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St. Jude CEO's Medtech Mantra? Mum's the Word

St. Jude CEO's Medtech Mantra? Mum's the Word

Daniel Starks is remarkably disciplined in his communications with analysts and prefers to keep many things close to his vest even if its means declining to answer questions repeatedly.   

Arundhati Parmar

St. Jude Medical's CEO Daniel Starks would make for a fascinating interview.

His view of the medtech industry and where it is going and how to succeed in a paradigm-shifting marketplace is decidedly different from say that of Medtronic's CEO, Omar Ishrak. And I have been longing for a deep dive with Starks, similar to the one I had with Ishrak back in 2011.

But so far that hasn't materialized.  

Even with analysts, Starks is remarkably disciplined in his messaging. They are never able to pry information from him unless Starks is ready and willing to share. And he has no qualms saying "no" repeatedly to questions that he doesn't want to answer - and Starks does so while profusely apologizing thereby taking some of the sting out of the rejection.

That quality was on full display during the company's earnings call Wednesday.

Starks was mostly generous with his description of the potential of CardioMEMS, the novel implantable sensor system that helps to monitor heart failure patients remotely. The system, which has been shown to reduce hospital readmissions of these chronically ill patients, is expected to garner $70 million in sales in 2015. Starks also noted how the device has reduced mortality in Class III heart failure patients who are comfortable only when they are resting and whose physical activity is decidedly limit. 

"When we apply these rates of clinical benefit to the existing heart failure demographics and cost burden it is easy to see how revenue from CardioMEMS products can evolve into a multibillion-dollar business once the market has been fully developed on a total global basis," Starks told analysts, according to a transcript of the call from Seeking Alpha. 

After providing a detailed case for CardioMEMS' potential in prepared remarks, Starks also answered direct questions from analysts about the product. 

However, when it came to other products that were of interest to analysts, it was mum's the word.

An analyst asked about St. Jude's progress of Amplatzer and left atrial appendage closure device given that a competitor's product - Boston Scientific's Watchman device - has been approved. Starks noted that the analyst had correctly noted that no update has been provided and none was forthcoming.

"So we continue to keep [Amplatzer] under evaluation similar to renal denervation, similar to PFO closure. And for all three of those potential growth drivers, we decided that this call would not be the right time and right forum for us to offer an update on any of those three," Starks said.

Renal denervation - a way to control uncontrolled hypertension - was considered a promising technology until the largest study conducted by Medtronic failed to achieve its primary efficacy endpoint. Medtronic, however, has relaunched relaunched a trial, with some major tweaks prompting an obvious query on St. Jude's plan. But Starks and other executives wouldn't comment on the company's renal denervation program even though he was willing to speculate why Medtronic's trial failed back in 2014.

Another fourth product also won a no-comment from Starks. That is the MediGuide system - a GPS-like mapping technology whose sensors mounted on certain catheters and other devices allow for real-time tracking. The company believes MediGuide-equipped catheters may reduce radiation exposure.

But Wednesday an analyst curious about the product came away empty handed. Starks provided a qualitative answer about 2014 having been a "good year" for the MediGuide business but provided no numbers.

"... we continue to make good progress with our MediGuide business," Starks replied. "And we haven't offered specific comments again for competitive reasons. And so I won't really say more about that. Forgive me, but I just won't say more about that for competitive reasons, yet."

Another company that offers mapping catheters is Johnson & Johnson's Biosense Webster division.

Messaging discipline for an executive of a public company is of course an invaluable asset. Nonetheless, given that the medtech industry is traversing uncharted waters these days, it would be great to really understand how the chief executive of a prominent company is navigating them.

So, if anyone can convince Starks to open up, I will be first in line. And I solemnly promise not to ask about tattoos. 

 Arundhati Parmar is senior editor at MD+DI. Reach her at arundhati.parmar@ubm.com and on Twitter @aparmarbb 

[Photo courtesy of St. Jude Medical]

Stay abreast of industry trends at BioMEDevice Boston, May 6-7 at the Boston Convention & Exhibition Center

St. Jude Trims Earnings Forecast as Its Stock Hits Record High

The company's overall sales dipped 1.3% year over year to $1.35 billion. Meanwhile, its stock is ticked up 6.41% on April 22.

Qmed Staff

St. Jude Medical Inc. trimmed its financial projections for the rest of the year as a result of currency fluctuations. The company expects adjusted earnings in the range of $3.92 to $3.97 per share--three cents per share lower than its earlier estimates.

The strong dollar has been to blame for low earning estimates for a range of companies. Recently, Johnson & Johnson partly explained that a dip in its medical device business was partly a result of the strong dollar. Will domestic sales ticked up in the most recent quarter by 5.7%, they fell 7.6% internationally as its products become more expensive abroad.

Like J&J and many other medical device firms, St. Jude Medical is doing a growing amount of business overseas as it looks to expand its business beyond its core U.S. market. St. Jude expects the strong dollar to cost the company between $385 million to $410 million this year, which is a good deal higher than its earlier projection of $325 million to $350 million.

On a brighter note, the company's stock increased 6.41% on April 22, hitting $73.55--an all-time high for the firm.

The Star Tribune explains that investors are confident in the prospects of the firm's core cardiac rhythm management business. Its CardioMEMS business is also faring well, and Barron's is upbeat about its prospects in the long term. The company's heart rhythm devices and atrial fibrillation product lines also both outperformed expectations.

The optimism makes sense. Factoring out the impact of currency fluctuations, the company's revenue would have increased by 5% in the most recent quarter.

In other news, the company recently announced its plans to buy neurostim firm Spinal Modulation Inc. for $175 million or more.

Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6-7, 2015.

What’s So Hard about Making Orthopedic Parts?

Bob Michaels

 
The feature dimensions of such orthopedic devices as this critical-fit bone plate with bone-screw interface from Autocam Medical are verified using a variety of different measurement machines.

Everyone knows that as the U.S. population ages, healthcare interventions will become more and more common—not least in the area of orthopedics. Hence, it is hardly surprising that by 2017, the global market for orthopedic devices and materials will reach $57.2 billion while the market for joint repairs and replacements will reach $40.2 billion, according to a 2015 Research and Markets report.

What does this mean for manufacturers of orthopedic devices and components? It means that they will face heightening demand for high-quality machined products. But it also means that they will be under increasing pressure to meet stringent quality standards so that their products not only fit right but also look right.

Measure for Measure

“Our big concern is not necessarily focused on the actual metal working itself,” remarks Joel Diemer, manufacturing engineer at Kentwood, MI–based Autocam Medical. “Being able to accurately measure parts is often a bigger concern. The customer puts certain specifications on a print, some of which may or may not be readily measureable without special gauging in order to verify features. Thus, one of our biggest challenges is having measurement methods in place that can prove that our parts have been manufactured to customer specs.”

Typical tolerances for noncritical or nonmating features are commonly around 0.005 in., although some tolerances can be as low 0.0002 in. in certain applications “That’s about as tight as we go for standard manufactured orthopedic parts,” Diemer says. “Most medical device applications don’t go beyond that tolerance. By the same token, because it is challenging to maintain critical dimensions with such small tolerances, process validation becomes critical, often requiring that manufacturers use specialized process and measurement equipment.

Standard tried-and-true measurement methods include optical comparators and micrometers, and calipers, according to Diemer. Every supplier that produces components for the orthopedic market has at least these instruments. In addition, coordinate measuring machines and vision machines with tactile probes are used to measure diameters, lengths, and geometric tolerances. Some of these instruments can measure threads, and some can measure more than one feature at a time, rapidly generating large volumes of dimensional information.

As you branch off from there, high-end computer-driven digital microscopes are employed to recognize minuscule features, Diemer notes. Such instruments must be programmed, and how well the operator programs the equipment plays into how well it will measure an orthopedic part.

“All part features must be dimensionally correct,” Diemer emphasizes. “Proving this has always been one of the hard parts of manufacturing orthopedic components. Utilizing such tools as gauge repeatability and reproducibility studies, as well as statistical process control, adds extra certainty that the components being manufactured will always meet customer specifications.”

A Day in the Life of an Ortho Parts Maker

An acetabular cup with an Asymmatrix coating from Orchid Orthopedic Solutions is manufactured based on detailed product quality planning procedures.

What steps does a manufacturer take to produce a typical orthopedic component? “When an order is received, we first go through a detailed order start process,” explains Ken Altman, director of advanced manufacturing, Machining Div., at Bridgeport, MI–based Orchid Orthopedic Solutions. “During this process all necessary specifications, including material choices and necessary processing sequences, are reviewed.”

The company then goes into great detail to develop suitable advanced product quality planning procedures in order to meet the customer's quality expectations. While the quality plans are being built, manufacturing engineers review the customer’s drawings, compile a tooling list, order the necessary tooling, create set-up sheets, and review the manufacturing programs for each stage of the process. In addition, routers and bills of materials are established based on the customer’s print, ensuring that the orthopedic part is processed to specification.

“After the machining steps have been completed, the part is cleaned according to standard procedures,” Altman says. “Then, it is electropolished, laser etched, passivated using a nitric or citric process, and reviewed for final acceptance. If required, the part is packaged and labeled in a certified cleanroom and sterilized.”

Importantly, every part has to be burr-free, according to Diemer. “We can’t compromise making a part faster if doing so creates more burrs, since no orthopedic component can be shipped if it has flakes of metal on it.” To ensure that parts are burr-free, manufacturers crack out their microscopes and visually inspect the parts for any type of debris—especially burrs—that might remain from the manufacturing process.

Hey Good Lookin’

Spinal screws (pedicles) from Autocam Medical are manufactured to meet customers' cosmetic requirements.

Especially in the medical device field, customers are very particular about the cosmetics of their parts. “Once they’ve been around for while, engineers have a good idea about how to manufacture a part,” Diemer states, “but every customer wants the part to have a specific visual look. One customer’s specification for a part with a satin finish is not necessarily the same as another’s. Thus, ensuring that we can meet each customer’s cosmetic expectations is one of our larger challenges.”

Many customers require that a portion of a component have a satin bead-blast finish and a coating on the same part. Transitioning from the one to the other can be difficult because there must be a smooth, accurate interface between the two types of surfaces. “The cosmetic appearance of a component can also depend on the cleanliness of the water in the facility,” Diemer adds. “Manufacturers must ensure that parts do not exhibit water stains because everything has to look clean and sharp.”

Bob Michaels is senior technical editor at UBM Canon. Reach him at bob.michaels@ubm.com.

Top 10 Star Wars Medical Technologies

Top 10 Star Wars Medical TechnologiesChris Newmarker and Brian BuntzUpdated December 16, 2015Star Wars fervor is peaking with the new Star Wars: The Force Awakens. We’ll have to wait to see how many people dress as Jedi Knights and Wookiees on December 18, when the seventh Star Wars feature film is released in the United States. In the meantime, the uptick in popularity provides a great reminder of the volume of medical technologies featured in the series. In a galaxy far, far, away, it was no big deal to lose a limb, or to be frozen in carbonite and survive the ordeal.In the following slides, we highlight 10 medical technologies featured in the original three Star Wars films. We also invite you to pick your favorite in a poll. Wherever possible, we’ll showcase how the technologies in the film have either inspired real-world medical technologies or at least anticipated them.Continue >>Learn more about cutting-edge medical devices at MD&M West, February 9–11 at the Anaheim Convention Center in Anaheim, CA. Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz. Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarkerLike what you’re reading? Subscribe to our daily e-newsletter.

Top 10 Star Wars Medical Technologies

Chris Newmarker and Brian Buntz

Updated December 16, 2015

Star Wars fervor is peaking with the new Star Wars: The Force Awakens. We’ll have to wait to see how many people dress as Jedi Knights and Wookiees on December 18, when the seventh Star Wars feature film is released in the United States. In the meantime, the uptick in popularity provides a great reminder of the volume of medical technologies featured in the series. In a galaxy far, far, away, it was no big deal to lose a limb, or to be frozen in carbonite and survive the ordeal.

In the following slides, we highlight 10 medical technologies featured in the original three Star Wars films. We also invite you to pick your favorite in a poll. Wherever possible, we’ll showcase how the technologies in the film have either inspired real-world medical technologies or at least anticipated them.

Continue >>

Learn more about cutting-edge medical devices at MD&M West, February 9–11 at the Anaheim Convention Center in Anaheim, CA.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntzChris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker

Like what you’re reading? Subscribe to our daily e-newsletter.

Can Da Vinci Xi Turn Around Intuitive Surgical?

Can Da Vinci Xi Turn Around Intuitive Surgical?

Jamie Hartford 

 The da Vinci Xi surgical robot received FDA approval in April 2014.

Following an abysmal 2013 that saw the company plagued by adverse event reports and a tumbling stock price, Intuitive Surgical was hopeful that last year’s launch of the da Vinci Xi System, the fourth generation of its surgical robot, would be a hit. Now, more than a year after the system received FDA approval, there are signs that could be the case.

The company exceeded Wall Street’s expectations and its own year-over-year performance by placing 99 da Vinci Systems in the first quarter of 2015—75 of them Xi models.

“da Vinci Xi continues to draw significant interest from our customers,” Gary Guthart, president and CEO of Intuitive Surgical, told analysts in an April 21 earnings call, according to a Seeking Alpha transcript.

In the United States, system placement was up 45% from the same quarter in 2014. Outside the United States, placements were down, but part of that drop could be due to a significant decline in Japan, where only one system was placed (vs. 19 in Q4 2014) as customers awaited approval of the Xi system there. Approval for the system in Japan was granted in late March.

“We continue to believe that the Xi configuration, which received FDA approval in 2Q14, will open the door to new surgical techniques and procedure growth for general surgery, especially [outside of the United States] procedures,” Sterne Agee senior research analyst Gregory P. Chodaczek wrote in a research note.

RBC Capital Markets analyst Glenn Novarro was also pleased with the Xi’s performance.

“The Xi launch is progressing nicely, which should be further aided by upcoming movable table and Xi single-site approvals,” he wrote in a research note.

Still, Chodaczek does not expect sales to skyrocket immediately.

"In line with our thesis, we expect to see continued early adopters of the Xi through FY2015 but do not expect to see considerable [quarter-over-quarter] growth in system sales of the Xi model," he wrote.

And there is room for improvement when it comes to costs associated with the Xi system. Intuitive Surgical’s margins took a hit last quarter in part due to higher manufacturing costs as a percentage of revenue associated with the system.

“New products like Xi and stapling have lower gross margins earlier in their life cycle than our mature products,” said Marshall Mohr, Intuitive Surgical’s chief financial officer. “We believe our efforts to reduce the cost of these products will begin to deliver limited improvements in our gross margins by the end of this year and greater improvement in fiscal 2016.”

But Guthart cautioned that Xi’s margins may never reach those of its predecessor, the da Vinci Si.

“We have always provided the caveat that it doesn’t necessarily mean you’ll get to the same level as our mature products,” he said. “They are highly complex products . . . And so we never committed that we would get back there. Having said that, I think that they had room to improve from where we are and we are working hard on those improvements.”

The Xi system is intended to replace open abdominal surgeries and includes several advances over the Si model, including an overhead instrument arm architecture; an improved endoscope digital architecture; smaller, thinner arms that provide a greater range of motion; and longer instrument shafts. 

Learn more about designing innovative medical devices at the MD&M East conference in New York City June 9–11, 2015.

Jamie Hartford is MD+DI's editor-in-chief. Reach her at jamie.hartford@ubm.com or on Twitter @MedTechJamie

[image courtesy of INTUITIVE SURGICAL] 

Are These Medical Devices Safe?

Are These Medical Devices Safe?

Marie Thibault

Here at MD+DI, we love medical devices and advances in healthcare technology. Innovative medical devices have helped us live longer, more enjoyable lives.

But unfortunately, a few devices have attracted the ire of some patients and activists for what they allege is causing more harm than good. We've gathered five devices and device categories that have been the subject of negative headlines recently.

Do you agree with the patients or the companies? Do you think these devices are safe? Tell us in the comments below.

 
 Power Morcellators

[image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

Stryker CEO: 5 Products That Will Make 2016 a Great Year

 

Orthopedics manufacturer Stryker reported a good quarter Tuesday with earnings per share beating what analysts were expecting. Analysts and company executives believe that the Kalamazoo, Michigan company will have a solid 2015.

But in an earnings call Tuesday, Kevin Lobo, Stryker's CEO, declared that a few products and businesses will make 2016 and onwards even better for the company. Here are those products and businesses:

MAKO
Stryker took a big bet in acquiring the robotics company back in 2013 for $1.65 billion, and integration has been no walk in the park. But it appears that the company is slowly ironing out some of the issues. There was a big interest in the MAKO robotics platform on which a partial Stryker knee and a total Stryker hip is available at the annual meeting of the American Academy of Orthopaedic Surgeons in Las Vegas in March. The company has sold 20 systems in the fourth quarter alone that comprises nearly 10% of its installed base. Another nine was sold in the first quarter.

By 2016, the company will have a total knee implant on the RIO robotic arm, and that is where Lobo and other senior executives believe the real opportunity for growth lies. By that time the company will also likely have smoothened supply issues that hampered MAKO revenue in the first quarter of this year. 

Acute Ischemic Stroke
In 2011, Stryker bought Concentric Medical for $135 million and the company makes products to remove clots in stroke patients as well as other minimally invasive stroke access products.  

"...over the past four months, an impressive amount of strong clinical data had been released supporting the use of device-based treatment of acute ischemic stroke," said Katherine Owen, vice president of strategy and investor relations, according to a transcript of the earnings call from Seeking Alpha. "From the acquisition of Concentric, we have pioneered this space in our unique and differentiated products."

Stryker's Concentric makes the Trevo Retriever, one of the clot retrievers that was used in a trial in the Netherlands data about which was published in the New England Journal of Medicine. The trial found that devices used to remove clots had better outcomes than using clot-busting drugs to dissolve the clots alone.

CoAlign Innovations
In 2014 Stryker acquired CoAlign Innovation, a reportedly small transaction, but the company makes another product that has room for fast growth.

The acquisition brings the FDA cleared Acculif expandable interbody devices for spine surgeons.

Pivot Medical
Sports Medicine is another growth business for Stryker, and its purchase of Pivot Medical in February 2014 for an undisclosed amount, helps it to address a subset of that market where patients are demanding less invasive products, according to Stryker.

Pivot Medical makes implants and instruments for hip arthroscopy to help quickly improve function and mobility of the hip.

Berchtold Holding 
Also in 2014, Stryker bought Berchtold for $176 million. The German company makes surgical infrastructure equipment such as surgical tables and surgical lighting systems among others. 


Arundhati Parmar is senior editor at MD+DI. Reach her at arundhati.parmar@ubm.com and on Twitter @aparmarbb  

Stay abreast of industry trends at BioMEDevice Boston, May 6-7 at the Boston Convention & Exhibition Center

5 Things Medical Device Companies Should Know About U.S. vs. International Patents

5 Things Medical Device Companies Should Know About U.S. vs. International Patents

Gabriela I. Coman

Medical devices, from bandages to replacement heart valves and surgical robots, as well as methods of using such medical devices and related surgeries have become part of our everyday life and are essential elements of modern medical care. Medical devices are also part of a highly competitive and litigious environment, especially when competitors enter the market.

To be successful in today’s marketplace, a medical device company needs a superior product and patent protection for its medical device and related methods of use, both in the United States and abroad.

Patents are critical. A granted patent is a legal right that excludes others from practicing, manufacturing, and selling the technology claimed in the patent (the medical device and/or method of use of the medical device). To obtain such patent protection, a medical device company must submit a separate patent application for each country (or region, in the case of the European patent application) in which it wishes to protect its investment and invention. The time, money, and effort required to obtain U.S. and international patents is an important consideration, because the process to obtain a patent requires a significant investment after filing the application.

Coman

Without patent protection, the costly product development process for medical devices may easily be copied by competitors. However, if the medical device is patentable (and once it has been patented), the medical device company will be able to:  

  • create legal barriers to entry for competing devices by preventing others from copying, selling, or manufacturing the patented device
  • license the patented device to generate revenue
  • enhance the value of the medical device company by building equity in the company and creating assets that may attract other investments

Before a medical device company invests time and money to develop a medical device and bring it to market (particularly for devices in the U.S. market that require FDA approval and clearance), the medical device company should consider the following:

1) What Is Patentable Matter in the United States May Be Different from Rest of World

Medical devices are protected and patentable in the United States and other countries. However, methods of surgery and medical treatment methods are protected and patentable in the United States and Australia but typically not in Europe and other countries such as Canada, South Korea, or Japan.

For example, in most countries, methods that include a surgical step on a human or animal body are not patentable even if the effect of surgery is not therapeutic. Claim terms such as “non-medical” or “diagnostic” could be used to make a claim acceptable (provided that the claim could be reasonably interpreted to be directed to a non-medical method without producing a therapeutic effect). In Europe, neither methods of medical treatment nor diagnostic methods are patentable subject matter. In contrast, in the United States, surgical techniques and methods of medical treatment, as well as methods of diagnosis or treatment, are patentable subject matter.

For example, an instrument which cuts bone in a retrograde manner to form a bone tunnel or socket may be patentable in both the United States and Europe. A method of arthroscopic surgery to form a bone tunnel or socket using a retrograde cutter instrument may be patentable in the United States but not in Europe, where methods of medical treatment are unpatentable.

2) U.S. Patent Standards Are Different from Rest of World

In the United States, two important requirements of patentability for a medical device (and related methods) are novelty and non-obviousness. Under 35 USC §§102, 103, an invention must be novel and non-obvious to be patentable. The requirement of novelty means that the invention (medical device or method) must be new, i.e., not previously known or used by others. The requirement of non-obviousness means that the invention must not be an obvious variation or combination of subject matter previously known to those of ordinary skill in the art.

Under European patent law, the two important requirements for patentability of a medical device are novelty and inventiveness. Under Article 52 EPC, inventiveness is a strict requirement, and the European Patent Office applies a problem-solution analysis. A European Patent (EP) application involves an inventive step if it solves a technical problem in a non-obvious way. Under EP law, this means that (i) it must solve a problem (if there is no problem, there is no inventive step) and (ii) the problem must be technical (solving a financial problem is not an inventive step).

The problem-solution approach requires the following: (i) a determination as to whether the invention is novel; and (ii) if it is, then choosing as the closest prior art the reference that shares the most features with the invention. The differences are then compared to determine the problem that is solved by the invention.

For example, if the invention relates to a retrograde cutter with a blade that can be flipped to cut a bone tunnel or socket in a retrograde manner, and the closest prior art is a cutter that does not include a blade that flips and is provided through a narrow cannula, the technical problem is to cut a relatively wide bone tunnel while inserting the instrument into the joint through a narrow cannula. This problem is solved by adding a feature to the blade of the cutter to allow the blade to flip or fall at a 90-degree angle, and to cut in a retrograde manner.

The question then becomes whether the solution would be obvious when solving the technical problem. In the retrograde cutter example, the common solution for cutting instruments would be to replace the cutting blade with a larger one. One skilled in the art would add a wider blade to the cutting instrument by providing a larger incision. This would make the solution of changing the blade angle non-obvious, so that the invention involves an inventive step and is patentable.

3) U.S. “First To File” Is Different from Rest of World

Since 2013, the United States has adopted a “first to file” approach to granting patents. That is, when two different entities apply for a patent, the first one to file an application for a patent will obtain the patent if the invention is patentable. The “first to file” approach changed the prior U.S. “first to invent” approach. The U.S. patent law adopted this major change to harmonize its patent process with that of the European Patent Office and other foreign countries. In an effort to ease the transition from the “first to invent” to the “first to file” system, the U.S. patent law provides a one-year grace period, meaning that the inventor (or someone who directly obtained the information from the inventor) still has the right to publish his/her invention within one year prior to the filing of the application without losing patent rights.

In contrast, the rest of the world does not observe any grace period. For example, European countries and many other countries in the world apply an absolute novelty standard, meaning that any public disclosure of invention before the filing of a patent application will render the invention unpatentable. If the invention has become publicly available in any way prior to the filing of the EP application, the application will be rejected. “Publicly available” under Article 54 EPC is defined to include selling the invention, publishing the invention in a printed publication such as a specialty brochure or magazine, giving a lecture about the invention, presenting it to an investor without a non-disclosure agreement, etc. The invention may be made “publicly available” by anyone, including the inventor, one of the inventors, or any independent third party. Thus, if an inventor releases—before the filing of a patent application—a surgical brochure describing a medical device, the inventor will be barred from obtaining patent protection on the medical device in Europe, whereas in the United States, the inventor has one year from the release of the surgical brochure to file a patent application.

4) U.S. Filing Costs Are Different from PCT and EP

A patent is only enforceable in the jurisdiction in which it is granted. If a medical device company wants worldwide protection of a medical device, the company must file a patent in individual countries worldwide. Filing in multiple countries can be, however, prohibitively expensive.

Various fees are associated with securing a patent. These fees include filing fees, fees for prosecuting the application, issue and maintenance fees once the application has matured into a patent, and attorney fees, among others.

Depending on the country or region, these fees may vary widely and may be spread unevenly over the course of filing and prosecuting an application, and maintenance of the patent.

In the United States, the majority of fees are incurred in the first several years (filing fees, prosecution fees, etc.). A patent is enforceable from the time that it is granted until 20 years after the initial filing date. Once the patent is issued, three additional maintenance fees must be paid to maintain the issued U.S. patent.

One mechanism to control costs is filing an international application or a Patent Cooperation Treaty (PCT) application. The international application does not mature into a single international patent; however, it provides the company the opportunity to delay making a final decision on whether to file a national application for up to 30 months in most countries. During this period of time, the company applying for the patent can assess whether the medical device is commercially viable, raise funds and explore potential markets, and decide whether to enter the national/regional phase.

Another mechanism is to file a regional patent application. In Europe for example, an EP patent can be obtained by filing a single application with the European Patent Office (EPO). A granted EP patent confers to its owner the same right as a national patent in those countries that are signatories to the European Patent Convention, namely Austria, Belgium, Bulgaria, Switzerland, Cyprus, the Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, Greece, Hungary, Ireland, Italy, Liechtenstein, Luxembourg, Monaco, the Netherlands, Portugal, Romania, Slovenia, Slovakia, Sweden, Turkey, and the United Kingdom. Securing an EP patent involves payment of an annuity every year from the filing of the application, as well as search, examination and designation fees, and translation fees if necessary. Once the mention of a grant has been published, the patent must be validated in each of the designated countries. In a number of contracting states, the patent owner may be required to file a translation of the specification in the official language of the national patent office.

5) Enforcement of Patent Rights in the United States Is Limited

As noted, what may be patentable in the United States may not be patentable in other countries and, even if patented, enforcement of the patented subject matter varies greatly. For example, methods of medical treatment are considered to fall outside the scope of patent protection in most countries including European countries, Canada, Japan, and South Korea.

Although methods of medical treatment are patentable in the United States, enforcement against an individual practitioner (surgeon) is not possible. In the United States, the Patent Act prohibits enforcement of patents for medical treatment against doctors and the medical facilities with which the doctors are associated (at least with respect to medical and surgical procedures and methods of treatment).

Stay on top of the latest trends in medtech by attending the MD&M East Conference, June 9–11, 2015, in New York City.

Gabriela Coman is counsel in Dickstein Shapiro’s Intellectual Property Practice. She practices primarily in the intellectual property area, concentrating in the fields of medical, biotechnology, pharmaceuticals, chemical, semiconductors, and design patents. Reach her at comang@dicksteinshapiro.com.

[Images courtesy of STUART MILES/FREEDIGITALPHOTOS.NET and DICKSTEIN SHAPIRO LLP]

Medtech Takes the Big Apple

Medtech Takes the Big Apple

Be sure to take advantage of these opportunities at the MD&M East conference and exposition in New York City June 9–11, 2015.

Jamie Hartford

New York City will again play host to the best and brightest minds in medtech when the industry gathers at the Jacob K. Javits Convention Center June 9–11, 2015, for the MD&M East conference and exposition. This three-day interactive event will feature live demonstrations, education programs, and other opportunities you won’t want to miss. Here are a few things we recommend checking out.

Keynotes from Industry Leaders

Anchoring this year’s MD&M East conference are keynote addresses from medtech industry leaders. On Tuesday, June 9, you’ll hear from Sean Hughes, vice president of Philips Design, the team tasked with ensuring the Philips brand continues to churn out meaningful, relevant innovations. Then, on Wednesday, June 10, Andy Christensen, vice president of personalized surgery and medical devices at 3D Systems Corp., will bring you up to speed on how innovations in the exciting field of 3-D printing are making their way into medtech.

In-Depth Learning

Following the keynotes, we’ll delve into conference tracks designed to send you home with actionable insights and spur innovation. One track on June 9 will focus on design innovation for medical devices, including a can’t-miss presentation on designing a medica

l device that will be used in space by NASA's Baraquiel Reyna. For a more nuts-and-bolts approach, attend the June 9 track on mastering process validation to benefit from an FDA update on general process validation principles and practices. The June 10 track will cover sensors, energy harvesting, flexible electronics, and other next-generation technologies, including a talk on electronic aspirin by Anthony Caparso, vice president of research and chief scientist at Autonomic Technologies. Last but not least, the June 11 track will focus on 3-D printing for medical device design and manufacturing, including a look at this emerging technology from the physician’s perspective.

Free Educational Sessions

Even if you're not heading to the conference, there are still opportunities to advance your learning right on the show floor. The Center Stage and Tech Theater areas will feature an assortment of free sessions you can take advantage of. On Tuesday, June 9, don't miss Bill Evans, founder of Bridge Design, discuss 10 ways innovation, design, demogrpahics, and global trends will affect healthcare in 10 years. On Wednesday, June 10, you can test your knowledge in a one-of-a-kind engineering trivia game sponsored by Nordson Medical. And on Thursday, June 11, Bill Betten, vice president of business solutions at Logic PD, will detail five ways Big Data is affecting digital health.   

Opportunities to Connect

With so many of your medtech industry peers under one roof, MD&M East presents an unparalleled opportunity for networking. To get in the mix, sign up for a speed networking session on June 9 or 10. Based on your answers in the registration questionnaire, we’ll pair you with other professionals who share your interests for 10 brief meetings. Best of all, it’s free with your MD&M East registration.

A Toast to Medtech Innovation

MD&M East also plays host to medtech’s version of the Oscars, the Medical Design Excellence Awards (MDEA). Each year, the MDEA program honors the most innovative medical devices on the market in categories ranging from over-the-counter and self-care to surgical equipment, instruments, and supplies. This year’s winners will be announced at a June 9 ceremony during which we’ll also honor 2015 MDEA Lifetime Achievement Award Winner John Abele and recognize up-and-coming innovators through VentureWell’s BMEIdea student competition. You can RSVP for the event when you register for the show.

Products and Services Showcase

If you’re looking for suppliers and service providers to help your medtech company innovate, be sure to set aside plenty of time to stroll the exposition floor. MD&M East is the leading industry innovation showcase on the East Coast, and you can browse booths exhibiting everything from next-generation materials and batteries to cybersecurity services and contract manufacturing capabilities. To help you get the lay of the land, we’ve put together guided Innovation Tours that will highlight advances in robotics, 3-D printing, and tools that make digital health possible.

Jamie Hartford is MD+DI's editor-in-chief. Reach her at jamie.hartford@ubm.com or on Twitter @MedTechJamie

[image courtesy of THEPHOTOHOLIC/FREEDIGITALPHOTOS.NET]

TI's FPGA Killer Could Drive Medical Imaging Advances

Texas Instruments (TI; Dallas) has introduced a new system on a chip (SOC) that could make FPGAs obsolete for many applications.

Brian Buntz

Texas Instruments' KeyStone II
The 66AK2L06 can do away with the need for an FPGA. Image courtesy of Texas Instruments.

[Updated on April 22]

The TI KeyStone II (66AK2L06) SOC is said to offer 50% cost and 60% power savings over similar technologies while offering a 66% reduction in board real estate.

Part of those figures are a result of the SOC's ability to do away with FPGAs. Traditionally, FPGAs (or ASIC) were used to serve as a bridge between a processor and the analog-front-end or analog-to-digital converters or digital-to-analog converters, says Robert Ferguson, marketing director and business manager, communications processors at TI.

Now you can effectively remove the FPGA from a system with the 66AK2L06 SOC. "The 66AK2L06 is a multicore processor, so you are combining both the FPGA and the processor functions into a single SOC," says "Removing the FPGA allows for simpler trace layouts and a smaller pin count, and that helps reduce system cost. And for applications that still require an FPGA, you could take a large one out and use a much smaller one instead."

Looking at the 66AK2L06 SoC in more detail, it has two ARM Cortex-A15 MPCore processors, that can run up to 1.2 GHz each. It also has four C66x DSP cores that can also run at a maximum of 1.2 GHz. The Keystone II also has four programmable accelerators that are linked to the six cores of the SOC, and to each other.

The digital front end is software programmable. "You can do up-down conversion, programmable filters in all of those functions that were typically done before in a FPGA," Ferguson says.

The technology is well suited to medical imaging as well as other high-speed data acquisition applications such as radar and avionics as well as test and measurement applications. Within the medical realm, portable imaging applications like portable ultrasound could benefit from the technology.

But potential applications of the technology are numerous. "It can be used anywhere you are going to need that high speed analog to digital converter," Ferguson notes.

The SOC benefits from the JESD204B interface, which is faster than low-voltage differential signaling (LVDS) and complementary metal-oxide-semiconductor technologies. The majority of contemporary high-performance analog-to-digital converters and digital-to-analog converters use this interface. The JESD204B interface is an industry standard, which helps facilitate interoperability. 

Another one of the key benefits of the 66AK2L06 SOC is that it can reportedly help developers get to market substantially faster--three times faster in TI's estimation based on input from their customers.  "Customers have shared with us that it took them weeks to work with FPGAs versus days with the new SOC. So these data points are validated from our customers," Ferguson says. "Because it is programmable, as opposed to an FPGA, when you are programming the up-down conversion or you are programming an algorithm, such as beamforming in medical imaging applications--whether it is in fixed point or floating point--you can do all of those things directly at the C, C++ layer in software," Ferguson says.

Because everything is programmable, device developers could reconfigure algorithms or filters on the device and upgrade them once the device is on the market. "You could do a software upgrade, which allows you to potentially redefine your product after it is deployed."

Another reason behind TI's boast that the SOC can help engineers get their products to the market three times faster is the support of a program they call TI Design. "The goal of TI Design is to give customers a headstart on their product development. We have about 1500 files in the library that covers everything from powering small motor drives to more of a full system level. We are providing schematics and performance data."

Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6-7, 2015.

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

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