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FDA Approves First-of-Kind Kidney Disease Test in 62 Days

FDA Approves First-of-Kind Kidney Disease Test in 62 Days

FDA has approved in 62 days a EuroImmun de novo petition to allow marketing of its Anti-PLA2R IFA blood test, the first test that can help determine if a specific type of kidney disease is due to the body’s rejection of its own kidney tissue or another cause, like an infection.

Membranous glomerulonephritis (MGN) is a chronic kidney disease that causes damage to the cluster of blood vessels in the kidney that filter blood and begin the process to remove waste and excess fluid from the blood.

Approval was based on FDA’s review of a clinical study involving 560 blood samples, of which 275 samples were obtained from patients with presumed primary MGN (pMGN), according to an FDA news release. “The test was able to detect pMGN in 77% of the presumed pMGN samples, and gave a false positive result in less than 1% of the other disease samples,” it says.

—Jim Dickinson is MD+DI's contributing editor.

[image courtesy of DIGITALART/FREEDIGITALPHOTOS.NET] 

FDA Finds Quality Violations at Utopia Group

FDA Finds Quality Violations at Utopia Group

A recent FDA inspection at Utopia Group, a specification developer for Loveland, OH-based Joey Medical’s Joey Spray Guard umbilical cord clamp and cutter, found multiple Quality System Regulation violations, according to a May 21 Warning Letter from the agency’s Cincinnati District Office.

Specific violations noted on a FDA-483 included:

  • Failing to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements.
  • Failing to establish and maintain procedures to control the device design to ensure that specified design requirements are met and demonstrate that the design was developed in accordance with the design control requirements.
  • Failing to establish and maintain procedures for implementing corrective and preventive actions, and to document all activities required under that regulation.
  • Failing to establish and maintain procedures to control product that does not conform to specified requirements.
  • Failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.
  • Failing to establish and maintain procedures to control all documents required by regulations.
  • Failing to establish procedures for quality audits and to conduct such audits to assure that the quality system complies with the established quality system requirements and to determine quality system effectiveness.
  • Failing to establish procedures for identifying training needs and ensuring that all personnel are trained to adequately perform their assigned responsibilities.
  • Failing to have management with executive responsibility ensure that an effective quality system has been established and implemented.

The adequacy of the firm’s response to the observations could not be determined at this time, the letter says. The inspection also found that the company failed to develop written medical device reporting procedures.

Utopia was told to take prompt action to correct the violations and to respond with a list of steps taken, documentation of each step, and a timetable for completion.

—Jim Dickinson is MD+DI's contributing editor. 

[image courtesy of KIBSRI/FREEDIGITALPHOTOS.NET] 

Miniaturized Cutting and Drilling Using Picosecond Lasers

Offering precision, high throughput, and cost savings, picosecond laser processing is suitable for fabricating microfluidic technologies, miniaturized implants, drug-delivery catheters, and other devices.

By Dirk Müller, Coherent Inc.

Sidebar:
Using Picosecond Lasers to Produce Disposable Ophthalmic Blades

Traditionally, electrical discharge machining (EDM) or conventional laser tools have been used to manufacture a range of precision medical devices. However, these manufacturing methods cannot be used to achieve the miniature features, precision, surface quality, and yields required for manufacturing microfluidic devices for clinical lab-on-a-chip applications, precision drug-delivery catheters, next-generation ophthalmic blades, and a host of miniaturized implants. To manufacture such devices, alternative high-precision micromachining methods are required. This article examines the use of the picosecond laser to perform micromachining processes in medical device manufacturing applications.

Making Microfluidic Devices

Microfluidics is a broad field that encompasses medical and clinical lab devices and applications. In addition to lowering costs, microfluidic devices enable miniaturization, automation, and parallel processing in lab-on-a-chip devices, supporting the growing demand for personalized medicine. Representing a massive growth opportunity for the medical device industry, the sector is forecast to grow beyond $5 billion before the end of the decade.

Figure 1. Picosecond lasers provide a flexible and versatile method of creating complex grooves, holes, and wells in various materials, including in glass microscope slides.

Relying on surface tension and other parameters, microfluidic devices contain, mix, or transport fluids through channels and holes at the submicron scale, as shown in Figure 1. They frequently incorporate a three-dimensional pattern of channels, which are typically created by machining two or more plastic or glass layers that are laminated together using a thermal frit, laser weld, or other bonding process.

The assembled device can be used in such emerging applications as patient genome sequencing and cancer genotyping applications, ultimately promising to miniaturize several existing macroscopic medical analysis methods. A primary benefit of microfluidic technology is that it can perform complex analysis and testing on minute amounts of blood and other fluids down to 0.001 ml. Microfluidics also encompasses catheter technologies and drug-release tools based on inkjet-type technology. In such applications, the use of holes with diameters as small as 20 µm enables automated drug delivery with unprecedented dosing capability and temporal precision.

Picosecond Laser Processing

A relatively new type of laser that is already used to produce such products as touch screens and solar cells, industrial picosecond lasers are capable of delivering the performance, speed, and economy required to fabricate microfluidic and other miniaturized medical devices. Picosecond lasers can create high-precision holes, channels, and marks on such materials as glass, silicon, and polymer without producing edge damage or debris. These simple features, in turn, become the building blocks for creating a variety of microfluidic devices.

Figure 2. By removing material partially through photoablation, picosecond lasers produce higher-quality holes than traditional laser techniques.

In contrast, current tools cannot achieve the micron-level precision requirements of microfluidic devices. For example, mechanical drills cannot produce the hole sizes required in microfluidic applications. Even at the larger end of the microfluidic range, tool wear and breakages make economical, consistent, high-throughput manufacturing impossible using mechanical methods.

EDM is a potential option for drilling simple holes in the few microfluidic devices based on metal. However, EDM electrodes wear with use, impacting product consistency and resulting in frequent replacement downtime. Moreover, EDM typically produces inferior hole quality, resulting in rough side walls.

While traditional pulsed lasers have long been employed in medical device manufacturing applications to produce micron-scale holes and other features, they have pulse widths in the tens of nanoseconds range. Nanosecond pulses remove material using a thermal process in which surface material is boiled and ejected as melted and vaporized material. As a result, most common pulsed laser sources also produce a heat-affected zone (HAZ), which results in thermal damage or microcracks.

Picosecond pulses, in contrast, are more than a thousand times shorter than nanosecond pulses, generating significantly higher peak power in the megawatt range. As illustrated in Figure 2, higher peak power triggers a cold photoablation process, in which a higher proportion of material is removed in a vaporized state. This process reduces HAZ and largely eliminates such defects as burrs on hole edges, recast material, and surface debris, as shown in Figure 3. Thus, picosecond laser processing is particularly suitable for drilling holes in such thermally sensitive materials as glass and polymers.

Figure 3. A 200-µm-diameter hole drilled in stainless steel using a picosecond laser (right) reveals cleaner results than a 200-µm-diameter hole drilled using a nanosecond laser (left).

While the processing advantages associated with picosecond lasers have long been known in the R&D lab, the recent advent of compact, robust picosecond lasers is enabling their emergence in cost-conscious volume manufacturing environments. For example, the Talisker and Rapid series of picosecond lasers from Santa Clara, CA-based Coherent Inc. feature laser head dimensions as small as 180 × 330 × 460 mm, simplifying integration into production lines and workstations. Available with a choice of infrared, visible, or ultraviolet outputs, they can machine most materials employing a wavelength that is optimally absorbed by the target, maximizing process efficiency and eliminating the potential for peripheral thermal effects. Their high power can achieve material ablation rates up to 1.5 mm3/sec.

Medical devices featuring complex machined patterns and shapes must often undergo advanced micromachining, requiring communication between the laser and the motion control system. Using picosecond laser systems, communication can be achieved using real-time control of pulse energy, pulse repetition rate, and pulse timing. When machining films, for example, the control of these parameters enables users to maintain a finite cut depth around sharp corners and ends, although the motion control system may not always deliver constant velocity. This control also allows machinists to avoid overshooting cuts onto background webbing or other support substrates.

Machining Medical Device Materials

While the deployment of picosecond lasers in the medical device manufacturing industry is still in its infancy, several materials have already been qualified for use with this technology, including nitinol, cobalt chrome, heat-sensitive polymers, and borosilicate glass.

Figure 4. A microfluidic channel machined in FEP using a 355-nm picosecond laser.

Machining Polymers. Several polymers exhibit a combination of biological inertness and mechanical properties, making them suitable for use in medical device applications. For example, microfluidic dispensing devices in catheter applications are often made from fluorinated ethylene propylene (FEP).

A strong absorber of ultraviolet light, FEP can be machined using any ultraviolet laser. However, because this material is sensitive to heat, processing micron-level features using traditional laser methods is impractical. Ultraviolet picosecond lasers, on the other hand, can cut, drill, and mark polymers using a maximum of processing energy with a minimum of unwanted heat. As shown in Figure 4, ultraviolet picosecond lasers can routinely drill hole diameters measuring less than 10 to 100 µm in FEP tubes, enabling catheters to deliver controlled dosage volumes.

Drilling Holes in Glass. The ability of picosecond laser pulses to achieve high peak power makes them suitable for cutting glass with clean edges, as illustrated in Figure 5. It also enables users to reverse-drill holes with aspect ratios as high as 100:1.

When lasers are used to drill small holes, the maximum aspect ratio is limited by the focusing properties of the beam. The smaller the hole, the tighter the required focus, which means a reduced depth of focus. As the focused laser is pushed farther into the hole, its entrance diameter increases. But the high peak power of picosecond lasers changes the optical properties of glass, causing an effect known as self-focusing. This effect can be exploited to drill glass by focusing through the glass onto the rear surface. The hole is then created as the focusing lens is backed away from the front surface. Based on this self-focusing effect, perfect tight focus is maintained throughout the drilling process, leading R&D groups to use this method to drill parallel-sided holes in 1-mm-thick glass with diameters as small as 10 µm. No other drilling method can match such high aspect ratios at such small diameters.

Figure 5. 3-mm-diameter (button) holes cut in a 5.5-mm-thick glass substrate.

Laminates. Another benefit of picosecond lasers is their ability to mark composite or layered materials. When the surface layer is transparent to a laser wavelength, the underlying layer can be marked without compromising the surface layer. While this method is commonly used to mark consumer electronics with a branded logo, it can also be used to produce microfluidic component markings for product traceability, such as a bar code or QR code. The untouched clear coating ensures biological inertness to the marked material.

Picosecond lasers can also be used to machine laminates. For example, when a composite material consists of a stack of layers--each with different material properties--a picosecond laser can selectively remove layers to create a functional electronic circuit on a nonconducting substrate. Software flexibility enables the laser to produce lab-on-a-chip devices in which complex fluid channels and electrical interconnects can be rapidly prototyped and evolved during preclinical trials.

Conclusion

There is a fast-growing need in the medical device industry for versatile tools that can perform drilling, cutting, and other machining processes. Because its processing capabilities have already been demonstrated in other demanding markets, the picosecond laser is a good candidate for supporting medical device applications.


Dirk Müller is director of product line management at Coherent Inc. Before joining Coherent, he was director of marketing and sales at Lumera Laser and vice president of operations at Kapteyn-Murnane Laboratories. He also worked as a senior research scientist at Corning Inc., where he specialized in characterizing photonic bandgap fibers. During his professional career Müller has published articles in numerous journals, including Science, Nature, Physical Review Letters, Optics Letters, and Laser Focus World. Reach him at dirk.mueller@coherent.com.

Top Trends in Stent Design and Manufacturing

Qmed took to the show floor at the recent MD&M East event to discuss some of the top trends in stent design and manufacturing with industry experts from Memry, Norman Noble, and MeKo. Check out the below video to learn more about the continued move toward increasingly complex geometries and more exotic materials, as well as the challenges that these trends present.

J&J Sells Ortho-Clinical for $4 Billion

Giant healthcare conglomerate Johnson & Johnson has announced that it has completed the sale of its Ortho-Clinical Diagnostics (OCD) business to The Carlyle Group for approximately $4 billion.

As we reported at the end of the first quarter, OCD accounted for $1.89 billion in revenue in 2013, which was a nearly 9 percent decline from 2012. The company is composed of two divisions. One supplies equipment and chemicals for screening and typing blood that will eventually wind up in transfusions, while the other does more-advanced blood testing for the diagnosis of a range of health conditions and monitoring of the effects of various medications.

Ortho Clinical Diagnostics
OCD's revenues had fallen in recent years. Image from Signs Express.

The Carlyle Group is described as a Washington, DC-based global asset management firm specializing in private equity. According to Wikipedia, The Carlyle Group had $170 billion in assets under management across 113 funds and 67 fund of fund vehicles as of December 31, 2012. The firm is said to have more than 1400 employees, including 650 investment professionals, with offices in 33 countries around the globe.

In conjunction with the sale of OCD, Robert Yates will assume the newly-created position of Chief Operating Officer, and will report directly to incoming OCD chairman and CEO, Martin Madaus. Yates will also be appointed to OCD's board of directors.

Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.

"We are excited at the prospect of having Robert's diagnostics and executive leadership experience on board at OCD," said Stephen H. Wise, Carlyle managing director. "In partnership with Martin, Robert will contribute significantly to OCD's transformation into a global standalone diagnostics leader." Madaus added, "Robert's strategic perspective and proven leadership abilities align well with OCD's new priorities of profitable growth and differentiated innovation for our customers and for patients around the world."

Yates will join OCD from Merck KgaA, where he was President and CEO of EMD/Merck Millipore, its global life sciences division. At EMD Millipore, Yates finalized the complex transition of Millipore from a standalone company into one integrated, global Life Science division.

Stephen Levy is a contributor to Qmed and MPMN.

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How Flight Simulator Software Could Reboot Surgery

They've had it in-flight simulators to help pilots train for life-or-death situations. Now 3-D and augmented reality is coming to another high stakes place--the operating room--after FDA clearance of Cleveland-based Surgical Theater's Surgical Navigation Advanced Platform (SNAP).

SNAP OR
The technology from Surgical Theater was inspired by F-16 flight simulator software.

The concept involves combining flight simulation technology with advanced CT/MRI imaging for use in brain surgery, according to Surgical Theater. The company's Surgical Rehearsal Platform (SRP) received FDA clearance last year when it came to providing a real-life "fly through" of a "patient-specific" surgery.

With the new FDA clearance, the Surgical Navigation Advanced Platform can now be also used in an operating room to help surgeons execute their surgery plan, using 3-D organ models created using a patient's CT/MRI scans. The system also takes into account the deformation that tissues may undergo in the procedure. For instance, in the case of cerebral aneurysm repair surgeries, the orientation of brain tissues can be distorted as the surgeon cuts and applies pressure to it, making it difficult to use CT or MRI scans.

Warren R. Selman, MD, chairman of the Department of Neurological Surgery at University Hospitals Case Medical Center in Cleveland, actually started Surgical Theater with two ex-Israeli Air Force R&D officers he met in a coffee shop in 2010, CNN reports. They were musing why flight simulator technology was not used to help surgeons prepare for difficult surgeries.

Selman is Surgical Theater's chief medical officer, while electrical and computer engineer Moty Avisar is president and software engineer Alon Geri is vice president of engineering.

University Hospitals Case Medical Center is now using SNAP as an integrated operating room device, Selman says.

"It is just like watching a football game when multiple cameras are located around the arena and an editor can freeze the image, rotate, zoom in, zoom out and see things that he could not otherwise see," Selman said in a news release. "In my recent surgeries, I was able to pause the navigation scene during the surgery to rotate the image and to verify that I removed the entire tumor and to make sure that I was within a safe distance from a vital artery while removing the tumor.  With the SNAP connected to the OR navigation platform, the OR team coordination is enhanced, and we are utilizing the best imaging technology tool to benefit our patients."

One wonders what other types of risky surgeries, not to mention other medical procedures, might benefit from using 3-D and augmented reality to help health practitioners train, as well as guide them through procedure.

The SNAP technology works by leveraging several networked PCs that have dedicated tasks such as the processing of visual information, user-interface data, and so forth, according to Surgical Theater's patents. The strategy of tapping the processing capability of several PCs affords precise simulation fidelity of complex medical procedures such as aneurysm repair. In addition, it minimizes processing lag time, enabling the surgeons to be immersed in realistic surgical training.

This is made possible in part by proprietary algorithms that crunch the data from the samples, and then calculate the parameters of the data communicated across the system's network notes.

A patented modeling system synthesizes patient medical images of one or more organs with the system's database of model organ data. The system then uses this combined data to generate life-like dynamic images of the relevant organs. The software also is able to realistically model the characteristics of surgical tools, probes, and medical devices, and determine how those tools would interact with the relevant anatomy in a surgical procedure based on user input.

Patent image
This high-level schematic of a hardware implementation is pulled from U.S. patent 12/907,285.

Surgical Theater says on its website: "The software engineers that designed the SRP also developed the flight simulation technology used by F-16 fighter pilots. Surgical Theater's patented and FDA-cleared Surgical Rehearsal Platform is patient-specific allowing surgeons to be prepared for complicated cases in a similar way to how F-16 fighter pilots prepare for complicated missions."

It was also important to have a slim and robust cart for the OR, and an iPad displays the main screen image, "with full control capabilities and is ideal for remote use and viewing," according to Surgical Theater marketing materials about the device.

A virtual clip appears at the tip of the navigation probe for evaluation, the navigation image can be frozen and rotated to observe multiple points of view, and markers on the virtual clip allows for measuring of the neck and to fit a clip. There's also an adjustable virtual probe extension for stereotactic and trajectory planning.

Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarkerBrian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.

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10 Technologies Designed by Medtech's Next Generation

Jack Andraka’s Potential Pancreatic Cancer DetectorJack Andraka, 17, earned the Gordon E. Moore Award, the top prize at the 2012 Intel International Science and Engineering Fair (Intel ISEF), for this noninvasive, nanotechnology-based paper sensor. Still only in high school, Andraka used carbon nanotubes on a dipstick sensor to figure out the level of  serum mesothelin in but a few drops of urine or blood. He’s claimed the test is mostly effective when it comes to detecting mesothelin, a substance thought to be associated with some early stage cancers.Andraka has said he hopes to commercialize his test someday, though not everyone is enthusiastic about the wunderkind’s claims. Matthew Herper pointed out in Forbes that Andraka's achievement was remarkable for a high school student, but "falls far short of changing science and is only a small step toward developing a workable cancer diagnostic." Medical publisher Kent Anderson also says Andraka’s claims need more scientific scrutiny.Read more about Andraka in Qmed's 30 under 30.

10 Technologies Designed by Medtech's Next Generation

Nanomachines Could Be on the Horizon

The Rosetta macromolecular modeling package developed by the University of Washington's David Baker, PhD, and colleagues has formed the basis of a recently developed computational method that may be an important step toward the goal of constructing protein nanomachines engineered for specific applications--including in the medical device space. 

Protein Nanocage
Computational model of a two-component protein nanocage with tetrahedral symmetry. (Courtesy Vikram Mulligan, PhD)

In "Accurate Design of Co-Assembling Multi-Component Protein Nanomaterials" (King, et al.), published in the journal Nature, the researchers describe the development and application of new Rosetta software. This new software has enabled the design of five novel, 24-subunit cage-like protein nanomaterials that arrange themselves into higher order, symmetrical architectures.

Importantly, the actual structures were in very close agreement with their computer modeling, the researchers observed. The Rosetta program was originally created to predict natural protein structures from amino acid sequences, but researchers in the Baker lab and around the world are increasingly using Rosetta to design new protein structures and sequences aimed at solving real-world problems.

The project was led by the University of Washington's Neil King, PhD, translational investigator; Jacob Bale, graduate student in Molecular and Cellular Biology; and William Sheffler in David Baker's laboratory at the University of Washington Institute for Protein Design, in collaboration with colleagues at UCLA and Janelia Farm.

"Proteins are amazing structures that can do remarkable things," King said. "They can respond to changes in their environment, Exposure to a particular metabolite or a rise in temperature, for example, can trigger an alteration in a particular protein's shape and function."

The researchers' method encodes pairs of protein amino acid sequences with the information needed to direct molecular assembly through protein-protein interfaces. The interfaces not only provide the motive forces that drive the assembly process, they also precisely orient the pairs of protein building blocks with the geometry required to yield the desired cage-like symmetric architectures.

King explained that since the immune system responds to repetitive, symmetric patterns, such as those on the surface of a virus or disease bacteria, building nano-decoys may be a way train the immune system to attack certain types of pathogens. "This concept may become the foundation for vaccines based on engineered nanomaterials," King said.

In the abstract of their paper, the scientists say, "(T)he accuracy of the method and the number and variety of two-component materials that it makes accessible suggest a route to the construction of functional protein nanomaterials tailored to specific applications."

Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.

Stephen Levy  is a contributor to Qmed and MPMN.

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Covidien Deal Illustrates How Omar Ishrak is Making All the Right Moves

Covidien Deal Illustrates How Omar Ishrak is Making All the Right Moves

Medtronic CEO Omar Ishrak is certainly a man with a vision for the mighty medtech multinational he helms—and he’s systematically making it a reality. 

The company’s announced acquisition of Covidien for a staggering $42.9 billion promptly elicited grumbling about layoffs, offshoring, and the potential impact on the American economy in addition to sparking a fierce debate about the practice of tax inversion. But the focus on tax savings and increased cash flow has eclipsed the fact that Medtronic’s acquisition of Covidien neatly checks all of Ishrak’s boxes for strategic growth opportunities. 

“This is a highly strategic and compelling acquisition, fully aligned with our mission of alleviating pain, restoring health, and extending life for patients around the world,” Ishrak said during a call with analysts. “It accelerates all three of our growth strategies—therapy innovation, globalization, and economic value—and bolsters the long-term sustainability and consistency of our mid-single-digit revenue growth expectations.” 

Just because this is a carefully crafted PR message doesn’t make it untrue. In a time when many companies are seemingly floundering for direction and wrestling with what to do in the face of a dramatically changing healthcare landscape, Ishrak has identified a clear path forward that—on paper at least—looks like a sustainable plan for growth.

He has been vocal, for instance, about the importance of emerging markets to Medtronic’s future, predicting in a 2012 interview with Fortune that they would be “the most important” driver of the business. Ishrak has also candidly admitted that establishing a foothold in and understanding the needs of emerging markets has been more challenging than expected.

The new entity, Medtronic plc, will generate $3.8 billion in emerging markets, substantially increasing Medtronic’s global footprint and reach. Ishrak added during the call that the company believes it “can sustain double-digit growth over an extended period of time” in emerging markets.

Ishrak has also expressed interest in R&D and innovation. Thanks to the increased cash flow and the ability to flexibly deploy that money as a result of the acquisition, Medtronic has pledged to invest $10 billion in technological innovation and R&D over the next decade, primarily in the United States.

But perhaps the most notable strategic benefit to this medtech takeover is that it accelerates Medtronic's transformation into an integrated healthcare company. To better compete in the dawning age of value-based healthcare, Ishrak has methodically been establishing the foundation on which to build a healthcare powerhouse capable of delivering a range of solutions across the continuum of care.

The acquisition of Cardiocom last year, for example, brought a “developer and provider of integrated telehealth and patient services for the management of chronic diseases” into Medtronic’s fold. More indicative of Ishrak’s master plan, however, was the formation last year of Medtronic Hospital Solutions, a new business unit established to improve hospital operational efficiency through service offerings. As its first venture, the business partnered with several European hospitals to manage their cath labs.

Moving forward, the complementary nature of Covidien’s product portfolio will undoubtedly extend Medtronic’s reach beyond its therapeutic sweet spot in the postacute setting, allowing it to further secure a strong position in the hospital. 

And it seems as though Ishrak and his team is already eyeing the OR as its next target for partnership opportunities. During the analyst call, he expressed enthusiasm from both Medtronic and Covidien for the untapped opportunities in the OR market and noted that such ventures could motivate future acquisitions. However, he emphasized that no specific plans were underway just yet.

This ability to facilitate hospital efficiency will, in turn, provide a value proposition that’s going to be tough to beat, according to Ishrak—and most would probably agree. “Now, with our collective financial strength, [we can] go in [to hospitals] and come up with innovative long-term contracts and some element of the risk sharing,” he said during the call. “There won't be too many other partners or companies out there in healthcare who can come up with proposals such as this. We're optimistic about what we can do.”

As he should be. Because if Medtronic doesn’t bungle the integration, the combined company could be a formidable force potentially capable of giving Johnson & Johnson a run for its money. 

So, yes, the primary drivers of this landmark deal appear to be tax savings and increased cash flow. But this deal is about much more than just a cash grab; Ishrak’s charting a course for Medtronic that will likely keep it afloat in the choppy, uncharted waters of outcomes-based healthcare while some unprepared or inflexible competitors may soon find themselves on a sinking ship.

 —Shana Leonard, group editorial director, medical content
shana.leonard@ubm.com