Electroporation

The Medical Device & Manufacturing West (MD&M West) tradeshow was held February 6-8 in Anaheim, CA with over 1,600 exhibitors and more than 14,000 attendees from the medical industry. Top medical device and equipment makers, power supply providers, thought leaders and engineers attend. Once again, Advanced Energy (AE) played a significant role as a featured exhibitor.

Four key trends at MD&M West 2024

The AE team engaged with industry leaders on the latest trends driving the medical industry– trends that inform and define medical product innovations powering customer needs. These trends include:

• Significant growth for electrosurgery

The electrosurgery market has grown steadily, driven by technology upgrades, increasing demand for minimally invasive procedures, and improved patient outcomes.

• Growing investments in cardiac ablation

The global cardiac ablation market is projected to grow at a Compound Annual Growth Rate (CAGR) of over 13% from 2023 to 2035. The major driver is the increase in an aging population. According to the WHO, one in six individuals on the planet is expected to be 60 years of age or older by 2030.

• Miniaturization

Technological advancements are shrinking medical devices making them less invasive, more efficient and increasingly personalized. 

• Growth in Aesthetic Lasers

The non-ablative lasers segment is projected to expand at a CAGR of 7.8% through 2033. Non-ablative lasers are less invasive than ablative lasers because they target the dermis beneath the skin without removing the top layer. Innovative treatments and new technologies are revolutionizing the world of cosmetic and dermatological care. Today’s med spas and skin clinics offer an array of combination treatments that deliver remarkable results without the need for invasive surgery.

Advanced Energy technologies address key trends

AE highlighted new technologies at MD&M that enable medical designers to deliver more advanced technologies with more features and improved performance to address medical market needs. Among these were the FlexiCharge AC-DC Power Supply that extends a modular concept to encompass HV capacitor charging and the AEQ series of micro-size HV power converters.


 
FlexiCharge - The world’s first capacitor charger and power supply system

FlexiCharge has a 1 kV capacitor charging output and incorporates five CoolX module slots (800 W total), powered from a single AC input. System designers can meet all their power needs from a single unit, minimizing leakage currents and simplifying system-level EMC design.


AEQ Series - Micro-size HV power converters

Products in the AEQ series represent the smallest isolated DC-DC HV power converters, providing a bias voltage up to 5 kV at 1.25 W. The units feature isolation of 1,500 VDC and a control pin for output voltage adjustment. A wide variety of applications benefit from this technology including mass spectrometry, gas chromatography, photomultiplier tubes (PMT), CT imaging, PET/SPECT and ultrasound as well as flat panel displays and portable detectors.

To meet the demands of the growth in cardiac ablation, AE displayed the NCF series of AC-DC CF rated front end power supplies that are designed to address critical medical applications that are moving CF ratings/isolation to the AC-DC front end. This market is increasingly served by custom designs versus limited and costly off-the-shelf products. Advanced Energy’s SL Power product line is expanding with the introduction of a standard line of AC-DC CF-rated open frame products from 150 W to 800 W across five families – ideal for use in pulsed electric field applications


 
Typical pulsed electric field system architecture


To meet the demands of growth in electrosurgery, AE introduced the next generation of precision power for the medical industry, AE’s RF and Pulsed Electric Field Generators, also shown at MD&M 2024. The AE Bipolar Sine and Square Wave RF Generator provides a wide power (up to 400 W) and frequency (up to 1 Mhz) range and square/sine wave options. The AE Pulse Electric Field Generator provides a wide voltage range, fast switching and highly configurable pulse trains up to 3000 V.  

Modularity and configurability enable use in and a rapid time to market for a wide range of medical applications. Safety-focused design focuses the wellbeing of the operator and patient as the highest priority.

The next generation power platforms are an extension of AE’s capabilities in precision power, and the fully user-configurable power platform provides faster time to market at lowest total cost of ownership.   

   
Pulsed Electric Field Generator

As well as advanced power solutions, visitors to the Advanced Energy booth saw monitoring and measurement technologies that are optimized for new and emerging medical applications. Among the latest products, for example, were fiber optic temperature and pressure sensors that combine simplicity with safety by eliminating galvanic / electrical patient contact while remaining minimally invasive. Additionally, the sensors are immune to EMI / RF interference, short circuits, electrical voltage levels and environmental effects such as corrosion, ensuring flexible implementation and long-term operation. This, plus their small size, allows the sensors to be fitted into catheters, forceps and other tiny devices.

Leadership in Medical

Advanced Energy offers the broadest portfolio of medically certified precision power supplies and, with over 40 years of leadership in power conversion, measurement and control solutions, continues to enable its customers’ medical innovations with standard, custom and configurable products. Designed to meet current and future international safety certifications, AE’s high-efficiency, high-performance power supplies deliver unrivalled reliability for medical applications.

MD&M West allowed medical professionals to see these technologies close-up and to discuss their evolving requirements – requirements that we will feed into future designs to ensure AE continues to develop the cutting-edge technologies demanded in this mission critical industry. 
 

Advanced Energy exhibited at the recent Pittcon Conference and EXPO that took place on Mar 20-22 at the Pennsylvania Convention Center, PA. With approximately 450 exhibitors and 15,000 attendees, Pittcon is the premier event to discover the latest solutions for life science and analytical equipment. In addition, the over 1,000 technical sessions highlighted the latest trends in the industry.

Pittcon 2023 was a return to an in-person event after two years. As some in the industry may remember, Pittcon 2020 was cut short due to concerns over the COVID-19 virus that was rapidly spreading through the U.S. In its first year back as an in-person event after the pandemic, we observe that COVID-19 continues to be a driving force behind some of the latest trends in the life science industry.

Here are some of the key trends we observed at the show:

Faster Testing and Analysis

The COVID-19 pandemic highlighted the need to conduct testing faster while maintaining the integrity of the results. Greater access to testing and rapid results improve patient outcomes and significantly help limit infection. This is driving companies to develop systems with higher throughput capability, increased laboratory automation and faster analysis methodologies.

Faster Time-to-Market

A study from the U.S. National Institutes of Health (NIH) Nature Public Health Emergency Collection finds that the risk of future pandemics has increased significantly in recent years due to human impact on the environment – from climate change and habitat degradation to destruction of biodiversity and animal trade.

RNA viruses are one of the most prevalent types of viral agents. With high mutation rates, they evolve and adapt to their environments rapidly, underlying the need for humans to react quickly to address their spread. The emergence of mRNA vaccine technology has aided the fight against these diseases. Life science companies face the challenge of bringing both the mRNA vaccines and the testing equipment to market quickly.

Now, it’s more important than ever to engage with strategic partners and collaborate early in the design and development process to bring products to market more quickly. Advanced Energy’s Customer Experience Centers (CEC) work with customers around the world to solve design challenges throughout their product lifecycle. Our Sharon, MA center services our life science customers with an experienced engineering team as well as sophisticated EMI, thermal and electronic test equipment.

Digital Transformations

Similar to many other industries, the pandemic has driven life science companies to dramatically alter how their businesses run, as well as how R&D can continue at pace. Digital transformations permeate many aspects of the industry.

There is an increased use of cloud technologies to enable employees to work remotely while fostering collaboration. Additionally, we see increasing adoption of Artificial Intelligence (AI) and Machine Learning (ML) algorithms to collect data, generate insights and accelerate analysis in a wide variety of applications ranging from drug discovery to personalized medicine.

In drug discovery, AI and ML can be used to analyze large datasets and predict which drug candidates are most likely to be effective, reducing the time and cost of bringing new drugs to market. AI and ML can also be used to identify potential side effects and drug interactions, improving the safety and efficacy of new drugs.

In personalized medicine, AI and ML can be used to analyze patient data and identify individualized treatment options based on a patient's unique genetic makeup and medical history. Next-generation cell therapies, including gene editing, enable personalized treatment, which can yield improved patient outcomes compared to mass-produced medicine.

Personalized Medicine: Cell Therapy Enters the Mainstream

Expanding upon the increased use of personalized medicine, the success of cell therapy in treating various diseases and conditions has contributed to its growing popularity. Cell therapy involves the injection of foreign material into a patient's cell to change the cell’s properties, tailoring treatment to alleviate symptoms and cure diseases.

These therapies, also known as transfection/electroporation, require precise high voltage power delivery and control. Electroporation works by suspending the target cells and the foreign materials being introduced into the cells in an electrically conductive solution. Very short and highly controlled electrical pulses are applied via electrodes to induce a reversible breakdown of the cell membrane and the opening of pores that allow the foreign molecules to enter. Ultra-miniature, programmable high voltage precision DC-DC converters such as Advanced Energy’s UltraVolt^© AEQ series and the high power UltraVolt C series deliver the stability and repeatability required to ensure reliable equipment operation over many years.
 

Miniaturization of Point-of-Care Treatment

Learnings from the COVID-19 pandemic have also accelerated the trend towards portable equipment in the life sciences industry. The need for flexibility, rapid testing and field research has increased the demand for portable technologies.

Companies are focusing on smaller, more portable devices that can be used at smaller clinics with greater proximity to the patient, in ambulatory environments, and even at home. This will have a significant impact on equipment design from a size perspective – the challenge is to reduce size while making sure testing outcomes are not compromised.

This trend is driving the use of power supplies with higher power densities, such as Advanced Energy’s CoolX series and UltraVolt high voltage solutions. Equipment makers are also designing systems that can support multiple functionalities, enabling a wider variety of tests using the same equipment.

Conclusion

The COVID-19 pandemic has driven significant changes in the life science industry, with many trends focused on digitalization, speed, efficiency and portability. In this dynamic environment, collaborating early in the design process and engaging strategic partners is crucial to bringing products to market quickly.

The process of transfection is widely used in life sciences and clinical and molecular biology. Applications span gene editing and drug delivery to diagnostics and industrial bioprocessing. In a transfection process, foreign nucleic acids or proteins are artificially introduced into a cell in order to change the cell’s properties.

While there are a number of different ways to transfect cells, one has grown in popularity in recent years. Electroporation is a highly effective physical transfection method that uses electrical pulses to induce cell membrane permeability and simplify the introduction of the foreign substance.

Electroporation works by suspending the target cells and the foreign materials being introduced into the cells in an electrically conductive solution to which very short and highly controlled electrical pulses are applied via electrodes. The pulses effectively induce a reversible breakdown of the cell membrane and the opening of pores that allow the foreign molecules to enter.

Electroporation has a number of advantages over other transfection methods, not least the fact that it is suitable for a wide variety of cell types. Electroporation can also support the rapid transfection of very high volumes of cell samples thanks to the latest flow electroporation techniques that use a stream of liquid rather than more conventional ‘static’ approaches based on transfecting a single vial of cells at a time.

As might be expected for any application that requires precise and accurate control of high-voltage pulses, electroporation equipment has demanding power requirements. Some of these requirements include:

• Flexibility: It must be possible to create a wide range of electrical pulses with varying shapes, pulse widths and intervals
• High Voltage: Supplied voltages need to be high and, typically, must be delivered in both polarities
• Rapid Ramp-Up Time Constant
• Stability, Repeatability and Reliability: Because pulse quality is fundamental to effective and reliable transfection of sample cells, then the power solution must ensure high stability and repeatable operation over many years of operation.

These were the challenges that one life science equipment manufacturer faced when it approached Advanced Energy to provide a power solution for its latest family of flow electroporation equipment. The requirement for this particular design was to deliver dual-polarity high-voltage power to a module that would create the various electrical pulses applied to the liquid. Voltage ratings were specified as +/- 500V.

After a careful review of the customer’s requirements, Advanced Energy recommended the 1/2C24-NP125-1 power supply from its UltraVolt^® C Series family of dual-polarity, high-voltage, high-power converters. Integrating two high-power DC-to-DC converters of opposite polarity into a single package, this single part eliminated the need for the customer to purchase two separate supplies, saving space, design complexity and cost. At the same time, robust operation and a variety of integrated protection features ensured immunity to flashovers arcs and short circuits – something that was important for the customer’s fast-charging, arc-prone application.

In addition to the power supply’s features and capabilities, the customer chose Advanced Energy for its ability to quickly provide prototypes in small volumes. This enables fast product development with reduced financial outlay and risk. The delivery of manufacturing volumes with short lead times was another critical factor. Advanced Energy’s extensive experience in life science and medical applications allowed the company to provide engineering support that included flexible adjustments to meet the needs of the specific application.

From MRI and CT scanners to diagnostics, electrosurgery and medical lasers, power schemes for many medical applications are characterized by lower to medium production volumes, specialized requirements and compliance with rigorous environmental and safety standards. As compromise is rarely an option in healthcare, designing these schemes often requires customized power supplies or extensive modification of off-the-shelf products. Both these approaches demand additional resources, cost and time - not least when it comes to test and certification.

However, for medium- to higher-power applications there is a ‘third way’ that brings together the benefits of custom design and standard product - the high-efficiency, configurable modular power supply.

Modular Power Supplies

A modular power supply allows engineers to combine a power factor correction (PFC) input stage (for converting AC mains to a DC voltage of around 400 V) with a variety of modular output options to match load voltages. The power supply housing will typically contain the front-end input stage, which is selected or configured based on the power rating and features required by the target application. This stage will also include the primary safety isolation.

The secondary power modules are connected to the front end via a backplane. These modules can be carefully selected to meet specific application requirements as they offer a variety of output voltages. Some of these outputs may also be adjustable, allowing designers and system architects to address more unusual requirements such as the voltages needed by certain medical sensor technologies, motors and other elements. Overvoltage, overcurrent, short-circuit and other protection is built into the modules and many offer integrated intelligence and remote sensing.

Modular power supplies minimize the time needed for development - designers choose the chassis that meets their power output needs and quickly pair it with the appropriate output modules. If requirements change during the development cycle, then modifying the architecture can be as simple as replacing one or more modules. In addition, the ability to use the same platform across multiple projects can speed time-to-market by minimizing learning curves for design teams - not to mention delivering economies of scale in purchasing.

In an industry heavily regulated by requirements for product testing to ensure the safety of patients and medical professionals, one of the biggest benefits of modular power supplies designed for medical applications is that they come pre-approved to all relevant safety and EMI standards, including IEC60601, the primary standard for medical power solutions. This standard defines minimum requirements for isolation voltage, creepage distance and insulation level to ensure patient / operator protection. Levels of protection are classified as ‘Means of Patient Protection (MOPP)’ and ‘Means of Operator Protection (MOOP)’, with MOPPs being slightly more stringent.

Power supplies are a safety critical component in medical equipment. By choosing a modular power supply that is already fully certified with IEC60601, the end system compliance is greatly simplified, removing a significant risk from the design process as well as saving significant time and cost associated with testing and certification.

Excelsys CoolX^TM Modular Power Supplies

Advanced Energy’s own family of Excelsys CoolX modular power supplies includes two fanless models: the CoolX600 and the CoolX1000 series, the world’s only fanless 1000 W modular power supply. Made possible by high operating efficiencies of up to 93%, the fanless operation of these power supplies is beneficial for a number of reasons. Reliability is improved by both removing the need for a moving part and eliminating the problem of drawing in dust and dirt that could eventually impede airflow or lead to component damage. What’s more, undesirable audio noise and vibration is eliminated.

CoolX front ends are combined with CoolMod modules to deliver fully compliant power supplies that precisely match application-specific requirements. Twelve different single- or dual-output CoolMod modules can be chosen, each of which occupies just one slot. By accepting up to six CoolMod modules, for example, the CoolX1000 supports up to 12 isolated DC outputs ranging from 2.5 to 200 V. In its medical version, this power supply carries full IEC60601-1 (3^rd edition) and IEC60601-1-2 (4^th edition, EMC) approvals.

For higher power applications, Advanced Energy offers the CoolX1800 and the CoolX3000 series, which is the market’s smallest 3000 W configurable modular power supply for medical applications. These fan-based systems feature variable speed fan control to provide optimized thermal management.

All CoolX power supplies feature on-board intelligence that allows system designers to monitor and control power supply performance via a PMBus™ interface and an easy-to-use GUI. This helps to quickly identify design margins that may require attention during design and development and provides a window into the health of the system when deployed in the field.