Maple Grove, Minnesota-based Avonix Imaging has opened a 2D X-ray imaging and 3D CT scanning lab in Dallas suburb Irving, Texas. The Avonix Imaging Texas Laboratory operates several systems to handle different part sizes and materials for medical producers and other manufuacturers. https://www.avoniximaging.com/inspection-services
Kays Engineering Inc. celebrated its 40th anniversary in December 2020. Founded Dec. 1, 1980, in Marshall, Missouri, as a small welding and repair shop, Kays Engineering is now the original equipment manufacturer of DeHoff, Eldorado, and TechniDrill gundrilling machines, serving customers in a range of industries. http://www.kays-dehoff.com
Gerald Vogt, previously responsible for the global business of Stäubli’s Robotics Division, assumed the role as Stäubli’s chief executive officer Jan. 1, 2021, replacing retired CEO Rolf Strebel. Vogt will manage introduction and implementation of the new business strategy until 2030. Christophe Coulongeat has taken responsibility for Stäubli’s Robotics Division. https://www.staubli.com
Gerald Vogt
Christophe Coulongeat
Michael Ross has joined JR Machine, a contract manufacturer of complex machined parts, as regional vice president of sales. Ross will be responsible for bringing JR Machine’s expertise in precision manufacturing to manufacturers along the West Coast and throughout the United States. https://www.jrmachine.com
Michael Ross
GWS Tool Group officials have appointed Bryan Comyns to the position of business development specialist and Walter Lopez to application specialist. Comyns will be responsible for business development and customer support for channel partners and end users in North & South California along with Northern Mexico. Lopez will be responsible for business development and application support for channel partners and end users in North and South California along with Northern Mexico. https://www.gwstoolgroup.com
Moving forward in 2021 in the medtech industry brings a true appreciation for everyone involved. Whether you are designing products, on the production line, or in the C-suite, you are making a difference every day and we applaud you. It’s not easy to succeed in this business or survive for the long term.
To be successful, make continuous strides forward or eventually you could fall back. One of the interesting observations in our 30 years in this industry is that size doesn’t matter in success and innovation.
Money does have an impact, but it doesn’t necessarily reflect whether a project or idea will be successful.
The market eventually decides the winners and the losers – not the biggest spenders or the ones who proclaim loudly about the latest trend (without substance). For those of you in the industry in the ’90s, think of those shouting dot.com.
At the time of this writing, Haven had just announced that it was closing down. For those of you not familiar, Haven was going to be an innovative new Healthcare business, created by the braintrust of Jeff Bezos (Amazon), Jamie Dimon (JP Morgan) and, Warren Buffet (Berkshire Hathaway). Although it was launched with much fanfare and significant resources, it never actually seized the moment to truly innovate and develop something special. It’s a shame as there’s so much opportunity for innovation in healthcare on multiple levels. True innovation can benefit all of us as creating greater efficiency in our healthcare system could lead to more innovative medical products.
As we ponder the fact that the mighty have once again fallen on their collective swords, we are reminded again of the dedication and persistence of those in this industry. We are successful at various levels within medtech and healthcare because we begin with respect for what this industry achieves every day – which ultimately is to benefit mankind through innovative developments that heal and save lives!
This success does not come easily. Innovation doesn’t happen overnight. However, those working every day in this business are doing something right. It doesn’t matter if you are the CEO or on another level of your organization, nor does it matter if your business is large or small, it’s clear you are a survivor in a vital industry.
And, of course, the events of the past year have further demonstrated how important our collective mission has become.
We respect and applaud you for what you do every day. And if you feel the same way, please be sure to pass along that recognition to others in our business. We can continue to win individually and together in 2021 and beyond.
About the authors: CEO Florence Joffroy-Black is a long-time MedTech M&A and marketing expert. She can be reached at florence jblack@medworldadvisors.com. Managing Director Dave Sheppard is a former medical OEM Fortune 500 executive and an experienced MedTech M&A professional. He can be reached at davesheppard @medworldadvisors.com.
Blasting light through human flesh to power implants
Departments - Medical Innovations
Active photonic wireless system pairs powerful LED lights with solar panels to eliminate invasive surgeries to replace implant batteries.
The use of medical implants generates the need for invasive surgery to replace exhausted batteries, which can lead to increased risk for patients undergoing surgery.
PHOTO: GWANGIU INSTITUTE OF SCIENCE AND TECHNOLOGY
During the past few decades, medical technology has seen advances in scope and efficiency, leading to increased use of electronic implants such as pacemakers to regulate heart rate and cerebrospinal shunts to control the flow of spinal fluid. Most of these medical devices require a constant source of energy, typically batteries, but they have finite lifespans. Replacing an exhausted battery requires invasive surgery, which risks surgical complications such as bruising, infections, and other adverse events.
A research group from South Korea, led by Professor Jongho Lee at the Gwangju Institute of Science and Technology (GIST), has developed a way to recharge the internal battery of devices without invasive surgery or risky penetrative procedures.
“One of the greatest demands in biomedical electronic implants is to provide sustainable electrical power for extended healthy life without battery replacement surgeries,” Lee explains.
Although this is a tricky concept, Lee believes the answer lies in the translucency of living tissue. When you hold your hand up to a powerful light, the edges of your hand glow as light passes through your skin. Taking inspiration from this, Lee and his team developed an active photonic power transfer method that generates electrical power in the body.
The system consists of two parts – a skin-attachable micro-LED source patch, which generates photons that penetrate through tissues, and a photovoltaic device [similar to ones used in solar panels] integrated into a medical implant, which captures photons and generates electrical energy. It provides a sustainable way of supplying the medical implant device with enough power to avoid high-risk replacement methods.
“Currently, a lack of a reliable source of power limits the functionality and performance of implant devices,” Lee says. “If we can secure enough electrical power in our body, new types of medical implants with diverse functions and high performance can be developed.”
When the scientists tested the power system in mice, they found it easy to use, regardless of weather, clothes, and indoor or outdoor conditions. The photons emitted from the source patch successfully penetrated live tissues in mice and wirelessly recharged the device.
“These results enable long-term use of currently available implants, in addition to accelerating emerging electrical implants that require higher power to provide diverse, convenient diagnostic and therapeutic functions in human bodies,” Lee says.
The 130-page catalog provides background information and features various hexapod (Stewart-Platform) motion and positioning systems with 6 degrees of freedom (DoF), high resolution, and repeatability in the <1µm and 1nm range.
The hexapods have travel ranges from 0.5" to several hundred millimeters and load ranges from 0.5kg to several tons. They can be optimized for high load, high precision, and high speed.
Each hexapod is operated by motion controllers and software. The required coordinate transformations are inside the controller and visible – all motions are programmed in X, Y, Z linear coordinates and Theta-X, Theta-Y, and Theta-Z rotations. User-defined coordinate systems and a user programmable center of rotation (pivot point) enhance use.
Achieving SIL 3/PLe compliance, safePGV and safePXV systems use a single sensor for safety and efficiency. Sensors combine a 2D reader and data matrix code, with each code containing position and safety information made visible by red and blue LED illumination.
The safePXV positioning system offers reliability for linear absolute positioning and is suitable for automated guided vehicle (AGV) navigation. In addition to the safe X position, the sensor supplies values required for reliable vehicle control. The plant operator can access angular feedback and Y positions to correct track deviations.
A large depth of focus provides optimal readability at data matrix code lengths up to 100,000m during production-tight curve radii and uphill and downhill gradients.
Velentium test systems in place and operating at a factory.
PHOTO: VELENTIUM
Throughout the last decade, advanced technologies and innovations have been pushing the boundaries for medical device capabilities. As designers use these innovations to find better, more efficient ways of delivering care, they find an increasing need to deliver consumer-centric solutions. Medical devices must be attractive, easy to use, and provide the necessary data for the patient and physician.
On top of accelerated consumerization resulting from COVID-19, designers are faced with new challenges and must focus on important considerations when developing next-generation systems. Dan Purvis, CEO of Velentium, discusses the top three trends and impacts on medical device design that will shape the market going forward.
1. REGULATIONS WILL STEER OPPORTUNITY
Regulations and standards largely influence the manufacture of technologies and medical devices, and vice versa. In 2020, we saw the U.S. Food and Drug Administration (FDA) enact quick review and approval processes as companies rushed to get necessary devices and vaccines to market.
“We need the tech world to help us,” Purvis says. “And we’re going to be pushing through because the need warrants the risk. But after that, when it’s kind of back to normal, there will be lessons learned not just at an FDA level, but by industry and FDA together. You’re going to see enhancements to the FDA certification process, and I would be surprised if there weren’t systemic gains in the approval process as a result.”
To get your device through FDA approval, it must pass design controls. Throughout the process, it’s important to have a robust and well-documented quality management system (QMS) in place to ensure guidelines are met and that everything can be tracked.
When writing requirements for design inputs, Purvis explains, ensure that all the requirements define an ethical and safe device. Next steps include running risk analysis and risk mitigation. Continue through that process iteratively until you get to the point where the severity and the likelihood of all the different critical risks in the system are mitigated. Understanding how the different standards in quality systems apply is critical as well.
2. CYBERSECURITY, RISK MANAGEMENT
Today, most medical devices and equipment are built with software and are networked together to share data. While this embedded data and exchange of information offers safer, more convenient care, it also poses possible risks as these technologies can become vulnerable to cyber threats. Therefore, risk management must be a top priority for medical device design.
“With diagnostics, for example, the last thing you want is for somebody to intercept that wireless connection between the device and the phone and put a different value in,” Purvis says. “You don’t want to have to question what you think may be your insulin level or blood sugar level. When designing, we must take steps to ensure that the data coming to that phone is correct, because you’re going to start making therapeutic diagnoses based on that information.”
Velentium offers a training program designed to prepare medical device designers for enhanced cyber threats. Mastering Embedded Cybersecurity establishes standards and educates participants about how to avoid and mitigate cybersecurity vulnerabilities that are frequently introduced during design, development, and production phases. Curriculum is supported by the recently published book, Medical Device Cybersecurity for Engineers and Manufacturers, co-authored by security strategists and technical experts at Velentium and MedCrypt.
“We wrote this book because there’s lots of material out there for cybersecurity, but it’s all network cybersecurity,” Purvis explains. “With cybersecurity analysis, you only look at vulnerabilities’ severity and exploitability, not likelihood. Embedded cybersecurity is different, so you need different ways of doing it.”
Having a secure design at the system and product levels will guarantee a secure product lifecycle throughout the design phase, implementation, embedded software, and the supply chain.
PHOTO: VELENTIUM
3. INCREASED USE OF WEARABLES
Individuals have become notably interested in tracking and recording data regarding their personal health through wearable technologies. Wearables devices track temperature, blood pressure, oxygen levels, and electrical signals from the heart, provide immediate, real-time information to users, set automated alerts, and may even impact behaviors.
“This technology and its proactive capabilities are what you’re going to see more and more of, and then increasingly, you’re also going to see patch-based therapies,” Purivs predicts. “Where, in the past, the therapy was delivered as either an implantable or something injected, patches could be used to deliver that medication.”
Purvis also expects to see a wave of new therapies roll out as data science continues to make huge strides. Now, even fewer amounts of embedded sensors are providing an increased amount of health information, which further aids physicians to make diagnoses and predictions. And as these wearable devices become more popular and users gain more ability to tease out additional information, designers need to keep form and function top of mind.
WHAT’S NEXT
There’s been a rapid level of innovation and emergency use cases recently. Purvis predicts that moving forward, we’ll continue to see improved efficiency in the marketplace and in FDA approvals. Digital health solutions will expand and mandates for interoperability will continue, creating more opportunities for modernized care. With more advancements, ingenuity will be key as companies continue to invest in advanced technologies and partner to meet global healthcare needs.
Elizabeth Engler Modic
