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; wide range of packaging choices; high reliability based on mature semiconductor batch processing capabilities; miniaturized solution based on 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 immuno-diagnostic systems and pharmaco-genetic treatment solutions that can help fulfill the promise of personalized medicine.

As processing power increases, computing speed accerates, and portable communications become more reliable, it will soon be possible to remotely facilitate personalized medicine therapies for individuals. Since these new pharmaco-genetic 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.

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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.