MEDTRONIC SEES ‘MASSIVE’ OPPORTUNITY IN THERAPEUTIC CATHETERS, LOW-PROFILE IMPLANTS AND ROBOTICS TECHNOLOGY.
• Can be opened quickly, easily and closed safely
• Good operability of components
• No restrictions for the assembly of internal ttings
MEDTRONIC SEES ‘MASSIVE’ OPPORTUNITY IN THERAPEUTIC CATHETERS, LOW-PROFILE IMPLANTS AND ROBOTICS TECHNOLOGY.
Discover the industry leader in nitinol solutions for medtech applications —Resonetics. With over 30 years of expertise, we specialize in producing high-quality nitinol semifinished materials, including tube, wire, and sheet, made with our in-house melt. We develop complex nitinol products for high-volume production and diverse applications, with precision and reliability in every product. Explore our advanced nitinol capabilities.
Discover the industry leader in nitinol solutions for medtech applications —Resonetics. With over 30 years of expertise, we specialize in producing high-quality nitinol semifinished materials, including tube, wire, and sheet, made with our in-house melt. We develop complex nitinol products for high-volume production and diverse applications, with precision and reliability in every product.
Discover the industry leader in nitinol solutions for medtech applications —Resonetics. With over 30 years of expertise, we specialize in producing high-quality nitinol semifinished materials, including tube, wire, and sheet, made with our in-house melt. We develop complex nitinol products for high-volume production and diverse applications, with precision and reliability in every product.
Explore our advanced nitinol capabilities.
Explore our advanced nitinol capabilities.
EDITORIAL
DIGITAL MARKETING
Editor in Chief Chris Newmarker cnewmarker@wtwhmedia.com
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The medical device industry just wrapped up another year with more blockbuster mergers grabbing headlines around the world and new, innovative technologies emerging seemingly every day.
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Audience Growth Manager Angela Tanner atanner@wtwhmedia.com
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This level of success wouldn’t be possible without the innovation, ingenuity and determination of the people who drive it: leaders. These individuals and companies are working for the growth of the entire medical device industry.
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The future of medtech will build on the foundation of today’s efforts and Medical Design & Outsourcing would like to acknowledge such achievements.
We think they deserve recognition from you, too. Vote online for one or more of the companies listed through October. leadership.medicaldesign andoutsourcing.com
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When Medtronic Chair and CEO Geoff Martha recently offered an overview of the innovations promising fast growth at the world’s largest medical device manufacturer, a theme quickly became apparent.
That theme was minimally invasive devices and procedures, from the Symplicity Spyral renal denervation catheter pictured on the cover of this issue to Medtronic’s pulsed field ablation devices, catheter-delivered implants and the much anticipated Hugo surgical robotics system.
Minimally invasive medtech generally includes devices for less traumatic procedures, which can reduce patient recovery times and complication rates. But there’s more to it than that, as we explore in interviews with device engineers, executives and experts in this issue of Medical Design & Outsourcing. Some of those philosophical discussions happened during the MDO Min-Vasive Medtech webinar series of live interviews with device engineers that we launched in 2024. That webinar series will return in August 2025 with speakers to be announced soon, but registration is free and open now at www.wtwh.me/ MDOminvasive.
Medtech suppliers, contract developers and manufacturing partners are playing a critical supporting role in bringing minimally
invasive medtech to market. This issue features contributions covering design and manufacturing advances for increasingly miniaturized medical devices and components — including high-precision micro 3D printing and heterogenous integration — as well as development advice on continuous integration/continuous deployment for AI-powered medical devices.
And as device developers continue to find new and innovative ways to use nitinol in a variety of minimally invasive applications, this issue of Medical Design & Outsourcing also includes nitinol know-how on processing the metal alloy into wire, tubes and sheets for medical devices.
We also cover nitinol at Johnson & Johnson MedTech, which uses nitinol for contact-force sensing in its cardiac ablation catheters, and offer you a first look at startup Flow Medical’s nitinol-enabled system for pulmonary embolism.
Don’t forget to bookmark www. medicaldesignandoutsourcing.com for constant coverage of the design, development and manufacturing of minimally invasive technologies, and go to www.wtwh.me/mdoemail to sign up for our free news emails, including our Nitinol Pulse and Surgical Robotics newsletters.
As always, I hope you enjoy this edition of Medical Design & Outsourcing — and thanks for reading.
HERE’S WHAT WE SEE:
Maximizing opportunities in minimally invasive medtech
ADDITIVE MANUFACTURING:
Three predictions for highprecision 3D printing and healthcare innovation
COMPONENTS:
Heterogenous integration packs big innovation into small medical devices
MANUFACTURING:
Medical nitinol processing: How NiTi is turned into wire, tubes and sheets for medical devices
NITINOL:
How Johnson & Johnson MedTech’s ThermoCool SmartTouch cardiac ablation catheters use nitinol for contact-force sensing
PRODUCT DEVELOPMENT:
Medtronic CEO Geoff Martha sees ‘massive’ opportunity in therapeutic catheters, low-profile implants and robotics technology.
Three strategies for unlocking the power of continuous integration/continuous deployment (CI/CD) for AIpowered medical devices
TUBING: First Look: Flow
next-generation thrombolysis catheter for pulmonary embolism
Device engineers, executives and experts share their
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High-precision micro 3D printing and new materials will accelerate medical innovation that redefines patient care.
Additive manufacturing has continued to drive innovation across industries in recent years, with unique applications in medtech and life sciences. Throughout my 30-plus years in the 3D printing industry, I’ve watched the technology offer opportunities for industry innovation, solving pain points that have a direct impact on patients and life sciences research.
As the pace of innovation accelerates across the healthcare and biopharmaceutical sectors, researchers are looking for ways to adapt and advance discovery — and 3D printing can offer a unique solution. Whether by developing new therapies for cancer, Alzheimer’s and other hardto-treat diseases, building medical technologies such as smart wearables, or personalizing medical devices that offer patients new treatment availability like micro stents that treat glaucoma, 3D printing helps bring new precision and accelerated development cycles to these applications.
The recent trend of miniaturization across industries makes 3D printing even more attractive. In some cases, it’s the only option to manufacture micro-sized parts with ultra-high precision. In 2025, I expect that micro 3D printing and the introduction of new materials for additive manufacturing — including those with increased biocompatibility and temperature resistance — will accelerate medical innovation that redefines patient care.
1. Materials and production runs enable specialized applications
There’s growing demand for advanced materials with sensitivity to temperature and biocompatibility to support disease modeling, precision medicine and other specialized applications. Medical technologies must use sterile and biocompatible materials to ensure patient safety, which is one reason why 3D printing becomes an attractive option for product designers and engineers. The technology allows them to work with a variety of materials from prototyping to production and offers the ability to produce small quantities or single-use materials for product testing.
Customization and single-use technologies are also common in healthcare, and 3D printing allows for more flexibility with lower sample runs than traditional manufacturing, making it a more cost-efficient option. Going forward, we’ll likely see 3D printing companies working closely with material scientists and researchers in niche applications to develop materials tailored to specific performance needs.
2. Innovation in niche medical areas led by 3D printing
In 2024, several new entrants to the medical device market had specialized focus areas that aimed to solve niche problems in subsectors of the medtech industry. For example, Pristine Surgical recently used 3D printing in the design process for arthroscope tips that will help to simplify endoscopic procedures with high-resolution 4K imaging.
By John Kawola Boston Micro Fabrication (BMF)
High-precision micro 3D printing solutions are also advancing therapeutic medicine via the improvement of tools that can be used to propel pharmaceutical research and development (R&D). Microfluidic devices (often called lab-ona-chip or organ-on-a-chip platforms) are used in pharmaceutical research to mimic human biology, offering scientists a more accurate depiction of bodily responses to new drugs and treatments in the testing phase. These devices can be used in medical research across application areas from drug development to disease treatment.
I expect that companies will home in on the ways in which their technology uniquely solves design or production pain points in medtech and healthcare. There will also likely be a focus on using 3D printing to accelerate life sciences research, bypassing expensive and timeintensive in vivo studies while offering a reliable alternative.
3. Miniaturization of medtech will continue leading innovation
The rise of miniaturization in therapeutic delivery methods and intra-procedural components has made micro 3D printing more appealing, as it is ideal for use in circumstances where innovative solutions require micron-level precision. In some instances, additive manufacturing may be the only solution that can repeatedly achieve the tight tolerances required of many parts.
Researchers recently utilized micro 3D printing technology to make bio-inspired intratumoral catheters. Designed to
3D-printed glacoma stents with a penny for scale
improve the delivery of medication to fight liver tumors, specifications for the catheter included 0.4 mm side holes and finely detailed barbs that couldn’t be made by a traditional manufacturing method. When researchers used 3D printing to manufacture this device, they found that this tiny catheter led to 183 times higher drug concentration delivered to the target area, which has promising implications for ultra-targeted cancer therapies.
Ultra-high-resolution parts are often essential, but harder to manufacture as parts get smaller. In the face of these challenges, there will be increased adoption of micro 3D printing across the industry to further medical care and life science research from drug development to surgical tools.
As we see more exciting innovations and progress in medicine, aided largely by unique technologies like 3D printing, I am excited for what comes next in the field. In my own sphere, I look forward to expanding into end-use applications in dental and medical environments and supporting customers as they continue to drive innovation in their respective industries.
John Kawola is CEO-global operations of Boston Micro Fabrication (BMF), which is focused on introducing and scaling micro-3D printing technology to a range of industries that demand a high level of resolution and precision. Kawola has more than two decades of business leadership experience across the additive manufacturing, 3D printing and materials science industries.
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By Dick Otte Promex
Adding materials and parts to a CMOS wafer can greatly increase the functions available at the die level.
The electronics industry began using the term heterogeneous integration (HI) in recent years to describe a new approach to building semiconductor devices that would allow for greater density and capability. The legacy approach to making transistors, lines, and spaces smaller was becoming more difficult due to the limitations of lithography. Thus, a new idea was spawned: adding material and/or parts to die on conventional complementary metal-oxide semiconductor (CMOS) wafers to add functionality beyond what is inherent in silicon CMOS.
John Bowers at the University of California Santa Barbara pioneered an early HI example, placing a small piece of indium phosphide onto a waveguide fabricated on a silicon
wafer. Doing so made it possible to build a laser on a CMOS wafer, something that was not possible with silicon alone because silicon does not have a bandgap. The result was a chip that generated light on die that could be used for a variety of purposes. The idea of adding materials and parts to a conventional CMOS wafer has spread to the point where now a wide variety of parts are combined on the wafer to greatly increase the functions available at the die level. Today’s CMOS wafers often serve as a platform on which parts and materials are combined with CMOS electronics to add functionality. The term HI is now generally used to describe electronic devices that incorporate non-electronic parts.
Heterogenous integration in the medical industry
Examples of devices with non-electronic parts combined with semiconductors include the pacemaker (an early application), the implanted defibrillator, the oximeter, and nerve stimulators. HI does not inherently provide new functionality, but enables increased functionality in smaller, lower power, and often lower-cost devices. Integration enables devices to perform in spaces where large devices are not viable. Medical applications of HI devices include diagnosis and treatment of conditions through interaction with the patient. Electronics do not directly measure or deliver medical functionality. Instead, electronic power sensors and/ or actuators act upon living things to gather, process, and report information. HI enables this combination. >>
Also, when highly functional, minimally invasive tools and devices are required, with a premium on quality, functionality, and smaller sizes (especially for devices that go into the body, even temporarily), HI can fulfill these requirements.
Communications functionality can also be added to medical devices using HI, enabling connection between the device/patient and the outside world. The information can be sent to the cloud where it is available for analysis (often using AI) to provide diagnosis or treatment. Adding integrated communication may be the most important capability that HI can add to a device.
HI can reduce the physical size of a device to make it implantable. Especially when it must function for years, an implantable
has very demanding requirements that call for careful engineering, material selection and thorough testing.
Modern CMOS devices can have billions of transistors per cubic millimeter and consume little power, attributes that are critical for implantable devices. This enhanced computing also enables a large amount of analysis and storage of information within a small space.
Technical methods to communicate with implanted devices include inductive coupling, infrared light, radiofrequency (RF) and even ultrasound. Some of these technologies enable charging a battery that is either in an implanted device like a pacemaker, or worn on the body like a neuromodulation device.
Bandgap = literally and open band in the energy spectrum. Electronic bandgaps are important for the optical absorption and emission properties of materials. InP possesses a direct bandgap by virtue of its physical properties, so it is ideal for lase diodes.
Adding DNA info to wafers via depositing chemistry enables everything from finding signs of disease to security. Big Data and supercomputers are supporting such new uses for DNA technology as advanced criminiology and fighting terrorism.
Optical modules combine various components by stacking them on top of each other, using wafer bondnig or other assembly methods. The “backbone” of most modules, whether sensing or projecting devices, are the optical components, which define the optical path of the light.
This class of device includes surgical tools like laparoscopic cameras and catheters used for diagnosis or treatment. These devices may be inserted into the body multiple times but are not left in the body for an extended period. They must be sterilized between uses and be highly dependable for repeated use. Disposable devices often benefit from the inclusion of heterogeneously integrated electronics to gather information from sensors, process information, and report results.
Medical practitioners historically have a variety of tools to gather information to diagnose conditions. Many of these devices are stand alone, special purpose “boxes” that do not communicate with anything other than the user, are complex to use, and expensive. HI enhances device usability by enabling acquisition of increasingly rich data (temperature, blood pressure, sugar level, pressure, acidity, protein types, etc.) gathered by adding suitable sensors, and onboard computing for data analysis and communication to the practitioner, patient or the cloud. HI makes devices smaller and enables higher-fidelity sensors, in many cases making novel, real-time measurements possible. Other diagnostic devices enabled by HI employ single-use cartridges with onboard chemistry to detect the presence of a target in blood, urine or similar samples. collected from a patient. Often, engineered chemistries
are deposited on the surface of a CMOS wafer at select points. The presence of a target that the chemistry is designed to detect activates the CMOS’ electronics in some manner, such as a change in electrical conductivity and/or charge density, emission of light, or changes in color or magnetic properties. Electronics not only detect the phenomena but can analyze and communicate information about the targets to the user of the device or to the cloud for comparison against library “fingerprint” datasets.
Adding functions to a medical device used to happen by assembling the appropriate parts using nuts and bolts, press fits and glues. The results were devices that were large, with high part and assembly costs, requiring significant power to operate. HI enables devices that are physically smaller, able to be manufactured at the cost and scale of microelectronics,
consuming less power while performing similar or enhanced functions.
HI is a modern manufacturing method mastered by assemblers with roots in the semiconductor industry, where HI was born. While it is a highly specialized practice that requires modifications and customizations of manufacturing approaches, the end results benefit the medical and biotech community, practitioners, innovators and patients.
The term HI is also now used generally to describe electronic devices that incorporate non-electronic parts. The infographic on page 10 illustrates some common combinations.
Today, a large variety of parts and materials can be added to electronics on a CMOS wafer.
Assembling non-electronic with electronic parts through HI requires special skill and experience. Parts
can be damaged if integrated using standard electronic assembly methods, such as reflow soldering at 260°C, washing in water, and exposure to ultraviolet curing conditions. Knowledge of proper assembly materials, joining methods, and manufacturing process/ workflows is critical.
Below are some considerations of building an HI device that incorporates a particular addition, along with process changes needed to accommodate HI additions to an electronic device.
Non-electronic part added:
InP, SiGe, GaN, SiN
• Function added: Lasting, efficient O-E conversion, power handling
• Characteristic to accommodate: Added in semiconductor fab
• Accommodation and assembly process solution: New fab processes need to be developed >>
Cadence is a full-service contract manufacturing partner for medical device OEMs worldwide. We provide best-in-class vertically integrated manufacturing solutions for the complex challenges of today’s medical devices.
Non-electronic part added:
Optical devices
• Function added: Transmit info with photons, cameras, Lidar, detect wavelength/s of specific species, utilize fluorescence
• Characteristics to accommodate: Maintain transparency and mechanical stability during manufacturing and lifetime of use
• Accommodations and assembly process solutions: Build in cleanroom to minimize particles that scatter light, deteriorate images; Highly accurate part placement; Ensure organics do not have volatiles that redeposit on optics over time; Adhesives and materials must not “yellow” over time; Utilize high modulus adhesives with low CTE; Ensure organics do not bleed onto adhesive, solder or wire bond surfaces
Non-electronic part added: MEMS Devices
• Function added: Provide micromechanical motion
• Characteristics to accommodate: Fragile, susceptible to scratches; Susceptible to particles and contamination; Susceptible to ESD
• Accommodations and assembly process solutions: Customized handling methods and tools; Build in class 5 to 7 cleanroom, minimize organics in the package; Build in ESD controlled environment
Non-electronic part added: Fluid channels
• Function added: Ability to utilize gas or liquid samples
• Characteristics to accommodate: Must not leak; Laminar flow required
• Accommodations and assembly process solutions: Careful deposition of sealants; Smooth well control shape to channels
Non-electronic part added:
Mechanical parts
• Function added: Mounting points, mechanical structure
• Characteristic to accommodate: Must not interfere with wafer functions
• Accommodation and assembly process solution: Careful automated dispensing of adhesives and placement of parts
Non-electronic part added: Chemistry on surface
• Function added: Ability to detect specific compounds
• Characteristics to accommodate: Must keep dry; May deteriorate if the temperature is over 40°C; Susceptible to scratching; UV sensitive
• Accommodations and assembly process solutions: Solder with vacuum, formic acid or forming gas versus flux that requires washing and temporarily protect part from wash water with tape, etc.; Process at less than 40°C; Specialized fixtures and handling tools for use in transporting items; Shield sensitive surfaces from UV when used.
Dick Otte is president and CEO of Promex Industries, a provider of microelectronic assembly for the medical and biotechnology markets. Otte has made significant contributions to electronics manufacturing technology and processes, mentored dozens of leaders in the industry, and managed teams of design, development, and manufacturing engineers and employees. He has more than 75 patents from throughout the world and holds BSEE and MSEE degrees from MIT and an MBA from Harvard University.
Miniaturization Experts
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Micro features, tight tolerances, micro holes, thin walls, and/or complex geometries
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Over 30 years as a trusted partner
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Achieving less than 1.5 micron positional accuracy
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All thermoplastic, PEEK, long-term implantable, bioresorbable, silicone, and
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Nissha Medical Technologies' expertise in endoscopic device design and Isometric’s micro-molding capabilities are transforming minimally invasive surgical instruments and robotics. Together, we drive innovation in miniaturization and precision, enhancing medical device e ciency and performance.
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Nissha Medical Technologies' expertise in endoscopic device design and Isometric’s micro-molding capabilities are transforming minimally invasive surgical instruments and robotics. Together, we drive innovation in miniaturization and precision, enhancing medical device e ciency and performance.
A
edical nitinol processing transforms raw nickel-titanium alloy into wire, coils, tubes and sheets for medical and dental device manufacturers.
We previously covered nitinol’s journey from the earth’s crust through high-temperature melting crucibles and forging operations to create nitinol ingots and then smaller, more workable shapes such as rods and plates.
But turning those into wires, coils, tubes and sheets can be challenging due to the same superelastic and shape memory properties that make nitinol so appealing for a variety of advanced medtech applications, including minimally invasive cardiac devices and next-generation neurovascular therapies.
To create nitinol wire, a processor will pull a lubricated nitinol rod through diamond-coated drawing dies to elongate the material and reduce its diameter to the desired size. Nitinol coils are made the same way but spooled to form one long continuous wire instead of cutting it into shorter lengths of wire.
Drawing can be done at ambient temperature or at elevated temperatures. A single draw pass can reduce the wire’s cross-section area by up to 80%.
Annealing is a heating and cooling process before and after passes to remove internal stresses in the nitinol that could later cause device fatigue or durability problems. Nitinol annealing takes the metal’s temperature up to 600800°C and holds it there for a period of treatment between passes.
Nitinol wire can be drawn down to diameters thinner than a human hair. Such a reduction takes hundreds of draw passes, resulting in an ultrafine wire. Dozens of those wires could be braided together to reinforce catheters, for example, or woven to create a mesh basket for embolization in aneurysm patients.
Making nitinol tubes for
Nitinol tubes can be used for catheters, guidewires, stents and needles.
To create a nitinol tube, a processor will take a rod and gun drill to form a cavity down the center. This gun-drilling process — named after the deep hole drills used to form the barrel of a gun — creates a thick-walled tube hollow.
That tube hollow will then go through multiple drawing steps with dies to stretch the hollow and form a tube. A mandrel inside the tube maintains the inner diameter, while the elongation process reduces the outer diameter and tube thickness to the desired dimensions.
Nitinol sheets used for products like bone staples or orthodontic brackets start in the form of plates, typically a quarter-inch thick and perhaps two to four feet long and 18 to 24 inches wide. Those plates go through rolling mills where hydraulic presses with hardened steel rollers compress the plates and make them thinner and thinner, down to the desired thickness.
Nitinol sheets can be stamped or cut with water or lasers to create the desired pattern or shape.
Next in nitinol
Once nitinol is in the form of wires, coils, tubes and sheets, there are a few more steps for medical device manufacturers to get to a finished component or device. Go to www.wtwh.me/nitimachining for more about nitinol machining, shapesetting and finishing, and www.wtwh.me/nitimelting for our previous article on raw nitinol manufacturing.
Terumo Neuro's Woven EndoBridge (WEB) aneurysm embolization system uses nitinol to treat wide neck bifurcation aneurysms.
Image courtesy of Terumo
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A nitinol spring near the tip of J&J MedTech’s ThermoCool SmartTouch SF navigation and cardiac ablation catheter senses and measures force applied to the heart wall. Image courtesy of J&J MedTech
Many cardiac ablation catheters use nitinol to expand inside a patient’s heart to treat atrial fibrillation (AFib), but Johnson & Johnson MedTech’s ThermoCool SmartTouch devices use the nickel-titanium alloy for
Those ThermoCool navigation and cardiac ablation catheters — both the ThermoCool SmartTouch radiofrequency (RF) ablation device and the newer ThermoCool SmartTouch SF (a dualenergy catheter that uses RF and pulse field energy for ablation) — use nitinol for contact-force sensing.
The sensor system tells the electrophysiologist in real-time how much force (measured in grams) is being applied to the heart wall and in what direction, via a display on the Carto 3 Navigation System used with the ThermoCool cardiac ablation catheters.
J&J says this contact-force sensing technology helps ensure consistent lesion formation during ablation for pulmonary vein isolation, which kills heart tissue to stop or block the irregular heart signals that cause AFib. Many cardiac ablation catheters — like J&J’s Varipulse system for pulse field ablation (PFA) — measure contact, but this technology takes it a step further by measuring how much force is applied by the catheter tip to the heart tissue.
with a nitinol spring next to the tip dome.
“A transmitting coil is located at the distal end of the spring and three receiving coils are located at the proximal end,” J&J MedTech explains in records filed with the FDA. “The three receiving coils are positioned 120º apart and measure the signal strength from the transmitting coil. The catheter is calibrated so that the force versus displacement of the spring is calculated and written to an EEPROM located in the catheter handle.”
When the tip is forced into contact with tissue, the nitinol spring’s displacement is signaled via the receiving coils and calculated for display on the Carto 3 Navigation System.
“The amplitude of the force signal emitted from the transmission coil is measured by the three vertical receiving coils proximal to the spring to determine the deflection of the spring,” J&J MedTech’s filing continued. “Those signals are used to calculate the force on the spring, and thus on the tip electrode, using the calibration information stored on the EEPROM related to each catheter’s unique spring constant.”
deployment (CI/CD) for AI-powered medical devices
Continuous integration and deployment is essential for successful development of devices enabled by artificial intelligence and machine learning.
By Erez Kaminski Ketryx
It’s no secret that AI-powered medical devices are revolutionizing healthcare, setting new standards for speed, precision, and accuracy in the diagnostics that drive better patient outcomes.
Artificial intelligence (AI) and machine learning (ML) technology is also at the forefront of the shift toward remote care, making it possible to deliver personalized treatments customized to each patient’s unique data, all while extending healthcare beyond traditional clinical settings.
As of late 2024, the FDA had greenlit more than 950 AI- and MLenabled medical devices. With the surge of connected devices and continued investment in AI, the growth of authorized AI-enabled tools shows no signs of slowing down.
A continuous integration/continuous deployment (CI/CD) strategy that champions frequent updates and adaptations isn’t optional for medtech developers — it’s essential. This piece will outline the best practices for designing CI/CD architectures and offer strategies to navigate the unique challenges of regulated environments.
Before diving into best practices, let’s quickly define CI/CD. It’s a critical component of modern DevOps methodology, relying on incremental code changes to increase the speed of releases while tightening feedback loops across the software development lifecycle.
CI/CD enables teams to independently develop, test, and deliver safe, incremental updates to software through automated integration and delivery pipelines. Image courtesy of Ketryx
But as these complex systems multiply, so do the challenges of ensuring their safety and reliability. Medtech requires a proactive approach, one that tech giants such as Google and Amazon have made central to their continued success.
While the word “speed” often sets off alarm bells in the medtech space, this practice is well aligned with new FDA guidance surrounding “Predetermined Change Control Plans” (PCCP). PCCP empowers medical device manufacturers to implement updates and improvements without the traditional, lengthy and costly process of submitting new premarket applications. While this flexibility is crucial for keeping pace with rapid technological advancements in AI, not all manufacturers are ready to take advantage of it.
Because a given software-as-amedical-device (SaMD) product can involve hundreds of data sources and thousands of requirements, specs, and tests, implementing CI/CD while still creating and approving all the needed documentation can seem daunting. The following strategies provide a practical approach for getting started. >>
CI/CD strategy No. 1: Design an architecture built for change
To design an adaptable architecture, you need the flexibility to identify AI/ ML subsystems, adjust design controls by adding or removing components, upgrading them, and then reintegrating and retesting the entire system to ensure it can perform its intended use while still meeting risk control standards. Many medtech companies shudder at this process as it’s traditionally a manual and timeconsuming task without CI/CD. However, this flexibility is essential for supporting AI-powered products. Implementing microservices makes sense for CI/CD pipelines as it allows for independent deployment, versioning,
Another benefit to this approach is it allows you to allocate and optimize resources based on the specific needs of each service, reducing costs and improving overall performance and reliability.
CI/CD strategy No. 2: Enforce procedures and automatically generate documentation With the pace of CI/CD, it’s simply not feasible to use traditional, manual workflows that rely on the exchange of spreadsheets and in-person meetings. Rather, your tools and systems should ensure that the right steps are being executed in the right order — with the needed evidence.
This graphic illustrates how medtechs can ensure quality management and regulatory compliance within medical device software without unnecessary manual efforts.
Image courtesy of Ketryx
To accomplish this objective, you need to automate the logic/rules of your quality management system (QMS) and use them as guardrails to guide developers through the required steps within their native workflows and familiar tools. In setting up your automation, choose tools that integrate with your team’s existing development environments, such as Jira and GitHub, rather than being forced to move data in and out of different systems, potentially introducing human error. Automating your QMS prevents a project from moving forward unless it is being executed exactly as written in your existing quality standard operating procedures, ensuring compliance. One example can be program gates, but there could be many other procedures that need to be automated. This strategy eliminates the need for manual oversight and the time-intensive meetings that are the enemies of CI/CD.
Continuous integration and deployment ensure that medical device software changes are tested, verified, and approved with automated traceability and compliance checks before reaching production.
Image courtesy of Ketryx
An additional benefit includes the automatic generation of key FDA documentation such as a design history file (DHF) from the data captured during development to further document realtime compliance and efficiency.
CI/CD strategy No. 3: Maintain endto-end traceability across dev tools
This last step can’t occur until you’ve built a flexible architecture designed for change. In effect, end-to-end traceability is the byproduct of the first two strategies when you’ve committed to generating traceability and testing evidence directly from your existing DevTools to streamline reporting.
Replacing attempts at manual traceability (e.g., spreadsheets and commitment documents) with an integrated, automated platform reduces errors and delays while resulting in safer software. An automated platform that is contextaware of your risks and regulatory requirements can also be used to automate change impact analysis — a critical, and time-consuming step.
As AI and ML continue to reshape healthcare, implementing CI/CD in medtech isn’t just a technical upgrade — it’s a competitive necessity. AI-enabled devices add layers of complexity, demanding that medtech companies innovate swiftly while staying compliant to bring safe, reliable products to market.
Leveraging automation, endto-end traceability, and a robust risk management framework empowers manufacturers to transform formerly complex challenges into achievable goals. Adopting CI/CD not only positions your organization to lead the next generation of medical technology but also ensures alignment with evolving FDA standards and patient expectations.
Erez Kaminski is the founder and CEO of Ketryx, which says it is the life sciences industry’s first and only connected application lifecycle management software designed to improve quality and release software faster. Kaminski founded Ketryx after working at Amgen as the head of AI/ ML for their medical device division.
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Flow Medical’s novel delivery scaffold uses hollow nitinol tubing to deliver clot-busting drugs.
Image courtesy of Flow Medical
First Look: Flow Medical’s next-generation thrombolysis catheter for pulmonary embolism
The startup designed its minimally invasive system to diagnose blood clots, expand inside them and deliver thrombolytic drugs with a single device.
Flow Medical is developing a thrombolysis catheter to improve the treatment of blood clots in pulmonary embolism patients.
The Chicago-based startup designed its minimally invasive system with a novel nitinol scaffold that perforates blood clots and infuses them with tissue plasminogen activator (TPA), a thrombolytic drug commonly referred to as a clot-buster.
Flow Medical recently offered Medical Design & Outsourcing our first good look at the prototype with some images that we’re sharing here.
“We wanted to build a device where you can perform pulmonary angiograms through the device with a scaffold that would expand into the clot and deliver thrombolytic drugs. That’s a lot of things to try and do in a relatively small-profile device,” Flow Medical co-founder and CEO Jennifer Fried said in an interview, though she
declined to dive too deep into design and engineering details for now.
Fried and her Flow Medical cofounders, Dr. Jonathan Paul and Dr. Osman Ahmed, were finalists for the MedTech Innovator accelerator’s 2024 grand prize.
Flow Medical has started verification and validation (V&V) testing, supported by a $5 million seed round the company closed in December 2024.
Here’s what we know about the system, including details from our previous interviews with Fried and other information the company has made public in recent months.
The Flow Medical system accesses a patient’s lungs via the femoral artery and through the heart. To help physicians navigate the multi-function catheter to where it’s needed, Flow Medical designed the outer sheath of its catheter for simultaneous highpressure diagnostics angiography. >>
“We wanted to build a device where you can perform pulmonary angiograms through the device with a scaffold that would expand into the clot and deliver thrombolytic drugs. That’s a lot of things to try and do in a relatively small-profile device.”
That outer sheath has holes in it to release dye for visualizing the patient’s vasculature, allowing the physician to locate the clot and place the device inside it with precision and accuracy — and avoiding the need for device swaps between diagnosing the clot and treating it.
After the catheter is all the way through the length of the clot, the sheath pulls back to reveal the scaffold. The adjustable catheter allows for different lengths of the scaffold to match the length of the clot.
The company engineered the delivery scaffold with hollow nitinol tubing and laser-cut holes specifically for thrombolytic delivery. Nitinol’s superelasticity allows the scaffold to compress down for catheter delivery and expand inside the patient when the sheath is retracted to disrupt the clot.
Flow Medical designed the scaffold to maximize surface contact with the clot as it delivers TPA.
The catheter also has a fiber-optic pulmonary artery pressure sensor for real-time hemodynamic monitoring. That’s meant to help physicians determine how much of the clot-busting drug to administer and for how long.
When the job is done, the scaffold compresses back down into the catheter as it retracts.
Flow Medical previously aimed for a diameter of 8 Fr for its catheter. The latest prototype is 9 Fr, and that’s the size the company plans to introduce to the market, Fried said.
“We’re really proud of the progress that we’ve made so far. We’ve done 15 animal studies to date, which have been super informative and helped us get to design freeze and to the stage where we are right now,” Fried said.
“It’s a multifunction catheter,” she later continued. “The scaffold itself took a lot of engineering in order to get it to the point where it is today. Having all of these nitinol tubes that come together, in addition to the fiber-optic sensor, in addition to the ability to perform pulmonary angiograms — that’s what makes us a 9 Fr device.”
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Innovation has “created a tailwind for the company that that we haven’t had in a long time,” Medtronic CEO Geoff Martha said at the 2025 J.P. Morgan Healthcare Conference.
“These are growth drivers across some of the most exciting markets in medtech,” he said. “… It started about five years ago with a renewed commitment to innovation, which is the lifeblood of the company.”
Founded as a pacemaker developer decades before it became the world’s largest medical device company, Medtronic is still innovating in cardiac rhythm management (CRM) with technology like its Micra leadless pacemakers.
But Martha spent the bulk of his presentation on growth-driving innovations in newer areas of minimally invasive medtech, including one therapy that he said “could be the biggest thing we ever do.”
Medtronic’s cardiac ablation portfolio now includes two pulsed field ablation (PFA) systems approved by the FDA for minimally invasive pulmonary vein isolation to treat atrial fibrillation (AFib), with another PFA catheter on the way.
PFA is “a $9 billion segment growing [in the] mid-teens, with a really strong growth runway in front of it,” Martha said, highlighting Medtronic’s FDAapproved PulseSelect and Affera Sphere-9 systems.
“Both of these are — in addition to being very competitive — the safest catheters out there,” he said. “We’ve got really strong safety data on both of these, and as we’ve seen over the last week, safety here really matters.”
Martha said Medtronic is “significantly expanding our manufacturing capability” to meet “overwhelming customer response and physician demand” for the Affera system. >>
Medtronic's next-gen RDN catheter and procedure are in the works to advance the Symplicity Spyral system and procedure that won FDA approval for treating hypertension in 2023.
"We're going into the renal artery and doing renal denervation, and then going up into the [liver's] hepatic artery and doing hepatic artery denervation because we have preclinical work that has shown us if you do those together, you further augment the reduction and the impact you can have on blood pressure,"
Medtronic VP and RDN GM Jason Fontana said in an interview with Medical Design & Outsourcing.
"Project Mercury was the program that brought our Spyral catheter to the U.S.," Fontana said. "Project Pulsar is our next-generation catheter. Project Gemini is our nextgeneration approach to doing both hepatic and renal."
He said Medtronic has already fully developed that next-generation catheter for wrist access (instead of the current generation's access via the femoral artery) and could have it on the market in about 18 months.
"We're leveraging our background on the coronary side to continue to bring that benefit of an easier, simpler procedure for patients and that quicker recovery," he said. "We're working our way through the manufacturing portion of it and the continued work with the FDA on it, but we're feeling really good." Read
Medtronic recently secured FDA approval for a new Affera manufacturing facility in Galway, Ireland, Medtronic EVP and Cardiovascular President Sean Salmon said.
“That’s one of our marquee factories,” he said. “Really high quality, excellent volume coming out of there, so that’s going to help a whole lot.”
Martha said cardiac ablation is the area that he feels best about growth over the coming year.
“The ablation space [is] so big and our technology is the most comprehensive. We believe it’s the best — particularly Afferra — and it’s the safest, no matter who you compare it against, all players,” Martha said. “We won’t be done here until we’re in every center, because that’s the kind of demand we have for Affera in particular.”
The Medtronic Evolut FX+ implant for transcatheter aortic valve replacement (TAVR) has a self-expanding nitinol frame.
Image courtesy of Medtronic
“We’re not fighting pharma on this,” he said. “Patients like it. Physicians know how to do it. Health systems are behind it. There’s just nothing to stop it, and it’s going to be a lot of fun.”
Structural heart
The next big innovation in Medtronic’s cardiac ablation pipeline is the Affera Sphere-360 PFA catheter for single-shot ablation to treat paroxysmal AFib.
Meanwhile, Medtronic’s Symplicity Spyral renal denervation (RDN) system for treating hypertension “could be the biggest thing we ever do,” Martha said, citing the “massive” opportunity of more than 1 billion hypertension patients globally, with only 1% penetration equaling a $1 billion market.
“Half of all heart-disease- and stroke-related deaths are caused by hypertension, leading to half a trillion [dollars] in direct costs in healthcare systems around the world,” Martha said. “… And if you have hypertension, it’s likely that you don’t have it under control: 75% of hypertensive patients do not have their blood pressure under control, and 50% of them stop taking their meds within one year. [Symplicity is] a safe, one-time, very tolerable procedure. It’s always on, and it’s going to drive meaningful benefits to patients.”
Symplicity Spyral is “poised to transform hypertension management, and it’s a large opportunity that’s right in front of us — and I really mean right in front of us. … This has been over 15 years in the making,” Martha said.
With a national coverage analysis coming for RDN, Martha said he couldn’t see any remaining obstacles to its widespread adoption.
Martha highlighted Medtronic’s Evolut FX+ transcatheter aortic valve replacement (TAVR) system as a key innovation in the structural heart space, which he quantified as $6 billion-plus market growing at high-single-digit rates.
“There are some skeptics out there who questioned our ability to grow our TAVR franchise as new entrants came into the market,” Martha said. “But we’ve shored up this business with new products, new data and better sales execution, and we’re seeing strong commercial traction of our latest-generation Evolut FX+ valve, which is designed to facilitate lifetime management and easier coronary access.”
“Engaging with customers on this new valve also allows us to reiterate the benefits of our technology as well as the clinical performance of our Low Risk and SMART trials,” he continued. “SMART demonstrated non inferior clinical outcomes and superior valve performance in patients with small annuli, many of them who are women, which is very underrepresented in clinical research. And we expect twoyear data from the smart trial later this year. And we remain committed to data transparency in patient outcomes, which is not always done in this space.”
The Intrepid transcatheter mitral and tricuspid valve replacement system are other structural heart innovations in Medtronic’s pipeline, and Martha also noted the company’s bid to win an expanded TAVR indication for moderate aortic stenosis.
Medtronic’s deep brain stimulation portfolio includes the Percept PC and RC (rechargeable) neurostimulators. Image courtesy of Medtronic
Neuromodulation
In 2024, Medtronic VP and Brain Modulation GM Amaza Reitmeier told Medical Design & Outsourcing that adaptive deep brain stimulation (DBS) was coming soon as the next big advance in neuromodulation. Medtronic announced a CE mark
Asahi_2023-MDO_printer.pdf 1 7/12/2023 3:39:01 PM
for that technology the same day as Martha’s presentation.
“It’s the world’s first complete closed-loop DBS system with real-time, self-adjusting brain stimulation for patients with Parkinson’s disease,” Martha said.
With the devices already implanted in 40,000 patients, that makes it the “most-scaled BCI technology in the world,” Martha continued.
Neuromodulation “has been a newer growth-driver for us,” Martha said. “Even though the business has been around a long time — we pioneered it — we’ve got a lot of momentum. … We’re in a strong innovation cycle, which enables even more innovation in the future. We’re working from a real position of strength, and we expect to remain the category leader. This is an area where the investments we’ve made over the past several years in sensing technology in the brain and the nervous system are now paying off.”
Another neuromodulation innovation to watch for in the pipeline is Medtronic’s tibial implant for overactive bladder.
Smart dosing for diabetes patients “is expected to dominate by the end of the decade, as CGM alone is just not sufficient for this patient population,” Martha said.
“We remain the only company investing in a comprehensive ecosystem of differentiated technology for intensive insulin patients that takes more of the work of the diabetes management off their plates,” he continued.
Martha described Medtronic’s new Simplera Sync sensor as “half the size and much easier to apply than our previous sensor,” and said there are more sensors in the pipeline, as well as next-generation AID systems including the 800-series pump and patch pump technology. >>
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“a lot of progress” on Medtronic’s surgical robotics platform, with year-over-year procedure volumes doubling.
“We’re confident in our position to become a strong No. 2 player in the surgical robotics space,” Martha said, without mentioning surgical robotics leader Intuitive by name. “Usually, we’re targeting No. 1, but right now, we’ll just target No. 2 here, and I think that’ll be pretty good.”
Medtronic plans to file with the FDA for a urology indication before April, and Martha said enrollment is progressing quickly for the next two U.S. indications: hernia and gynecology.
“We’re leveraging data and AI capabilities in intraoperative solutions with Touch Surgery that will continue to advance this technology. We’re also making progress on bringing our advanced surgical technologies to Hugo with ICG (an abbreviation for indocyanine green) visualization technology, and we look to add our market-leading ligature vessel sealing technology this calendar year.”
During his presentation, Martha mentioned the articulating catheter technology Medtronic acquired from Fortimedix Surgical in 2024, noting that it has robotic and non-robotic applications.
and growing well, and then we’re stacking growth drivers on top of it,” Martha said. “… We’re well positioned in the moment, tomorrow and out into the future with innovation.”
“These are growth drivers across some of the most exciting markets in medtech. ... It started about five years ago with a renewed commitment to innovation, which is the lifeblood of the company.”
Medical is developing a structural heart robotics platform for minimally invasive, catheter-delivered mitral and tricuspid valve replacements.
BY JIM HAMMERAND MANAGING EDITOR
DEVICE ENGINEERS, EXECUTIVES AND EXPERTS SHARE THEIR PERSONAL PHILOSOPHIES ON WHAT MAKES MEDTECH “MINIMALLY INVASIVE.”
Minimally invasive medtech includes cutting-edge products such as surgical robotics systems, miniaturized implants and catheters designed to treat a condition with less trauma to the patient and/or faster recovery times.
But there’s so much more to it depending on who you ask, whether they be medical device designers, engineers and executives who develop and manufacture minimally invasive medical devices and systems, or the physicians who test and use them.
In interviews with a range of minimally invasive technology experts — including those featured in our MDO Min-Vasive Medtech webinar series, which returns in August — Medical Design & Outsourcing asked for their thoughts on minimally invasive devices, systems and procedures and how their individual philosophies might be unique. The following excerpts have been lightly edited for clarity and space.
Stan Rowe, former Edwards Lifesciences chief scientific officer and co-founder of transcatheter aortic valve replacement (TAVR) pioneer Percutaneous Valve Technologies
“Through my career, open surgery was always the standard of care and huge numbers of patients still get big sternotomies or open surgeries. Anytime we can significantly reduce the trauma of open surgery and the recovery time associated with that, it’s hugely important. Now, something like TAVR had the added benefit of not requiring cardiopulmonary bypass. So when you eliminate that and all the complications and recovery time associated with cardiopulmonary bypass, you’ve taken a three-hour procedure down to a 45-minute procedure. Most of the patients go home the next day instead of six to nine days later. That’s hugely beneficial to patients and especially given the average age — something to always consider — of most of the surgical trials and the TAVR trials was around 80. >>
Former Edwards Lifesciences Chief Scientific Officer and Percutaneous Valve Technologies
co-founder and CEO
Stan Rowe
That’s the average, so imagine what that spread looks like. Having patients take months to recover at that age is really, really tough. Anything you can do to minimize that surgical trauma and improve the recovery time is hugely beneficial to patients. Then you get the secondary benefits: it’s a more efficient procedure, so it’s shorter in time and you tie up the operating room less, it costs less to do that procedure, and patients may stay in the hospital a lot shorter period of time. All those are kind of ancillary benefits. But it all starts off with that benefit for the patients.”
Capstan Medical CEO Maggie Nixon
“In my mind, it is the least impact to the patient to get the clinical outcome. It’s not just the size of the incision. It’s how much movement happens at that incision, how does that patient feel in the hours and days post their intervention. That’s why there is such a broad spectrum and why there’s such debate on multi-port, singleport, natural orifice and what we’re trying
the vascular system. All of those things are minimally invasive, but what we’re all seeking to do is to maximize the outcome of that clinical intervention with getting the patient feeling better as quickly as they possibly can. You’ve got to look at that through all the different facets, all the way from if you’re in the abdomen doing surgery, the more you’re moving around, the longer it takes to get the patient feeling better, and so [it’s] minimizing all of those elements to still get that same clinical outcome.”
Mechanical Systems
Darragh McDermott
Synchron Director of Neural Interfaces and Mechanical Systems
Darragh McDermott
“I think about it as what is best from a patient recovery perspective — what is the least amount of injury to the patient that you can possibly make while still treating the issue at hand for the patient? It’s minimizing any sort of damage you do at the access location, be that an incision on the skin, or even any sort of trauma that you cause within the patient as you’re trying to pass through the body to get to the intended target location that you’re trying to access. So from a cardiovascular stenting perspective, that’s a very small incision site and then you navigate through the vascular system to get your intended target. For deep brain stimulation, your target is deep within the brain so you perform a craniotomy and access through the brain tissue for that particular procedure. Both, in my mind, would be considered minimally invasive. However, the paradigm shift is a little bit different depending on the condition you’re trying to treat and the region within the body you’re trying to access. My main
focus is always just trying to minimize the the trauma that the patient has to go through in order to get the treatment that they need for the condition at hand.”
Johnson & Johnson MedTech Spine Principal Product Development Engineer Joshua Rodriguez
“What we’re focusing on at J&J MedTech for minimally invasive spine has to do with the posterior transforaminal lumbar interbody fusion (TLIF) approach. … It really is about maximizing the surgeon’s visualization and what they can see, helping them understand and orient themselves in this very tight space, and then also maximizing their ability to place the correct implants for the right patient and for the pathology. Both of those things are critical to doing MIS successfully, because it is in its nature more challenging than a standard open procedure where you have a lot more freedom of movement and you can see a lot more things, but it is typically more disruptive to the patient’s soft tissue and can have a longer recovery. To me, it really is about maximizing visualization and maximizing the ability to do the work they need to do and deliver the implants they need to deliver. Because at the end of the day, the implants are what the patient goes home with. They don’t go home with the navigation system or the robot. They go home with the implants.”
Matthew Fishler, chief engineer and director of systems engineering for the leadless platform in Abbott’s cardiac rhythm management business “For where we’re coming from, probably the biggest definition is taking a procedure and taking it from a surgically based procedure to a nonsurgically based procedure.
(continued on page 36)
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(continued from page 34)
So for us and the pacemakers and implanted devices that we do for cardiac rhythm management, it’s taking it from a pocket — which requires a surgical incision — and doing it through a percutaneous catheter-based approach.”
clock for a 7:30 procedure and you’re back home by 9:30 and probably back to your life by noon. … But if you have an implant that is small and placed as a procedure, and that implant can adjust to your activity over time in a minimally invasive way [where] you can update that with software over time so it’s constantly reacting to your body, I think that’s pretty exciting, too.”
Dr. Jonathan Piccini, a cardiac electrophysiologist and professor of medicine and population health at Duke University Hospital and the Duke Clinical Research Institute who is studying Medtronic’s LINQ insertable cardiac monitors (pictured)
“Minimally invasive is relative. When people have heart surgery, they can have open-heart surgery where they have an incision down the middle of their chest and their chest is literally cracked open. They can also have a thoracoscopic surgical procedure where large ports are placed at several points in their chest, and then equipment is put through those ports. … An ILR (implantable loop recorder) insertion is minimally invasive, but it’s certainly way more invasive than a 12-lead ECG. So everything is relative and everything is changing. For example, the original implantable defibrillators were massive compared to today’s standards. Yes, everything is becoming less invasive over time, but it’s also relative, and sometimes the information yield on something that’s more invasive really makes the risk-benefit ratio weigh in favor of choosing the more invasive option.”
Medtronic Renal Denervation GM
Jason Fontana
“A minimally invasive procedure for me would be something that someone could have done either under conscious sedation or minimal sedation in the morning — you come in, you’re on the
Retired Edwards Lifesciences CEO and Chair Mike Mussallem
“Minimally invasive is important because of the impact it has on patients’ lives. When you talk to the patients about what’s important, it’s fascinating. The docs have their goal of what they want to accomplish in a procedure, but if you ask the patient what’s important to them, they say, ‘Well, my granddaughter is going to get married in June, and I really want to be at the wedding, and I want to be able to dance there.’ They have clear goals in life, and the value of less invasive allows people to get back to life. If the doc can say, ‘I think I can get you there,’ that’s the power of a less invasive procedure. You’re always making these tough trade-offs between what is durable and less invasive. Often the old way gets protected because there’s data on the old way and there’s no data on the new way. And so the physicians stay with the old way even longer than they should, maybe sometimes because they’re waiting for the evidence to say that the new way not only has faster recovery, but it has good long-term impact. Those are the challenges for those of us in medtech, is can we not only do it, but can we prove with evidence that our way is not only less invasive, but it’s a durable procedure, and the patients are going to be happy?”
Endiatx co-founder and CEO
Torrey Smith
Endiatx co-founder and CEO
Torrey
Smith
“Traditional minimum invasiveness is how you minimize the trauma to the human body when you go looking around, but there’s almost a new flavor to minimum invasive. Now that we have endoscopes and catheters that can go deep into the human body, what’s the next major frontier? Could we make tools that behave like the tip of an endoscope or the tip of an atherectomy catheter, but subtract the catheter itself, possibly subtract the hospital itself? Could we get technology like this into your living room or into a care facility or a naval vessel or maybe a refugee camp?”
CMR Surgical co-founder and Chief Medical Officer Dr. Mark Slack
“I was an open surgeon, then I converted to minimally invasive surgery and then I ran a training course for 25 years on minimally invasive surgery. … To me, the definition is you’re operating through trocars with minimally invasive — usually 5 mm — instrumentation. Some systems are
CMR Surgical co-founder and Chief
Medical Officer Dr. Mark Slack
5 mm, some are 8 mm, some are 10 mm, and the minute you start to get to 10, the advantages of minimally invasive start to fall off slightly. One of the other problems is tissue retrieval. You do a minimally invasive operation, but then you got to do a big cut to get the specimen out. That is a complication. And then there are nuances where you have extraperitoneal or transperitoneal operations. So my aim was to increase the use of operations that could be done minimally invasively safely, and we would train more surgeons to do it, and therefore more patients would get it. You halve the complications with minimally invasive compared with open surgery. Open surgery is 3 cm and above [and] a single-port surgery has got a 5 cm wound. That’s not minimally invasive. So the minute your holes start going above 8 mm or 10 mm, I think you’re exiting the advantages of minimally invasive surgery, and that’s why I fought so hard for our instruments to be 5 mm trocar instruments.”
Abbott EVP and Medical Devices
Group President Lisa Earnhardt
“A procedure that I consider maximally invasive like tricuspid repair or replacement — rarely done surgically because of the mortality and morbidity associated with the procedure — now we’re able to do that transvenously in a very minimally invasive fashion with TriClip, which is our tricuspid repair device. Same story with MitraClip. … You’re avoiding the cost of the operating room time, a longer length of stay for the patient in the hospital, complications that occur with recovery from a surgical procedure, getting people ambulating sooner so they can get back to work sooner. There’s societal costs associated with it.”
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