Three More Success Stories

Originally Published MDDI September/October 2003

MEDICAL MANUFACTURER OF THE YEAR

Erik Swain

When MD&DI began searching for a company to be recognized as its Medical Manufacturer of the Year, it invited readers to make nominations. A number of suggestions came in, and the accomplishments of the following three companies, in addition to Johnson & Johnson, stood out in the estimation of MD&DI's editors. Other nominated firms are highlighted in the "From the Editors" column.

Alaris Medical Systems

Alaris Medical Systems Inc. (San Diego) has made a name for itself as a developer of devices that administer drugs more safely. Recognizing that as many as 60% of the most serious medication errors are intravenous-drug related, Alaris developed a needle-free IV system called SmartSite.

Activated by a standard luer and featuring a simple design with few components, the system reduces accidental transmission of bloodborne pathogens. Notably, the company sought input from clinicians during the design process to ensure ease-of-use and patient comfort. Products from the SmartSite line won Medical Design Excellence Awards in 1996 and 2003, have received safety awards from the U.S. Department of Labor, and have garnered the New Product Award from the National Society of Professional Engineers.

Alaris has extended its drive to reduce medication errors into computer technology, developing hardware and software that integrate infusion procedures, patient monitoring, and best practice guidelines. It further showed its commitment to medication safety in 2002 by establishing the Alaris Center for Medication Safety and Clinical Improvement. It aims to educate health care professionals about the risks presented by drug delivery errors, to share clinical best practices to enhance safety, and to maintain a medication error data repository.

The company's manufacturing processes are also noteworthy. Its manufacturing team leak tests and flow tests all products before they are shipped out. The firm uses six-sigma objectives in the supply-chain process and has achieved better than the six-sigma level in defects per million.

Intuitive Surgical/Computer Motion

Intuitive Surgical Inc. (Sunnyvale, CA) has made a significant contribution to the medical device industry with its innovations in surgical robotics. Its da Vinci Surgical System was the first operative surgical robotic system to receive FDA approval.

The company's technologies enable surgeons to perform complicated surgeries through 1-cm ports with improved dexterity and greater precision. This enables minimally invasive surgery (MIS) in areas where it hadn't been possible, and may help reduce trauma, postoperative pain, and surgical complications. The technology makes it possible for routine procedures to be easier, for complex procedures to be routine, and for new procedures to be possible.

Systems have been cleared for use in general laparoscopic surgery, thoracoscopic (chest) surgery, laparoscopic radical prostatectomies, and thoracoscopically assisted cardiotomy procedures. Clinical trials are ongoing for other applications in cardiac surgery.

The company also contributes to the good of the industry though a program it offers hospitals. The goal is to provide a foundation for short-term and long-term success with robotically assisted MIS. In addition to the technology, Intuitive provides comprehensive surgical training, protocols for clinical success, and information about economic benefits. The latter include increased patient volume and market share, and attraction and retention of top surgical talent. The firm has also entered into partnerships with a number of leading device companies.

A recent merger with a former competitor, Computer Motion, will enable the company to market a wider range of MIS products, including a system that enables a surgeon to control by voice a network of "smart" medical devices.

SonoSite

SonoSite Inc. (Bothell, WA) is a pioneer in the point-of-care ultrasound market. In 1995, the U.S. Defense Advanced Research Project Administration awarded a two-year matching grant to Philips Medical Systems' ATL Ultrasound. It asked ATL to develop a highly portable ultrasound device for use on battlefields or during manmade and natural disasters. As a result, ATL created a handheld equipment division and spun it off as SonoSite in 1998.

Before the new company's first handheld unit came on the market in 1999, ultrasound equipment required its own room—which required an appointment or moving the patient to the room—or a bulky cart-based system.

Now, the equipment, which weighs as little as 6 lb, can be carried easily by a healthcare professional and brought quickly to a patient. That, plus its ability to create images in real time, makes it especially useful for emergency room applications.

This has removed barriers to use of ultrasound equipment and created new markets for it. Miniaturization has not come at the expense of image quality, which is comparable to a mid-range larger machine. The ability to achieve good image quality is no surprise considering the firm's history.

Its products have won Medical Design Excellence Awards in 2000 and 2003, and been cited in Popular Science's "Best of What's New" feature in 2002. Some parts of the product line are modular and can be customized with features as needed. Fields of application include cardiology, emergency medicine, obstetrics/gynecology, radiology, surgery, and vascular.

The company's excellence also manifests itself in its SonoSite Institute for Training and Education. The program provides educational materials and services to further the appropriate and efficient use of diagnostic ultrasound to improve patient care. These include skills workshops provided at clients' facilities and classroom courses.

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