Arab Health 2013 Day Two: Demand for American-Made Medical Devices in the Middle East

Arab Health 2013 Day Two: Demand for American-Made Medical Devices in the Middle East

Approaching the venue Tuesday, I caught a glimpse of the world’s tallest building, the Burj Khalifa Tower, from the convention site of Arab Health 2013, the world’s longest-running healthcare event. Come to think of it, from where wouldn’t the world’s tallest building be visible?

Attendees check out exhibits at Arab Health 2013.

The event really got into full swing Tuesday. Show floor traffic was noticeably higher than the first day, as more attendees arrived in Dubai. In addition to the exposition, they came for education to attend conference sessions on key topics in healthcare. There were 19 sessions, with topics ranging from orthopedics, biomedical engineering, pediatrics, big data, and imaging and diagnostics. Some were sold out, some were invitation only, but all were geared toward the growing healthcare market in the Middle East.

I was able to catch up with several U.S. companies exhibiting at the event. Some of them have been in the Arab market for a few years, while others were at the show for the first time. All of them seemed to project optimism and enthusiasm for the impact of the event and the potential for this market. I continued to hear that American products and services are considered premium offerings and are sought out by the Arab marketplace. However, this came with a qualifier: Medical devices have to be FDA approved to succeed here, and adding CE is a useful compliment. This question of FDA approval was not always the first one asked, but it always came.

Several companies showcased new products or technology at the event. Some were introducing their products globally, and others were bringing them to this region for the first time.  A Pennsylvania company called CurveBeam introduced a new weight-bearing 3-D cone-beam CT scanner product call PedCAT. Nonin presented its Model 7600 Regional Oximeter System, a four-channel regional rSO2 oxygenation sensing system. Chattanooga featured a prototype of it's new Vectra Neo physiotherapy device.

Don Beery is president of Blendon Group Consulting and executive director of the West Michigan Medical Device Consortium. Check back throughout the week for more of his posts from Arab Health 2013. 

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Mobile Medical Device Technology on Display on NBC

Famed cardiologist Eric Topol, MD demonstrated an array of digital health technologies in a segment titled "iDoctor" on NBC's Rock Center with Brian Williams. In the segment, a number of mobile medical devices were on display (also pictured below), ranging from AliveCor's iPhone ECG to a smartphone-compatible continuous glucose monitor from Dexcom. In the clip, Topol explained how such technologies are fueling the future of healthcare by enabling better monitoring of health metrics. "The new medicine is plugged into you," he said. "It is understanding you, which we've never really done before."

The accuracy of the AliveCor's FDA-cleared iPhone ECG has been validated in clinical trials. The device has two metal electrodes (shown above right) that detect physiological signals from the user's skin and converts them into an ultrasonic signal detected by the phone's microphone.

The GE Vscan was featured in TIME magazine as one of the 50 best inventions of the year in 2009. The pocket-sized device packs real-time ultrasound display functionality into a unit that is roughly the size as a smart phone. The Vscan is powered by a 7.4 V lithium-polymer battery.

Dexcom's glucose monitoring technology was also on display in the NBC clip. Shown here is the company's G4 CGM. The company's sensor technology can communicate with a number of insulin pumps.

The ViSi Mobile medical device from Sotera Wireless enables wireless, body-worn vital sign monitoring of metrics such as blood pressure, SPO2, ECG, heart rate, and temperature. The schematic for the technology below was drawn from U.S. patent 8180440, which was granted to Sotera in 2012.  

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

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Cal Poly to Host Alumni Event at MD&M West

Patrick Stewart
Patrick Stewart, senior director of development for the College of Engineering at Cal Poly Pomona, describes the event as an outreach effort, both or alumni and for industry to learn more about the school and its programs. He says Cal Poly is looking to expand its course and degree offerings into areas that will be of interest to the medical device industry, including biomedical engineering.
“Medical device design and manufacturing is one of the areas we've identified that would be a great area of concentration and focus for the college moving forward.” He say that members of Cal Poly Pomona's leadership board have been pushing in this direction, particularly with so many device companies in Orange County, CA and the surrounding areas. Stewart says the school is actively looking to recruit faculty in these fields as well.
Under the guidance of its new dean, Mahyar Amouzegar, a former professor at Cal State Long Beach who also served on staff at the Rand Corporation for 10 years, the school is also looking to work with a number of organizations and device manufacturers including Applied Medical, a provider of products for minimally invasive surgeries, and Pendat Design Corp., an engineering firm that works with medical device manufacturers, on a number of fronts from designing concentrations to creating entire academic programs. “We're reaching out to different constituencies to find out what they think would be the best course of action for students looking to enter their particular field or industry. And how we can take existing resources and maximize or leverage those to the best or our ability to help our students and faculty,” says Stewart. The goals is for students to stay up to date on contemporary practices and gain insight into what's coming next. “We're trying to create those ties to people in those different types of organizations that will help us better understand how we can position the college to be more of a service to them and better prepare students looking to enter that field,” he adds.
While the bulk of Cal Poly Pomona's students have historically been undergraduate, one of Amouzegar's primary charges as dean has been to grow the school's graduate program to create more engagement with the device industry. Having students and faculty involved in grant and contract work is viewed as a perfect opportunity to keep them abreast of the industry. “Projects for graduate work can tackle contemporary problems with contemporary technologies. Doing this the students and faculty are insights on how their studies or their work could be of current and future benefit to organizations they may be looking to partner with. By growing the graduate program you keep you faculty current and sharp; you also expose students to problem solving issues related to the career they want to pursue,” Stewart says.
The Cal Poly Pomona event will be held Tuesday, Feb 12, from 5:00-6:30 p.m. in Room 205A in the Anaheim Convention Center as part of MD&M West.
-Chris Wiltz is the Associate Editor of MD+DI
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Boston Scientific to Lay Off Up to 1000 Employees

Boston Scientific, a medical device manufacturer based in Natick, Massachusetts, announced that it would cut up to 1000 jobs as it deals with the fallout from the United States healthcare overhaul, the Affordable Care Act and limited growth potential in some markets. While the recent layoffs spell dire news for many employees at Boston Scientific, investors remain upbeat. Following the release of positive fourth-quarter results on Tuesday, shares of the company's stock rose on Tuesday. In addition, Boston Scientific's 2013 profit forecast beat analysts' expectations. To reduce costs at the company, Boston Scientific will shed an estimated 900 to 1,000 jobs in 2013. In addition to layoffs, the job cuts will eliminate positions at the company that are currently unfilled. These layoffs follow a 2011 restructuring plan that led to 1,200 to 1,400 job cuts. As of now, Boston Scientific employs approximately 24,000 around the world. The total workforce reduction planned for 2013 could result in a four percent reduction in the company's human capital. According to Steven Campani, a spokesman at Boston Scientific, the company has not yet decided where it will cut jobs. According to information from the company, Boston Scientific expects to cut costs by $340 to $375 million by the end of the year. This figure includes an additional $100 to $115 million in savings from additional restructuring initiatives. References Related content The Layoff List: Medtech Job Cuts Run Deep
The Old Medtech Business Model Is Unsustainable. Now What?

FDA Approves Conventus Orthopaedics's Wrist Fracture Implant

Conventus Orthopedics, a medical device manufacturer based in Plymouth, Minnesota, announced that it received approval from the United States Food and Drug Administration for its wrist fracture implant, the Conventus DRS. According to a press release by the company, the Conventus DRS is designed to replace the volar plate implants traditionally used to correct fractures of the distal radius. The new Conventus DRS only require a small incision on the forearm and a few very small incisions on a patient's wrist. The fragment-specific system also has similar fix stability compared to traditional screws and plates. The company also stated that the Conventus DRS is the first FDA-approved device that addresses a wide variety of different fractures. The device will also be able to reduce surgical trauma from an operation by 80 percent compared to traditional techniques. The device can preserve soft tissue around the site of a fracture to minimize pain, swelling and stiffness. Paul Hindrichs in the CEO of Conventus. In prepared remarks, he said, "Conventus is very pleased to bring this innovative technology to the U.S., expanding the possibilities for quality patient care. The results from our European clinical study indicate that this will be a very successful technology for distal radius fractures in the U.S. and around the globe. We are enthusiastic about receiving our FDA 510(k) clearance. This supports Conventus' plans for both U.S. and OUS business expansion." References

How Medical Device Makers Can Accelerate RoHS Compliance

How Medical Device Makers Can Accelerate RoHS Compliance

RoHSMost global consumer electronics makers changed their supply chain processes to comply with the Restriction of Hazardous Substances (RoHS) directive in July 2006. Many lessons and best practices learned from these changes can be offered to the medical device world. Medical device companies looking to sell their products in Europe must comply with the law by July 2014. Similar legislation can also be anticipated in China, Japan, and North America.
Medical device makers have much to gain by partnering with institutions that have demonstrated experience and expertise in RoHS implementation at the global level. By doing so, they can take advantage of the work that was already done by consumer electronics OEMs and tackle the new challenges unique to the healthcare technology industry. The sooner medical device manufacturers start redesigning their products and planning their go-to-market strategy, the more time they will have to perform all of their required testing and evaluations before the fast approaching deadline.

The first area of concern is supply-chain readiness.

Medical device manufacturers will not only need to understand their supply chain in a post-RoHS world, but also their ability to provide evidence of RoHS compliance for all of the components, parts, and materials they ship. This is a key lesson learned from the consumer electronics world and is an often overlooked issue for companies in their initial planning for RoHS compliance.
It is important to note that non-electronic peripheral items such as SKU numbering and packaging systems are often considered to be a part of the electronic device. For example, leather cases that exhibited residues of RoHS-regulated chemicals could have led to regulatory non-compliance for a product, if these trace amounts were not found through meticulous due diligence processes instituted by one high end mobile device manufacturer.

An oversight in this area can also lead to significant financial losses, due to product inventory seizures and fines.

A preview of this financial loss occurred while many consumer electronics manufacturers were ramping up their RoHS compliance efforts leading up to the 2006 deadline. The Netherlands, which had a regulation banning cadmium in place by 1999, seized millions of gaming consoles and accessory packs worth millions due to cadmium found in some of the cables.

These situations can be avoided by a comprehensive supply chain verification exercise that addresses all aspects of the product and its packaging, not just the electronic components. In medical products, serious attention needs to be paid to the enclosures, connectors, interconnects, accessories, and mechanical support devices.

More from Celestica:

Component suppliers that are unique to the medical device field or to a related industry that has not yet been affected by RoHS will also need to be evaluated. These suppliers may not have the skills and the knowledge to demonstrate full RoHS compliancy. It is critical to understand how these suppliers separate compliant materials from non-compliant materials to ensure the correct inventory segregation and prevent these supplies from mixing.

Of course, this leads to another area of concern, which is, what happens after product material changes are made.

Consumer electronics manufacturers quickly learned that changing to lead-free component terminations —as well as interconnect solders—had a significant effect on the product’s reliability in the field. These material changes led to greater brittleness of the resultant interconnect and an overall more fragile product.

To overcome this technical challenge, consumer device manufacturers moved to implementation of modified solder formulations, ultimately resulting in improved reliability.

For many consumer electronics OEMs, RoHS compliance also signalled a shift in manufacturing culture. For the higher end consumer devices, the emphasis on brand protection in terms of product reliability and cost-to-performance ratio were always important throughout the transition to RoHS compliance.

Celestica has found that one positive benefit of the transition to RoHS compliant products was the improved electrical performance characteristics of some of the RoHS compliant printed wiring board laminate materials, as compared to their precursors designed for lower temperature processing using leaded solders.  

It is important to begin the conversion process early to prevent stockpiles of non-compliant inventory, which would be deemed unusable after July 2014. Using a partner with global presence and expertise in RoHS compliance practices can help get the process started and ensure medical device manufacturers can perform the required testing and evaluations well before the RoHS deadline.

Simin BagheriSimin Bagheri, M.A.Sc., P.Eng. is the customer engagement lead for the engineering services division at Celestica Healthtech. She will be presenting this topic and the RoHS implications for materials selection in depth at MD&M West 2013 Conference, Feb. 11 – 14 in Anaheim, CA.

Arab Health 2013 Day One: Healthcare Opportunities Abound in the Middle East

Arab Health 2013 Day One: Healthcare Opportunities Abound in the Middle East

The city of Dubai was shrouded in morning fog as the beehive of last-minute exhibit preparations reached a crescendo on the show floor. Yet the day turned bright and blue as the sun chased away the haze and the doors swung open for day one of Arab Health 2013

Ambassador Corbin addressed the U.S. Pavilion on the opening day of Arab Health 2013.

In the U.S. Pavilion, U.S. ambassador to the United Arab Emirates Michael H. Corbin kicked off the American participation with a ribbon cutting (red, white, and blue streamer, of course) and an energetic speech that exuded the friendship we have with this Arab state. Corbin also inspired the gathered group with a portrayal of the Emirati people as those who seek out and value made-in-the-USA-branded products and services. It’s clear we can do business here in healthcare—lots of it! It may require some occasional cultural adjustments and patience, but opportunities abound.

I spoke with one person, a non-Arab expatriate here, and asked her to describe the business potential in Dubai. Her simple one-word answer: Excellent. In fact, of the approximately 2 million people in Dubai, less than 20% are native Emerati. Most are foreign nationals doing business in one market sector or another. Projected healthcare spending in the region will hit $133 billion within 5 years, and there were 420 health projects launched in Saudi Arabia alone last October.

Floor traffic picked up steadily throughout the day as attendees toured booths from nearly every medical device manufacturer around the world and many major hospital systems (including Cleveland Clinic, Johns Hopkins, and University of Chicago Medical Center). Exhibitors are showcasing everything from hi-tech surgical suite equipment suspended from the ceiling to “med bars” (apparently an edible medicine delivery method). Although U.S. presence among exhibitors is strong, the number of companies from China surged 40% from 2012, to 428.

Don Beery is president of Blendon Group Consulting and executive director of the West Michigan Medical Device Consortium. Check back throughout the week for more of his posts from Arab Health 2013. 

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Manufacturing Systems Today: Assembly Equipment

Ultraclean assembly robots
Compact VS-series six-axis robots from Denso Robotics are available in ISO Class 5 and ISO Class 3 cleanroom versions for use in medical device assembly applications requiring very high levels of contamination control. The high degree of flexibility inherent in the robots' articulated design and choice of end effectors, according to the manufacturer, makes them suitable for performing a variety of high-speed, high-precision assembly tasks and for carrying out such secondary operations as packaging, testing, and inspection. Assembly cycle times range between 0.37 and 0.33 seconds and repeatability between ±0.03 and ±0.02 mm. Offering reaches of 500 to 900 mm and payload capacities of 4 to 7 kg, the robots can be mounted on the floor, ceiling, or wall. They have ultraslim arms that facilitate production-line integration, and an optional bottom-side cable connection saves floor space.
Denso Robotics
Long Beach, CA

Manual dispensing systems
Manually controlled dispensing systems from Dymax Corp. feature the normally closed handheld Model 200 diaphragm valve, which is designed to facilitate accurate dispensing of such low- to medium-viscosity fluids as light-curable adhesives, epoxy resins, cyanoacrylates, and activator-cured adhesives. Made from materials compatible with a variety of assembly fluids and characterized by a lightweight, ergonomic wand-style body, the precision valve is engineered to deliver good performance over a long service life. Each dispensing system includes light-blocking polyethylene tubing in two sizes: 3/8 in. OD for maximum flow and 1/4 in. OD for handling flexibility. An air filter regulator with an integrated shutoff valve and pressure exhaust to quickly and safely depressurize the system is another key design element. The turnkey dispensing systems can be used for dot, bead, and potting applications.
Dymax Corp.
Torrington, CT

Assembly fluid dispensers
Available from Nordson EFD, the high-precision Ultimus V and Optimeter dispensing systems for adhesives and other fluids used in critical medical device assembly processes have been designed to keep fluid quantities consistent as viscosity changes or the volume of fluid in the syringe decreases. The former dispenser models can store and then automatically adjust dispense settings to keep the volume of applied fluid constant in the case of fluids that undergo viscosity changes. To compensate for changing fluid levels when thinner fluids are used, the latter model automatically adjusts airflow to maintain uniform deposit size. The dispensers enable users to set dispense parameters in standard, metric, or SI units and to select among English, Chinese, French, German, Italian, Japanese, Korean, and Spanish as the language for menu displays and prompts.
Nordson EFD
East Providence, RI

SCARA robots
THL300 and THL400 SCARA robots, offered by Toshiba Machine Co. as additions to its THL series of small robots, have arm lengths of 300 and 400 mm, respectively, and a 5-kg payload capacity. Equipped with lightweight yet rigid die-cast-aluminum arms, the robots are designed to help automation system integrators reduce costs by requiring only minimal supporting and vibration-suppression elements. Other system design advantages include relatively low energy consumption, which contributes to good overall system efficiency, and easy-to-maintain gearboxes and motors. A high-rpm motor maximizes robot speed, and cycle times are 0.48 seconds with a 2-kg load. The lightweight SCARA systems feature a four-axis working envelope and 360° z-axis rotation. They are suited for handling and assembling small medical devices and components.
Toshiba Machine Co., America
Elk Grove Village, IL

Laser-welding system
The compact LQ-Smart system for particle-free laser-welding of plastic medical device assemblies with welding contours as large as 4 × 4 in. is suitable for benchtop use or integration into a production line. By splitting its system into a 16 × 21 × 24-in. control unit and a 13 × 24 × 15-in. welding unit, LPKF Laser & Electronics North America has made the welder flexible enough to fit into virtually any production environment. The control unit contains full control electronics and safety technology, and the welding unit houses the laser optics and clamping tools. The company claims that weld seams produced by the system are tough, optically perfect, and hermetic. The welder can join transparent materials to other transparent materials. It also contains all of the functions necessary for melt travel monitoring and can accommodate the optional integration of pyrometer control and burn-detection monitoring systems.
LPKF Laser & Electronics North America

Outsourcing Outlook on Cleanroom Manufacturing and Assembly

By partnering with a manufacturer that specializes in cleanroom services, OEMs can cut costs and rely on the supplier's specialized expertise, according to Harold Faig, CEO of MedPlast (Tempe, AZ).

MPMN: What advantages do medical device OEMs enjoy by partnering with contract manufacturers that offer cleanroom capabilities?
Faig: OEMs enjoy numerous benefits by partnering with outsourcing companies with cleanroom expertise. Operating a medical device manufacturing cleanroom requires capital equipment and expenses, annual certifications and maintenance, regular testing, cleanroom attire, and personnel trained to maintain and operate within the cleanroom environment. By bearing these expenses, the contract manufacturer can help the OEM to reduce costs while providing specialized services beyond the OEM's range of expertise.
MPMN: What cleanroom infrastructure, systems, and equipment skills should the medical device OEM expect of a contract manufacturer?
Faig: While cleanroom infrastructure and mechanical systems are common in the manufacturing world, they differ depending on the cleanroom class. In most cases, the contract manufacturer builds and certifies the cleanroom, but only then does it prove its true expertise and skills by developing maintenance and environmental testing programs and by training cleanroom personnel. The OEM should expect that the contract manufacturer has implemented a robust monitoring program, a thorough cleaning schedule, regular training programs, and competency assessments.
MPMN: What trends and advances in cleanroom manufacturing should the medical device OEM bear in mind when seeking a vendor?
Faig: The first question an OEM should ask is what cleanroom class is required to manufacture the medical device in question. Depending on the function, regulatory requirements, and sterility demands of the device, different levels of cleanroom manufacturing may be required. While flexible, modular options have been developed for less-stringent environments, modular cleanrooms are not an option for more-demanding operations. The medical device OEM should also be aware of the latest trends in measurement and filtration equipment, which are continuing to improve as new materials and methodologies are developed. Nevertheless, despite improvements in mechanical efficiency, physical design, and filtration, the need to filter and pressurize cleanroom air results in high energy-consumption levels. Hence, the most noticeable trend in the cleanroom manufacturing and assembly space is the emergence of efficient 'green cleanrooms' and advances in smart cleanrooms--computer-monitored facilities in which mechanical equipment can be adjusted as necessary to optimize performance.

Related: Outsourcing Outlook on Cleanroom Manufacturing and Assembly: Services

Think Like a Designer

Think Like a Designer

As an innovation program manager at Medtronic, Craig Lauchner is charged with helping one of biggest medical device companies in the world stay on the cutting edge of design. That’s a tall order but one Lauchner is more than capable of fulfilling. In his eclectic career, he has designed retail, computer, industrial, and medical products—and even designed for the extreme amusement ride market. Lauchner is also the inventor of Assumption Storming, a philosophy that urges adherents to set aside what they think they know in order to create new, more innovative solutions to problems.

Craig Lauchner will give a two-part presentation on Assumption Storming at MD&M West

MD+DI caught up with him in advance of his MD&M West presentation to talk about Assumption Storming, industrial design, and how his background in interior design informs his approach to medical device design.

 What is Assumption Storming, and why is it an important thing for medical device designers to do?

Lauchner: At a very high level, our schools and universities are not doing a good job of teaching critical thinking skills. Our thinking as a culture has become too quick, too shallow, undiscerning, and less able to think deeply about why we do things. Where are the wise philosophers? One result of our mental decline is a shrinking ability to think broadly and deeply about what type of therapy or product would best suit a given set of customer needs. Without higher level thinking, given a product and a customer need, we tend to design the most expedient change, pick concepts most like the existing product. We predictably get really good at incremental, line-extension design but less able to see the larger picture and discover disruptive, game-changing ideas. Assumption Storming efficiently fills the gap between shallow design and breakthrough concepts, offering a tool that forces the deep thinking we neglect and resulting in a broader, more diverse set of raw concepts to choose from.

Medical device design has improved by leaps and bounds, but we still haven't seen a medical device like the iPhone or iPad, which people just intuitively know how to use it. Why is that?

Lauchner: It’s hard work to make devices elegant and intuitive, and industrial design is almost always an afterthought, rather than a primary design driver, like [it is] at Apple. Medical device designers accustomed to writing reports and living in test labs are not trained or necessarily motivated by industrial design excellence.

Also, I learned years ago the hard way at Hewlett-Packard that an engineer who creates a design is the world’s least qualified person to evaluate that design for usability effectiveness. Why? Anyone who designs invests their own mental use models into their designs. A designer naturally (and uncritically) believes their design is the most usable thing in the world. They’re shocked to watch stupid users fail to understand the brilliance of their design. “User error!” they scream, when it’s just design error.

To create an iPhone medical device, industrial designers (who should have a better grasp of how people use things) need to drive the look and feel of a device before mechanical engineers muck it up by creating objects that require only simple sketch and extrude shapes in Solidworks.

I read on your LinkedIn profile that you have a background in home/interior design. How has that helped you in designing medical devices?

Lauchner: As a designer, I’m often appalled at what passes for interior design and architecture these days. There’s so little curiosity or humility about the needs or personalities of homeowners. Where people drop their bags, keys, and phone when they get home, for example, is not thought through well, or how they process mail. Or what type of space kids need to do their homework—they need a dedicated space (not the kitchen table) that’s connected to family activity (not an isolating bedroom) and not distracted by TV. Where is that? Architects don’t even ask the question. And interior designers don’t realize that wall colors need to relate to human skin and eye color, intensified or muted to match personal intensity—shouldn’t that be obvious?

My work as an interior designer just intensifies my passion for user experience. I’m an experience architect at core. How surgical tools are experienced is important to me: correct handling angles, forces required, intuitive interfaces are really important to me, and need to drive design, not be delegated to a contracting industrial designer at the end of the project.

 Any advice on how to become a more effective designer?

Lauchner: Keep a bug book. Pay attention to the little things that bother you and write them down. We overlook so much in our experience of design that we don’t grasp how much power we have to improve others’ experience of our designs. Common bugs most people don’t acknowledge: opening doors with full hands, straight rows of cubes that feel impersonal, “dead” internal spaces, being cut off in conversation, embarrassment making “noise” in the bathroom.

Keeping a bug book opens your mind to usability issues that can lead to innovation. For example, I listen to worship music in the morning, and when I listen to a song too many times, it eventually fails to inspire me. That’s a bug for me that I recorded. Because I wrote it down, I pondered what assumptions drive that bug, and I came up with “Recorded songs don’t change.” As you’ll learn in Assumption Storming, once you write down an assumption you have the power to break it, so I had the notion that perhaps recorded songs could change, and I thrilled to the idea that my favorite songs could change each time I play them. Different endings, different instrument and vocal tracks! Awesome! No one has done that before. There’s probably a free patent idea there for anyone who can reinvent MP4 protocols.

Craig Lauchner's two-part workshop on Assumption Storming begins Monday, February 11, 2013, at 10:10 a.m., at MD&M West.

Jamie Hartford is the managing editor of MD+DI.  


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