Agents of Change

The future is never quite as innovatory as the past imagines it to be. Throughout history, mankind has vainly attempted to envision his fate upon Planet Earth. Most efforts have begat pipe dreams—a fool’s paradise of outlandish and often technologically impossible contraptions like back-rubbing clock radios, personal jetpacks, urban people-moving tubes, hoverboards, weather control, roofed cities, “magic beam” highways, and, of course, flying cars (the most common fantasy).

Every once in a while, though, someone gets it right. In a December 1900 article in Ladies’ Home Journal, civil engineer John Elfreth Watkins Jr. accurately forecast ready-cooked meals, wireless telephone and telegraph circuits, color photographs, military tanks (which he called “huge forts on wheels”), and, arguably, satellite television. “Man will see around the world,” Watkins predicted in his one-page prospect, aptly titled, “What May Happen in the Next Hundred Years.” “Persons and things of all kinds will be brought within focus of cameras connected electrically with screens at opposite ends of circuits, thousands of miles at a span.”

The concept of satellite television resurfaced 45 years later through the ingenuity of British science-fiction author, inventor and futurist Arthur C. Clarke, who also anticipated the advent of the Global Positioning System. In a 1956 letter to Andrew Haley of the American Rocket Society, Clarke briefly outlined the technological possibilities associated with two dozen geostationary or-biting satellites.

“…the three stations in the 24-hour orbit could provide not only an interference- and censorship-free global TV service for the same power as a single modern transmitter, but could also make possible a position-finding grid whereby anyone on earth could locate himself by means of a couple of dials on an instrument the size of a watch,” he wrote.

The late Steve Jobs was another innovator with a rare gift for spot-on prognostication. A year after launching the Apple Macintosh through its legendary Super Bowl commercial, Jobs granted an interview to Playboy magazine and discussed a wide range of topics, from the impending home computing revolution and the increasing role of information technology, to the ways in which artificial intelligence could change human thought processes. During a far-reaching Q&A, Jobs outlined his vision of the future and made various predictions that both revealed his genius and cemented his reputation as a modern-day Leonardo da Vinci.

Many of Jobs’ forecasts were so remarkably accurate, it seemed as if the electronics aficionado had just returned from a trip to the future. When asked by freelance journalist David Sheff about the need for home computers, he responded by matter-of-factly stating, “The most compelling reason for most people to buy a computer for the home will be to link it to a nationwide communications network.” That network—otherwise known as the Internet—officially came online a decade later.

Jobs also portended the development of laptops and netbooks (“…wait till we do it,” he gushed to Sheff, “the power of a Macintosh in something the size of a book!”), color computer screens, and online education.

One of the most uncanny prophecies, however, came toward the end of Sheff’s interview as Jobs contemplated the long-term future of computers and software. He spoke of a day when computers would act as agents rather than servants, harnessing the ability to track and mine data, recognize patterns, and anticipate users’ desires.

“There will be a time when our computers…[are] going to be much more like an agent for us,” the Apple co-founder predicted. “…it’s going to do more in terms of anticipating what we want and doing it for us, noticing connections and patterns in what we do…Simple things like monitoring stocks every hour or every day. When a stock gets beyond set limits, the computer will call my broker and electronically sell it and then let me know. We’re going to be able to ask our computers to monitor things for us, and when certain conditions happen, [or] are triggered, the computers will take certain actions and inform us after the fact. That’s the next breakthrough.”

The seed that eventually sprouted the blossoms for that progress was planted well before Jobs began tinkering with do-it-yourself computer kits in his garage; it was sowed in the 1960s with the advent of enterprise resource planning (ERP) software, a programming system created initially to improve inventory control and management in manufacturing plants. Though its scope expanded considerably during the next two decades to include various production and materials management functions, ERP remained primarily a manufacturing-related application until vendors like German-based SAP AG, PeopleSoft Inc., J.D. Edwards & Co., and Oracle Corp. discovered that other types of businesses also could benefit from linking their internal mechanisms in a cohesive and coordinated way. During the 1990s, ERP evolved into a broad-reaching environment that encompassed all activities across the back-office of a company.

Comprised of a series of “modules” or applications that seamlessly are linked together through a common database, an ERP system enables various departments or operating units within a company such as accounting and finance, human resources, production, and fulfillment and distribution to coordinate activities, share information and collaborate. ERP is designed to enhance all aspects of a company’s key operations—from planning through execution, management and control—by taking processes and functions that previously were disparate and disjointed and seamlessly integrating and coordinating them.

Like an agent.

“ERP software has always been such a broad idea for companies,” Needham, Mass.-based ERP consultant and analyst Chris Selland told Goterp.com, a website, blog and aspiring business software technology meeting place. “It’s been an umbrella term since the 1990s. It was originally seen as software for companies that make money by making stuff, and then integrating and bringing all the processes and data together. What is going on these days is more and more demand for solutions that can be up and running more quickly. On-demand ERP is also capturing the attention of the marketplace…People just want to get things running.”

That need for speed, data integration and overall operating efficiency has long driven the growth of ERP, CRM (customer-relationship management) and other software systems in the medical device industry. Though they primarily were employed to help streamline operations and achieve future sales and marketing objectives, ERP and CRM systems have evolved to support a broad set of activities that help manage and coordinate business functions, including production planning, purchasing, inventory control, supplier interaction, order tracking and customer service. Over the last decade, however, software has become an integral part of the design, prototyping and manufacturing process as well.

“It’s the classic case of better, faster, cheaper. One of the big benefits for medical device manufacturers is that things generally are better when software is introduced into the process,” said Timothy J. Kulbago, CEO of ImageIQ Inc., a Cleveland Clinic Innovations-founded imaging contract research organization providing imaging analysis, software development and services for medical device and pharmaceutical companies. “Designs, manufacturing and inspections are more consistent. It’s like the latest Boeing [aircraft]—until it was built—existed in a computer, and even flew its first test flight in a computer. It’s the same principle in medical devices—the more software that is integrated, the cheaper it is to design, the more objective it is to inspect them and quite frankly, the faster it is to make changes. If someone wants changes to a design and you have a software-enabled system, you can make those changes fairly quickly as opposed to having to redo everything by hand. So it really is better, faster and cheaper for [device] manufacturers. And in the case of biomedicine, it improves data and documentation used for regulatory purposes.”

Quality, Risk and eMDR

Kulbago’s take on the overall benefits of computer software would not have surprised Steve Jobs. During the same Playboy interview in which he predicted the iPhone and mobile computing, the often brash but always brilliant innovator touted the chameleon-like quality of written computer code, noting that software could turn its host into “a writing tool, a communications center, a supercalculator, a planner, a filer and an artistic instrument all in one…We have no idea how far it’s going to go. Right now, computers make our lives easer. They do work for us in fractions of a second that would take us hours. They increase the quality of life, some of that by simply automating drudgery and some of that by broadening our possibilities. As things progress, they’ll be doing more and more for us.”

Indeed, the possibilities are endless. Within the last 30 years, software has progressed from basic database management to word processing, digital communications and more recently, artificial intelligence. Manufacturers have taken full advantage of these advancements, regularly giving their digital servants more responsibilities for running and sustaining operations.

Medical device firms traditionally have used software to manage inventory, simplify documentation, monitor supplier performance, strengthen partnerships, and enhance self-improvement efforts. But globalization, shorter product development cycles and increased legal and regulatory scrutiny is prompting investment in risk management, adverse event reporting and quality control software.

“The medical device industry is under a lot of scrutiny from regulatory agencies like the FDA. What companies are looking for is not only a way to address any adverse events but do so with complete traceability,” noted Timothy Lozier, marketing manager at Farmingdale, N.Y.-based EtQ Inc., a provider of quality and environmental health and safety management software solutions. “They’re looking to determine what is and what is not reportable to the FDA, and if an event does happen, figure out the level of severity of that event and the kind of corrective action that should be taken. Being able to take adverse event data, assess the severity of it and then electronically submitting it to the FDA is becoming a larger trend now because the FDA continues to say that [electronic] reporting is going to be required versus manually doing it by mail or by fax.”

EtQ developed a software program called Reliance several years ago in part to help companies meet the U.S. Food and Drug Administration’s electronic reporting requirements. The software is designed to manage and track adverse events as well as investigate, correct and mitigate the risk of recurrence.
As adverse events enter the system via complaint, a non-conformance or an audit, Reliance incorporates risk tables that include information such as severity, frequency, or pre-defined risk elements, according to the company’s description of the software. Based on the risk table results, the event either can be immediately corrected within the process or investigated more thoroughly. Recorded results build a “knowledge base” of potential critical events to further automate the risk assessment process.

Augmenting EtQ’s Reliance software is the Risk Register, an assessment tool that allows companies to configure and integrate risk-based assessment tables within any of EtQ’s modules, or as an independent risk event. Serving as a central repository for all risk items and controls, the Register features risk assessment templates with tables and charts to identify severity, frequency or other risk-based criteria. These templates can be used for an independent risk assessment event and also can be linked to modules with EtQ’s Quality, EHS (Environmental Health & Safety), and Compliance Management software system.

“There’s a lot more complexity in this day and age. Product life cycles move faster, supply chains are more complex and on top of that, medical device companies are turning a product out faster,” Lozier said. “As a [device] company, one of the things you want to maintain is a level of compliance and quality. The old ways of investigating and trying to figure it all out doesn’t hold up anymore. Companies are looking for new ways to benchmark compliance and risk has become more of a quantitative, systematic formula that people are using to say, ‘If these conditions exist, what is the risk?’ A lot of our software is centered around building risk assessment into adverse events.”

A lot of software also is becoming centered around patient-specific implants as companies attempt to overcome the shortcomings in existing designs, accommodate joint deformities and tap into the growing demand for personalized medicine (the market currently is estimated at $232 billion and is projected to nearly double to $450 billion by 2015, according to data from tax and consulting services giant PricewaterhouseCoopers). Bedford, Mass.-based ConforMIS, for instance, uses patented software called iFit to convert magnetic resonance imaging and computed tomography scans into customized knee implants, while Within Technologies Ltd. digitally sculpts scaffold lattices for patient-specific cranial, dental and spinal implants.

One of the more interesting technologies developed in the wake of patient-specific implants is 3-D printing, a process that creates objects by piling up, or adding successive layers of material (hence its more technical term, “additive manufacturing”). Special software slices up a computer-designed product and translates it into a stack of two-dimensional layers for a 3-D printer, which gradually builds the item by depositing the first layer of material (such as molten plastic that eventually hardens) and then additional coatings until the desired shape takes form. This can be used to make virtually anything (a Canadian engineer recently unveiled a three-wheel, two-passenger car that reportedly is as strong as steel, half the weight and can travel at speeds of up to 69.5 mph) but its most promising applications lie within the medical industry, where researchers have used the process to make custom orthotics for disabled American veterans, a sophisticated cardiac surgery tool, a custom-designed pediatric robotic exoskeleton, a titanium total lower jaw, heart valves, ears, kidney cells, experimental knee cartilage, and skin cells. Experiments in printing soft tissue are underway, and may soon allow printed veins and arteries to be used in surgeries. Late last year, 3-D design and engineering firm Autodesk Inc. joined forces with Organovo Holdings Inc., a manufacturer of functional 3-D human tissues for medical research and therapeutic applications, to develop software that can design printable human tissue.

“The manufacturing process is starting to change from a software perspective into effectively, building a model in software, and then 3-D printing it. It’s an interesting topic,” noted ImageIQ’s Kulbago. “We’re seeing companies starting to do [3-D] printing for customized patient implants and that’s all software-driven. That’s the whole software mentality as opposed to the traditional machining mentality. What is driving 3-D printing is patient-specific devices. The industry is pushing people toward patient-specific work. If you don’t do a 3-D printing or a severely computer-controlled milling manufacturing of these devices, the amount of work and expense that goes into each and every one of those devices is spectacular. You’re basically building a custom design for every one of them, and you can’t retool all your manufacturing equipment, so you have to have a software environment that can adapt to that. Otherwise, it’s like making Pepsi cans—you’re just spitting out Pepsi cans a million times a second. The drive for patient-specific devices is pushing manufacturers to be much more software-savvy and much more in tune with customized manufacturing processes.”

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