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IP Watch: Appeals Court Upholds Victory for Stryker, Karl Storz


On April 10, the U.S. Court of Appeals for the Federal Circuit handed a definitive victory to Stryker Corp. (Kalamazoo, MI) and Karl Storz Endoscopy-America Inc. (Culver City, CA) in a patent infringement case that lasted nearly six years. In its ruling, the court affirmed that the companies did not infringe certain patents held by Luma Corp. because the patents were invalid.

The decision upholds an earlier summary judgment of noninfringement and invalidity by the U.S. District Court for the Southern District of West Virginia. According to McAndrews, Held & Malloy (Chicago)—Stryker's legal counsel during the case— Luma filed the suit in September 2002, alleging that the companies infringed 10 claims of Luma's U.S. Patent No. 5,740,801. The patent, titled “Managing Information in an Endoscopy System,” relates to a system for acquiring and storing images during a medical procedure.

 
Surrette
 
Surrette: A definitive win.

The accused Stryker products included the Stryker SDC Pro and SDC Pro II digital picture capture systems, and Hermes, a system for controlling medical devices in an operating room through voice commands.

In 2006, the district court ruled that the defendants did not infringe eight asserted claims of the patent. The court further ruled that two other claims of the patent were invalid.

“This ruling effectively ends the plaintiff's case against Stryker,” said Bob Surrette, a shareholder at McAndrews, Held & Malloy. “The federal circuit found that the district court did not commit any errors in construing the claims when granting the summary judgment.”

In addition to Surrette, McAndrews attorneys Greg Vogler, Tim Malloy, and Merle Elliott represented Stryker.

Industry IP in Brief

In addition to the above intellectual property development, the following medtech IP news was announced this past month.

  • Terumo Cardiovascular Systems (Ann Arbor, MI) responded to a recent patent infringement complaint by Maquet Cardiovascular LLC (Bridgewater, NJ). The complaint alleges that Terumo CVS and its parent company, Terumo Corp., infringed on two patents related to the sale of the Terumo VirtuoSaph endoscopic vein harvesting system. In response, Terumo stated that it does not infringe on valid intellectual property rights of any company. It also noted that the VirtuoSaph system is protected by multiple Terumo patents. “Frankly, we're surprised at this lawsuit as these patents are several years old and our product has been on the market for more than three years with great success,” said Mark DiClemente, vice president of sales for Terumo Cardiovascular Systems.
  • Given Imaging Ltd. (Yoqneam, Israel) has signed a settlement with Olympus Corp. (Tokyo) that puts an end to patent litigation between the two companies in the United States concerning their respective capsule endoscopy products. The settlement, the terms of which are confidential, reportedly includes certain worldwide cross-licenses under which each party receives a royalty-free license under all existing patents of the other party for its respective existing capsule endoscopy products. The parties also agreed not to sue on currently available medical device products and agreed to a release of all past causes of action. The settlement also includes a payment to Given Imaging of $2.33 million and an agreement to cooperate in future mutually beneficial joint market-development projects.
  • St. Jude Medical Inc. (St. Paul, MN) has been awarded a patent for treating depression using neurostimulation therapy in an area of the brain known as Brodmann Area 25. The area is the focus of a St. Jude Medical study that is evaluating whether deep brain stimulation therapy can help people who suffer from major depressive disorder, a severe form of depression. The study is being conducted under an FDA investigational device exemption. “This patent is a cornerstone in developing our approach to deep brain stimulation for depression, which is the leading cause of disability in the U.S. among illnesses,” said Chris Chavez, president of St. Jude Medical's Advanced Neuromodulation Systems division.

© 2008 Canon Communications LLC

Return to MX: Issues Update.

Improving Medical Care, One Design at a Time

MDEA 2008

Outstanding medical device design is often thought of in terms of out-of-the-box, sweeping innovations. While that perception is certainly appropriate, and applies to some of the 2008 Medical Design Excellence Award winners, it's not the only kind of design worth rewarding. Several of this year's winners took a technology or process that was already well known and made it better or more efficient through improved design.

“By and large, this year's winning products were refined versions of predecessor devices that serve similar functions,” says juror Michael Wiklund, PE, CHFP, president of Wiklund Research & Design (Concord, MA). “The jury found the design and engineering refinements compelling, noting that improvements in device efficacy, safety, performance, and usability can be the key to widespread adoption and greater patient benefits.”

MDEA juror Molly Story

Specifically, he said, winning devices had “simpler, smaller, and more-attractive product forms; ergonomic enhancements that promised greater worker effectiveness, efficiency, and satisfaction; and higher levels of automation, eliminating the chance of use error and reducing workload.”

A subset of winners did an excellent job of eliminating steps in the caregiving process. “The trend that stood out for me was the introduction of technologies that enable healthcare providers to do more with a patient in a single visit,” says juror Molly Story, president of Human Spectrum Design LLC (Santa Rosa, CA). “These advances improve care by increasing the quality of care and by reducing the number of patient visits needed—and in some cases, time under anesthesia—which saves time and money, as well as risk to the patient.”

For example, two winners enable healthcare providers to fabricate objects on the spot—in one case, dental inlays and crowns; in the other case, radioactive seeds. Two others enable caregivers to assess patients on-site in ways that weren't possible before. All of these products take two or more steps and condense them into one, saving the patient a return trip or other inconvenience.

Many winners were rewarded for their strict attention to the intricacies of the user interface.

MDEA juror Michael Wiklund

“Paying appropriate attention to the user interface is valuable, especially when it addresses issues such as use error or efficiency, or does not add another burdensome device to the clinician's already task-challenged life,” says juror William Hyman, ScD, MS, PE. He is a professor of biomedical engineering at Texas A&M University (College Station).

This is particularly important in the current day and age, says jury chair Herbert Voigt. “We are an aging society, so the human–machine interface must take that into account,” says Voigt, who is a professor of biomedical engineering at Boston University. “Displays must be easy to see; buttons must be easy to handle. One of the products this year had textured buttons so that it could be controlled in the dark.”

When designing an outstanding medical product, no detail is too small or insignificant, as you can see from the winners profiled in the following articles:

2008 Winning Products and Suppliers

Caring for the Caregiver

Design Appeal: The Patient Perspective

Whole-In-One: Devices that Do More

Web Exclusive! See demonstration videos of select MDEA winners.

Copyright ©2008 Medical Device & Diagnostic Industry

Remote Monitoring Market Poised for Growth


Earlier this month, Representative Anna Eshoo (D–CA) introduced the Medicare Remote Monitoring Access Act of 2008 in the House. The legislation would amend the Social Security Act to cover remote patient management services for certain chronic health conditions under the Medicare program.

 
Ubl
 
AdvaMed's Ubl: Enhancing care, reducing costs.

Stephen J. Ubl, president and CEO of industry association AdvaMed (Washington, DC), applauded the bill's introduction, as well as the potential that remote monitoring holds for enhancing patient care and reducing healthcare costs. “What was once only science fiction is now patient care reality,” he stated. “With remote monitoring technologies, a physician can evaluate and manage complex chronic diseases from remote locations and provide real-time care for patients. Unfortunately, the adoption and widespread diffusion of such innovations have been stymied by antiquated reimbursement systems.”

Ubl noted that the legislation would require Medicare to cover remote monitoring services used to manage care for patients with congestive heart failure and cardiac arrhythmia. “It also requires CMS to work with stakeholders to develop a standard of care for using remote monitoring for those conditions,” he said. “We are pleased the bill also establishes a demonstration program to evaluate the promise of Medicare coverage of remote monitoring services for three other serious and chronic conditions: diabetes, epilepsy, and sleep apnea.”

Kalorama Information (New York City) reports that the development of remote monitoring technologies is being driven by current healthcare trends, including an aging population and a shortage of healthcare workers, as well as the advent of new wireless technologies. In a new report, High-Tech Patient Monitoring Systems, the market research firm reports that U.S. sales of new-generation patient monitoring systems added up to an estimated $3.9 billion dollars for device manufacturers in 2007—a figure that could more than double in five years.

The report—which encompasses wireless and remote patient monitors, patient data processing applications and equipment, and electronic medical record (EMR) data transfer equipment and applications—estimates that the U.S. market for new technologies in patient monitoring will grow to $11.1 billion by 2012, reflecting compound annual growth of 23.3%. Growth will increase over the forecast period as compatibility, privacy, and security issues continue to be resolved, the firm reports.

Kalorama further observes that the diseases that constitute the greatest portion of U.S. healthcare spending—asthma, chronic obstructive pulmonary disease, congestive heart failure, chronic heart disease, and diabetes—are also among those most amenable to patient monitoring. “Unfortunately, there are significant barriers to implementation, including costs, technological incompatibility, privacy and security issues, and education of healthcare personnel in use of the technologies,” the report states. “Through the efforts of federal agencies, international agencies, and industry groups, these concerns should be overcome in the foreseeable future, resulting in a more efficient, more productive, and more cost-effective healthcare system.”

The report notes that a vast number of companies offer some form of wireless and remote technologies, patient data processing applications and equipment, and EMR data transfer equipment. “Competitors supplying new technologies in patient monitoring to hospitals are large, established healthcare companies, often working in conjunction with information technology (IT) companies on an entire system,” the report states. “The home healthcare and other sectors are much more fragmented and are dominated by privately held companies.”

Within the hospital market, leaders include Abbott, Drager Medical, GE Healthcare, Philips Medical, Roche, and Welch Allyn, the report states. Leaders in the home healthcare market include Honeywell HomMed and Viterion TeleHealthcare.

In addition, some companies supply innovative products focused on a small segment of the market. Examples cited in the report include Medtronic and St. Jude Medical, both with cardiac monitoring products. Others, such as AMD Telemedicine, supply only peripherals.

To read more about the latest IT innovations driving medical device connectivity—including remote patient monitoring technologies—check out MX magazine's annual IT Showcase in the upcoming May/June issue.

© 2008 Canon Communications LLC

Return to MX: Issues Update.

008 Winning Products and Suppliers

HemCon bandage, manufactured by HemCon Medical Technologies Inc. (Portland, OR) and submitted by Capstrat (Raleigh, NC). The HemCon bandage was developed to address severe arterial bleeding. It provides an efficacious, lifesaving antibacterial barrier that is also ready to use, easy to apply, and cost-effective.

Supply and design credit: Oregon Medical Laser Center (Portland, OR).

NetGuard wireless electrocardiograph system, manufactured and submitted by Datascope Corp. (Montvale, NJ). See description here.

Supply and design credit: Corex Design Group Inc. (Glen Rock, NJ), Stratos Product Development LLC (Seattle), Lead-Lok Inc. (Sandpoint, ID), and United Plastics Group Inc. (Anaheim, CA).

Dental Instruments, Equipment, and Supplies

E4D Dentist system, manufactured and submitted by D4D Technologies LLC (Richardson, TX). See description here. See a demonstration video of this product here.

The Single Tooth Anesthesia (STA) system, manufactured by Milestone Scientific (Livingston, NJ) and submitted by Tricor Systems Inc. (Elgin, IL). See description here.

Supply and design credit: Tricor Systems Inc. (Elgin, IL) and Habitech Inc. (Glen Head, NY).

Finished Packaging

Veramyst and Avamys (Fluticasone Furoate) nasal spray delivery device, manufactured and submitted by GlaxoSmithKline R&D (Ware, Hertfordshire, UK). See description here.

General Hospital Devices and Therapeutic Products

InTouch critical-care hospital bed, manufactured and submitted by Stryker Medical (Portage, MI). See description here.

Panda iRes and Giraffe infant warmers, manufactured and submitted by GE Healthcare (Laurel, MD). See description here.

Supply and design credit: Biomed Devices Inc. (Guilford, CT) and HumanCentric Technologies Inc. (Cary, NC).

PowrSyringe injector, manufactured by Pinyons Medical Technology Inc. (Park City, UT) and submitted by Globe Medical Tech Inc. (Houston). The PowrSyringe is a handheld disposable injector that provides power, control, and tactile feedback. It injects and aspirates fluids quickly and easily during clinical procedures such as angiography, angioplasty balloon inflation, and discography.

See a demonstration video of this product here.

Supply and design credit: Globe Medical Tech Inc. (Houston), Integrated BioSciences Inc. (Lewisberry, PA), and The Tech Group, a West Pharmaceutical Services company (Scottsdale, AZ).

Tono-Pen Avia applanation tonometer, manufactured by Reichert Inc. (Depew, NY) and submitted by Metaphase Design Group Inc. (St. Louis). See description here.

Supply and design credit: Metaphase Design Group Inc. (St. Louis) and Medtronic Xomed (Jacksonville, FL).

TotalCare Bariatric Plus therapy system, manufactured and submitted by Hill-Rom Company, Inc. (Charleston, SC). See description here.

Implant and Tissue-Replacement Products

Akreos AO microincision lens, model MI60, manufactured and submitted by Bausch & Lomb (Rochester, NY). See description here.

Supply and design credit: Contamac (Saffron Walden, Essex, UK), Complices (Toulouse, France), and Medicel (Widnau, Switzerland).

Peak Fx hip plate, manufactured by DePuy, a Johnson & Johnson Co. (Warsaw, IN) and submitted by Primordial Soup LLC (St. Paul, MN). The Peak Fx hip plate represents the next generation of hip-plate devices for the treatment of peritrochanteric hip fractures, combining the benefits of plate and intramedullary nail
technologies.

Supply and design credit: Alexandria Research Technologies LLC (Plymouth, MN), Omnitool Inc. (Minneapolis), and Kyber Design Inc. (St. Paul, MN).

In Vitro Diagnostics

Tube Rotator, manufactured by Labnet (Edison, NJ) and submitted by Pensa (Brooklyn, NY). The Tube Rotator's rotisserie assemblies enable operators to mix test tubes horizontally, vertically, or in any position in between. The mixing angle is changed with a simple turn of the rotisserie plate—no tools are required.

See a demonstration video of this product here.

Supply and design credit: Pensa (Brooklyn, NY).

Over-The-Counter and Self-Care Products

GeeWhiz male external condom catheter, manufactured and submitted by Leading Edge Innovations Inc. (Camarillo, CA). The GeeWhiz external male condom catheter is designed for males suffering from urinary incontinence. It incorporates a nonirritating silicone seal that does not adhere to hair, an antikink catheter tip design, and a quick-connect/disconnect nozzle.

Healthy Living ThinLine deluxe flat-screen blood pressure monitor, model BSD-3007, manufactured by Health & Life (Chung Ho City, Taipei, Taiwan) and submitted by Samsung America Inc. (Ridgefield Park, NJ). See description here.

Supply and design credit: Samsung America Inc. (Ridgefield Park, NJ).

Natural Nurser baby bottle, manufactured by Adiri Inc. (Palo Alto, CA) and submitted by Whipsaw Inc. (San Jose). The Natural Nurser baby bottle improves the feeding experience for both the parent and child. It uses materials and shapes that mimic breastfeeding. It is soft, safe, simple, easy to clean, and contains no harmful
polycarbonate.

Supply and design credit: Whipsaw Inc. (San Jose).

NovoFine Autocover automatic safety pen needle, manufactured and submitted by Novo Nordisk A/S, Denmark (Hilleroed, Denmark). The NovoFine Autocover is a safety pen needle used for injecting insulin and growth hormone. It features automatic needle-shield locking to reduce the risk of needlestick injuries and cross-
contamination of healthcare providers and patients. See a demonstration video of this product here.

Uresta continence care kit, manufactured and submitted by EastMed Inc. (Halifax, Nova Scotia, Canada). The Uresta continence care kit is a set of three bladder supports designed to stop stress urinary incontinence in women. Its novel design permits self-fitting and self-management.

Radiological and Electromechanical Devices

Acuson P10 handheld diagnostic ultrasound unit, manufactured by Siemens Medical Solutions (Mountain View, CA) and submitted by Coyne PR (Parsippany, NJ). See description here.

Supply and design credit: GMT Design Services (Boulder, CO), Acorn Product Development (Fremont, CA), and Elemental8 Inc. (San Jose).

MicroDose mammography system, manufactured and submitted by Sectra Mamea AB (Solna, Sweden). The
MicroDose mammography system is a full-field digital mammography system intended for x-ray examination of breasts. The system improves patient safety by generating a low average glandular dose of x-ray radiation.
Nuance full-field digital mammography unit, manufactured and submitted by Planmed Oy (Helsinki, Finland). The Nuance full-field digital mammography unit combines high-quality digital imaging technology with good working ergonomics and straightforward work flow, resulting in fast and effortless imaging in high-throughput mammography screening clinics.

QuickLink loader, manufactured by C. R. Bard, Bard Urological Division (Covington, GA) and submitted by Big Bang (Decatur, GA). See description here.

Supply and design credit: Big Bang and Function Engineering (both in Decatur, GA).

xCAT computed tomography scanner, manufactured by Xoran Technologies Inc. (Ann Arbor, MI) and submitted by Insight Product Development (Chicago). See description here.

Supply and design credit: Insight Product Development (Chicago).

XDS extravasation detector, manufactured by Medrad Inc. (Indianola, PA) and submitted by Battelle Medical Device Solutions (Columbus, OH). The XDS extravasation detector is a safety accessory designed to prevent moderate to severe extravasation of contrast agents that may seriously injure patients. This technology integrates with the company's Stellant computed tomography injection system.

Supply and design credit: Battelle Medical Device Solutions (Columbus, OH) and Cincinnati Technologies (Mason, OH).

Rehabilitation and Assistive-Technology Products

Fuze T50 Manual Tilt-in-Space wheelchair, manufactured and submitted by PDG Product Design Group (Vancouver). The Fuze T50 Manual Tilt-in-Space wheelchair features 50° of tilt from a unique pivot point, for zero center-of-gravity shift. It is easily set up and adjusted, and it offers a small overall footprint that enables easy maneuverability.

Supply and design credit: Revolution Design (Burnaby, BC, Canada).

Genesis DM telehealth device, manufactured by Honeywell HomMed (Brookfield, WI) and submitted by Weber Shandwick (Minneapolis). See description here.

The Hand Mentor Pro rehabilitation system, manufactured and submitted by Kinetic Muscles Inc. (Tempe, AZ). See description here.

Supply and design credit: Arizona State University (Chandler, AZ), Donavan Group Inc. (Chandler, AZ), and Florida Custom Mold (Odessa, FL).

Plié microprocessor-controlled knee, manufactured and submitted by Freedom Innovations (Irvine, CA). The Plié microprocessor-controlled knee is a single-axis prosthetic knee providing swing and stance control. Integrated sensors provide precise control, assuring stability and safety. Software allows adjustment for each user's style and preference.

Supply and design credit: Turner Technology Group (Victorville, CA) and Turbo Jet Products (Rosemead, CA).

REMstar Auto M Series continuous positive airway pressure system, manufactured by Respironics Inc. (Murrysville, PA) and submitted by Continuum (West Newton, MA). The REMstar Auto M Series is a flow-based smart continuous positive airway pressure system for use in the lab or home. Sleek lines and a minimal user interface define it as more of a piece of home electronics than a medical device.

Supply and design credit: Continuum (West Newton, MA).

Surgical Equipment, Instruments, and Supplies

Amaris excimer laser, manufactured and submitted by Schwind Eye-Tech Solutions GmbH & Co. KG (Kleinostheim, Germany). See description here.

Supply and design credit: SMI (Berlin).

Patient Registration Mask, manufactured and submitted by Stryker Leibinger GmbH & Co. KG (Freiburg, Germany). See description here.

InteguSeal microbial sealant, manufactured by Kimberly-Clark Health Care (Roswell, GA) and submitted by Three Atlanta LLC (Atlanta). InteguSeal is a fast-drying, film-forming cyanoacrylate compound delivered in a single-use applicator. Applied to a surgical site immediately before the surgical incision is made, it immobilizes bacteria to help prevent its migration into the incision. See a demonstration video of this product here.

Supply and design credit: Medlogic Global Ltd. (Plymouth, UK).

RealHand high-dexterity instruments, manufactured and submitted by Novare Surgical Systems Inc. (Cupertino, CA). See description here.

Supply and design credit: Micro Medical Technologies (Somerset, NJ), Smith Metal Products (Lindstrom, MN), Micro Star Innovations (Largo, FL), Phillips Plastic Corp. (Hudson, WI), Matthew Hern Consulting (Malibu, CA), Hiemstra Product Development LLC (San Francisco), Baird Industries (Hohokus, NJ), and Thermoforming Process Products (North East, MD).

PTO's Proposed Rule Changes Halted (for Now)

More information on the PTO ruling:

Inventions are all about being new. They embody the very essence of change. But in the United States, the patent laws and rules for implementing them—effectively, the guidelines by which inventions find the protection necessary to enter the market—have traditionally been remarkably staid and free of drama.

For the past several years, however, that long tradition has seemed destined to undergo significant change as a result of new rules proposed by the U.S. Patent and Trademark Office (PTO). Implementation of those proposed changes has been on hold since last fall, when the federal district court for the Eastern District of Virginia issued a temporary restraining order. But a ruling issued by the court at the beginning of this month has now stopped PTO's proposal in its tracks—at least for the time being.

 
Limbach
 
Limbach: PTO derailed.

Since the first U.S. patent statute of 1790, major revisions of the law have occurred only three times, in 1793, 1836, and 1952. Against this glacially slow backdrop, the rule changes proposed by PTO in early 2006 burst on the scene like global warming, and aroused a similar level of alarm.

The rule changes proposed by PTO included a number of features. But what most caught the attention of inventors and patent attorneys was that the new rules would have starkly limited the number of claims that could be filed in a single invention's patent application, and would also have limited the number of continuation applications that could follow an initial patent filing.

Other than cost considerations, there have never been any constraints on the number of patent claims that could be made for an invention. Indeed, the detailing, granularity, and nuance of claiming is at the heart of capturing inventions in words, and thereby protecting them. Similarly, there has never been a numerical limit on the practice of elaborating on an initial invention by filing continuing applications, which has become a central part of patent practice.

 
Cohen
 
Cohen: A more radical shift?

Thus, because PTO's proposed rule changes would have imposed novel limits on the scope of patent protection, they were widely opposed within the community of patent lawyers, patent holders, and active inventors. Nevertheless, the perception was that PTO and its rule changes were unstoppable, and lawyers and clients spent a great deal of costly time reviewing their portfolios of active patent applications and reformulating long-standing patent strategies, so that they would be able to go forward, playing under the new rules.

PTO tried to sell the rule changes under the banner of streamlining the patent process and strengthening the system. But patent attorneys and their clients interpreted PTO's actions as an effort to find a way through the enormous backlog of cases pending in the office, and also as a way to shift the burden of patent prosecution onto the applicants themselves.

Throughout 2006 and 2007, a number of efforts to derail PTO's rule changes were mounted. Among those efforts were independent suits filed by pharmaceutical giant GlaxoSmithKline and by Dr. Triantafyllos Tafas, an inventor and chief technology officer at Ikonysis (New Haven, CT), a laboratory instrumentation company. Those suits were joined together in the Eastern District of Virginia, where the plaintiffs sought a declaratory judgment to stop implementation of the rules on a number of grounds. On October 31, 2007, the day before the new rules were to go into effect, the court issued a temporary restraining order and preliminary injunction, temporarily blocking implementation of the new rules.

With that decision, most patent lawyers and their clients breathed a sigh of relief, put their revised strategies in a drawer, and continued business as usual. There appeared to be no consensus on predicting the ultimate fate of the temporary injunction, but PTO was still generally cast as the 800-lb gorilla. Thus it came as a surprise, and not without irony, that on April 1, the court granted the motion for summary judgment (Tafas and GSK v. Dudas, Jon Dudas being the PTO commissioner), thus permanently enjoining the patent office from implementing the new rules.

The judge in the Eastern District of Virginia based his ruling primarily on the view that the rules proposed by PTO were substantive to the extent that they reached beyond the scope of implementing law. Instead, PTO's proposal had moved the office into the role of making law—a power that is under the purview of Congress, not an agency or department of the executive branch.

In spite of the district court's ruling, however, the story may not be over yet. PTO has reportedly indicated that it will appeal the ruling, and it may approach the same ends more incrementally. A typical appeal to the Court of Appeals for the Federal Circuit takes more than a year, but such a timeframe can often be shortened for important cases.

An even more radical shift in the patent landscape could be brought about if Congress passes legislation specifically granting PTO authority to make changes such as those that were just permanently enjoined. The House version of the Patent Reform Act of 2007, passed in September 2007, does in fact give such rule making authority to PTO. The Senate version, on the other hand, does not contain such a provision and is still under consideration.

Douglas C. Limbach is an attorney at Shay Law Group LLP (San Mateo, CA), where he counsels technology companies, primarily in the medical device industry. David C. Cohen, PhD, is a patent agent at Shay Law Group. Both focus on representing early stage medical device companies.

© 2008 Canon Communications LLC

Return to MX: Issues Update.

Caring for the Caregiver

MDEA 2008

A common thread among some 2008 Medical Design Excellence Award winners is that their designs are so well thought-out that they make the caregiver's job much easier.

The basic approach for accomplishing this is not too difficult, jurors say. “Do a good usability study, conduct ethnographic research with existing models to understand their pros and cons, and test and evaluate prototypes with users before going further into final development,” says juror Pascal Malassigné. He is a professor of industrial art and design at the Milwaukee Institute of Art and Design.

The winners profiled below are very different from one another. On the surface, a laparoscopic surgical instrument would seem to have little to do with a small patient monitor. But what their developers share is a commitment to designing devices in a way that makes the caregiver more effective at what he or she does.

Akreos AO Micro Incision Lens

The curling action of the Akreos intraocular lens ensures that it can be implanted through a small incision.
Microincision techniques are now available to eye surgeons. The surgeons are eager to use them, because eye surgery is a high-risk endeavor and, chances are, the smaller the incision on the eye, the safer the procedure will be. But those implanting intraocular lenses (IOLs) could not take advantage of them, because those products were too large to pass through microincisions. This changed when Bausch & Lomb Inc. (Rochester, NY) introduced Model MI60 of the Akreos AO Micro Incision Lens. The result is less trauma to the patient and faster healing times.

For cataract surgery, micro­incisions as small as 0.7 mm could be used to remove the eye's defective natural lens, so it was natural to try to find a way to use them for implanting the new lens, too. In 2003, the average incision size for cataract surgery was 3.2 mm. Around that time, Bausch & Lomb was working on a system that would pass through an incision of 2.8 mm, but that still required a larger incision than what was required for removal, says Joel Pynson, the firm's director of design engineering. Then the company began collaborating with Medicel (Widnau, Switzerland) that had developed a new design for a lens inserter. “[It] used a soft silicone tip to gently push the IOL in the inserter,” says Pynson. “This allowed for a stronger push of the IOL through the inserter with less chance of damage to the IOL.” And that meant that designing a smaller IOL got easier, because worries about its fragility were lessened.

The new design had to be able to fit through an incision as small as 1.8 mm, but it could not sacrifice essential characteristics such as mechanical stability and optical quality, Pynson says.

Corporate headquarters wasn't optimistic and declined to fully fund the project. “However, a small group of R&D personnel continued to pursue the microincision effort with little resources but a lot of passion,” he says.

The group knew it had to deviate from traditional IOL designs in order to enable the smaller IOL to be captured and stabilized within the eye. “We developed a concept that would allow the IOL to curl itself into a stable position while not transferring force that could deform the thin optic,” says Pynson. Once that was accomplished, headquarters changed its tune and the project was fully funded.

“The lens embodies design excellence in a figuratively and literally monolithic sense,” says juror Michael Wiklund. “It is a single element with no moving parts, although it can be curled upon itself to enable insertion into the eye. The lens promises to stay where the physician places it by virtue of its haptics—four extended corners, twice the number found in predecessor lenses.”

NetGuard Single-Use Electrode Monitor

The small size and low price point of NetGuard could lead to more-frequent monitoring of waiting-room patients.
Real-time monitoring has become commonplace for patients who are critically ill. But patients who come in to a hospital for routine procedures typically aren't monitored at all. In most cases, that has no consequences. But when an unmonitored patient dies, “that's a catastrophic event for a hospital,” says Tim Krauskopf, vice president of regulatory and clinical affairs for Datascope Corp. (Montvale, NJ). “So they are keenly aware of the need” to monitor the unmonitored.

Of course, hospitals aren't going to want to spend a whole lot of money on monitors for low-risk patients. So Datascope set out to design a simple monitor that was small and inexpensive, but allowed nurses to be aware of when a low-risk patient is suddenly at risk.

The NetGuard monitors the electrical activity of the heart and alerts nurses when it detects a life-threatening heart rhythm. It seems like a simple device, but achieving that simplicity, small size, and low cost was a significant challenge.

“We wanted to be sure it was low-cost enough to be applied to every unmonitored patient, but it also had to be usable by hospital staff who are not as highly trained as a typical ECG nurse would be,” says Krauskopf. “The device itself needed to do the analysis of the patient's heart rhythm. Personnel on standard floors do not have that type of training.”

Datascope talked to a number of physicians and hospital administrators, seeking their input on aspects such as the skill set of users, the location of the display, and the price point. Then, says Krauskopf, the challenge was to come up with a design that reflected those needs. Power issues had to be wrestled with in particular. The battery had to be small enough to fit in a tiny device, yet powerful enough to handle the functional requirements. The device also had to be wireless, because many of the patients using it are ambulatory, and rugged, because it is worn in environments such as the shower. “When you wear it, you hardly notice it,” he says.

“The patient-worn part of the system is nicely designed and seemingly easy to use,” says juror William Hyman, a professor of biomedical engineering at Texas A&M University (College Station).

The firm came up with a design that is 3.5 × 1.5 in. and costs about $150. (Single-use electrodes are an additional $15 each.) Hospital response has been enthusiastic, perhaps because the NetGuard gives caregivers peace of mind.

Patient Registration Mask

Stryker's Patient Registration Mask is an easy-to-apply navigation system.
Surgical navigation systems are a neat technology, but they don't work unless the system knows what it has to navigate around. Therefore, they require tracking devices. And tracking devices require registration, which tells the system where the patient and his or her features are located. Registration used to be a cumbersome process, with a series of manual interactions required. In some cases, it was an invasive process as well. But that is not the case with the Patient Registration Mask, developed by Stryker Leibinger GmbH & Co. KG (Freiberg, Germany). It is used in ear, nose, and throat surgeries.

The mask accomplishes both registration and tracking. It contains light-emitting diodes (LEDs) that are visible to a navigation system's infrared camera. When the mask is placed on the patient's face, the LEDs show the navigation system where the patient and his or her features are. It allows the system to recognize the patient's face and correlate it with his or her data. The correlation between the physical and the virtual patient in the system can be determined automatically. This is a quicker and more reliable way for the ear, nose, and throat (ENT) surgeon to get everything oriented properly.

“Like other companies, we had a noninvasive tracker fixation for the head, but we weren't content with it,” says Hans Schoepp, Stryker's manager of rapid concepts in its R&D division. “It was a head strap that served to hold a tracker, but the way the tracker was attached, it was prone to movement during surgery. One way around that is to use sharp pins to fixate the skull, like neurosurgeons do, but this was too invasive for ENT surgeries.”

So the team came up with a way to attach the mask in a way that would not allow the LEDs to move during surgery. And it came up with a way to achieve automatic registration based on just 31 fiducial points. (In the manual registration procedure, the surgeon must touch as many as 100 points on the face with a pointing device.) It does not require help from auxiliary devices, like other registration systems do. It makes for a fast, standard, and reproducible procedure. But it was not easy to achieve: Intense
mechanical, electronic, and software development was required, says Schoepp.

“Applying the mask is a simple, quick procedure akin to applying stickers on a toy,” says Wiklund. “The noninvasive navigational aid avoids the blood loss and risk of infection associated with alternative devices.”

RealHand High-Dexterity Instruments

The added dexterity of the RealHand instruments was
developed using computer-guided motion techniques.
Laparoscopic surgery is a technique that has been around for a while. But the Real­Hand high-dexterity instruments enable surgeons to perform laparoscopic procedures in ways they never did before. “It gives the surgeon added dexterity and control that you do not get with standard laparoscopic instrumentation,” says Joe Guido, vice president of sales and marketing for Novare Surgical Systems Inc. (Cupertino, CA).

Doctors had been asking for a handheld surgical instrument with dynamic articulation, but no one had been able to figure out how to make it happen. Then inventor David Danitz, vice president of research and development for Novare, used his background in computer-guided-motion research to come up with an instrument whose jaws could be articulated in any direction.

The effect is like having your hand, and its full range of motion, inside the patient instead of an instrument. Hence the name.

To make it happen, says Danitz, “I had to use multiple cable sets to connect links on the different ends of the shaft, but the links are fully constrained. As a result, the mechanism is very rigid. That's why it works well as a surgical tool.”

This also means that the angle at which the surgical target is attacked no longer has to be related to where the incision was made. So a procedure that involves multiple angles can be performed with one incision instead of many. “Even if there's just one incision in the belly button, it's as if the instrument is coming from ports much further apart,” says Danitz. “It's like it erases port locations.” And that means that some surgeries that weren't previously able to be performed laparoscopically now can be.

Also, because the RealHand enables surgery to be performed through one incision, it allows the surgeon to hold the instrument in a naturally comfortable position. This reduces the chance of fatigue and repetitive-motion injuries.

Schwind Amaris Excimer Laser

The Amaris adjusts for eye rotations, which are the most common movements by a patient during refractive surgery.
Refractive surgery has gotten pretty advanced, but researchers at Schwind Eye-Tech Solutions GmbH & Co. KG (Kleinostheim, Germany) weren't satisfied. They had an ambitious goal: to integrate everything technically possible in refractive surgery into one device, with every feature advanced. With the Schwind Amaris excimer laser, they succeeded.

“Engineers with different specializations worked toward a single goal: to realize the maximum of today's possibilities and to integrate the experience gained through developing generations of lasers,” says Antje Splittdorf, head of marketing and communications for Schwind. To do that, the team consulted with a number of internationally renowned refractive surgeons.

Among the improvements are:

  • Increased speed. A faster repetition rate plus a new technique significantly shortened treatment time.
  • Better ablation control. The team came up with an automatic fluence level adjustment method. Before, the procedure had to be performed with a high fluence level, which made for shorter treatment times but less accuracy, or a low one, which made for better precision but longer treatment times. The adjustment method enables short treatment times without compromising on precision. And that enables refractive surgeons to do a much better job.
  • Smaller laser spots for ablating. The beam is just 0.54 mm in diameter, compared to the 0.7–1-mm-diam. beams for other lasers. This means less of the eye is exposed to the laser.
  • Better eye tracking. The eye-tracking system is more than twice as fast as the laser repetition rate and adjusts for eye movements in five dimensions, instead of one or two. This enables it to adjust for eye rotations, which are the most common movements by the patient during the procedure. And that makes it a safer procedure.

“The Schwind Amaris excimer laser reflects overall design excellence,” says Wiklund. “The product achieves a high level of performance in important categories such as treatment speed and safety. The workstation ergonomics appear to be top-notch, placing controls within the comfortable reach of various-sized users. The product's simple, clean appearance promises to please the purchasers, the direct users, and the patients who might emotionally associate attractive design with greater effectiveness.”

Tono-Pen Avia Applanation Tonometer

Minimal need for training and portability were positive aspects of the Tono-Pen Avia cited by MDEA jurors.
A tonometer is a device that is used to measure the fluid pressure inside the eye, which can be an indication of glaucoma or other conditions. The standard had been a bulky device that is affixed to a slit lamp. But the Tono-Pen Avia Applanation Tonometer, made by Reichert Inc. (DePew, NY), is a lightweight, portable, hand­held instrument with a small-diameter tip that can be used in all clinical situations. It makes the operator's job easier because it can be used with minimal training. And it enables them to take fast and accurate intraoccular pressure measurements confidently anytime, anywhere, and in any position.

This allows the test to be performed on patients in beds, wheelchairs, or any other location that doesn't allow them to get to a slit lamp. It also allows the test to be performed by caregivers who are not optometrists or ophthalmologists.

Reichert enlisted Metaphase Design Group (St. Louis) to test a variety of different options with caregivers and patients. The one feature that particularly resonated, says Metaphase founder and CEO Bryce Rutter, was having two liquid-crystal displays in the middle of the device. That ensured that both left-handed and right-handed users could easily view the results while holding the instrument.

And that enabled the procedure to be done more quickly. “Time-on-cornea was a crucial design consideration,” says Rutter. “So we also designed it in a way that put a small amount of pressure on the cornea.”

The team also made the grip easy to grasp and manipulate. “You need a lot of control when you're moving something toward the eyeball,” says Rutter.

“The Tono-Pen is an excellent design that adds portability without sacrificing reliability in the measurement of intraocular pressure,” says juror Edmond Israelski, PhD. “It significantly expands the set of patients that can get this test because of its smart handheld design. The statistical analysis and resulting readout nicely address the previous problems in measuring intraocular pressure, which typically has large variability.” Israelski is human factors program manager for Abbott (Abbott Park, IL).

Juror Craig Jackson, PhD, president and chief technical officer of Hemosaga Diagnostics Corp., agrees. “Human factors are being considered more seriously in the design of new products,” he says. “An example in the Tono-Pen is the dual displays; the results can be seen by right- and left-handed users equally well.”

Copyright ©2008 Medical Device & Diagnostic Industry

Massachusetts Bill Would Ban All Gifts to Physicians


Last month, the Massachusetts State Senate unveiled a far-reaching healthcare reform bill that would, among other provisions, impose a ban on all gifts to healthcare providers and their immediate family members. The gift ban provision of the bill—titled An Act to Promote Cost Containment, Transparency, and Efficiency in the Delivery of Quality Healthcare (S 2526)—would apply to medical device manufacturers as well as pharmaceutical and biotechnology companies.

 
Sommer
 
MassMedic's Sommer: Unreasonable limits.

The state senate passed the legislation on April 17, leaving the gift ban provision intact, says Tom Sommer, president of the Massachusetts Medical Device Industry Council (MassMedic; Boston). “In addition, an amendment was approved that would establish a licensing procedure that would require sales reps and any other life sciences company reps to obtain a license and pay an annual fee of $500 to interact with healthcare professionals in the state,” Sommer says. “We're working with key members of the Massachusetts House to knock this provision out of the bill.”

As proposed, the legislation defines the term gift broadly, as “a payment, entertainment, meals, travel, honorarium, subscription, advance, services, or anything of value, unless consideration of equal or greater value is received.” Although the legislation outlines the proposal under the heading “Pharmaceutical Industry Gift Ban,” it lumps the promotion of medical devices in with its definition of who constitutes a pharmaceutical manufacturer agent.

In detailing the ban, the proposed legislation states, “No pharmaceutical manufacturer agent shall knowingly and willfully offer or give to a physician, a member of a physician's immediate family, a physician's employee or agent, a healthcare facility or employee or agent of a healthcare facility, a gift of any value.”

Violations of the ban could be punished through fines of up to $5000, by imprisonment for no more than two years, or both.

Following the bill's introduction in the Senate, MassMedic sent a letter to all members of the Massachusetts State Senate. In it, Sommer voiced strong opposition to the gift ban provision of S 2526 and urged the senate to allow medical device companies to incur reasonable expenses related to medical device education and training for healthcare professionals.

In the letter, Sommer stated, “While MassMedic applauds the Senate's efforts to contain healthcare costs and promote transparency in the healthcare system, we are concerned that Section 22 of the legislation, the Pharmaceutical Industry Gift Ban, will have a negative effect on the ability of medical device manufacturers to provide the training and education necessary to operate a range of innovative medical products. MassMedic is also concerned that this language would criminalize ordinary business practices such as providing refreshments at an educational seminar.”

Sommer also pointed to the fact that many companies within the medical device industry have already adopted voluntary codes—such as the Code of Ethics on Interactions with Healthcare Professionals developed by industry association AdvaMed (Washington, DC)—that limit gifts and prohibit cash payments to healthcare purchasers and providers.

“Additionally, the national and state organizations representing physicians and hospitals have approved guidelines regarding interaction with life sciences industries,” Sommer wrote. “The issuance of these multiple codes of ethics have made payments for entertainment, lavish gifts, and meals an unacceptable practice by medical device manufacturers in the United States.”

Massachusetts' proposed ban on gifts to healthcare practitioners represents an extreme example of a much broader move to limit the perceived financial influence that pharmaceutical and medical device manufacturers wield over their customers. For example, last month, Representatives Peter DeFazio (D–OR) and Pete Stark (D–CA) introduced a companion bill to the Senate's Physician Payments Sunshine Act. Both bills (HR 5605 and S 2029) would require many drug and device manufacturers to file quarterly reports listing all physician payments and gifts with a value of $25 or more. For more details on the implications of the legislation, check out the article “Sunshine and Its Glare,” by attorney Wayne Wolff, in the upcoming May/June issue of MX magazine. For past coverage of the Sunshine Act in MX: Issues Update, visit http://devicelink.com/mx/issuesupdate/08/03/Sunshine.html.

© 2008 Canon Communications LLC

Return to MX: Issues Update.

Design Appeal: The Patient Perspective

MDEA 2008

No pain. More comfort. More attractive. And, how about more fun? This year's Medical Design Excellence Awards turned up more than a few winners that made appeal to the patient a top priority. One promises little or no pain for a traditionally terrifying dental injection. Others make the patient—or in one case, the patient's parent—feel more at ease. Some were designed to fit into the patient's home décor. And another simply makes the product fun so that the patient will stick with the therapy.

“Clearly, enhanced performance and patient experience is an appropriate and useful design opportunity, benefiting patients—and the company, if it is able to achieve a business advantage,” says juror William Hyman, a professor of biomedical engineering at Texas A&M University.

Jurors attribute the trend to several factors. “Demands by users are being heard, in part, because of the shortage of nurses and similar caregivers,” says juror Craig Jackson, PhD. Jackson is president of Hemosaga Diagnostics Corp. (San Diego). “Also, there is competitive pressure. If pricing is somewhat inelastic, then innovative features are necessary to make one product desirable over another,” he says.

“The reason for the trend toward positive user experiences is that this topic is getting more attention among designers of all types of devices,” says juror Molly Story. Story is president of Human Spectrum Design LLC.

“It might also be that FDA's requirement that medical device developers use a human factors process is causing them to pay more attention to the user experience in general,” she says.

Overcoming the Fear of the Dentist

The STA system controls the flow rate of a dental injection so that pain is maintained below human perception.
The Single Tooth Anesthesia (STA) system by Milestone Scientific Inc. (Livingston, NJ) addresses a long-dreaded dental fear. The system precisely controls the flow rate of the injection so that it can be maintained below the human pain perception level, resulting in an injection that the company says is “a truly painless experience to the patient.” The initial intended use is for dentistry, but the company says that future versions will be suitable for medical injections and other medical applications.

“This product is patient friendly because it limits the area of the mouth that gets anesthetized, and the dentist controls the speed, and therefore the pressure, at which he inserts the anesthesia solution,” says Story. “Both of these reduce the discomfort the patient experiences. The technological breakthrough is the feedback mechanism that communicates to the dentist how much pressure he is applying as he inserts the solution.”

The system uses a computer-controlled sensing technology to deliver the anesthetic. Continuous audible and visual real-time pressure feedback allows the clinician to accurately identify a specific anatomic target for the injection based on the interstitial tissue pressure. According to the company, the STA system performs a dental injection that is typically very difficult and painful to perform when using a syringe. With the system, however, a single tooth can be anesthetized without producing numbness to the patient's lip, tongue, or other teeth.

“The innovation here was truly technical in that the pressure feedback system identifies the target tissue's location and thereby allows delivery of the drug with less pain and greater efficacy and localization,” says Hyman.

Hyman notes that “the patient-friendly part” of the design is the actual reduction in pain and greater comfort, especially in the dental environment, which is not known for patients enjoying their experience. “In a broader sense, a pain-free experience might lead to a more timely return for subsequent dental treatment, thereby contributing to individual and public health,” he says.

A Warm and Fuzzy Experience

Full-color panels and trending are among many features designed to provide an optimum environment not only for patients, but also for caregivers and visiting parents.
GE Healthcare's two infant warmers—the Panda iRes and the Giraffe—have a sleek, modern design that the company says appeals to clinicians and families alike. “Our Panda and Giraffe warmers are the result of five years of intensive research into customer, patient, and clinical needs in neonatal intensive care (NICU) and in well baby care,” says Mike Genau, vice president, and general manager of GE Healthcare, Maternal & Infant Care.

“The overall aesthetic of the GE warmers is open and friendly,” notes juror Sandra Miller. “The monitoring is displayed with a simple user interface that is not frightening in appearance for parents who have enough to worry about if their baby is in the neonatal intensive care unit,” she says. Miller is managing director of the Stanford Biodesign Program at Stanford University.

Another feature of the warmers is a rotating mattress—called the Baby Susan. It reduces the frequency and duration of procedural contact. “The Baby Susan helps decrease negative touches for the fragile NICU patient by allowing the clinician to position the baby with a rotating mattress,” says Genau. “Our customers tell us that one of the most significant features of the Giraffe and Panda platforms is the hands-free alarm silence, allowing the clinician to silence alarms without touching the unit—which some studies suggest can be an area susceptible to contamination.”

“GE's warmers were particularly impressive because they elegantly addressed interface issues for the multiple users encountered in labor and delivery and in the neonatal intensive care units: the newborn patient, healthcare providers, and the parents,” adds Miller. Because the warmers have integrated the monitoring functionality normally addressed by other equipment, they also reduce clutter in the unit, a much-desired trait, she says. “It improves the newborn's experience with easier, friendlier handling.”

Sonic the Hedgehog Meets Medical Devices?

A video game–like interface provides an engaging and entertaining environment to stimulate patient effort and dedication during lengthy therapy sessions.
A user-friendly feature of the Hand Mentor Pro Rehabilitation System is its video game–like patient interface. According to Kinetic Muscles Inc. (KMI), numerous games can be programmed to guide the patient through the rehabilitation steps. The interactive interface is designed to provide an entertaining treatment environment that stimulates patient effort and dedication during lengthy therapy sessions. The system promotes restoration of function in the wrist, hand, and fingers of stroke survivors and other neurological injury patients suffering from mild to moderate hemiplegia. The two-part system is designed for use under the guidance of occupational therapists.

“I think the Hand Mentor is a noble device that converts tedious physical therapy—repeated hand movement and stretching intended to reestablish good brain-to-hand communication after a stroke—into a more pleasing activity,” notes juror Michael Wiklund, president of Wiklund Research & Design Inc. (Concord, MA). “The software associated with the mechanical device asks patients to perform object-tracking tasks that promise to improve hand function, but turns it into an encouraging game.”

Ed Koeneman, founder and COO of KMI, talks about the user-interface development. “There are two groups of users that influenced the design of our device: stroke patients and their physical or occupational therapists. Extensive field testing of prototypes and early models were used to collect feedback from both groups. What we learned from the patients is that the therapy experience needed to be more interactive—more fun,” says Koeneman. “What we learned from the therapists is that a short learning curve and a more automated method of monitoring patient progress were essential to widespread adoption of this product.”

Koeneman explains that the key to successful neurological rehabilitation is extensive repetition. “But repetitious tasks can often be boring,” he says. “The games in the Hand Mentor Pro are designed to engage the patient for long periods of time. [Patients] focus on the game, not on the therapy.”

KMI has received positive feedback from the rehabilitation industry for its efforts. Barbara Feth, associate national director of therapy operations at HealthSouth, recently told the company, “What I like about KMI, compared with most other rehabilitation equipment companies, is that they listen to the patients and the therapists.”

“The most important feedback that we can get is from our beta testers. We have a handful of therapy clinics that we work very closely with in order to get very candid feedback on new design features. We value the tough love that we get from their comments and critiques of our products. If something isn't just right, they let us know, and we listen and do something about it,” says Koeneman.

The Customer Has Spoken

The Veramyst nasal spray package was designed to improve ease of use for both the patient and caregiver.
Patient feedback and targeted voice-of-the-customer studies were of paramount importance to the design concept of the Veramyst and Avamys nasal spray packages by GlaxoSmithKline (GSK). According to GSK, this feedback led to the development of an ergonomically designed device that addresses important benefits in terms of ease of use by either the patient or their caregiver. The design incorporates comfort and reproducibility of dosing of an effective medication to improve symptom relief. “By listening to the customers, improved patient compliance can be achieved through
innovative design,” says GSK.

One of those attributes is the device's side-actuated delivery, which enables easy third-party administration by caregivers to children or to patients unable to administer it themselves. The design improves control for the administrator, and the side actuation is less invasive for the patient than top-actuated pumps.

“I've noticed that many drug manufacturers have introduced novel and innovative drug-delivery systems,” says Wiklund. “The Veramyst device is certainly an example of this, embodying features that make it easier to take the drug while also increasing the device's overall appeal. Whereas old nasal spray bottles were arguably annoying to use and made it hard to deliver an accurate dose, Veramyst is actually pleasing to use, maybe even fun to use. It appears to deliver a precise dose, due to the smooth action of the device's side lever,” he explains.

The device delivers a prescribed once-daily nasal spray for the treatment of seasonal and perennial rhinitis. According to the company, this device has been ergonomically designed using feedback from customers and human factors studies for ease of use by both a patient and a caregiver.

“I should add that the product's shape and graphics also contribute to the device's overall appeal. I expect that users' perception of Veramyst and its effectiveness is substantially enhanced by the device's attractive packaging and usability,” says Wiklund. “The trend toward user-pleasing drug-delivery systems is also reflected in the latest insulin pens, which makes accurate drug delivery a snap (actually, a click and press).”

Giving Patients Freedom

The Genesis DM made incremental improvements, such as an angled display that users can view while standing.
The Genesis DM by Honeywell is the latest generation of the company's telehealth vital signs monitor. The device measures objective and subjective patient data for a complete picture of a chronic patient's health from home.

It is a Web-enabled device that also has general packet radio service communication capability.

“Honeywell has incorporated several user preference factors into the design of the new Genesis DM monitor. The major design modification was the introduction of an angled display area,” says Eric Zalas, emerging-segment marketing manager for Honeywell HomMed (Brookfield, WI). “Our focus group feedback indicated that patients wanted a device that was easy to read when they were standing. This simple design modification made it much easier for the elderly patient to read the graphic display,” he explains.

The Genesis DM provides remote patient biometric and symptom evaluation by measuring heart rate, blood pressure, weight, pulse oximetry, and blood glucose readings. It allows clinicians to remotely monitor the vital signs of chronically ill patients on a daily basis. It may help clinicians detect the onset of a negative outcome that may result in early rehospitalization. The Genesis DM is used by patients suffering from chronic conditions such as congestive heart failure, COPD, CAD, diabetes, and hypertension.

Zalas says that customer feedback also helped Honeywell design a monitor with a small footprint. “The Genesis DM is small enough to easily fit on a patient's nightstand. In addition, the Genesis DM weighs less than 2 lb, making it easy for patients to move it around the house if necessary,” he says.

Honeywell conducted primary research with its elderly Medicare patients during the design phase, says Zalas. “Most of the patients that use the monitor are over 70, and many are frail. We learned early in the process that patients didn't want to have a device in their homes that looked medical,” he says. Based on this input, Honeywell designed the Genesis DM to resemble an alarm clock or small stereo component.

Honeywell's ergonomic studies with the control buttons have resulted in a design for maximum ease of use for chronic patients. “Our research showed that elderly patients are easily confused by multiple buttons, so the Genesis DM was designed with simplicity in mind. Each of the six control buttons is large and color-coded. Each button also has a rounded-outward or convex surface that helps the patient feel when his or her finger is on exactly the right spot,” says Zalas.

Patients can use the Yes or No buttons on the monitor to answer more than 50 detailed disease-specific symptom-management questions. This feature allows physicians and clinicians to not only assess the patient's objective vital signs (i.e., weight, blood pressure, etc.), but also subjective inputs (e.g., “Are you feeling better today?” or “Are your ankles swollen?”), explains Zalas. “The patients like this feature because they can provide subjective feedback to their clinician on a routine basis.”

In Plain Sight? No Problem

Users can set the Healthy Living blood pressure monitor to issue a warning if certain blood pressure levels are exceeded.
Those who suffer from hypertension, diabetes, and obesity are usually encouraged to watch their blood pressure and share the results with their healthcare provider. The Healthy Living ThinLine Deluxe flat-screen blood pressure monitor is intended for home monitoring of blood pressure. The twist? When not in use, it sits nicely on a desk or table and functions as a clock.

“The design brings this out from under the sink and puts it in your life,” says the company. “It is now part of your nightstand or desk, and seeing it will remind you to take your blood pressure.” The design is intended to make it the process more relaxed and commonplace. “It does what it's supposed to do—measure blood pressure—and does so with a sleek, modern look,” says Healthy Living. Users can also set the monitor to warn them if certain levels are exceeded.

“The dual function of this product—a blood pressure monitor as well as a household object—is innovative because it transforms a medical product that can be seen as stigmatizing into a friendly and common everyday object. Is it indicative of a trend, perhaps, for simple products like this one,” says juror Pascal Malassigné, professor of industrial design at the Milwaukee Institute of Art and Design.

“The see-through screen with its large text and numerals facilitates viewing from a distance. Everyone in the household benefits: youngsters, adults, and older family members. . . . [Its] a true example of universal product design,” says Malassigné.

Conclusion

Modern living has made patients much more aware of what is pleasing to them. They have become more vocal in letting their healthcare providers know what works for them personally. For OEMs, that translates to incorporating patient demands into their designs.

“The word pleasing may be too weak,” notes Hyman. “I don't want to just be pleased. I want my medical experience enhanced with respect to efficiency of my time, reduction of anxiety and pain, and efficacy of treatment. These issues to me go beyond pleasing.”

As a trend, satisfying patients could be a business opportunity to create or secure a niche. There is more opportunity through improvements than through breakthroughs. “Improvements also are likely to present a lower regulatory hurdle, especially if you are improving your own product,” Hyman says.

There is more to making a device easier to use than just improving functionality. Human factors, ergonomics, patient studies—these are just a few of the methods that were part of the design process for some of the 2008 MDEA winners. Whether the results made a process less painful or a device more pleasing, appealing to the patient was a key factor in the designs.

Copyright ©2008 Medical Device & Diagnostic Industry

Industry Insights: PTO's Potential Next Moves


More information on the PTO ruling:

On April 1, the U.S. District Court for the Eastern District of Virginia struck down controversial continuation and claims rules that the U.S. Patent and Trademark Office (PTO) first published in 2006. PTO had scheduled the rules to take effect on November 1, 2007. At that time, however, the same court preliminarily enjoined the rules from taking effect while it considered their legality.

James J. Foster, a shareholder and litigator at Wolf, Greenfield & Sacks PC (Boston), says PTO had drafted the new rules to speed up the patent examination process. “The new rules limited the number of continuing applications that an applicant could file and the number of claims that an applicant could pursue as a matter of right,” he says. “The old system did not limit either. The new rules also, in some circumstances, required the applicant to conduct a prior art search and explain the prior art. The old system had no such requirement.”

 
Foster
 
Foster: Substantive limits rejected.

In its decision, the court held that PTO does not have the statutory authority to make the new rules because such rules would have a substantive impact on applicants' rights, Foster notes. PTO's authority is currently limited to enacting procedural rules.

Les Bookoff, a partner at Finnegan, Henderson, Farabow, Garrett & Dunner LLP (Washington, DC), says that PTO rules limiting continuation applications could reduce the ability of medical device companies to obtain commercially significant patent coverage for their inventions. “For example, in contrast to some other industries, time-consuming R&D and regulatory approval may follow invention and precede commercialization,” he says. “Yet, a medical device company may use up its available opportunities for patent coverage prior to understanding the commercially significant aspects of its invention. This could lead to copying of the company's products—without recourse through the patent system.”

 
Bookoff
 
Bookoff: Significant medtech implications.

As such, the permanent injunction came as a relief to many medtech companies that were preparing revised patenting strategies in light of the rule changes. But such relief may be fleeting, as PTO still has several options left in pursuing its desired patent rule changes.

Courtenay Brinckerhoff, an IP partner at Foley & Lardner (Washington, DC), says PTO has 60 days from the final decision to file an appeal in the U.S. Court of Appeals for the Federal Circuit. “If the appeal follows a normal schedule, it could take up to a year or longer for the court to render a decision,” she says.

Bookoff says PTO could also seek to work around the court's decision by proposing different, less-substantive rules that may accomplish similar results. “Or, PTO could attempt to use current rules to accomplish its goals,” he says. “For example, some of the proposed rules sought to have patent applicants identify certain related patent applications during prosecution. PTO could use its current rules to request that information from applicants.”

 
Brinckerhoff
 
Brinckerhoff: Appealing options.

In any case, the outcome of a PTO appeal or work-around attempt could be incidental if Congress chooses to intervene and grant the office the needed authority to move forward with its proposed rules.

“The U.S. Congress is currently considering specific patent reform legislation,” Foster says. “The version that passed the House would amend the patent statute to grant the Patent Office the authority to promulgate such rules. If similar legislation passes the Senate, and the president signs it into law, the court may permit the Patent Office to restore these rules, but only after a further notice and comment period.”

Brinckerhoff adds, “Predicting when or even whether Congress will take final action on the Patent Reform Act is more difficult than predicting the weather forecast for an April day in Washington, DC. While the Patent Office is strongly behind these provisions, patent bar organizations are lobbying heavily against them because of the increased burdens they would place on applicants.”

Other provisions of the Patent Reform Act have divided industry groups along technology lines, with biotechnology and pharmaceutical groups falling on one side, and computer groups falling on the other, Brinckerhoff says. She notes that medical device companies—depending on the provisions being discussed—currently fall on both sides of the debate.

Certain patent reform provisions have also been opposed by Chief Judge Paul Michel of the U.S. Court of Appeals for the Federal Circuit, Brinckerhoff notes. “Unless and until these groups find a compromise, Congress is not likely to take sides and risk alienating important constituents,” she says.

© 2008 Canon Communications LLC

Return to MX: Issues Update.

Whole-In-One: Devices that Do More

MDEA 2008

It may not be easy, but caregivers like to have everything they need in one place. And patients like having everything they need done in one visit. Fulfilling those needs means either creating devices that perform multiple tasks or increasing a device's portability. Many of this year's Medical Design Excellence Awards (MDEA) winners embody these principles. The devices enable users to control a system, which can make treatments fast and intuitive. Manufacturers must limit the number of steps of a procedure in a user-friendly way that facilitates timely care. This is key to developing award-winning products.

Automation Sets You Free

Actually, automation sets patients free—from multiple appointments and from settling for a device that might not be quite right. But it also allows healthcare providers to cut down on work traditionally sent out to laboratories or done by hand. The result is more-immediate and more-personalized care. “The advantages of a single, inclusive device are several,” says MDEA juror Craig Jackson. “You only have one device to learn and to maintain. An integrated system minimizes the manpower required.”

Dental restorations from the E4D can be performed in a single visit.
E4D Dentist System. The E4D Dentist System from D4D Technologies LLC (Richardson, TX) is a chairside system that enables dentists to create digital impressions and fabricate inlays, onlays, and full contour crowns. Every step can be done in a single visit to the dentist's office, thereby eliminating the need for temporary crowns and second appointments. Patients receive custom-made dental restorations without having to make repeated visits.

The E4D combines several machines into one. First, a design server allows dentists to scan and design the restoration. It comes with an IntraOral Digitizer that scans the prepared tooth and its neighbors. It also scans the preoperative tooth and bite registration. A 3-D digital impression is created. The second machine is the job server that uses a personal computer to run the software. The job server sends the data from the design center to the third machine, the milling center, where a unique implant is created.

There are multiple challenges presented by each aspect of these machines. Although none of the technologies are new, presenting them in one set of machines required a blending of several engineering
disciplines.

For example, the milling machine must produce a restoration that has less than a 50-µm difference from the original tooth, for clinical acceptability. Millions of 3-D coordinates are captured and the software intuitively generates a restoration that accounts for neighboring teeth, opposing teeth, and aesthetic factors.

The designers spent considerable time creating intuitive software. “Users can follow tabs from left to right, see visually descriptive icons, and access all of the features with a two-button and scroll-bar mouse to proceed from start to finish rather easily,” says Gary Severance, vice president of marketing and clinical affairs at D4D.

Juror Molly Story says there are various aspects that the MDEA jury found the E4D improved compared with traditional approaches. “Dangers with the traditional approach include the fact that the temporary [crown] itself may break, it may damage other teeth, or the surrounding teeth may shift during the time that it is in place,” she says. “The E4D device improves tooth safety and patient health, and reduces total cost.”

The company estimates that if an office performs 20 or more restorations per month, it can achieve significant revenue enhancement. “The short-term cost is steep, especially for a small office,” says Story, “but it would be practical for a fairly large facility.”

By automating a previously tedious process, the QuickLink loader enables quick treatment, which can alleviate anxiety for the patient.
QuickLink Loader. Fewer doctor visits often means that several treatment steps must be condensed. These steps may traditionally have been performed between patient visits. To compress such steps into a single visit, the procedures must be made safer and more efficient. The rewards, however, are often more important than just saving time.

The QuickLink Loader from the urological division of C.R. Bard Inc. (Covington, GA) is used in conjunction with a radiation treatment of prostate cancer called brachytherapy. Brachytherapy has typically been a three-step procedure that involves three specialists and two patient visits. During the first visit, a urologist creates an ultrasound map of the cancerous area and the prostate, defining a grid for the quantity, location, and composition of the radioactive strands used to treat the tumor. Between hospital visits, a physician constructs the strands by hand in a central radiation lab, selecting the appropriate radioactive seed or bioabsorbable connector and placing it on a grooved track with tweezers. During the third step, the patient returns and a radiation oncologist injects the strands into the patient.

The QuickLink loader compresses the steps in the procedure into a single visit by automating the strand creation. “This automation replaces what is a painstaking manual task that is highly dependent on the skills and availability of the trained user,” says Hyman.

For patients, it translates to better care in surprising ways. “Besides being efficient, single-visit treatment in the cancer arena addresses the often overlooked anxiety factor that challenges patients as they move through diagnosis and treatment,” Hyman explains. “The days between these events, while perhaps not being clinically harmful, are torturous in terms of worrying about the next encounter. [Getting] treatment under way in a single visit can be an important adjunct to the direct clinical effect.”

In terms of safety, the QuickLink loader makes several improvements over previous versions. Users do not have to handle seeds and connectors. The cartridge placement includes visual and physical clues to reduce the risk of poor placement. The design team considered how to organize those cartridges so that the radiation seeds are farthest away from the loading site to reduce accidental seed placement. In addition, each part of the loader can be separated and removed to ensure that no seeds are lost.

Mobile Diagnostics: Seeing Is Believing

Among this year's winners, portability is a clear focus, says Story. “The technology has been miniaturized and made portable to maximize the amount of treatment it can deliver.” This is especially true for imaging devices.

Imaging technology is one of the most important aspects of diagnostics. For many years, however, this technology has been hindered because the equipment takes up entire rooms and patients must move to the system. Designers have put more emphasis on creating imagers that go to the patients.

The xCAT provides surgeons with immediate feedback by bringing computed tomography to the operating room.
xCAT Computed Tomography Scanner. “Imaging in the operating room is highly desirable for many procedures because it allows immediate results without having to move the patient, disrupt the procedure, or rely on pre- or post-images separated by long periods of time,” Hyman says. Xoran Technologies (Ann Arbor, MI) created its xCAT to work in the OR. It is designed to provide intra­operative scanning for ENT surgeries. The entire 500-lb system stands about 5 ft tall and 4 ft wide.

The weight and mobility of the device were important to the company, which wanted nurses, technicians, and doctors to be able to move the system quickly, without needing to ask for help. “Its large handles give workers plenty of gripping choices, ensuring that the device does not get away from them on ramps,” says juror Michael Wiklund. The design team worked hard to get the weight down to 500 lb. “We used lightweight materials such as aluminum,” explains Tara Prasad of Insight Product Development, the company that designed the xCAT.

The designers used a C-arm to ease access to patients and to relieve patients who might experience claustrophobia. Another key aspect of the design was ensuring that visuals were comparable with traditional scanners. “While the quality of the imagery is not as high as that of its full-scale counterpart, this device's portability makes it sufficient for this purpose,” Story says.

The design team interviewed and consulted numerous ENT surgeons to ensure that the device could be used in an operating room and still maintain the sterile field. They developed high-contrast visuals so that a display could be up to eight feet away and still be readable.

With traditional systems, a diagnostic image is taken weeks before the surgery. Such scans may be quickly outdated with a progressive disease or infection. In contrast, the xCAT enables a surgeon to continuously monitor during surgery, thereby increasing the chance of success. Surgeons testing the xCAT found that 30% of the time, when the surgeon believed that the surgery was complete, an intraoperative scan on the xCAT indicated the surgery was not finished and the surgeon continued.

In emergency situations, patients must be stabilized and diagnosed in one location and then immediately proceed to treatment. With the xCAT, there is no need to unhook patient monitors and equipment. “The xCAT brings sophisticated scanning to the patient, rather than making the patient go to the scanner,” says Wiklund. “This approach promises to make life easier for nurses who normally spend hours a week preparing patients to go for scans.”

With its pocket size, the Acuson acts as a stethoscope ultrasound for immediate diagnoses of critical conditions.
Acuson P10. Increasing portability is all about making choices. There is always a cost for miniaturization. Siemens Medical Solutions (Mountain View, CA) created the Acuson P10 diagnostic ultrasound imaging tool with visual limitations in mind. But even with trade-offs, the device stands to have a dramatic effect on how medicine is practiced.

Weighing only 1.6 lb and small enough to fit in a lab coat pocket, the Acuson P10 is intended for both routine and urgent care. It provides immediate visual data to improve exam accuracy and to detect potentially life-threatening conditions at an early stage. The portable system can be used in intensive care units (ICUs), ambulances, and medical helicopters.

MDEA jurors were impressed with the system. “Could anyone have envisioned a pocket-sized ultrasound scanner a decade ago?” asks Wiklund. “[This] is the stethoscope of ultrasound scanners, stepping ahead of laptop computer–sized devices in terms of portability.”

Unlike many portable ultrasound systems, the Acuson doesn't try to do everything that the larger machines do. Instead it is targeted to provide a quick-look capability, giving clinicians immediate answers to the questions that guide patient-
care decisions.

However, the company readily admits that image quality is key to customer acceptance of any imaging device. Therefore, the designers adapted signal processing intellectual property and ASICs used in other Siemens products. Imaging and display were optimized using newly patented algorithms.

Benefits at the Bedside

A bed can't be just a bed anymore. Inpatient care requires a variety of daily tasks that can be difficult for busy hospital staff to manage. The beds that garnered juror attention go beyond singular function. “These [beds] relieve caregivers of concern for simple but important tasks and enable them to focus on critical aspects of the care,” Jackson says.

The InTouch bed features a display panel at the foot that contains relevant buttons for bed operation and protocol reminders.
InTouch Critical-Care Hospital Bed. The InTouch hospital bed from Stryker Medical (Portage, MI) combines connectivity, intuitive operation, and ergonomics. It can be used as a general medical and surgical bed, but its primary intent is for ICU settings.

InTouch incorporates protocol reminders that help ensure compliance with patient care. A touch screen provides access to multiple menus and reduces the number of buttons. The touch screen is used for bed control, scale, and protocol reminders, with alarms for scheduled processes. “Foremost among the features of this product was its integration of the collection of mundane tasks into a unified product,” says Jackson. “Reminders for tasks that are necessary to meet the requirements of the protocol are provided by a data station at the foot of the bed.” Events such as feeding, medication, and baths can be programmed.

In addition, the InTouch bed features a shearless pivot that ensures minimal displacement of the patient when the head section of the bed is raised. The design enables an upward and horizontal motion that keeps the patient from sliding down. Various buttons around the bed also help achieve clinical body positions.

The company also designed a one-button electric brake. Other models have a footpad that requires 60 lb of pressure to lock the bed in place. A mechanical backup ensures the brakes function in the event of a power outage.

Motorized wheels enhance the bed's movement for events such as scans or x-rays. Even when pushing a 500-lb patient, the user only exerts the energy of pushing 20 lb.

Another notable feature is the height of the bed. At its lowest position, the bed is only 16 in. from the floor, so that patients can stand or transfer to a wheelchair.

“Stryker's bed has an athletic appearance when placed in an upright position, owing to its arcing profile. As such, it creates a very different impression than the conventional metal-frame beds,” says Wiklund. “Patients may feel that they are receiving higher-quality care and caregivers may feel that they are enabled to do their best work.”

Bariatric care is made easier for both patients and caregivers by the subtle and sleek design of the TotalCare bed.
TotalCare Bariatric Plus Therapy System. Manufactured by Hill-Rom Company, Inc. (Charleston, SC), the TotalCare Bariatric Plus is an integrated bed that addresses microclimate management, pulmonary management, and immobility in care settings. “This bed is as much of a medical device as other actively therapeutic devices. It's not just a piece of furniture,” says Wiklund.

Both the frame and the mattress have been designed to serve bariatric patients weighing up to 500 lb. The system addresses patient-base concerns, including mitigating pressure ulcers, lung infections, and falls. For these reasons, Wiklund has high praise for the bed. “This modern-looking bed meets a critical need in the patient-care world—accommodating large individuals who do not fit in conventionally sized hospital beds,” he says. “Clearly, designing such a bed takes a keen knowledge of bariatric patients' physical dimensions, mobility, and special needs.”

Engineering features were designed to help both patients and caregivers. The movement of a bariatric patient puts the caregiver and the patient at risk for injury. Designers included a deflate function that decreases air pressure in the seat and foot section to allow the patient to get 6 in. closer to the ground than a normal hospital bed. A cradle transition feature minimizes sliding and provides stability when egress or ingress is needed. This makes the patient less likely to need the support of the caregiver while exiting from bed. Bariatric patients may also find it difficult to move or reposition themselves without aid. A triangular trapeze hangs above the bed, providing support that patients can grasp when moving or repositioning.

Possibly the most significant design factor of the Total­Care is its mattress. Adipose tissue and skin folds can generate excessive heat and moisture that, along with friction, pressure, shear, and immobility, promote the generation of pressure ulcers while on a mattress. The bed features microclimate management, which wicks heat and moisture underneath the patient to the head of the mattress and expels them to the atmosphere. In addition, the mattress can be calculated to adjust to individual patients to optimize interface pressure. Bladders in the mattress can be inflated and deflated to minimize surface area that comes in contact with the patient.

Conclusion

Whether the goal is to combine several treatment steps into one device, make a device more portable, or to make furniture active, the approach must be from the user's perspective. Giving users more control means designing around limitations. Users are more likely to accept some limitations if the trade-off leads to increased mobility and better patient care. Getting users to buy in to a device early could help mitigate those design trade-offs. “Design of such a product is not necessarily difficult, but doing it well requires that engineers communicate with the end-users,” says Jackson.


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