Medical Product and Drug Delivery Systems Development: Client Success Stories
SRI's interdisciplinary scientific and engineering teams help clients capitalize on new medical product opportunities and build value for their organizations. Read about some of our other client successes here:
You can also read about SRI's work in ultrasound research and development, telepresence surgery, and other, non-medical product successes.
 Space Shuttle Technology... Applied to the Ear
InSound Medical, Inc. of Newark, California, develops and manufactures next-generation hearing solutions. After the company's first product, LyricTM, was warmly received in test markets, InSound Medical recognized they could enhance this success through advancements in their manufacturing process. InSound first identified the significant technical issues they encountered using standard quality-control techniques; they then asked SRI International to help resolve their greatest challenge. Read about SRI's solution.
 Dry-Powder Drug Formulation and Production Process
Dura Pharmaceuticals sought to gain market leadership in pulmonary drug delivery with an inhaler device not powered by chlorofluorocarbons (CFCs). Dura realized that its staff did not have the specific required skills to develop the necessary manufacturing processes to bring the device to market. Dura strategically aligned itself with SRI because of SRI's experience with fine-particle technologies, drug formulation expertise, and mechanical engineering.
Working with Dura, SRI developed the "Dryhaler" device, which met all market needs and included several ease-of-operation features. SRI's regulatory affairs expertise enabled the project to move from concept to clinical trials in 18 months – considerably faster than the average in the medical device sector. In 2000, Elan Corporation acquired Dura. Read more about this project at http://www.sri.com/about/timeline/dry-powder.html.
 Needleless Powder Injection Drug Delivery
PowderJect (now Chinron), a leading international vaccines company, engaged SRI to design the drug-containing cassette for an ultrasonic transdermal drug delivery device. The manufacturing process applied SRI's powder handling and mechanical design experience to develop a process capable of high-speed fully automated production in a GMP pharmaceutical setting. The device propels fine-particle drug formulations to supersonic speed into the target skin tissue whereby the drug either acts locally or is absorbed via the blood capillaries to reach the systemic circulation.
The technology is designed to provide effective delivery of pharmaceutical agents and vaccines to skin and mucosal injection sites, without pain or the use of needles. SRI also developed techniques for batch filling and sealing, and a semi-automated filling system, and contributed to the overall product design.
This product won a “Product of the Millennium” award in 1999, given by the United Kingdom's Prime Minister, Tony Blair.
 Oral Geriatrics/Pediatrics Drug Delivery
Alza Corporation, a leading drug delivery solutions company, needed to evaluate a drug delivery concept, with an emphasis on failure modes and manufacturing cost reductions. Alza looked to SRI because of its experience in drug formulation and drug delivery systems design. SRI identified key design changes that addressed the areas of concern, and added features and intrinsic value to the device while reducing its production cost. SRI demonstrated the critical manufacturing processes and delivered prototypes for marketing purposes.
Fast-dissolving Tablet
A pharmaceutical company developed a fast-dissolving tablet for drug delivery. The new tablet for drug delivery formulation had been made successfully in the lab but could not be manufactured on conventional equipment. SRI assembled a multidisciplinary team of mechanical, chemical engineers and pharmaceutical formulation experts that examined, tested and analyzed several options. The final approach was a combination of traditional manufacturing processes and new materials technology. A pilot-scale system was designed, fabricated and tested in SRI's GMP facility.
 Tonometry Technology for Blood Pressure Monitors
Colin Medical Instruments came to SRI in search of a new method for monitoring blood pressure that would address problems with existing blood pressure measurement systems. At the time, there existed no device suitable for long-term use that was non-invasive. SRI developed a non-invasive, microfabricated device that used arterial tonometry to perform the blood pressure measurements. This device records the entire blood pressure waveform, which is quite useful in diagnosing various ailments, and was licensed to Colin.
 Automated Syringe-filling System
A large life-sciences and medical device supplier felt its market leadership for insulin drug delivery threatened by an emerging European insulin drug delivery device. The company tapped SRI's drug delivery system expertise to develop a compact, home device for diabetics that would help them fill their insulin syringes accurately. The system needed to handle both long- and fast-acting insulin formulations and needed to be easy to use and reliable for elderly and vision-impaired patients. SRI used its industrial design expertise, along with its engineering and product development expertise, to develop an automated system that stored both types of insulin, automatically resuspended the long-acting insulin, checked for adequate drug supply, dispensed the proper amount, and kept a dosage record.
 Disposable Drug Infusion Pump
A medical devices and pharmaceutical company turned to SRI when it needed to design a prototype disposable drug infusion pump that it had under development. The prototype used the client's proprietary power technology but was difficult to operate and too complex to manufacture. The client looked to SRI for its expertise in design for manufacturing, medical technologies, and design of medical devices, to handle the reengineering. SRI worked closely with the client's clinical and engineering team to develop a design that reduced the number of parts by 30% (from 27 to 17).
 Telepresence Surgery System
SRI developed a revolutionary method of performing surgery with computer-mediated surgical tools that improve accuracy and flexibility, especially in minimally invasive procedures, and provide a technology platform for remotely performing surgical procedures. In 1995, SRI spun off a new company to bring this new technology to market. Intuitive Surgical is now the market leader in operative surgical robotics. Visit www.intuitivesurgical.com for more information.
Ultrasonic Camera
Under a grant from the National Institute of General Medical Sciences, the SRI ultrasonic camera was developed to the point at which clinical application could be demonstrated in several areas of medical diagnosis. The latest version of this transmission imaging system was installed in West Germany. The camera combines the advantages of two X-ray techniques – laminography and fluoroscopy – and allows risk-free visualization of tendons, ligaments, muscle, cartilage, blood vessels, and organ tissues, as well as bone silhouette. It has also been used successfully to demonstrate breast disease. Read more about SRI's Ultrasonics program.
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