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15 Highest-Paid MedTech CEOs In the U.S. (#2)

Jeffrey Immelt, Chairman and CEO, General Electric  


Last year Immelt made $19.8 million, a decline of 23.4% from his 2012 compensation. 


15 Highest-Paid MedTech CEOs In the U.S. (slideshow)

15 Highest-Paid MedTech CEOs In the U.S. (slideshow)

We researched MD+DI's Top 40 Medical Device Companies, including only U.S-based medtech companies, and then scoured data from FindtheBest and, in some cases, company proxy statements to come up with the list of 15 highest-paid medtech CEOs in the country.

The results are interesting because in many cases CEOs of firms such as Danaher that have more than a billion in revenue from medtech but pull in much more from other industry segments ended up ranking higher on the list with a larger compensation than CEOs of pure-play device firms like Medtronic. And then, not surprisingly, CEOs of diversified firms like General Electric and Johnson & Johnson also did better than other medtech CEOs.

Without further ado, here are the top 15 highest-paid medtech CEOs in the U.S, starting with no.15 on the list. Drumroll please...

Kevin Lobo, President and CEO, Stryker 


[Photo Adapted from a Wall Street Journal YouTube Video]

In 2013, Lobo made $8.4 million, which brought his compensation down 8.6% from the previous year.


[Feature Image Credit: user thorbjorn66]

-- By Arundhati Parmar, Senior Editor, MD+DI

15 Highest-Paid MedTech CEOs In the U.S. (#1)

And the U.S. medtech CEO who made the most money in 2013 was ...

Miles D, White, CEO of Abbot Labs 


White made $20.9 million in 2013, a 17% drop from his compensation the previous year.

Return to Beginning


Body-Heat Powered Wearable Electronics May Be Coming Soon to a Wrist Near You

Flexible, wearable thermoelectric generator (Courtesy Korea Advanced Institute of Science and Technology)

A paper published by three researchers at the Korea Advanced Institute of Science and Technology (KAIST; Daejeon, Republic of Korea) has been generating considerable buzz in the wearables space. The scientists have formulated and screen printed thermoelectric generators on a flexible glass fabric.

The glass-fabric generator produces an order of magnitude more electricity than previous flexible thermoelectric generators and is said to have a bending radius as low as 20 mm. The assembled generator is sufficiently flexible to bend 120 times without losing its electrical generation capabilities, the researchers say.

Led by Byung Jin Cho, PhD, professor of electrical engineering at KAIST, the team came up with new concepts and techniques to product the fabric. First, they formulated liquid-like pastes of n-type and p-type thermoelectric compounds.

Previous wearable generators placed the positive and negative poles of the generator on a substrate, which absorbs much of the heat and therefore reduces power generation efficiency.

Cho and his team printed the poles directly between two layers of the flexible glass substrate, thus increasing both flexibility and power generation efficiency.

Cho explained in a press release, "For our case, the glass fabric itself serves as the upper and lower substrates of a TE generator, keeping the inorganic TE materials in between. This is quite a revolutionary approach to design a generator. In so doing, we were able to significantly reduce the weight of our generator, which is an essential element for wearable electronics."

Continuing, Cho describes thermoelectric power generation patches of 10 x 10 cm, about 500 ?m thick, that weigh 13 g and produce about 40 mW of power when the temperature difference between the ambient air and the wearer's skin is around 31°F. This amounts to a normal, healthy person in a room or still outdoor air at approximately 60°F, a bit chilly for most. A lesser temperature differential will produce less power.

"Our technology presents an easy and simple way of fabricating an extremely flexible, light, and high-performance TE generator," Cho says. "We expect that this technology will find further applications in scale-up systems such as automobiles, factories, aircrafts, and vessels where we see abundant thermal energy being wasted."

The team's paper, "A Wearable Thermoelectric Generator Fabricated on a Glass Fabric," was published in the Royal Society of Chemistry's journal Energy & Environmental Science. Lead author on the paper is Sun Jin Kim.

Stephen Levy is a contributor to Qmed and MPMN.

6 Recent Medical Device Failures Catching FDA's Eye

From surgical devices with flaking coating issues to a confusing hook-up for an LVAD backup system controller, there have been six medical device safety issues since mid-March that have drawn attention from the FDA owing to their potential to cause serious injury or death:

1. Covidien Surgical Devices with Flaking Coating Issues

The FDA on Monday announced a Class I designation for Covidien's voluntary recall of two surgical devices used in the area of the brain, both of which have issues involving flaking polytetrafluoroethylene (PTFE) coatings. Surgeons use the the Alligator Retrieval Device is used to remove foreign bodies in the peripheral and neurovasculature, while the Pipeline Embolization Device is in endovascular surgical procedures treating large intracranial aneurysms in the internal carotid artery, from the petrous to the superior hypophyseal segments. FDA officials think the recalled devices could cause stroke or even death because a detached particle of PTFE could cause a blockage (embolism) in blood vessels in the brain. Covidien has had no reports of injuries or deaths, but has received one report of an incident in which the delamination occurred.
Covidien Alligator Retrieval Device
Covidien's Alligator Retrieval Device, as shown on its website
Affected products were manufactured and distributed from May 2013 to March 2014. Covidien is asking that unused devices be returned for replacement. PTFE (marketed as Teflon by DuPont) was once the gold standard for coating guidewires and related medical device products, due to its low friction coefficient. But then the EPA required that manufacturers eliminate perfluorooctanoic acid (PFOA) from their PTFE formulations by 2015. The move, meant to answer cancer concerns, also appears to be related to a series of recalls involving flaking coatings, including the Covidien recall. The FDA over the past six months has also announced Class I designations involving coated guidewire recalls at Medtronic and Medline. Suppliers including Surface Solutions Group have been searching for solutions to the issue.

2. Dräger Ventilators with Battery Issues

A Dräger Medical ventilators recall received a Class I designation from the FDA this month.
Dräger optional PS500 Power Supply
This Dräger picture shows the location of the optional PS500 power supply units on the ventilators.
The company said it has not received any patient injury reports due to the Evita V500 and Babylog VN500 Ventilators, which apparently have optional power supply unit batteries that deplete faster than expected. FDA officials, though, caution that serious injury or even death could result with the issues around the ventilators. Dräger discovered that the battery issue in some cases could cause the ventilators to shut down even though visual indicators showed a sufficient charge, according to the FDA. In some cases, neither the "battery low" nor the "battery depleted" alarm was triggered when the remaining battery capacity was below 10%. Dräger elaborated in its own news release. A power fail alarm, though, did go off when the battery was depleted completely. Battery capacity itself was down due to the occurrence of sulfation within the battery. The batteries were for the optional PS500 power supply units for the ventilators. As an interim solution, Dräger says the batteries in the PS500 will be replaced free of charge. The Evita V500 and Babylog VN500 Ventilators are for adult, child, and infant patients, and are for stationary use in hospitals or for patient transport within hospitals. Affected products were manufactured and distributed from June 1, 2011 through January 31, 2014.

3. Spacelabs Anesthesia Delivery System's Software Glitch

Arkon Anesthesia Delivery System
The Arkon Anesthesia Delivery System, as shown on Spacelab's website.
The FDA on April 16 designated a Spacelabs Healthcare recall of an anesthesia delivery system as Class I. The Arkon Anesthesia Delivery System is used in hospital operating rooms. The device is actually a Medical Design Excellence Awards finalist for the way it allows anesthesiologists to keep their patients in full view while simultaneously controlling and monitoring gas delivery using their preferred workflow. Snoqualmie, WA-based Spacelabs in March initiated a voluntary recall of Arkon's with version 2.0 software because the software may cause the system to stop working, requiring manual ventilation of patients and potentially endangering their lives. The error is triggered by the combination of a spirometry loop save and a change in waveform configuration. There was also potential for the system to stop working if a mobile phone or other USB device is plugged into one of the device's four USB ports for charging, according to the FDA. Spacelabs Healthcare received a single report related to the software defect. The FDA says there has been no injuries or deaths associated with the software malfunction. The company has field service personnel contacting customers affected by the recall to schedule a free software update installation that may resolve this issue.

4. Abbott Blood Glucose Meters with Test Strip Issues

The FDA this monthly apparently issued another Class I designation involving Abbott Laboratories' voluntary recall of diabetes products. Freestyle test strips Back in January, the FDA said FreeStyle and FreeStyle Lite test strips could cause serious injury or death because they were found to provide inaccurate readings of blood glucose when used with the FreeStyle and FreeStyle Flash meters and the Insulet OmniPod. (The FreeStyle and FreeStyle Flash devices have not been produced since 2010.) Late last week, an additional Class I designation was announced involving the actual FreeStyle and FreeStyle Flash Blood Glucose Meters, including the FreeStyle Blood Glucose Meter built into the OmniPod Personal Diabetes Manager. The FDA says: "Abbott Diabetes Care has identified that certain meters have the potential to produce erroneously low blood glucose results when used in conjunction with certain Free Style test strips." Abbott has asked users of the FreeStyle and FreeStyle Flash Blood Glucose Meters to discontinue, and to call Abbott for a new unaffected meter. Those using a built-in FreeStyle meter in the OmniPod Personal Diabetes Manager should discontinue use of affected test strips and call Abbott for replacement unaffected test strips.

5. Thoratec LVAD Patients Confused over Controller

The FDA on April 1 issued a Class I recall designation over Thoratec's advisory involving four patient deaths related to its HeartMate II left ventricular assist device (LVAD).
HeartMate II
HeartMate II, as shown on Thoratec's website
The issue actually has nothing to do with the LVAD itself, but rather is related to patients and caregivers who were unable to understand instructions and lacked the training needed to hook up a back-up system controller in cases of device alarm or malfunction. Besides resulting in four deaths, such difficulties also caused lost consciousness or reduced blood flow for five other patients, according to Pleasanton, CA-based Thoratec and the FDA. The FDA elaborates on what happened: "All reports were linked to patients whose HeartMate II LVAS device was originally attached to an older model of controller, the EPC System controller. When the Pocket System Controller became available, patients were switched from the EPC System Controller to the Pocket System Controller. However, these patients did not receive intensive training on connecting the new controller." Thoratec sent an "Urgent Medical Device Correction" letter by email to all affected customers in early March. The company is updating labeling and training materials for the HeartMate II LVAS Pocket System Controller and has been urging physicians, caregivers and patients to get up to speed on the new instructions and training. Thoratec isn't the only company experiencing potentially deadly issues around device instructions. The FDA has also been warning that a Greatbatch Medical Orthopedic surgical tool could cause serious injury or death because it came with inadequate sterilization recommendations.

6. McKesson Anesthesia Care's Patient Data Issues

The FDA last month issued a Class I designation over McKesson Technologies Inc.'s recall of its McKesson Anesthesia Care, a computer-based system used in environments such as operating rooms. An anesthesia provider uses the system to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care. But there was an occurrence where a patient's data in the system included information from another case, the FDA said when announcing the Class I designation on Friday. McKesson Anesthesia Care collects data both through manual entry and from monitors attached to patients.
Refresh your medical device industry knowledge at MD&M East, June 9-12, 2014 in New York City.
Alpharetta, GA-based McKesson Technologies Inc., which is part of San Francisco-based McKesson Corp., issued a Clinical Alert in March 2013 over the issue, calling customers on the phone and following up with email.

Previously in March

7 Recent Medical Device Failures Catching FDA's Eye

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker.

TriVascular IPO a Winner in First Two Trading Days

TriVascular's Ovation abdominal stent graft system. (Courtesy TriVascular Technologies Inc.)

Braving choppy initial public offering (IPO) seas in the medical device industry, Santa Rosa, CA-based TriVascular Technologies Inc. launched their stock issue the day after Tax Day and caught a bit of a tailwind.

At the closing bell on the first day of trading, the stock was up almost 15 percent at $13.79. It briefly touched the $16 mark intraday on its second day before closing at $14.32, better than a 19.3 percent gain.

The company's shares began trading on the NASDAQ Global Select Market on April 16 under the ticker symbol TRIV. When the IPO was first announced, we reported that the company hoped to raise $100 million. That works out to over $15 per share, which apparently was thought to be too optimistic as the actual IPO offering price was $12.

TriVacular makes the Ovation Prime abdominal stent graft system, a minimally invasive treatment for abdominal aortic aneurysms which, if left untreated, can rupture and cause internal bleeding and death. The company says the Ovation Prime is the lowest profile system approved by FDA, and is available in sizes down to 13Fr. Further, it uses a novel, polymer-based sealing mechanism. Ovation Prime has more flexibility to make its way through the femoral artery, the company says. The new device also has more markers that show up in imaging to help doctors better position the device in the body.

TriVascular received CE Mark approval for its original Ovation system in September 2010. FDA approval followed in October 2012. The company's newest product, the Ovation Prime system, was approved by FDA in January 2013.

According to TriVascular's prospectus, it a net loss of $50.3 million last year on revenues of $19.5 million and had a deficit of $238.5 million. Cash and equivalents totaled $38.1 million.

Robert Digitale, writing for the Santa Rosa Press Democrat, said, "The company plans to use about $4.6 million from the IPO to pay off a note to Boston Scientific, which purchased the company in 2005 and then closed it the following year in a cost-cutting move. The company reopened in 2008 after investors raised $65 million to buy out Boston Scientific."

TriVascular's brisk launch may signal the beginning of a wave of medtech startups. According to the Med Tech Startup Blog, "Investors are starting to see that the medical device IPOs are meaningful as the medical devices target some unmet clinical needs." The blogger predicts that "2014 to 2017 will see the new highs in the medical device IPOs, acquisitions" space.

Stephen Levy is a contributor to Qmed and MPMN.

How Surface Solutions Group Solved a Dangerous MedTech Coating Issue

At Surface Solutions Group, we think that we've come up with an answer for a medical device coatings issue that has recently dogged the industry. 

Flaking Coating
Submitted image from Surface Solutions Group

Pure polytetrafluoroethylene (PTFE) coatings for decades were the "gold standard" for coating guidewires and related products, with unmatched low friction coefficient.

But then the EPA required that manufacturers eliminate perfluorooctanoic acid (PFOA) from their PTFE formulations by 2015. The move, meant to answer cancer concerns, also appears to be related to a series of recalls involving flaking coatings.

The FDA over the past six months has announced Class I designations involving coated guidewire recalls at Medtronic (245 lot numbers) and Medline (3 lot numbers).

On April 1, Covidien, issued a voluntary recall of 650 of its Pipeline embolization devices and Alligator retrieval devices after internal testing revealed coating delamination.  In a communication to customers, Covidien noted that, "Delamination of the PTFE coating could potentially lead to embolic occlusion in the cerebral vasculature with the risk of stroke and/or death."

The FDA itself now says: "There is a potential for PTFE (polytetrafluoroethylene) coating to delaminate and detach from guidewires. ... Uses of this recalled product may result in serious adverse health consequences."

The delamination problem is taking place around the same time as the reduction and eventual elimination of PFOA, which as a surfactant was thought to enhance adhesion in water-based PTFE formulations.

It is also worth noting that medical device manufacturers have starting to require saline soak testing performed at coating facilities, after reports of "green flakes" in an operating room when PTFE coated guidewires were immersed in a saline soak tank prior to an intravascular procedure. The PTFE coating process, in the past, may have been less sensitive to saline, but not anymore.

The reflex reaction for some device engineers has been to turn to resin-bonded PTFE coatings that have better adhesion to most surfaces. Many coating manufacturers also make these coatings that contain PTFE, but that is where the similarity ends.  

The resin-bonded coatings are tough, tenacious, and abrasion resistant, but they have neither the extremely low friction nor flexibility pure PTFE coatings. Plus, they have limited elongation.

However, Surface Solutions Group (SSG) of Chicago has discovered that by using new stringent surface preparation techniques and adjusting how the coating is applied makes the problem go away. The new coatings adhere as well as the old ones did.   

Applying low-friction films to biomedical products--from stainless steel, titanium, nitinol, and even plastic or glass--has been our exclusive focus.  For the guidewire problem, we were able to bond pure PTFE--containing no PFOA--so tenaciously that delamination is eliminated, even after saline exposure, tape test, mandrel wrap test, and cross hatch/ boil and fingernail tests. 

This is how the process works: The wire surface is hypercleaned, and then the coating is applied in a controlled environment, using a robotic system to keep precise control of all the physical parameters (pressure, feed rate, and electrostatic level) in the spray system so that only an exact amount of coating is deposited to the wire. Finally, every individual part can be saline and tape tested, per the OEM's requirements, if necessary.

Both patient and physician benefit from the SSG breakthrough. The patient benefits from the improved safety of guidewires that won't delaminate. The physician benefits from guidewires that, once again, deliver the smooth tactile "feel" that he counted on from wires that were coated with the original gold standard coating.

Contributed article from Bruce Nesbitt, Surface Solutions Group LLC

How an EMS Firm and a Lean Startup Are Taking on Chronic Pain

The Senza high-frequency spinal cord stimulation technology could offer relief to many patients with chronic pain.

In many ways, neurostimulator maker Nevro (Menlo Park, CA) functions like a quintessential Silicon Valley lean startup. The company has embraced the concept of rapid iteration, and was already working on the 10th generation of its pain-relieving neuromodulation technology before taking the product to the market. After receiving CE Mark approval to commercialize the technology in Europe, the company enlisted the help of contract manufacturer Hunter Technology (Milpitas, CA), enabling it to produce and ship more than 1000 units in two years. Longer term, the startup hopes to obtain FDA approval for its technology and ultimately claim a significant piece of the $1.5-billion global spinal stimulation market and provide an alternative to some pharmaceutical and surgical therapies for treating chronic back and leg pain.

As a budget-minded startup that is working on obtaining FDA approval for its implantable Senza device, the partnership with Hunter helped Nevro to streamline the process of integrating design changes while meeting ISO 13485 requirements.

MPMN recently had the opportunity to tour Hunter's 62,500-sq-ft electronics manufacturing services (EMS) facilities in Milpitas. During the visit, Hunter and Nevro executives explained how the two firms collaborated in the development of the Senza platform, which generates up to 10,000 electrical pulses to the spinal cord every second--a rate many times faster than traditional low-frequency spinal-cord-stimulation (SCS) devices. Nevro's technology is said to be both more effective than traditional devices, while also eliminating paresthesia--an annoying buzzing sensation caused by conventional SCS devices.

Refresh your medical device industry knowledge at MD&M East, June 9-12, 2014 in New York City.

Partnering with Hunter helped keep the startup nimble, explained Nevro's founder and senior vice president Andre Walker. Hunter oversees roughly 100 unique manufacturing projects per week. It takes the company about 20 minutes to shut down a production line and retool it to produce a different product. A team of 15 full-time process engineers helps make that happen by constantly churning out build instructions.

Similarly, Nevro had been developing four prototypes at once before settling on the tenth-generation of the technology it intended to commercialize. "We had a new version every two to three months," Walker said.

Working with Hunter is enabling Nevro to focus on its pivotal trial needed to ultimately commercialize its technology in the United States. When the Nevro was founded, Walker assumed it would take about three years to commercialize its device in the United States. But the regulatory rules changed midstream, he says. Now, the company is about seven years in, and is now in the middle of a pivotal U.S. study with a price tag thus far of upwards of $90 million.  

It helps that the company was fortunate enough to begin receiving millions in funding before the financial meltdown of 2008. And the company has obtained several rounds of funding since, including from the likes of Johnson & Johnson, Covidien, Mayo Clinic Ventures, and several other VC firms.

Still, the company is doing everything it can to preserve its cash for essential functions. "A startup should never be in the position of needing money," explained Nevro's founder and senior vice president Andre Walker. Instead, the firm should have a singular focus on developing the best-possible product--one that investors will prize. Accomplishing that goal is no easy feat, of course, and the shifting regulatory climate has been difficult and expensive for medical device firms to navigate.

The partnership with Hunter has been helpful in that regard because the contract manufacturer is well versed in medical device production. The biggest market the firm serves is the medical device sector. Hunter is certified to ISO 13485 and expects to certify its quality management system to 21 CFR 820 requirements.

The EMS provider, which has a strong engineering front-end, is also helping Nevro integrate design changes, while churning out new devices as quickly as possible to meet market demand.

Brian Buntz is the editor-in-chief of Qmed and MPMN. Follow him on Twitter at @brian_buntz and Google+.

3 MedTech Firms That Raised Millions in Seed Stage Funding Last Quarter

 3 MedTech Firms That Raised Millions in Seed Stage Funding Last Quarter

As a medtech firm, getting venture capitalists to invest in a seed stage of financing is akin to trying to get water out of stone.

However, exceptions prove the rule, and so here are three companies that managed the impossible in the first quarter of 2014 in order of most money raised. The information comes from the PricewaterhouseCoopers LLP (PwC) and the National Venture Capital Association (NVCA), based on data provided by Thomson Reuters.

Drum roll please…

Despite their name, scPharmaceuticals is not really a typical pharma company interesting in developing novel formulations to treat diseases via oral, injectable or intravenous means. Rather this Lexington, Massachusetts-based company has a novel drug delivery device that allows certain drugs to be delivered subcutaneously.

It raised $16 million in March in a round co-led by 5AM Ventures and Lundbeckfond Ventures.

The money will help to further develop two drugs and the associated drug delivery components. The first drug is meant to treat heart failure by which the company's dime-sized medical grade micropump will deliver a diuretic directly under the skin.

Traditionally furosemide is delivered either in oral form in heart failure patients to prevent fluid build-up or in the emergency room in intravenous form, according to scPharmaceuticals website.

A second product is meant to create a new drug-device combination product of a cephalosporin antibiotic to counter bacterial infections. Today the drug can be delivered only through intramuscular and intravenous administration, the website notes.

The products have piqued the interest of investors who are following the overall trend in healthcare to look for cost-effective alternatives to current standards of care.

““scPharmaceuticals has the potential to establish a new pharmaceutical and care paradigm, where common and widely used parenteral drugs can be conveniently self-administered subcutaneously,” said Dr. Kush Parmar, a Partner at 5AM Ventures and a Director of scPharmaceuticals, in a statement at the time of the funding. “What most excites us is the potential to build a portfolio of products that help shift care to more convenient and cost-effective settings.”

Element Science
Very little information seems to be available on Element Science. The company is based in San Francisco and raised $12.5 million, according to a regulatory filing with the Securities & Exchange Commission, which also shows the company is actually looking for a total of $40 million.

The MoneyTree Report says investors in the firm include Google Ventures, Prospect Venture Partners and Third Rock Ventures. It is developing a device to treat sudden cardiac arrest and the company was previously called Revive Defibrillation Systems.

It is founded and run by Uday Kumar, cardiologist and cardiac electrophysiologist.

BioTrace Medical
Similar to Element Science, BioTrace Medical appears to be a firm in stealth mode.

A regulatory filing shows the company is based in San Mateo and has raised $3.5 million. Investors in the seed round were Okapi Venture Capital and an undisclosed firm. An article points to Xandex Investments and the fact that BioTrace Medical is developing a temporary cardiac pacing device which can treat reversible symptomatic bradycardia (reduced heart rate).

The company is run by Laura Dietch, president and CEO, an angel investor and medical devices consultant who was formerly Vice President of Global Marketing for Medtronic’s vascular business.

[Photo Credit: user AlexSava

-- By Arundhati Parmar, Senior Editor, MD+DI

Q1 MedTech Financings Results Mixed While Total VC Investment Highest Since Q2, 2001

Q1 MedTech Financings Results Mixed While Total VC Investment Highest Since Q2, 2001

Venture capitalists poured in $9.5 billion in 951 deals in the first quarter of 2014, which represents the highest quarterly total since the second quarter of 2001, according to the MoneyTree Report from PricewaterhouseCoopers LLP (PwC) and the National Venture Capital Association (NVCA), based on data provided by Thomson Reuters.

But medtech saw mixed results. 

As expected, the software industry accounted for the largest share of venture capital invested - 42% of total dollars and 44% of total deals in the first quarter. But it also scored big in the  quarterly increase in amount invested which rose 39% to $4 billion from the fourth quarter of 2013. There was also a slight uptick in the number of software deals to 414 from 409 in the fourth quarter of 2013.

By contrast the medical devices and equipment industry saw the number of deals plummet 37% to 61 in the first quarter from the prior quarter. However, on a heartening note, dollars invested rose 28% to $588 million. Overall, investments in Q1 in the life sciences sector that includes biotechnology and medical devices fell 10% in dollars and 28% in deals when compared to fourth quarter of last year.

Here is a geographical distribution of where the $588 million was invested in the U.S., taken from the MoneyTree Report website. 

[Photo Credit: user SaulHerrera]

-- By Arundhati Parmar, Senior Editor, MD+DI