Customer-centric Stellartech Research Corporation is making waves in the medical equipment manufacturing industry, eyeing development of the next generation of clinical solutions

“The devices we develop and manufacture for our partners are complex, smart systems that are designed to analyze physiologic inputs to precisely monitor and control the diagnostic or therapeutic process.”

Stellartech Research Corporation is known for providing cutting-edge medical technology solutions that transform the practice of medicine. The company has been key to numerous medical device success stories, often inventing breakthrough technologies for its customers. As an example, some years ago two physicians approached Stellartech to help them invent a way to endoscopically eliminate pre-cancerous esophageal tissue to reduce a patient’s chances of developing cancer. Stellartech designed the BarrxTM System to precisely ablate the superficial lining of the esophagus while simultaneously preserving underlying normal tissue. Working with the two physicians, Stellartech invented the technology and performed not only design, development, and manufacturing, but also conducted all preclinical and clinical testing and made the required regulatory submissions to the FDA.

To date, this product is the standard of care. The BarrxTM Radiofrequency Ablation System is now owned by Medtronic; it continues to have a 95% market share because no product has been able to compete with it. Most importantly, clinical studies show it to be associated with a high rate of complete eradication of pre-cancerous tissue and reduced risk of progression to esophageal cancer.

Unquestionably, Stellartech Research Corporation is a global leader in the design, development and contract manufacturing of complex medical systems utilizing radiofrequency, ultrasound and other energy sources. Over the years, Stellartech has built deep expertise in the therapeutic energy delivery segment, pioneering many energy-based therapies, among them the first temperature-controlled cardiac ablation system and the first balloon-based esophageal ablation system. The company’s therapeutic energy expertise has expanded and now encompasses many different modalities including radiofrequency (RF), cooled (RF), microwave, high-intensity focused ultrasound (HIFU), steam vapor, and cryogen.

Stellartech maintains a QSR/ISO 13485:2016 quality system for the design and manufacturing of Class II and Class III medical devices. It has a highly trained staff of quality engineers who perform extensive product design and verification testing and assure that every device is manufactured in strict accordance with approved device master records.

Customers have access to Stellartech’s comprehensive in-house capabilities, which include all the necessary resources to develop a product from “concept to market”. Product development services include theoretical analysis, modelling and bench testing, as well as electronic, mechanical and software engineering and graphics and industrial design. Capabilities also include regulatory assistance. Stellartech acts as a “one-stop-shop” for both design and commercial manufacturing, offering customers a streamlined process and eliminating the need to manage multiple vendors. Customers have the advantage of a smooth transfer to commercial manufacturing at Stellartech, with ongoing sustaining engineering and product servicing.

Organized innovation culture

The Silicon Review reached out to Roger A. Stern, Ph.D., founder, President and CEO of Stellartech Research Corporation, and here’s what he had to say:

“We collaborate with companies that are at the forefront of medicine and are developing novel approaches to disease detection and treatment. We make a significant contribution to our partners’ success by helping them optimize the clinical effectiveness of their devices. To do this successfully, we must study and understand the scientific and clinical principles underlying the clinical application, which allows us to develop an innovative device approach.”

“Our process first requires the rigorous specification of clinical requirements. The all-important second step is to approach these clinical needs with no preconceived ideas; instead, through a multi-physics integration of science, with modeling, testing and applied expertise, we identify the approach with the highest potential for success. This invariably yields the most innovative, highest performance and cost-effective solution.”

“The devices we develop and manufacture for our partners are complex, smart systems that are designed to analyze physiologic inputs to precisely monitor and control the diagnostic or therapeutic process. These devices integrate sophisticated catheter and probe technology with advanced capital equipment design. We offer both complex and simple capital equipment platforms that allow for complete customization, together with speed to market. Our aim is to go above and beyond in speeding up the discovery and development of innovative medical device technology for medical device startups, venture capital investors and OEMs.”

“Most importantly, quality is at the heart of everything we do. We aim to meet or exceed our customers’ quality requirements in all areas to assure that our products perform at the highest level.”

Team of experts

 The experts at Stellartech act as partners to its customers, taking a proprietary interest in leveraging Stellartech’s passion, assets, and engineering expertise to help them solve product development challenges and achieve commercial success. In addition, they have unparalleled expertise in therapeutic energy delivery.

“When it comes to delivering therapeutic energy, it is critical to understand the physics behind the interaction of energy with tissue. We have built a team that excels at this and as a result, we can meet some of the most difficult technical challenges involved in therapeutic energy delivery.”

Therapeutic energy uses are expanding into new areas of medicine such as the treatment of complex cardiac arrhythmias, hypertension, type-2 diabetes, and other areas. Stellartech continues to be at the forefront of innovation in many of these new clinical applications.

“We seek to innovate into new clinical applications of therapeutic energy to develop the next generation of clinical solutions for our customers and patients.”

Roger A. Stern, Ph.D. | Founder, President, CEO

Roger is recognized as an expert in the application of radiofrequency, ultrasound, and other directed energy sources for therapeutic applications, including ablation and electrosurgery. Over the past 25 years, he has developed key technology for more than 40 medical device start-up companies, in areas including gastroenterology, interventional cardiology and electrophysiology, cardiovascular surgery, gynecology, urology, dermatology, arthroscopy, and general surgery. Utilizing Stellartech’s Virtual Company model, he has co-founded and incubated several device companies, many of which have gone public or been acquired.

Roger is named as the inventor of more than 70 U.S. patents, with over 60 patents pending. Roger received a BSEE from Syracuse University and a Masters and Ph.D. degrees in Electrical Engineering from Stanford University, where he specialized in medical imaging systems. He currently serves on the Board of Directors of five medical device companies. Roger has been recognized as one of the Medical Device and Diagnostic Industry’s 100 Notable People.

“When it comes to delivering therapeutic energy, it‘s key to understand the physics behind the interaction of energy with tissue. We have built a team that excels at this and as a result, we can meet some of the most difficult technical challenges involved in therapeutic energy delivery.”

Stellartech Research Corporation, Milpitas, CA