dying market?

Contributor: Karen Gierszewski

In a world where more and more information is constantly available at our fingertips through our smartphones and computers, customers are becoming increasingly empowered. Is a restaurant any good? Let’s quickly check some reviews online. In fact, we can even check out if it’s ever been closed for any health violations. Virtually no industry is immune to this shift, which is arguably an advantage for us, the consumer. The health care industry has been a little slower to see the impact of this trend, however.

Contributor: Sohaib Perwaiz

We often hear about diabetes in terms of the growing health epidemic in the US—as the US population becomes more obese and less physically active, more adults are diagnosed with type 2 diabetes every year. However, type 1 diabetes—which accounts for about 5% of all diagnosed cases of diabetes—tends to get less attention. Nonetheless, given the difficulties and risks associated with managing type 1 diabetes, the development of an artificial pancreas has long been hailed as the holy grail of diabetes care research.

Contributor: Karen Gierszewski

Good news: the Eurozone appears to have avoided a full-scale economic meltdown…so far. And the US managed to narrowly avoid the “fiscal cliff”. But we’re not out of the woods yet. The American and European markets continue to be extremely important on a global scale, and pretty much everyone—including medtech—is hurting from the ongoing economic problems in both regions.

Contributors: Karen Gierszewski and Carmen Chan

The other day, we discussed the surprising lack of regulations surrounding who can operate cosmetic laser, light, and energy devices. Well, a similar problem exists for the facial injectable market, which includes products such as Allergan’s well-known BOTOX Cosmetic.

Contributor: Tonya Martin

Imagine you are traveling in a subway, and when the train pulls into the station it misses its mark a little so that your car, at the end, ends up stuck in the tunnel. As the doors open, and passengers from other cars flow onto the platform, your door opens into the tunnel. Unfortunately it looks like you will be missing this stop! Let’s take a moment to introduce the medical device side of our analogy: endovascular aortic repair (EVAR) devices.

Contributor: Jeremy Seath

In researching for the most recent iteration of our US Markets for Laser, Light, and Energy Devices report, I was unsurprised to find that there are few regulations surrounding who can operate these devices in North America. In North America, minimally invasive aesthetics procedures notoriously lack stringent regulations and, as a result, dentists and general practitioners are performing procedures that incorporate facial injectables and aesthetic lasers that penetrate deep into the patient’s skin.

Contributor: Priyanka Narayanan

Remember The Jetsons—an animated sitcom set in 2026 that suggested the idea of food capsules, space travel, and more importantly, digital medicine? Looks like the FDA is preparing for any such futuristic possibilities!

Contributors: Karen Gierszewski and Dan Brown

Much of the attention in medical device news (and our blog is no exception) tends to go toward new, dynamic, “sexy” markets featuring new technologies and changing competitive landscapes. This, however, often means that a lot of important markets—those that have already gone through their exciting growth phase years ago—are overlooked. So today I want to bring some focus on a market that doesn’t often make headline news these days: the trauma device market.

Contributor: Karen Gierszewski

Welcome back from the holidays and happy new year! To get us back into the groove, I thought I would start with a few medtech-related articles that I don’t have much to say about, but are interesting nonetheless. Ever wondered which companies are the top medtech competitors? How the FDA is doing at lowering device review times? What new controversy surrounds the digital medtech age these days? Check out the articles below.

Contributors: Karen Gierszewski and René Azeez

The use of bone grafts is a hot topic in the orthopedic world right now. Whether discussing the INFUSE controversy or the escalating incidence of cadaver theft for tissue, the bone graft substitute (BGS) market has made it into the mainstream media.

Contributor: Karen Gierszewski

I have a confession to make: this post isn’t directly about the medical device market. However, Canada so infrequently makes headlines in medical device market news that when I saw a chance, I pounced on it. 

Contributors: Karen Gierszewski and Chantal Dougan

In the early 2000s, gastric banding was a newly discovered gem in bariatric surgery. The reimbursement situation was looking good, and the procedure offered a less expensive and less traumatic option for patients compared to gastric bypass, the main alternative at the time. Everyone expected revenues to take off, and Allergan, which developed the product, looked ready to reap huge profits. In just a few years, things took a noticeable turn for the worse.

Contributor: Karen Gierszewski

Medical device manufacturers aren’t the only ones dreading the implementation of the much reviled 2.3% medical device excise tax, which will take effect on January 1, 2013.

Contributor: Karen Gierszewski

We all know that nothing that happened this year can really compare with Johnson & Johnson's acquisition of Synthes, which was agreed to in 2011 but finally closed in mid-2012 when J&J agreed to spin off its trauma device unit to Biomet. But nonetheless, some other interesting deals did happen throughout the year that are worth mentioning—and it's not over quite yet.

Contributors: Karen Gierszewski and Mirel Giugaru

We've written before about the ongoing problems in the cardiac rhythm management (CRM) device market. It's a mature market, and there's not much happening in the way of device innovation. St. Jude's problems continue to be bigger than that though.

Contributor: Mike Phung

RSNA this year in particular seems to feature a significant number of Women's Health products and sessions. I'd like to take today's post to highlight some of these products.

Contributor: Mike Phung

Day two at RSNA had a decidedly health care information technology (HCIT) focus for me, with the GNAX Health, Acuo Technologies and Client Outlook Case Study, and Agfa Healthcare ICIS/Xero presentations at the Exhibitor Product Theater (EPT) as well as Monday’s Plenary session by Keith J. Dreyer, DO, PhD and Paul J. Chang, MD on imaging informatics.

Contributor: Kristina Vidug

After a mastectomy, there exist two options when it comes to breast reconstruction: autologous reconstruction or reconstruction with an implant. While the end result—reconstructed breasts—is the same, that’s about where the similarities between the options end.

Contributor: Mike Phung

The 98th annual meeting of the Radiological Society of North America (RSNA) kicked off Sunday in Chicago and MRG is here with a full contingent looking to see the latest technology, gather insights, and interact with vendors. 

Contributors: Karen Gierszewski and Steven Edgar

Now that some of the hype in the US has died down following the election, it’s time for us to turn our attention to some big news in Europe. Recently, the European Commission put forward a proposal to revamp the medical device directives in the region.

Contributor: Sohaib Perwaiz

AdvaMed, an American medtech industry association, recently sponsored a study evaluating the evolution of medtech costs over the last two decades.

Contributors: Karen Gierszewski and Travis Allen

Meaningful use incentive funding has been a big (and somewhat confusing) topic in the medical device world and is something we’ve touched on before.

Contributor: Andrew Lee

The second full day of the North American Spine Society (NASS) Annual Meeting featured a series of captivating debates on current controversies in spine care and surgery.

Contributor: Karen Gierszewski

As the November 6 US presidential election approaches, probably one of the biggest issues that I, as a Canadian, should care about is the proposed pipeline to deliver Alberta’s oil to the US.

Contributor: Melissa Hussey

The story in the spinal implant market has been the same for awhile: as the market for spinal fusion implants becomes more commoditized with less innovation, focus is increasingly shifting to the market for spinal nonfusion technologies.

Contributors: Karen Gierszewski and Canny Ho

We’ve all heard the horror stories about patients being sewn up after surgery with sponges, clamps, or scissors left inside of them—and you don’t have to be a doctor to know that this is definitely a bad thing.

Contributor: Ian Swanson

Transcatheter heart valves to treat aortic heart valve disease became a reality a year ago in the US after Edwards Lifesciences received approval for its Sapien transcatheter aortic heart valve.

Contributor: Sean Messenger

Last week, Stryker took steps to expand its neurovascular product offering when it agreed to acquire Surpass Medical, developer of the CE-marked NeuroEndoGraft flow-diverting aneurysm treatment device, for $100 million in cash up front and an extra $35 million provided the device reaches certain milestones.

Contributor: Ian Swanson

I am lucky enough to take a week off from the Canadian fall and coming winter (especially with the NHL lockout) to head down to tropical Miami to attend the Transcatheter Cardiovascular Therapeutics (TCT) conference.

Contributor: Karen Gierszewski

Has enough time passed for me to talk about the medical device excise tax again ? Yes, it’s still making headlines.

Contributors: Karen Gierszewski and Tonya Martin

When we in North America think of Saudi Arabia, we don’t necessarily picture a country with high rates of road accidents. Apparently, it’s time for us to adjust our thinking.

Contributors: Karen Gierszewski and Daniel Brown

Brace yourselves: the second round of the CMS’ competitive bidding program is right around the corner. In winter 2012/2013, the CMS is expected to announce reimbursement cuts across a wide variety of medical device types that it perceives as over-reimbursed.

Contributor: Karen Gierszewski

Let’s take a step back from all of the uproar around health care reform for a second and talk about something you don’t hear too often in connection with medtech: corporate sustainability. I’m actually a bit surprised, now that I think of it, that this topic seems to so rarely come up in the industry given how much of a buzzword it’s becoming for businesses globally.

Contributors: Karen Gierszewski and Mirel Giugaru

The global cardiac rhythm management (CRM) device market is massive, generating about $9.4 billion in revenue in the US, big four European countries (France, Germany, Italy, and the UK), and Japan in 2011.

Contributor: Karen Gierszewski

As we predicted, confidence in medtech in the US fell slightly in Q2 as the summer approached. This seems to be the usual—in both 2010 and 2011, job growth looked positive in the first quarter of the year before falling back approaching the summer

Contributors: Karen Gierszewski and Ian Swanson
 
As we mentioned in an earlier post, renal denervation was set to be one of the biggest trends in medtech in 2012, and it hasn’t failed us. It’s been a hot topic at numerous conferences this year, including the European Society of Cardiology Conference, the American College of Cardiology Conference, and the Society of Interventional Radiology Meeting. Positive clinical results continue to position this technology as a breakthrough in health care and potentially one of the most profitable medtech markets out there.

Contributor: Kristina Vidug

My name is Kristina and I have been working at MRG for over 3 months now. My background in sociology imparted me with a passion for research and analysis, which led me to the market research analyst position. I am part of the dental and aesthetics team; our team researches and reports on the variety of medical devices used in all manners of dental work and in the world of aesthetics. Below is a brief snapshot of a typical day in the life of an analyst at MRG.

Contributor: Karen Gierszewski

A couple articles have recently caught my eye that I would love to share. They’ve been gathering dust in my “Blog Ideas” folder though because they pretty much stand on their own and don’t require much more insight from me or our therapy experts. In an effort to clean out the clutter though, here you go: random medtech article round-up, summer 2012 edition.

Contributors: Karen Gierszewski and Kyle Verleyen

Finding body parts packed in coolers in a “grimy minibus” seems like something you might find in a TV show or movie. It goes right alongside folklore involving waking up in an ice-filled bathtub with your kidneys missing…not something that someone realistically worries about on a regular basis.

Contributors: Karen Gierszewski and Louise Murphy

Following the 2012 American Association of Neurological Surgeons (AANS)’ conference, we wrote about the controversy surrounding Stryker’s Wingspan Stent. Specifically, following some negative trial results, the consumer watchdog group Public Citizen was pressuring the FDA to withdraw humanitarian device exemption (HDE) approval for the stent.

Contributors: Karen Gierszewski and Sohaib Perwaiz

As we’ve discussed already, medical device reprocessing is becoming an area of increasing interest and debate in the industry. Let’s take a look at the arguments for and against the reprocessing of medical devices in a bit more detail.

Contributors: Karen Gierszewski and Travis Allen

While much of the buzz in the endoscopy/urology & gynecology realm recently has revolved around robotic surgeries and problems with the various meshes, there are a number of other interesting topics in this space. For example,  there are some new treatments that are potentially on the rise, such as high-intensity focused ultrasound. Another area that is gaining an increasing amount of attention these days is endoscopic ultrasound (EUS).

Contributors: Karen Gierszewski and April Lee

Whenever I bite into my Monday morning doughnut, I suffer a brief moment of guilt over how unhealthy it is. Although that feeling is fairly quickly wiped away by the sugar high, it does emphasize the focus in society on body image and particularly on remaining trim. In any event, one flip through a magazine will show the focus on perfectly shaped flawless bodies.

Contributors: Karen Gierszewski and Sean Messenger

Although they have been available in the US for a while, peripheral vascular (PV) plugs have only recently emerged as a product of interest in the transcatheter embolization and occlusion (TEO) device space.

Contributor: Karen Gierszewski

As we discussed previously, some developing countries, particularly those close to Europe, are becoming increasingly attractive targets for medtech companies itching for expansion. Another article was recently brought to my attention discussing the specific medical technology that is emerging in these countries, namely, better jaundice treatments, knee replacements, wheelchairs, drug authenticity verification technology, electrocardiogram (ECG) supplies, sterilization equipment, and sanitary pads.

Contributor: Karen Gierszewski

I’m a huge fan of the Olympics. Even though I pay very little attention to sports the rest of the time, during the Olympics I suddenly become very patriotic and care about even the most obscure sports (apparently fencing is an Olympic sport?). Although not everyone is as excited as I am (my roommate included), I think most people agree that the Olympics are a fun way to bring the world together for a few days.

Contributors: Karen Gierszewski and Sean Messenger

As far as complications go, “might get stuck in your brain” has to be high up on the list of most terrifying. Recently, the FDA issued a warning regarding Covidien’s Onyx liquid embolic product, stating that that is exactly what might happen if you use it.

Contributors: Karen Gierszewski and Nancy Huynh

On July 3, 2012, the US Food and Drug Administration (FDA) released the long-awaited proposal regarding the implementation of a unique device identification system for medical devices. The proposal stipulates that most medical devices will require a unique device identifier (UDI) that will include a device identifier—a unique code specific to a particular device model—and a production identifier, which will contain production-related information such as a device’s expiry date (if applicable) or a batch number.

Contributor: Karen Gierszewski

We all get it: the BRIC markets will be huge , and it’s no secret. Medtech companies are hungrily flocking there, setting up manufacturing facilities, subsidiary headquarters, training centers, and R&D facilities. The medtech markets have exploded in size and show no immediate signs of slowing down, particularly in the two BRIC giants: China and India.

Contributor: Kristina Vidug

In June 2012, the United States introduced bipartisan legislation aimed at increasing women’s awareness about the reconstructive options available to them after a mastectomy.

Contributor: Karen Gierszewski

We previously mentioned that in both 2010 and 2011, the economy in the US has looked its best in the first quarter before suffering setbacks as the summer approaches. That seems to be exactly what has happened this year, with increases in jobs and consumer confidence in the US throughout the first few months of the year before slowdowns in the second quarter. Nonetheless, it looks like facilities weren’t taking the optimistic first quarter results for granted—confidence in medtech in Q1 was slightly positive, but relatively unchanged since Q4 2011.

Contributors: Karen Gierszewski and Daniel Brown

Hip resurfacing has been the subject of much controversy in the large-joint reconstructive implant field over the last few years due to its high revision rate. Interestingly, though, partial (unicondylar and patellofemoral) knee implant procedures—which are generally performed on similar patients, namely those who are younger and have isolated osteoarthritis—have not been subjected to the same scrutiny.

Contributor: Karen Gierszewski

To celebrate the Canada Day long weekend, I did what most Torontonians do: I braved hours of traffic to get up to Northern (but still pretty Southern) Ontario, where we are lucky to have many lakes and where a good chunk of the population owns cottages. Even if you or your family don’t have one (as is the case for me), someone you know will and you can likely convince one of them to let you come along for the ride. So myself and three friends piled into an SUV and headed north to enjoy a weekend of sunshine, swimming, and campfires.

Contributors: Karen Gierszewski and Kyle Verleyen

Although it got off to a bit of a rough start, more and more experts are claiming that adhesion barriers for spinal applications are going to be huge. Adhesions, which are fibrous scar tissue, involve an abnormal connection between the soft tissue and organs and are a common complication following abdominal, spinal, and pelvic surgery.

Contributor: Karen Gierszewski

Well, at least the US senate can agree on one thing: on June 26, the senate overwhelmingly passed the Medical Device User Fee Act  with a vote of 92 to 4. The act now just awaits a signature from President Barack Obama to become law.

Contributors: Karen Gierszewski and Lexie Code

In Europe, adoption of some minimally invasive procedures, such as transcatheter heart valve placements , has been really strong. However, there is another area where the uptake of minimally invasive procedures in the region has been notably lacking. The adoption of both laparoscopy and arthroscopy is much lower in Europe compared to the US, even though the technique was actually developed in Europe.

Contributor: Isuru Silva

This year’s Society for Imaging Informatics in Medicine (SIIM) annual meeting is behind us, and the hot topics of the conference among physicians and vendors alike were unquestionably cloud archives and vendor-neutral archives (VNAs). Many panels outlined how far picture archiving and communication systems (PACS) and archives have come in the last ten or so years. Back in the day, image management and image sharing were functions only expected in radiology…but since that time, these functions have come to be commonly expected in cardiology and across other departments as well.

Contributors: Karen Gierszewski and Jennifer Smith

At the recent American Urological Association conference, there was significant discussion surrounding high-intensity focused ultrasound (HIFU), a potential new treatment for prostate cancer. Affecting approximately one in six men, prostate cancer is a frighteningly common diagnosis, although only a fraction of men diagnosed with the condition will die from it. This is probably not, however, super comforting to those men told that they have this cancer.

Contributor: Karen Gierszewski

For a Canadian, it was hard to miss the fact that Queen Elizabeth II recently celebrated her Diamond Jubilee, marking 60 years on the throne. After ascending to the throne in February 1952, the Queen has seen the UK and the Commonwealth countries through a lot, including everything from conflicts in Ireland, Argentina, and the Middle East to the much publicized death of Diana, Princess of Wales.

Contributor: Karen Gierszewski

Let’s face it: We call it the “BRIC” region, but everyone’s interest primarily lies in India and China—these countries’ extremely large populations combined with their fast-growing economies give them the potential to eclipse the size of many of the US medtech markets in the not-so-distant future.

Contributors: Karen Gierszewski and Mashkur Reza

For anyone suffering from rheumatoid arthritis, the news that Pfizer’s new arthritis drug, tofacitinib, is nearing FDA approval, is no doubt uplifting. On May 9, an FDA advisory committee announced that it supported the approval of the arthritis pill, which would represent the first pill to be able to potentially battle the debilitating effects of rheumatoid arthritis—by contrast, the drugs available currently focus on simply numbing the pain.

Contributors: Karen Gierszewski and Julie McLaughlin

Recently, St. Jude Medical and Abbott announced that they were strengthening their alliance to sell cardiovascular devices in the US. This announcement follows widespread speculation that the two companies would merge—both companies have strong product portfolios but do not have the breadth of product lines on their own to compete with the big name cardiovascular companies such as Medtronic and Boston Scientific.

Contributors: Karen Gierszewski and Sean Messenger

At the recent meeting of the Society of Interventional Radiology in San Francisco, a potential new indication for embolization was unveiled. Early research shows that benign prostatic hyperplasia may be able to be treated effectively with embolization. In fact, according to the study presented at the SIR meeting in March, the treatment is associated with few serious side effects and may reduce prostate size by more than 30%.

Contributor: Mirel Giugaru

St Jude’s reputation has literally seen its stock fall over the past month—from a six-month high of $44.54 in late March, to hovering in the $38 range for most of April and into May—as the shocking debacle over its Riata leads has shaken physician and investor confidence.

Contributor: Julie McLaughlin

At Thursday’s HRS session the importance of lead safety seemed to be everywhere. Interest in the early morning session “Riata ICD Lead Safety Alert Update” had physicians standing in the hallway outside the presentation room to hear what presenters had to say about the Riata, Riata ST, and Durata leads.

Contributor: Julie McLaughlin

Wednesday’s AF Summit, held at the annual Heart Rhythm Society conference in Boston, brought to light many issues surrounding catheter ablation. A constant theme through the day was the need to improve long-term ablation outcomes. Presenters agreed that catheter ablation to treat paroxysmal atrial fibrillation (AF) is a better alternative than antiarrhythmic drugs, but that there is still more to be done to achieve better longer-term success.

Contributor: Karen Gierszewski

While medical device companies certainly don’t like having to hand over more money to the government than they did before, there are definitely some people who don’t buy in to the theory that the tax will reduce the US medical device industry to a fiery rubble.

Contributor: Karen Gierszewski

The primary argument against the tax from medtech, as we’ve heard before, is that it will severely hinder innovation and prevent companies in the US from developing devices to provide better health care. But there are a number of other interesting issues going on here as well.

Contributors: Karen Gierszewski and Mickel Phung

How early would you want to know if you had Alzheimer’s disease? Undoubtedly one of the scariest conditions out there, new technologies might actually allow Alzheimer’s to be detected much earlier in suspected cases. The new technology in question is an imaging agent that can be used with positron emission tomography (PET) scans to identify clumps of brain proteins called beta amyloid that are potential markers of the disease.

Contributor: Karen Gierszewski

The Eastern European markets are being increasingly recognized as growth opportunities among medical device manufacturers, particularly as growth in the more mature markets, such as the US and large European countries, stagnates. Furthermore, the Eastern European markets might be more reachable for smaller companies without the resources to set up shop in emerging markets further abroad, such as China.

Contributor: Karen Gierszewski

Medtech giant Johnson & Johnson made headlines late in 2011 when it announced its intention to purchase Synthes, a large orthopedic company. This acquisition was, however, brought under review by the EU’s antitrust commission over concerns with how much of the orthopedics market J&J would control.

Contributor: Louise Murphy

Stryker may have gotten a bit more than they bargained for when it acquired Boston Scientific’s neurovascular division in January 2011.

Contributor: Karen Gierszewski

It would seem fairly intuitive that women and men would react differently to medical devices—even a non-medical professional (like myself) could guess that size, hormones, past pregnancies, and the use of oral contraceptives could mess with clinical outcomes. Yet women remain underrepresented in clinical trials.

Contributor: Karen Gierszewski and Mickel Phung

Although the Indian markets have traditionally been more immune to global economic instability, showing strong growth throughout 2008 and 2009, the recent depreciation of the Indian rupee might be a sign that economic difficulties have caught up to the region.

Contributor: Karen Gierszewski and Carmen Chan

Allergan has historically had a stranglehold in the US facial injectable market, particularly in the botulinum toxin market, where the company’s BOTOX Cosmetic brand has become synonymous with the product itself. In recent years, however, it was looking like Allergan’s uncontested reign was coming to an end, with a variety of new companies launching BTX and dermal filler products.

Contributor: Karen Gierszewski

The industry can breathe a sigh of relief: confidence in the US medtech market appeared to be recovering in Q4 2011 after fairly steep falls in Q2 and Q3. This seems to be happening in line with a tentatively optimistic outlook on the US economy: unemployment is declining, the housing market is looking healthier, and tax revenues are recovering. But can this rising confidence be maintained throughout the rest of 2012?

Contributor: Karen Gierszewski

It’s hard to remember the days when a debate at dinner over a minor piece of trivia couldn’t be resolved by someone quickly whipping out their smartphone and googling the answer. Welcome to 2012, when babies can’t figure out magazines because they’re so used to iPads. And our leaps and bounds in technology are affecting health care, too—medical-related apps are one of the top ten trends to look out for in the medtech world in 2012.

Contributor: Fareed Hameed

Several topics were of particular interest at the 2012 Society of Interventional Radiology (SIR) conference , ranging from advanced clinical techniques in peripheral revascularization and embolization to the regulatory and economic climate for IR practice in the US.

Contributor: Ian Swanson

When the one year results from the PARTNER US pivotal trial for Edwards Lifesciences’ SAPIEN transcatheter aortic valve replacement (TAVR) device were announced at last year's ACC conference, they demonstrated the great potential for this technology to treat aortic stenosis. They also, however, indicated some concerns with the technology, namely the stroke risk. To Edwards Lifesciences’ relief, however, two-year results from this trial demonstrated no significant difference in stroke rates between TAVR and surgical aortic valve replacement in the PARTNER A arm of the trial.

Contributor: Ian Swanson

With late breaking trials, spirited debates, and hundreds of other great talks, the American College of Cardiology’s 2012 (ACC.12) annual meeting in Chicago this past weekend provided a ton of exciting news. Standing out from the crowd was a panel of talks on renal denervation, a promising catheter-based treatment for hypertension, and clearly the topic of the week.

Contributor: Fareed Hameed

One of the highlights of the Tuesday sessions of SIR was the very lively Hot Topics debate, featuring teams of two interventionists arguing for or against current topics of interest. One of the big recent developments in the industry is Medtronics' $1 billion acquisition of Ardian for their renal denervation technology. This has generated some buzz both through industry and clinicians, leaving many wondering about the future role of renal artery stenting and angioplasty in the face of this emerging denervation technology.

Contributor: Karen Gierszewski and Mickel Phung

There has been much discussion in the US lately surrounding ACOs, a piece of the Affordable Care Act anticipated to be implemented sometime in 2012. These organizations offer a lot of benefits in theory—they are designed to improve the overall quality of health care in the US while lowering health care costs. How is this possible?

Contributor: Karen Gierszewski

As we’ve heard multiple times before, the Food and Drug Administration (FDA) really takes a beating from medtech manufacturers and patient advocacy groups because of the long medical device approval times in the US—the fear is that the US will fall behind in terms of innovation, with the most advanced devices entering other markets, such as Europe, years before they become available in the US.

Contributor: Karen Gierszewski

Historically, patients haven’t gotten too involved in selecting products to be used for their medical treatments—patients have generally deferred to their doctor to select an appropriate drug, knee implant, or cardiac rhythm management device brand. But this seems to be changing—patients are increasingly wanting to be involved in their own health care.

Contributor: Karen Gierszewski

Faulty implants in both the US (metal-on-metal hip implants) and Europe (breast implants) have put pressure on regulatory bodies to increase postmarket surveillance, as we’ve discussed previously . But this does leave an interesting niche for manufacturers—are there devices that can be developed that can specifically be used for surveillance postapproval?

Contributor: Karen Gierszewski

As women worldwide celebrate International Women’s Day—or in my case, discover that it’s International Women’s Day when trying to google something this morning—I thought it might be relevant to take a quick look at the latest and greatest in women’s health in the medical device world.

Contributor: Karen Gierszewski and Sara Scharf

Having recently commented on the appeal of investing in depressed European countries, an article in the New York Times caught our attention. This article discusses how, recently, the appeals panel of the World Trade Organization ruled that China has to eliminate its export taxes and quotas on nine widely-used minerals.

Contributor: Mickel Phung

Implementation of an electronic health record (EHR) is a gigantic undertaking for a practice or hospital, both financially and logistically. Properly training staff and physicians to break old habits and utilize the system to a level to qualify for meaningful use is an even bigger task. With meaningful use Stage 2 approaching however, another spectre looms in the distance, the health information exchange (HIE). One of the proposed criteria for Stage 2 is that exchange of data will no longer simply be tested, but actual exchange will be required.

Contributor: Alex Jablokow

This Saturday, at Western University, a group of students will have the opportunity to experience first hand what life as an MRG Analyst is like. They will be given an actual MRG case to analyze. Competing against other teams, they will perform a full market and company analysis, and be judged on the results.

Contributor: Karen Gierszewski

It’s been interesting to note that in the past few months several companies have chosen to separate their medtech and pharma units.

Contributors: Karen Gierszewski, Sara Scharf and Aaron McCracken

The popularity of robotic-assisted surgery has exploded in recent years, with these systems rapidly becoming a “must have” for high-end health care facilities. This technique has been particularly rapidly adopted for urology procedures such as prostatectomies due to the fact that the angles used in these procedures make traditional laparoscopy uncomfortable and difficult for surgeons—nearly 80% of prostatectomies removed in the US were removed with Intuitive Surgical’s da Vinci system, by far the most common surgical robot in use. But do the benefits of these robots really justify the cost?

Contributors: Karen Gierszewski and Sara Scharf

A lot of companies lately have been heading over to the emerging Chinese, Indian, and Brazilian markets to set up research & development (R&D) and manufacturing facilities. This is usually a smart move for large companies because they can benefit from lower manufacturing and labour costs while having convenient access to these large and fast-growing markets.

Contributor: Mickel Phung

Only 50% of family practitioners stated they were satisfied overall with their Electronic Health Records (EHRs), and 30% stated they were dissatisfied. The most interesting statistic however from a vendor’s perspective is that only 38% of practitioners stated they would purchase their system again!

Contributor: Mickel Phung

HIMSS 2012 has been eagerly awaiting details of Meaningful Use Stage 2, and officials from ONC and CMS packed the conference room and even required the opening of a second space to accommodate everyone. So what details were announced?

Contributor: Karen Gierszewski

Over the last few years, a slowdown in the growth rate of the US medtech industry has occurred—while 2004 yielded a growth rate of more than 15%, 2010 showed a much more modest 3.5% expansion. It’s easy to quickly blame this on the allegedly burdensome Food and Drug Administration (FDA) approval process or economic difficulties, but are there other factors at play here?

Contributor: Karen Gierszewski, Mashkur Reza, Kyle Verleyen

There have been a couple interesting and unexpected events in the orthopedic biomaterial market over the last few weeks. First, BioMimetic Therapeutics has not yet received Food and Drug Administration approval for its Augment Bone Graft , which was originally anticipated to enter the market in 2012 following a positive recommendation for approval in May 2011 .

Contributor: Karen Gierszewski

As Valentine’s day 2012 rolls around, we can barely go anywhere without being inundated with hearts—heart-shaped decorations, heart-shaped candies, teddy bears holding hearts. All great indications of a fun, happy holiday. But what about for those of us nursing a broken heart this year?

Contributor: Karen Gierszewski

Several instances of faulty implants have recently put pressure on regulatory bodies to examine if they need to better track devices postapproval. In the US, this pressure has occurred amid concerns over metal-on-metal hip implants.

Contributor: Karen Gierszewski

I think we can all agree that as we come out of a rough 2011 for medtech, a number of questions are weighing on everyone’s minds for 2012. On January 31, MRG COO Ken McLaren answered these questions with his presentation on the top 10 trends that medtech companies should look out for this year.

Contributor: Karen Gierszewski

Both Medtronic and Boston Scientific have been hit with multimillion dollar tax claims by the US Internal Revenue Service (IRS). Combined, the two companies could owe the IRS approximately $2 billion, although both companies plan to contest the allegations in US Tax Court.

Contributor: Karen Gierszewski

The first time I came across an article on hacking into digital medical devices, I dismissed it pretty quickly. After all, what could be the possible motivation for hacking an insulin pump or a pacemaker? But then I came across another one. And then another one. Maybe this topic does deserve some attention?

Contributors: Karen Gierszewski and Sara Scharf

The threat of pay cuts for doctors treating Medicare patients still looms. While the implication for medical device manufacturers will not be as obvious as for the reimbursement prepayment audits, discussed yesterday, it could potentially hinder the adoption of electronic medical records (EMRs) among physician practices due to lower incomes in general.

Contributors: Karen Gierszewski and Sara Scharf

Physicians have been reacting to the news that the CMS is rolling out a new pre-reimbursement review system across 11 states. This system would involve challenging doctors for proof that a procedure is necessary before granting reimbursement, which is a significant change from the status quo.

Contributors: Karen Gierszewski and Sara Scharf

With the economic turmoil affecting the European countries, it seems natural that the medtech industry would suffer the consequences. But how exactly are each of the big five European countries feeling the effects of economic instability? Are recent health care reforms substantially changing anything?

Contributor: Karen Gierszewski

In 2011, a number of major mergers and acquisitions considerably changed the landscape of the global medtech market. The most interesting deal of the year was made by pharmaceutical giant Johnson & Johnson, which has indicated its intent to acquire Synthes—this deal is so interesting, in fact, that it is still under antitrust review by the European Commission.

Contributors: Karen Gierszewski and Shriram Venkataramana

In the endoscopy device market, the reprocessing of single-use devices (SUDs) has historically been an annoyance of original equipment manufacturers such as Covidien, Ethicon Endo-Surgery, and Stryker. While historically major manufacturers have been vocal in their position against reprocessing, a few have recently had a change of heart.

Contributor: Karen Gierszewski

I know we’ve focused a lot on Food and Drug Administration (FDA) regulations and other innovation concerns in the US in prior blog posts, but this article was too good to pass up.

Contributors: Karen Gierszewski

Physicians in the US are increasingly worried that innovation in the US has taken a bad turn. This has stemmed partly from two topics we’ve discussed before: the purportedly strict FDA approval process and the fact that many new devices released in the US have been brought under fire—most notably, metal-on-metal hip implants.

Contributors: Karen Gierszewski

Product development in the medtech space is always ongoing, with lots of interesting new devices being released each year. But are all new products really worth it? Recent research says no.

Contributors: Karen Gierszewski and Sara Scharf

Medtech companies across the US are understandably upset because of the looming medical device tax that was signed into law in 2010 as part of the Affordable Care Act. Under this act, companies will be required to pay a 2.3% tax on their total revenues starting in 2013. Many industry leaders have spoken out against the tax, saying that it will stifle innovation—this tax could be particularly detrimental to smaller companies looking to bring new innovations to the US. Furthermore, the tax does not take into account whether or not a company is profitable.

Contributor: Karen Gierszewski and Mickel Phung

As the time frame for year one of the meaningful use of electronic medical records (EMR) incentive program draws to a close, US policymakers will no doubt be examining what caused the adoption of this program to be so lackluster.

Contributor: Karen Gierszewski

When thinking about medical tourism—involving posh resorts where you can get a complex cardiovascular procedure thrown in—the BRIC markets come immediately to mind. And that’s for a good reason—Brazil, India, and China are all becoming increasingly popular destinations for medical procedures because of low costs, well-trained surgeons (in the urban centers, that is), and the ability for patients to bypass lengthy waiting lists in their own countries.

Contributor: Karen Gierszewski

As we commented earlier , the Chinese medtech market is gaining considerable attention among major medical device manufacturers because of a rapidly expanding economy and fast procedure growth. But, it is worth noting that in many markets much of this growth stems from a small procedure base, which makes the growth numbers somewhat inflated. So when will China and the other BRIC countries actually reach a point to make a dent in the revenues of large international medtech companies?

Contributors: Karen Gierszewski and Daniel Brown

On October 1, 2011, the New York Times reported that metal-on-metal hip implants have been associated with severe and permanent side effects, with the article even saying that one surgeon found a “biological dead zone” when replacing a failed metal-on-metal hip in a patient.

Contributor: Alex Jablokow

Back in 2008, at the height of the financial crisis, many of our clients called us and asked for our take on how the market was doing in general. How closely tied is confidence in medtech to confidence in the economy? How were procedure volumes likely to change?

Contributor: Karen Gierszewski

I was wracking my brain this morning to come up with an appropriate Halloween-themed blogpost that was somehow related to medical devices. The pharma industry has it easy—the so-called ‘zombie virus’ creates a great opportunity for a spooky, yet relevant blog entry. As I was checking out people’s costumes on my way into work this morning though it suddenly came to me: vampire face lifts.

Contributor: Karen Gierszewski

A trend that is becoming painfully obvious in the US medtech market is the increasing cost-consciousness of hospitals, in response to both economic and governmental pressures.

Contributors: Karen Gierszewski, Mashkur Reza and Ian Swanson

Traditionally, the US Food and Drug Administration (FDA) and the European CE mark have been at opposite ends of the approval spectrum. While the FDA approval process has typically been long, stringent, and expensive, CE marking is much easier to obtain (on a relative scale, of course!).

Contributor: April Lee

On Thursday, September 29th, 2011, MRG participated in the annual Heart & Stroke Big Bike Fundraiser to raise both awareness and money for the Heart & Stroke Foundation.

Contributor: Karen Gierszewski

Over the next few years, some of the most dramatic medical procedure volume growth will be seen in China, an emerging economic powerhouse.

Contributor: Karen Gierszewski

While many markets still struggle to reach pre-2008 levels, the news that health care insurance costs rose sharply in the US in 2011—as reported by the New York Times —was not welcomed.