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Spotlight on Software

CAPA system
Supporting corrective and preventive action (CAPA) practices, a quality system software application for medical device manufacturing has user-friendly and democratic collaboration features designed to maximize an organization's level of participation in CAPA and ensure that CAPA teams generate high-quality documentation. The Windows-based AcQualis program automatically updates on every PC in an organization, and a fast, secure Microsoft SQL Server 2005 database can provide nearly instantaneous response. Licensed by concurrent users rather than installed seats, it is available to everyone at a company anytime. A rules engine allows administrators to specify the stages that a document goes through and the rules that govern its readiness for the next stage. Additional features include connectivity to an enterprise resource planning system, built-in search and reporting functions, and regular background saves to the local hard drive.
Commonwealth Software

ERP software
A company offers a flexible enterprise resource planning (ERP) software system designed to meet the regulatory and tight process control challenges of medical device manufacturing. Featuring capabilities in product data management, quality process control, and cradle-to-grave product traceability, the medical device ERP software provides a framework for managing product innovation. By including functionality that supports device manufacturers' extended operations--such as financial management, customer-relationship management, quality management, product life cycle management, supply-chain management, global business management, and advanced planning and scheduling--it exceeds the scope of traditional ERP, according to its manufacturer.

Fortran compiler
Medical device engineers and researchers can use an upgraded medical technology Fortran compiler for testing prototypes. Featuring more information in run-time messages, more Fortran 2003 features, and a multithreaded I/O library, the Fortran Builder 5.2 checking compiler offers virtually complete implementation of the latest Fortran 2003 standard and an integrated development environment, according to the company. Designed for the Windows platform and providing a Fortran-aware editor, build system, GUI debugger, and help system, the portable compiler delivers standards conformance. It interprets Fortran standards precisely and incorporates such run-time checking features as procedure interface checking across multiple files, undefined variable trapping, and memory-leak detection.
Numerical Algorithms Group Inc.

Product life cycle management system
A product life cycle management (PLM) software system for small and medium-sized medical device and equipment manufacturers is designed for rapid implementation. The RapidStart PLM suite offers features for improving product development, such as product data management, bill of materials management, engineering change and engineering change order management, document management, compliance management, and integration with engineering environments. It can also be scaled to incorporate additional functionality, such as corrective and preventive action and training-record management capabilities, from other PLM systems. The software suite helps device manufacturers to meet 21 CFR Part 11 guidelines by providing a central location for managing product data and tracking electronic audit trails, logging password-protected electronic sign-offs, and maintaining lists of authorized signatures.
Omnify Software

Document control system
Providing compliance management, process mapping, and analysis software, a vendor offers a process-based, on-demand document control system that works as a software-as-a-service subscription application. Document Control On Demand software is intended to help medical product manufacturers to graphically map business processes through its Allclear application and to integrate a Web-based document control tool. Providing security and supporting compliance with applicable ISO and FDA regulations, the digital service features a fast implementation cycle, quick start-up, flexible licensing, and no hardware costs. Organizations can use this on-demand software to save time and economize in the management of regulatory compliance, achieving real-time life cycle control of their documents and processes, according to its manufacturer.

Spotlight on Sensors

Differential low-pressure sensors
Featuring high sensitivity and good offset stability, a series of differential-pressure sensors optimized for low-pressure measurement in medical respiratory devices offer ranges of 250 and 500 Pa full scale. LBA-series sensors perform fully analog on-chip CMOS signal conditioning to allow for linear and temperature-compensated outputs with a typical differential-pressure resolution of 0.1% and typical response time of 1 millisecond. The sensors are based on thermal flow measurement of gas through a narrow flow channel integrated within the sensor chip. The low gas flow ensures strong immunity to dust, contamination, and condensation, and allows connecting tubes and input filters to be used without any need to recalibrate or correct the output signal, according to the manufacturer. Because the flow impedance is predefined at the sensor chip level, these components feature small PCB-mountable housings.
Sensortechnics GmbH

Membrane potentiometers
A line of wear-free and hermetically sealed linear and rotary position sensors can fulfill both position sensing and user-input functions, making them useful in medical equipment applications for physical rehabilitation, imaging, and radiology. The ultraflat, 0.7- to 1.7-mm-thick Sensofoil membrane potentiometers can be activated by a mechanical wiper or with the touch of a finger. If user input is selected, two design options are available: a two-layer sensor that performs a scroll function strictly and a three-layer sensor with a scroll function and a z-directional selection function. Besides being hermetically sealed, the potentiometers can be coated with an antimicrobial finish during production to destroy bacteria and mold and to inhibit new growth. Standard linear elements of 50 to 500 mm and custom variants up to 1000 mm are offered, while the rotary model can be customized to sense a rotational position anywhere between 0° and 360°.
Hoffmann + Krippner

Nanopower magnetic sensors
Low-voltage nanopower magnetic sensors designed for battery-powered implantable medical devices are housed in miniature four-pin 1.1 × 1.1 × 0.4-mm ULLGA leadless packages and operate at supply voltages between 0.9 and 2.4 V. Also offered as 0.625 × 0.625-mm bare die for wire-bonding assembly, the BDx27 family of sensors is configured as a magnetic switch, whereby sensor output turns on whenever a magnetic field is applied and off when the field is removed. The standard magnetic operation point, which is stable over the supply voltage and temperature ranges, is 15 Oe. The sensors' integrated circuits consist of GMR sensor elements, signal-processing circuitry to convert the analog sensor element output to a digital output, and optional oscillator and timing circuitry for power-management duty cycling. A model internally duty-cycled to conserve power typically consumes 29 nW at 0.9 V. A continuous-duty version is also available.
NVE Corp.

Low-pressure sensor
Available in differential and gauge models and with an I2C or SPI digital interface, a low-pressure sensor based on microelectromechanical system technology is available for use in respirators, ventilators, leak-detection equipment, liquid-level meters, and other applications. The differential version of the MS5701 measures pressures in the range of ±2.5 to ±10 in.H2O, and the gauge model measures ranges of 2 to 20 in.H2O. Using supply voltage of 1.8 to 3.6 V with 1-?A power consumption and providing digital output, the sensor features a resolution of 0.0004 in.H2O and a conversion rate of 0.54 milliseconds. Its 24-bit pressure and temperature output enables integration with any microcontroller. Low hysteresis and a stable pressure and temperature signal make this sensor reliable in demanding high-performance applications, according to its manufacturer. A model calibrated for 5 in.H2O offers accuracy of ±0.04 in.H2O at 25°C and ±0.1 in.H2O over the full operating temperature range of -20° to 85°C.
Servoflo Corp.

Tilt sensor
A single-axis linear-output electrolytic tilt sensor is offered as a single-sensor solution for measuring a full tilt range in medical positioning and monitoring applications. The midrange TrueTilt 0703-1601-99 sensor can replace multiple sensors in legacy designs that required more than one sensor. It provides a measurement range of ±25° angle/±10° linear and resolution of 1 in., with a null repeat of better than 10 in. Featuring long-term stability over its angle and temperature range, the sensor has an all-metal design and good dimensional tolerances. It can be mounted and soldered to PCBs and does not require special packaging for operation when exposed to extreme conditions.
The Fredericks Co.

Motion sensor
Featuring a flat profile, a flexible foil sensor is suitable for precise travel sensing and positioning applications, including those that require high adjustment speeds, light weight, and operation within cramped assemblies. The MetaPot MMP sensor uses Aptiv film made from Victrex PEEK polymer as a spacer that can resist friction and wear, high heat, chemicals, and radiation. The film also provides the purity, electrical insulation, and hydrolytic stability the sensor needs to cope with challenging motion control applications, according to the company. It exhibits a low coefficient of friction in contact with the metal foil, has a lower tendency to generate static charge than traditional polyimide film, and supports a range of design options. FDA compliant, it is inherently halogen free and flame resistant. Used as a linear and angular sensor in custom applications, the sensor is based on a foil potentiometer technology that includes contact-free functionality. In addition to featuring an operational lifetime of more than 100 million cycles, it offers a measurement range of 50 to 500 mm.
Metallux AG

Optical O2 sensors
Fluorescence-based optical sensors measure dissolved- and gaseous-oxygen pressure in a variety of media, including biological samples, without requiring electrodes. Each sensor uses a proprietary sol-gel coating that is embedded with a fluorescing oxygen indicator and can be applied to patches or probes. Patches are useful for monitoring oxygen in headspace gases and other media inside packages such as blood bags. Probe options include 300-µm-diam fibers for applications requiring fine spatial resolution and 18- and 21-gauge needle probes for penetrating vial septa and rigid packaging. Coating formulations are available for general laboratory use, high-sensitivity applications, and hydrocarbon-rich environments. A typical sensor system comprises the probe- or patch-based sensor, a phase fluorometer, and operating software. Response times range from less than 1 second in gas to approximately 30 seconds in liquids, and the dissolved-oxygen measurement range is 0-100% for most applications.
Ocean Optics

Taking the Lead

Several pacemaker and implantable cardioverter defibrillator (ICD) manufacturers are taking the seriousness of lead fractures to heart. As a result, some next-generation cardiac rhythm-management (CRM) devices could feature 'leadless' designs.

Leads have historically carried out a critical function in devices. In ICDs, for instance, leads are typically attached transvenously to the heart on one end and to a pulse generator at the other end. They deliver electrical stimuli from the generator to the heart in order to restore a life-threatening abnormal heart rhythm to normal.

But as is the case with most implants, there are risks, including perforation of the heart during implantation and possible lead fracture. The latter issue has been subjected to heightened scrutiny in the wake of a 2007 Medtronic Inc. recall of its Sprint Fidelis transvenous defibrillator leads; their potential for fracture has been implicated in 13 deaths.  

Although the benefits of transvenous leads appear to outweigh the risks, it can't hurt to explore design options that promote safer products and procedures. That's what a few pioneering companies are doing with 'leadless' devices, which do not directly interface with the heart through transvenous wires.

While the term 'leadless' has been used to describe these unconventional devices, it is not always an accurate label, notes Thomas Osypka, president and CEO of Oscor Inc., a specialist in implantable lead fabrication. "Even though the system is called leadless, there is still a highly reliable conductor connected between the generator and cardiac muscle that very much looks and functions like a lead," he says. "The way the electrode system is implanted is completely different compared to what we are used to seeing. However, the electrical connection stays and looks the same."

Falling into this category is a subcutaneous ICD developed by Cameron Health Inc. for the treatment of sudden cardiac arrest. Consisting of a parasternal electrode and a left lateral thoracic pulse generator, the S-ICD system provides life-saving shocks while eliminating direct contact between wires and the heart. Studies published in the July issue of the New England Journal of Medicine reported that the S-ICD detected ventricular fibrillation in 100% of 137 induced episodes.

Critics, however, have condemned the system's higher energy requirements, compared with traditional ICDs, as well as the resulting larger form factor. The S-ICD is also not suitable for use in patients that require a pacing system as well; it may provide effective treatment in only 25% of current defibrillator patients, according to a May New York Times article. Yet despite these limitations, the 'leadless' system presents an interesting option for that 25% of patients for whom the S-ICD is optimized.

In the pacemaker space, Medtronic is also leaving leads behind, although it has remained tight-lipped about the details. "Medtronic is developing a leadless pacemaker that would be delivered to the heart by a catheter. We would expect to begin human implants in the next three to five years," says Medtronic spokesperson Christopher Garland. "While we cannot predict the future of the market, we do believe that a leadless pacemaker could achieve market acceptance."

With Medtronic leading the leadless charge, others may follow in due time. Could a new era of CRM device design be on the horizon?

Ac-Cent-Tchu-Ate the Positive on Healthcare Reform

"The resource we need more than any other is optimism. At this time of fretfulness about our economy and the state of healthcare in the country, no leadership is more important than leadership that says we can do this, that we can invent our way into the healthcare system that we want and need for ourselves and our loved ones," Berwick told attendees of the MedTech conference in Washington, D.C.

Get more of the story from MassDevice. A podcast of Berwick's speech is also available.

This Week In Brief: October 19, 2010

Electronics manufacturing service provider SMTC Corp. (Toronto, ON, Canada) has achieved ISO 13485:2003 certification for its facilities in Toronto, San Jose, and Chihuahua, Mexico. The company specializes in engineering support, material supply-chain design and advanced procurement support, prototyping and product qualification, PCBA assembly through final product and system manufacturing, global distribution, and product life cycle management.
Diversified Plastics Inc. (Minneapolis) has expanded its component-production capabilities with the addition of an 85-tn Toshiba EC85 electric plastic injection molding machine. This machine will enable the company to produce high-precision parts for the medical device industry that weigh as little as a few grams up to 3 oz.

Balloon catheter manufacturing specialist Interface Catheter Solutions (Laguna Niguel, CA) has completed the initial phase of a three-phase facility expansion plan that includes a renovated and expanded equipment assembly operation, an expanded extruded balloon tubing cleanroom, and an expanded balloon production cleanroom. The company's offerings include balloon design and development, extruded balloon tubing, balloon contract manufacturing, and balloon catheter production and testing equipment.

Vision metrology company Quality Vision International Inc. has moved into a larger, more-modern facility in Tempe, Arizona. The 12,500-sq-ft technical center houses the sales and service operations of Optical Gaging Products, View Micro-Metrology, and the Quality Vision Services divisions of the company.

The NanoFabrication Systems Div. of NanoInk (Skokie, IL) will present free workshops focusing on tip-based patterning for bio- and nanoengineering at Georgia Tech on October 25, and Princeton University on November 2. The workshops will feature technical talks, discussions, and product demonstrations, in addition to highlighting the most-recent applications and protocols related to deposition of biomaterials using the company's NLP 2000 desktop nanolithography platform.

Despite Weathering the Economic Storm, Medtech Industry's Not in the Clear Just Yet

Although the medtech industry has fared well during the economic downturn, it may need to reevaluate its longstanding business model, thanks to pressure stemming from new trends and sweeping reforms, according to Ernst & Young. The provider of assurance, tax, transaction, and advisory services released today its annual Pulse of the Industry report for 2010 in conjunction with the AdvaMed conference.

"The medtech industry showed impressive discipline last year by improving bottom-line performance even as revenues remained flat, but even bigger challenges lie ahead," says John Babitt, Ernst & Young's medtech leader for the Americas. "With the financing model under enormous strain, the industry will need new ways to fund innovation. As hospitals consolidate purchasing decisions and payors look to comparative effectiveness research, companies will need to demonstrate value as never before, and with revenues plateauing--particularly in mature markets--they will have to find new sources of growth."  

Among the biggest questions raised by the report is whether or not emerging obstacles such as the medical device tax, comparative effectiveness research, and conservative investing strategies may stymie medtech innovation. Experts expressed concern in the report that innovation stemming from startups and small companies may especially be at risk to be stifled in the changing environment. The economic climate, for example, has prompted investors to wait to contribute funding until commercialization or proof of commercialization of an emerging technology. This decline in early-stage funding could, according to the report, seriously hamper development efforts of potentially revolutionary technologies.

Similarly, the report speculates that, although comparative effectiveness  has potential benefits, it could harm innovation because a completely new technology may be dismissed or discounted. The impending 2.3% excise tax on medical device products, unless restricted, could also impact innovation by proving to be an unbearable burden on innovative small companies and startups. And finally, a push for transparency in physician interaction as well as proposed changes to the 510(k) process could pose new threats to innovation.

Additional emerging challenges to the industry identified in the report include the need to determine a long-term path for growth and increased scrutiny of a product's value proposition. "This is a world in which firms will no longer be rewarded based on how many units of a product they sell, but rather on their ability to deliver health outcomes, i.e. improve patient health and access, while decreasing cost to the system," the report states. --Shana Leonard

MD&M Keynoter provides opinion on healthcare reform

I had the good fortune to interview Capretta right after he delivered the keynote. That interview, which was videotaped, was an eye-opener for me.

Carbon Nanotube Technology Provides 10x More Power than Conventional Lithium-Ion Batteries

Portable power company Contour Energy Systems (Azusa, CA) has licensed a carbon nanotube technology from MIT (Cambridge, MA) that it claims can deliver 10 times more power than conventional lithium-ion batteries. The technology has the potential to improve numerous products, including portable medical devices.

Contour will build on MIT's technology, which we reported on earlier this year, to optimize the battery electrode. The technology relies on electrostatic-driven self-assembly of carbon nanotubes into a porous, tightly bound structure--a process that is induced by a controlled deposition technique. The ability to yield a porous electrode from charged molecules integrated on the nanotubes is advantageous, according to the MIT researchers, because it provides accessibility to a greater number of nanotubes for lithium-ion storage and release.

"These carbon nanotubes contain numerous functional groups on their surfaces that can store a large number of lithium ions per unit mass," says Shao-Horn, a professor of mechanical engineering and materials science and engineering at MIT. "For the first time, carbon nanotubes can serve as the cathode in lithium-ion batteries, instead of the traditional role that carbon materials have played as the anode in such systems. This lithium storage reaction on the surface of carbon nanotubes is much faster than conventional lithium intercalation reactions, so [it] can deliver high power."

Supported by the carbon nanotubes, the battery can deliver high power outputs in short bursts or lower power steadily over long periods of time. It also has demonstrated stability, showing no detectable change in performance after 1000 cycles of charging and discharging a test battery, the researchers state.

MX: Rx for Healthcare

Stephen Krupa

Now what?

Many critics say the United States simply can’t afford such an expensive program, and they may be right. The healthcare bill focuses primarily on access and insurance reforms but does very little to address the underlying costs and structural issues that have kept the healthcare inflation rate two to three times higher than the rate of overall inflation for two decades. Adding 32 million insured people will place additional stress on a system that was already on pace to grow from 16.2% of GDP in 2009 to more than 19.5% by 2017.

Healthcare is the single largest drag on corporate America’s prosperity. In fact, the United States spends a greater percentage of its gross domestic product on healthcare than any other country by nearly a factor of two, yet it ranks only 25th in global life expectancy. A report released recently by the Commonwealth Fund, a Washington-based foundation focused on improving healthcare, said the U.S. ranked seventh out of seven in overall healthcare system quality and efficacy. That places us behind Australia, Canada, Germany, the Netherlands, New Zealand, and the United Kingdom.

Business and government will be soon forced to confront significant change. Rationing of care, while sometimes discussed, means accepting a financial model designed to let some people die. Americans won’t accept that as an outcome, but it’s clear that the U.S. must devise a remedy that that goes beyond the provisions in the new healthcare legislation.

That solution must be the implementation of more productive and efficient healthcare. Both the private and public sectors must cut costs, improve quality, and realign incentives across payers, providers, and patients. As reform moves from policy to practice, it is more critical than ever that medical device manufacturers and other elements of the healthcare industry finally embrace the productivity reforms that have transformed almost every other American industry, including much more aggressive implementation of information technology. Ultimately, significant new healthcare regulation will spark a new “industrial revolution” in healthcare delivery.

Need for Educated Consumers, Providers

Critical to the success of innovation will be the broad-ranging education of both consumers and providers. Consumers must learn to actively manage their own care, which substantially mitigates big health problems later, and they must be provided with the tools and incentives to do so. Some believe consumers aren’t smart enough to oversee their own healthcare, but that is simply not the case. One example of consumers’ skill at making the best decisions is shown by their extensive use of the Internet to acquire healthcare information. The problem is that this information isn’t customized, is often unearthed too late, and, depending on the source, can be completely inaccurate.

Through the creation of personalized channels of information and improved consumer education about personal health records, social media outlets, and other modes of communication, consumers can begin to “own” their healthcare in the same way that they own responsibility for every other part of their financial and social lives. It is essential to put consumers squarely in the middle of clinical decisions because their historic lack of understanding of the cost and consequences of the care they receive is a key cause of stress on the healthcare economy. Fortunately, when patients are presented with all of their options in a clear and comprehensive way, studies have shown that their choices overwhelmingly favor the least costly and more productive interventions.

Doctors and hospitals must also have access to high-quality, timely information about the validity and relative effectiveness of the treatments they prescribe. It has been estimated that up to 40% of patients do not receive care in lockstep with current scientific evidence and that 25% of the care that is provided is unnecessary or potentially harmful. In addition, multiple modes of treatment are practiced without sufficient evidence about which one is best for a particular patient. All this falls well short of what the standard should be for quality healthcare delivery. Doctors and hospitals must make the commitment to determine what works best for individual patients, then rapidly disseminate information about best practices to physicians to improve our healthcare system.

Here are five additional areas of the healthcare economy that are especially ripe for implementation:

  • Venture capital investment in healthcare information technology, medical devices, and related areas. Venture capitalists must sponsor more entrepreneurs committed to developing solutions for most of the previously mentioned challenges. Some already are doing this, which is why some of the required technology already exists. But we have a long way to go, especially in healthcare IT, which comprises less than 1% of venture capital investment. One of many goals is the creation of better software analytics and decision-support tools to speed the development of evidence-based medicine, further contributing to the improved state of our healthcare economy.
  • Personal health records and accompanying decision-support technologies. Personal health records (PHRs) must become ubiquitous. Beyond simply digitizing medical records in a provider-centric manner, as electronic medical records do, PHRs would provide patients and their caregivers with an integrated view of the patient’s health status. This approach offers a wealth of information for making optimal treatment decisions. PHR software analytics enable providers to identify high-risk patient behavior, reduce the risk of medication errors, and eliminate redundant testing at the point of care. Such decision-support technologies also enable providers to more effectively coordinate treatment for patients with multiple conditions.
  • Consumer-focused health plans and pay-for-prevention incentives. Studies show that 50% to 70% of the nation’s healthcare costs are preventable. Much of the healthcare tab goes to treat a few chronic conditions closely linked to behavioral patterns, including cardiovascular disease, diabetes, obesity, and cancer. Bad genes and bad luck matter, but behavior—exercise and diet—matters every bit as much. People must take seriously the notion of getting healthy and staying healthy. Improved consumer education, coupled with employer efforts to reward employees who take better care of their health, will go far in accomplishing this and simultaneously improving U.S. healthcare economics.
  • A fledgling “pay-for-prevention” industry—also known as value-based health plans—is beginning to emerge. These plans offer employers ways to reward workers with cash or reduced insurance premiums for exercising more, eating wisely, getting regular check-ups, and taking insulin and other medications. Some big companies, such as Safeway, Pitney Bowes, General Electric, and Hewlett Packard, are experimenting with their own financial incentives to persuade employees to adopt healthy habits or drop bad ones. Early adopters of value-based health plans have experienced meaningful reductions in their healthcare utilization rates.
  • Accountable care organizations and other alternatives to traditional fee-for-service medicine. The rapid aging of America will lead to further increases in incidences of expensive chronic illnesses, which already account for 75% of all medical costs today. A recent study by the Milken Institute found that if current chronic disease trends continue, the nation will lose $1.1 trillion annually by 2023. For the chronically ill, i.e., people with four or more chronic illnesses, (including 15 million on Medicare alone), the adoption of accountable care organizations offers a model to help centralize and coordinate care for the chronically ill, improve treatment, and remove costly redundancies. These organizations are built upon performance-based reimbursement programs that reward high quality outcomes and clinical results. Unlike traditional approaches, they are not centered on maximizing the number of medical procedures performed. Accountable care organizations managed by the Center for Medicare and Medicaid Services and others have also successfully introduced distance-based telemedicine to monitor patients status far more frequently, significantly reducing hospital admissions.
  • The elimination of medical errors. Healthcare experts estimate that one-third of total healthcare spending is the result of treatment that is wasteful, redundant, or flat-out wrong. Hospital-based errors result in more than 100,000 American deaths annually and billions of dollars of avoidable medical costs. Fortunately, widely available technologies can be applied to remedy these errors. Barcode scanners, for example, can be used in hospitals to make sure patients get the right medicine in the right dose every time. By contrast, about 20% of medicines administered in hospitals today are done so in error. In short, the aggressive adoption of information technology in hospital settings can bring about the same kinds of improvements they have wrought in U.S. manufacturing.

Time for ‘Change Agents’

Achieving this healthcare revolution will require serious consumer engagement and a real partnership between business and government. It will also require an end to the ongoing acrimonious debate over healthcare reform. There are no devils in healthcare—only a worn-out, broken system.

On the bright side, this is an exciting time for innovators in the new healthcare economy. The Patient Protection and Affordable Care Act, imperfect as it may be, creates significant impetus to develop ideas and technologies that will improve our healthcare system. The federal budget deficit and other economic pressures place even greater focus on the need to address the rising cost of U.S. healthcare. The market is especially ripe for new business models and innovative solutions that simultaneously improve healthcare delivery quality and reduce costs.

What the market is seeking is change agents, or “first movers,” and pioneering companies that enhance value and efficiency. Innovation will be driven by smaller companies and private ventures, which can afford to make riskier long-term investments. Later, mainstream providers and payers will adopt the innovations as the only way to achieve the dual and consistent goals of cost reduction and quality improvement.

Failure to invest in the innovations required to cure our healthcare system’s ills is not an option. Absent healthcare innovation, we may be tempted to enact a single-payer system, which is used by many countries with lower overall costs than those in the United States. The single-payer approach is effective at rationing care and lowering the baseline costs of national healthcare. It does not, however, address the underlying drivers of medical inflation. Every country that has adopted a single-payer approach is experiencing a healthcare inflation rate similar to or greater than the rate we are battling in the United States. These countries are also lagging behind other parts of the world in fostering innovation.

Ultimately, the United States will straighten out its healthcare plight. This is another unfolding chapter in the ongoing story of America’s history, which is one of solving serious problems and renewing the country through industrial innovation and public-private partnerships that foster growth.

Stephen Krupa is a cofounder and managing member of Psilos Group (New York), a venture capital firm that invests in healthcare services, healthcare information technology, and medical technology companies. Krupa can be reached at 212/242-8844 or [email protected]

Medical Errors Persist Despite Safeguards

In 2004, the Joint Commission, which regulates medical professions, introduced a Universal Protocol for all hospitals and outpatient facilities that perform medical procedures. The protocol is designed to reduce medical errors. It consists of three parts: a preprocedure verification, a surgical site marking, and a time-out performed immediately before the surgical procedure. During the time-out members of the team performing the procedure confirm the identification of the patient, the type of procedure, and the procedure site.

“The findings from the present study emphasize a continuing and concerning occurrence of wrong-site and wrong-patient procedures in the current era of the Universal Protocol, leading to frequent patient harm and rarely, patient death,” write researcher Philip F. Stahel, MD, of the University of Colorado, and colleagues in the Archives of Surgery. “Shockingly, nonsurgical disciplines equally contribute to patient injuries related to wrong-site procedures.”
Better Planning, Prevention Needed

Researchers found the main factors behind wrong-patient medical mistakes were errors in diagnosis (56%) and errors in communication (100%).

Errors in judgment contributed to 85% of wrong-site medical errors and the lack of performing a time out before starting the surgical procedure was cited as the cause in 72% of these mistakes.

The researchers call for strict adherence to the protocol and sayy that that the policy be expanded to nonsurgical specialties to promote a zero-tolerance philosophy for such preventable incidents.