News and Events

AdvaMed 2012

Via RAVI PARIKH October 9th, 2012.

I spent last Wednesday at AdvaMed 2012, the annual global medtech conference, speaking to individual entrepreneurs and country representatives. It was a nice contrast to the large-scale roundtables and panels, as it gave me a chance to see what specific companies have in the pipeline and what services they offer. This post will focus on the company representatives I spoke to, while my next post will focus on interviews with foreign country reps.

I first spoke with Larry Gerrans, CEO of Sanovas, a Sausalito, a CA-based company launched in 2010. Sanovas is developing an innovative micro-surgical platform for diagnosing and treating lung cancer and other pulmonary diseases. According to Larry, 96 million people have or at risk for developing pulmonary disease, most notably lung cancer. However, diagnosis often occurs when the disease has already metastasized throughout the lungs and/or body. Larry and colleagues had an idea in 2001 to advance the miniaturization of lung-based diagnostics, as the lung was a traditionally difficult area to visualize non-operatively. Utilizing the world’s smallest surgical camera, Sanovas’ technology allows surgeons to access, visualize and deliver treatments to areas of the anatomy that were previously inaccessible with lower risks of bleeding that other devices due to a non-thermal recannulation methods. In addition to the camera, Sanovas is working on technologies in both diagnostics and targeted delivery therapeutics. For example, Larry showed me an internal video of a balloon-based catheter that allows for targeted resection of lung disease. Such a procedure, among other benefits, could transform what would normally be a 1-week postoperative stay for an open lung biopsy to a 23-hour stay after an outpatient procedure.

Check out a video of Larry speaking as part of a segment on lung cancer on the TV show “Profiles with Terry Bradshaw”.

I next spoke with Chris Jones, CEO of Glysure Limited. Glysure is working to develop in-hospital continuous glucose monitoring devices. Tight glucose monitoring (TGM) has been shown in several studies to be a critical determinant of mortality in ICU and critically ill patients. To achieve TGM, however, we must first have a method to measure glucose real-time in ICUs rather than by fingersticks. The GlySure solution is a single-use multi-day intravascular fiber optic sensor with integrated automatic calibration. Its particular chemistry enables low-cost, high margin sensors. Clinical trials in ICU settings, which began in 2010, have confirmed the sensors’ performance and the ability of Glysure to provide a new dimension in Intensive Insulin Therapy (IIT).

I next had a chance to speak with Patty Nichols, Director of Medical Technology at Travelers. Travelers, a Texas-based insurance company, works to protect emerging global medtech companies by providing property and liability coverage. Speaking to Patty was interesting because it brought to light many of the potential issues that emerging entrepreneurs may face as they work to develop their technologies and brought to light potential unforeseen problems. For example, Travelers gave a presentation at AdvaMed this year on “Device Hacking”, potential theft of data from emerging companies, and how these companies can protect against that.

My last two interviews of the day were with two companies that focus in part on product development. I spoke to Gillian Davies, Ph.D., Senior Consultant of Sagentia, a global technology and product development company. Sagentia focuses on both large multinational companies and small startups in providing consulting for product design and company development. Gillian and I had a great conversation on how medtech companies can no longer focus on just the “coolness” of their technologies. With increasing focus on outcomes and impact in health care systems, companies must work backward from an unmet need to a technology and not the other way around. Gillian spoke about how the “technology push” has persisted for far too long in the US, and how clinical need and usability will become the primary determinants of success, especially as venture capital funding becomes more limited. The example she specifically gave to me was of iBGStar, Sanofi’s blood glucose monitoring system, which now sells on the Apple Store in addition to directly to physicians.

The last person I spoke to at the end of a very long day was Simon Karger, Associate Director of Surgical & Interventional products at Cambridge Consultants. Cambridge Consultants is a leading medical technology design and development firm with offices in Cambridge, MA, and UK. Coincidentally, they also hosted an industry workshop in Boston recently to discuss the future of surgery, so they had some interesting insights and thoughts in that area. Cambridge Consultants has been focusing on the surgical and interventional space of surgery to develop ideas into usable tools for general surgeons. In particular, they touted the success of their leadless pacemaker, the Wireless Cardiac Stimulation system (WiCS), in collaboration with start-up company EBR Systems. Cambridge Consultants has several technologies in the pipeline including an ultrasonic technology to diagnose and mechanically reduce blood clots in the legs.

Miniaturization of Healthcare, by Larry Gerrans, Medical Design Technology, July 25, 2012

altIn 2011 the medical device market in the US was estimated to be $105.8 billion - a market based largely upon clinical and surgical interventions administered in hospitals. However, the design and manufacture of medical devices is undergoing paradigm shifts in cost and utility, motivated largely by miniaturization, which has revolutionized consumer products. The miniaturization, portability, capacity and speed of cell phones, personal computers, digital cameras and gaming consoles has been realized by the continuing efforts of the semiconductor industry to inexorably reduce chip size and increase their performance. Thanks to the fundamentals and economies of scale driven by Moore’s Law (semiconductors will become half the size, twice as fast and cost half as much every two years), there has been significant progress in adapting medical technologies to advance their clinical and home-based utility.

Miniaturization, enabled by sector integration, will significantly improve patient care in the near future. Chip-based technologies for diagnosis, imaging, and drug delivery represent the latest generation of miniaturized medical devices. Semiconductor technology driven by mobile phone and consumer electronics applications will steward efforts dedicated to portable medical applications. Advantages of these devices include: power consumption requirements being met by batteries rather than a power cord, lending support to autonomous device operation; and dedicated systems-on-chip (SoC) that integrate as much functionality as possible to optimize power consumption and performance, as well as minimizing the number of separate components that have to be individually melded and controlled. This is especially important for implantable devices that impose strict limitations on device size, shape, weight, and reliability.

The SoC issue is obviously of paramount importance to these efforts. These multi-functional chips require integration of and communication between at a minimum the following components: digital signal processor, coprocessor, RF transceiver, sensors, microcontroller, sensor-analog interface, power management and program & memory data. The electronics industry has evolved over several decades from reliance on discrete components to increasingly complex multifunctional chips. There are off-the-shelf standard products (ASSP - application specific standard product), as well as custom-made chips (ASIC – application specific integrated circuit). ASSPs are suitable when a platform of common specifications has been identified, but there are numerous arguments in favor of ASICs for medical applications. These include low power consumption; several sensors on one chip; a wide range of packaging choices; high reliability based on mature semiconductor batch processing capabilities; miniaturized solution based on a minimal number of components; built-in functionality validation; reprogrammable; flexibility, exclusivity, and protection of intellectual property.

While the evolution of consumer-driven medical devices is inevitable, the contribution of miniaturization to clinical and surgical interventions is less obvious. The convergence of supercomputing and genomics will give rise to a new era of portable immunodiagnostic systems and pharmacogenetic treatment solutions that can help fulfill the promise of personalized medicine.

As processing power increases, computing speed accelerates, and portable communications become more reliable, it will soon be possible to remotely facilitate personalized medicine therapies for individuals. Since these new pharmacogenetic drugs will be personalized, they can be delivered at elevated concentrations as they will have minimal effects on non-target cells, tissues or organs, mitigating the systemic toxicity and side effects of the intravenous and orally delivered pharmacologic compounds currently available. We are now on the verge self-administered molecular diagnostics, dosage analyzers, and drug delivery.  

The advantages of miniaturization will also enable natural orifice surgery. Despite the fact that we are only now perfecting minimally invasive surgery, the rapid advance in consumer-driven technology will lead to the re-invention of the surgical sciences within this decade. The ability to access the body through natural orifices will lead to safer, faster, lower risk and more cost- effective treatments throughout the human body.

The improvements in abdominal and vascular surgery will be remarkable; however, the greatest contribution of miniaturization for natural orifice surgery will be in anatomic regions that are less than 3mm in diameter. For example, many lung tumors proliferate in peripheral areas of the human respiratory tree that are less than 3 mm in diameter. Miniaturization will make it possible to provide therapeutic treatment to the lungs, an area of the body that has historically been neglected due to high procedural risk and the lack of miniaturized technology. The lungs have been acknowledged as the last frontier of innovation and intervention due to their inability to be ‘turned off’ to perform surgery as well as the lack of technological capability to access peripheral airways of the pulmonary anatomy. Medical devices designed to overcome the complex problems necessary for successful pulmonary interventions will have a significant impact on a plethora of medical procedures. Overcoming the complexities, dimensions, and sophistications of airway intervention will improve the capabilities of the interventional sciences throughout the human body.

Larry Gerrans is the CEO of Sanovas, Inc.

You can read the original article here:

FDA REGULATORY DISCLOSURE: Sanovas Inc. is an emerging technology company.
These products are investigational medical devices that have not been approved or cleared for use in the United States.