Mark Crawford, Contributing Writer08.17.21
Minimally invasive surgery (MIS) is a rapidly growing market in the healthcare industry. It is being used across a wider variety of surgeries because it reduces trauma, creates less pain and discomfort, reduces hospital stays, and enables same-day surgeries, faster recoveries, and lower costs. Because the procedures are shorter, it also reduces surgeon fatigue.
Currently, the value of the global MIS market is about $44 billion, which, by some reports, could grow steadily at a compound annual growth rate of about 10 percent through 2026.1,2 This kind of demand makes MIS wide open for innovation—surgeons continue to work with orthopedic OEMs to develop new and advanced MIS procedures and instruments.
“Advancements in preoperative imaging and intraoperative navigation have allowed for greater application of MIS techniques, which often lead to faster recovery time versus conventional open procedures,” said Scott Reese, director of business development at Orchid Orthopedic Solutions, a Holt, Mich.-based provider of manufacturing solutions for the orthopedic market.
The entire healthcare ecosystem now recognizes the benefits of MIS surgical interventions, including lower infection risks. MIS also enables a greater variety of outpatient procedures, which significantly reduces overall healthcare costs.
“What excites me about the drive toward MI interventions is that success often depends on the ingenuity and creativity of designers and engineers,” said Scott Thielman, chief technology officer for Product Creation Studio, a Seattle, Wash.-based developer of consumer, medical, and industrial products. “We must take up the challenge to understand the complex needs of the surgeons and patients and build innovative tools that meet them. It’s a moon-shot industry focused on improving the lives of millions.”
That said, for some surgeons, MIS is not just about miniaturized components or the latest functions and technologies.
“The key to minimally invasive surgery is not just the length of the incision; it is also how the surgeon handles the soft tissues, and minimizes the risk of inflammation for the patient’s recovery,” said Joseph Assini, an orthopedic surgeon with OrthoONE, an orthopedic practice in Denver, Colo. “As a whole, minimally invasive surgery needs to be thought of as soft tissue management.”
Latest Trends in MIS
The term “minimally invasive” surgery was first used decades ago, when in the 1980s/early 1990s it might have meant a six-inch-long incision instead of a ten-inch-long incision, with surgery time reduced from three-four hours to one-two hours. Today, many joint replacements can be done within an hour and patients get up and ambulate the same day, which leads to a much shorter hospital stay. “There is an element of rapid recovery that, in my opinion, goes hand in hand with minimally invasive surgery,” said Assini.
An increasing number of procedures are shifting from traditional, open surgery to minimally invasive surgery. “For example, posterior deformity correction surgery can be invasive in terms of blood loss and muscle disruption, may involve numerous implants, and in general, takes a patient a long time to recover,” said Josh Rubin, senior group manager of engineering for Stryker’s Spine Division, a Leesburg, Va.-based division of Stryker, a medical technology company that provides orthopedic solutions in several fields, including neurotechnology and spine.
MIS innovation is driven by enabling technologies that allow surgeons to do more complex surgeries less invasively, especially with enhanced visualization and real-time feedback tools. Open surgical techniques are now becoming MIS procedures with the use of smaller and fewer access ports and high precision guides and navigational systems—especially in the spine market. Modern diagnostics can catch tumors earlier than ever, so surgeons want increased precision for biopsies and tissue resection so they can leave more healthy tissue untouched. “Robotic surgery continues to push the boundaries on how tools can be manipulated and tissues visualized beyond a diminutive access port,” said Thielman. “However, not every procedure demands a robotic option—surgeons also want increased capabilities in handheld tools as well.”
In the spinal market, navigated instruments, pre-operative planning, and predictive analysis, combined with state-of-the-art manufacturing through additive techniques, coupled with complex implant designs that can move and expand after implantation, “have all been the focus of innovation in MIS for spine,” said Seth R. Anderson, co-founder and chief innovation officer at Camber Spine Technologies, a King of Prussia, Pa.-based spine and medical technology company focused on tools and technologies for minimally invasive and minimally disruptive surgical procedures.
MIS designers rely on unique architectures and surface designs to maximize the spinal cage’s ability to fuse—even in compromised patients. They then develop minimally disruptive instruments and delivery systems that allow the surgeons to perform minimally invasive, single-position complex spine surgeries. These design firms and engineers sometimes collaborate with leading predictive analysis software companies to create “customized patient-specific implants with a predictable outcome measuring system, all while navigating every instrument and implant to the perfect location in the patient’s spine—through a tiny incision,” added Anderson.
A big trend in MIS is toward single-use devices.
“Although single-use devices are disposable, they still have highly sophisticated functions and are not trivial to make,” said Mike Treleaven, senior vice president of engineering for Tegra Medical, a Franklin, Mass.-based, full-service contract manufacturer of medical devices. “The challenge is in controlling costs for something that will never be used twice. It’s not that hard to design a device to perform a specific function; the hard part is figuring out how to manufacture it in a way that makes it practical and cost-effective to dispose of after one use.”
What OEMs Want
OEMs, serious about improving surgical outcomes and patient care by providing surgeons with devices and instruments with improved features and functionality, are eager for “precision tools, including handheld and articulating instruments, that offer greater bend, flexibility, and reach to aid in accessing small and hard-to-reach areas of the body through MIS,” said Steve Santoro, executive vice president for MICRO, a Somerset, N.J.-based full-service contract manufacturer of precision medical devices. “For handheld articulating instruments, the instrument handle must articulate relative to the instrument shaft, with proper control interface that allows the surgeon more natural dexterity while reducing shoulder, hand, or arm fatigue during surgery. Tip and position control need to be seamless.”
OEMs are focused on getting their MIS devices refined to the point where they can be manufactured efficiently and cost-effectively. Once they know the concept and characteristics they want in the device, they typically turn to contract manufacturers (CMs) with deep experience in MIS to work out the details. Because of design complexities, design for manufacturing (DFM) is essential for reducing design complexity and manufacturing costs.
“Today, because MIS devices are increasingly single-use and disposable, the customer will end up manufacturing a lot of them—sometimes tens or hundreds of thousands, or even more than a million,” said Treleaven. “This is when DFM and the efficiencies it brings can really pay off over the lifetime of a product.”
While almost anyone can ideate a design, that does not mean it will be something that can be made in high-volume production. DFM can help with the identification of raw materials and in creating processes that will optimize the manufacturing process of high-volume parts or products by lessening steps and ensuring standardization in parts quality—thereby shortening design and development cycles.
“With articulating instruments,” said Santoro, “contract manufacturers must understand the nature of these tools to effectively design functional, high-quality components, keeping in mind the number of times a tube must articulate, the degree of articulation, and how the instrument will interact with human anatomy. All of these considerations will impact material selection, laser-cut geometry, and what post-processing will be needed to achieve the desired shape and properties. DFM can be applied to match functional requirements to the optimal engineering process, whether that be machining, metal injection molding, or laser cutting.”
Over the past decade, the emphasis on risk management has led to increased documentation of critical quality characteristics. This is driving large amounts of capability settings, expanded tool sets for gathering data, and greater use of statistical process control (SPC) tools. “For example, data collection and the ability to understand trends is paramount when determining if your process is effective,” said Reese. “We use data collected from our process to find opportunity for improvements that help reduce the future occurrence of adverse results. The same is now possible with respect to surgical techniques as we automate procedures and pull in data that is collected throughout the patient treatment cycle.”
Even though they have turned the work over to their trusted CM partners, OEMs still are hungry for knowledge and insights into actual workflows, use scenarios, and user preferences. For example, hybrid operating rooms (those that combine real-time advanced imaging with traditional interventional capabilities) bring together a wide variety of tools and teams. “Understanding how they are used is actually non-obvious and requires investigation,” said Thielman. “As a result, we have been building more interaction mock-ups and conducting more user research than ever before.”
New Tools, Technologies, and Approaches
Endoscopes are now being used in conjunction with tools to access parts of the body that were not easily accessed before, serving as “working channels” that go beyond the role of just carrying lights and cameras. For example, endoscopes can be used for procedures such as tissue removal for biopsies or suturing. Also, although they have traditionally been reusable, there is now a market for disposable endoscopes. Traditional endoscopes are expensive to reprocess, repair, and autoclave to make them ready for reuse. Disposables reduce cleaning and maintenance costs and time. They also reduce infections from inefficient cleaning. “Particularly with COVID-19, it has become important to use single-use endoscopes for bronchial procedures to avoid hospital-acquired infections in COVID patients,” said Treleaven. “I expect to see an increased demand in single-use endoscopes that are cost-effective to manufacture.”
Surgeons are working with smaller tools to help minimize incisions, which require more precise navigation systems. Using technology for visualization has existed for some time, but now that visualization tools are more sophisticated, the adoption curve is increasing. “Navigation solutions are definitely advancing,” said Oliver Buchert, director of R&D for Stryker’s Spine Division. “Workflows are improving, computing power is getting faster, and visualization on the screen is getting more refined. Also, with augmented reality, surgeons can visualize the surgical plan before starting difficult procedures, helping to reduce some of the strain during MI surgery.”
An important goal in MIS is to get patients on their feet and moving as soon as possible, which is easier to do when there is minimal soft tissue damage that resulted from the surgery. An MIS system that effectively manages soft tissue is MicroPort Orthopedics’ Anterior Path, a cannula-based approach for total hip arthroplasty.3 “The biggest benefit we have seen so far with this procedure is that it allows us to use less dissection in a more optimal position on the patient’s body, so there is less soft tissue damage and smaller incisions, which allow patients to get moving faster,” said Assini. “These technologies are getting patients out of the hospital faster.”
Robotic surgery also has a big impact on the MIS market, with a growing number of procedures that can be completed or enhanced with robotics. While some robot-assisted surgery platforms were originally designed to handle procedures in areas such as cardiology, gynecology, or head and neck, they are now becoming more market-specific, including eye surgery, lung biopsies, and joint replacements. The ultimate goal is for robotic-assisted surgery to become so advanced that the use of expensive magnetic resonance imaging (MRI) and computed tomography (CT) scans will not be required.
“We are seeing more platforms that require parts for robotic systems,” said Reese. “Tolerancing is tighter because of the interaction between robots and the software that controls the robots—for example, robotic end effectors, arrays, and other navigated instruments. That makes our DFM a critical contribution to ensure a cost effective and timely product launch.”
StereoTaxis is a robotic magnetic navigation system where the external robotically controlled actuators actually simultaneously track and guide the tip of an intravascular catheter.4 “This creates a platform for precision interventions with a single access port, and perhaps no external incision in cases where a catheter could be delivered through an existing orifice,” said Thielman.
Stryker’s allows surgeons to do lateral surgery in controlled and versatile ways. “Generally, in lateral surgery, numerous X-rays are taken and instrumentation may encounter significant force when holding or retracting anatomical structures out of the way,” said Rubin. “This means the instruments need to be rigid without interfering with the images that are taken. To resolve both issues, we utilized carbon fiber in the Niagara retractor, a material that is strong yet also radiolucent.”
Assini believes the next step from robotics will be more advanced augmented realities. “Most of today’s robotics have been around for quite some time,” he said. “Using them almost moves away from rapid recovery or minimally invasive surgery, due to all the adjunct things necessary to make the robotics work. Moving forward, I believe patient-derived augmented reality systems will allow us to accurately place implants during a minimally invasive surgery, without the need for CT scans or accessory pins, both of which can lead to longer OR times and increased surgical costs."
Augmented Reality (AR)
Augmented reality and navigation technologies continue to advance in orthopedics, sometimes adopted from other fields of practice. As sophisticated as MIS is, it does present a narrow field of view, which can slow down the procedure and add to surgeon fatigue. This is especially true for complex procedures that require three-dimensional visualization, such as placing a medical device or the removal (or avoidance) of sensitive or critical tissues.
“AR allows the user to see the real world overlaid with a layer of digital content,” stated GlobalData Thematic Research in a Medical Device Network article. “The integration of AR into MIS means surgeons will not solely rely on endoscopes. Instead, AR projections of scans can be superimposed on patients in real-time to aid planning and increase accuracy when placing devices. For patients, this could reduce the chances of trauma and scarring while also accelerating postoperative recovery.”5
“I recently had the opportunity to use a Mimic simulation platform for robotic surgery and was astounded at the level of simulation the company had achieved for training purposes,” said Thielman. “A notable collaboration between FundamentalVR and HaptX will add another layer of convincing realism to training simulations. Surgeons of the near future will be able to log more simulation hours easily and conveniently to hone their skills and conduct surgical planning.”
Royal Philips recently announced its ClarifEye Augmented Reality Surgical Navigation system for minimally-invasive spine procedures.6 By combining 2D and 3D visualizations at low X-ray dose with 3D AR, the system provides live intra-operative visual feedback to support accurate placement of pedicle screws during spinal fusion procedures. Four high-resolution optical cameras augment the surgical field with 3D cone-beam CT imaging, without the need for additional X-ray. “The system combines the view of the surgical field with the internal 3D view of the patient to construct a 3D augmented-reality view of the patient’s external and internal anatomy,” stated Fabienne van der Feer, communications director for Philips Image-Guided Therapy in the Netherlands.
In another accomplishment, in June 2020, Frank Phillips, professor and director of the Division of Spine Surgery and the Section of Minimally Invasive Spine Surgery at Rush University Medical Center in Chicago, completed an augmented reality minimally invasive spine surgery using Augmedics’ xvision Spine System surgical guidance system.7 Phillips, who performed a lumbar fusion with spinal implants on a patient with spinal instability, could “see” the patient’s 3D spinal anatomy through the skin using a transparent near-eye-display headset. This device determines the position of surgical tools, in real time, and a virtual trajectory is then superimposed on the patient’s CT data, with the highest precision. The 3D navigation data was projected onto the surgeon’s retina using the headset, allowing him to simultaneously look at the patient and see the navigation data, without having to divert his gaze to a remote screen during the procedure.
“Having 3D spinal anatomic and 2D CT scan images directly projected onto the surgeon’s retina and superimposed over the surgical field takes spinal surgery to another level,” said Phillips. “Being able to place minimally invasive spinal instrumentation extremely accurately and efficiently, reducing surgical time and complication risk, is critical to improving outcomes for spinal surgery. Traditional surgical navigation platforms have been shown to improve accuracy of implant placement, however, using augmented reality allows for the advantages of traditional (non-3D) navigation, plus the ability to visualize the patient’s spinal anatomy in 3D through the skin.”
Moving Forward
Size and scale is a big challenge in MI innovation. It is relatively easy to zoom in and design parts in computer-aided design (CAD) that cannot be easily be built. “One tool that our development teams leverage is large-scale prototypes at 2x, 5x, or even 10x the final design size,” said Thielman. “Obviously we don’t use a 10x scale prototype on a human, but these larger sizes can teach us a lot about kinematic feasibility and are much easier and faster to fabricate and work with, compared to a prototype of normal size.”
It is easy to get caught up in the drive to make devices, components, and instruments that are more complex, multifunctional, and smaller, that push the edge of innovation. However, there is also something to be said for simplicity. Products that are less complex, with one or two main functions or applications, are easier to make, have less potential for failure, are lower cost, and easier to use—especially for disposable, single-use devices.
“We need to adjust our thinking from providing surgical instrumentation that support multiple surgical techniques,” said Reese. “In doing so, instruments can be slimmed down and designs fine-tuned for a specific approach/technique. We need develop procedure kits that are best-suited for MI as opposed to redesigned versions initially developed for open procedures. It is also important to consider alternate materials and manufacturing processes that allow for the miniaturization and accuracy of instruments.”
Assini maintains that minimally invasive surgery will really accelerate when all the key factors are brought together: appropriate soft tissue management training, implant delivery, 3D printing, and regional blocks from an anesthesia standpoint. “Considering all the components of a minimally invasive surgery will make MIS become the standard of care,” he said.
Thielman believes the difference between the possible and the impossible depends on how well understood the problem is and whether or not the right team has been deployed to solve it.
“OEMs often task our development teams with very challenging problems because we are comfortable thinking about solutions at different levels and are not bound by assumed constraints their internal teams might have adopted,” said Thielman. “An outside perspective can lead to lines of beneficial questioning that help cross the boundary of feasibility. Even when these projects don’t finish in a marketable device, they generally result in valuable technology that may open up new opportunities in the near future.”
Santoro agreed.
A client came to MICRO years ago to design a revolutionary handheld articulating device for use in laparoscopic surgery. It was going to be the first to articulate in a way that imitated a specific hand motion, which had not been done previously. Although the product did not reach long-term market value, the company’s intellectual property signified a breakthrough in medical technology innovation and was a precursor to robotics applications for surgery.
This experience improved how MICRO approaches its business, noted Santoro. “As a result, we established and reinforced the project management and complex supply chain operations we still use today, which propelled us on a growth trajectory as a full-service contract manufacturing operation. This experience also led to even greater education on the assembly of minimally invasive, articulating devices, which ultimately opened the door to the robotic-assisted surgery market—something we would not have been able to do without this initial project presenting a valuable learning opportunity.”
References
Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. His clients range from startups to global manufacturing leaders. He also writes a variety of feature articles for regional and national publications and is the author of five books.
Currently, the value of the global MIS market is about $44 billion, which, by some reports, could grow steadily at a compound annual growth rate of about 10 percent through 2026.1,2 This kind of demand makes MIS wide open for innovation—surgeons continue to work with orthopedic OEMs to develop new and advanced MIS procedures and instruments.
“Advancements in preoperative imaging and intraoperative navigation have allowed for greater application of MIS techniques, which often lead to faster recovery time versus conventional open procedures,” said Scott Reese, director of business development at Orchid Orthopedic Solutions, a Holt, Mich.-based provider of manufacturing solutions for the orthopedic market.
The entire healthcare ecosystem now recognizes the benefits of MIS surgical interventions, including lower infection risks. MIS also enables a greater variety of outpatient procedures, which significantly reduces overall healthcare costs.
“What excites me about the drive toward MI interventions is that success often depends on the ingenuity and creativity of designers and engineers,” said Scott Thielman, chief technology officer for Product Creation Studio, a Seattle, Wash.-based developer of consumer, medical, and industrial products. “We must take up the challenge to understand the complex needs of the surgeons and patients and build innovative tools that meet them. It’s a moon-shot industry focused on improving the lives of millions.”
That said, for some surgeons, MIS is not just about miniaturized components or the latest functions and technologies.
“The key to minimally invasive surgery is not just the length of the incision; it is also how the surgeon handles the soft tissues, and minimizes the risk of inflammation for the patient’s recovery,” said Joseph Assini, an orthopedic surgeon with OrthoONE, an orthopedic practice in Denver, Colo. “As a whole, minimally invasive surgery needs to be thought of as soft tissue management.”
Latest Trends in MIS
The term “minimally invasive” surgery was first used decades ago, when in the 1980s/early 1990s it might have meant a six-inch-long incision instead of a ten-inch-long incision, with surgery time reduced from three-four hours to one-two hours. Today, many joint replacements can be done within an hour and patients get up and ambulate the same day, which leads to a much shorter hospital stay. “There is an element of rapid recovery that, in my opinion, goes hand in hand with minimally invasive surgery,” said Assini.
An increasing number of procedures are shifting from traditional, open surgery to minimally invasive surgery. “For example, posterior deformity correction surgery can be invasive in terms of blood loss and muscle disruption, may involve numerous implants, and in general, takes a patient a long time to recover,” said Josh Rubin, senior group manager of engineering for Stryker’s Spine Division, a Leesburg, Va.-based division of Stryker, a medical technology company that provides orthopedic solutions in several fields, including neurotechnology and spine.
MIS innovation is driven by enabling technologies that allow surgeons to do more complex surgeries less invasively, especially with enhanced visualization and real-time feedback tools. Open surgical techniques are now becoming MIS procedures with the use of smaller and fewer access ports and high precision guides and navigational systems—especially in the spine market. Modern diagnostics can catch tumors earlier than ever, so surgeons want increased precision for biopsies and tissue resection so they can leave more healthy tissue untouched. “Robotic surgery continues to push the boundaries on how tools can be manipulated and tissues visualized beyond a diminutive access port,” said Thielman. “However, not every procedure demands a robotic option—surgeons also want increased capabilities in handheld tools as well.”
In the spinal market, navigated instruments, pre-operative planning, and predictive analysis, combined with state-of-the-art manufacturing through additive techniques, coupled with complex implant designs that can move and expand after implantation, “have all been the focus of innovation in MIS for spine,” said Seth R. Anderson, co-founder and chief innovation officer at Camber Spine Technologies, a King of Prussia, Pa.-based spine and medical technology company focused on tools and technologies for minimally invasive and minimally disruptive surgical procedures.
MIS designers rely on unique architectures and surface designs to maximize the spinal cage’s ability to fuse—even in compromised patients. They then develop minimally disruptive instruments and delivery systems that allow the surgeons to perform minimally invasive, single-position complex spine surgeries. These design firms and engineers sometimes collaborate with leading predictive analysis software companies to create “customized patient-specific implants with a predictable outcome measuring system, all while navigating every instrument and implant to the perfect location in the patient’s spine—through a tiny incision,” added Anderson.
A big trend in MIS is toward single-use devices.
“Although single-use devices are disposable, they still have highly sophisticated functions and are not trivial to make,” said Mike Treleaven, senior vice president of engineering for Tegra Medical, a Franklin, Mass.-based, full-service contract manufacturer of medical devices. “The challenge is in controlling costs for something that will never be used twice. It’s not that hard to design a device to perform a specific function; the hard part is figuring out how to manufacture it in a way that makes it practical and cost-effective to dispose of after one use.”
What OEMs Want
OEMs, serious about improving surgical outcomes and patient care by providing surgeons with devices and instruments with improved features and functionality, are eager for “precision tools, including handheld and articulating instruments, that offer greater bend, flexibility, and reach to aid in accessing small and hard-to-reach areas of the body through MIS,” said Steve Santoro, executive vice president for MICRO, a Somerset, N.J.-based full-service contract manufacturer of precision medical devices. “For handheld articulating instruments, the instrument handle must articulate relative to the instrument shaft, with proper control interface that allows the surgeon more natural dexterity while reducing shoulder, hand, or arm fatigue during surgery. Tip and position control need to be seamless.”
OEMs are focused on getting their MIS devices refined to the point where they can be manufactured efficiently and cost-effectively. Once they know the concept and characteristics they want in the device, they typically turn to contract manufacturers (CMs) with deep experience in MIS to work out the details. Because of design complexities, design for manufacturing (DFM) is essential for reducing design complexity and manufacturing costs.
“Today, because MIS devices are increasingly single-use and disposable, the customer will end up manufacturing a lot of them—sometimes tens or hundreds of thousands, or even more than a million,” said Treleaven. “This is when DFM and the efficiencies it brings can really pay off over the lifetime of a product.”
While almost anyone can ideate a design, that does not mean it will be something that can be made in high-volume production. DFM can help with the identification of raw materials and in creating processes that will optimize the manufacturing process of high-volume parts or products by lessening steps and ensuring standardization in parts quality—thereby shortening design and development cycles.
“With articulating instruments,” said Santoro, “contract manufacturers must understand the nature of these tools to effectively design functional, high-quality components, keeping in mind the number of times a tube must articulate, the degree of articulation, and how the instrument will interact with human anatomy. All of these considerations will impact material selection, laser-cut geometry, and what post-processing will be needed to achieve the desired shape and properties. DFM can be applied to match functional requirements to the optimal engineering process, whether that be machining, metal injection molding, or laser cutting.”
Over the past decade, the emphasis on risk management has led to increased documentation of critical quality characteristics. This is driving large amounts of capability settings, expanded tool sets for gathering data, and greater use of statistical process control (SPC) tools. “For example, data collection and the ability to understand trends is paramount when determining if your process is effective,” said Reese. “We use data collected from our process to find opportunity for improvements that help reduce the future occurrence of adverse results. The same is now possible with respect to surgical techniques as we automate procedures and pull in data that is collected throughout the patient treatment cycle.”
Even though they have turned the work over to their trusted CM partners, OEMs still are hungry for knowledge and insights into actual workflows, use scenarios, and user preferences. For example, hybrid operating rooms (those that combine real-time advanced imaging with traditional interventional capabilities) bring together a wide variety of tools and teams. “Understanding how they are used is actually non-obvious and requires investigation,” said Thielman. “As a result, we have been building more interaction mock-ups and conducting more user research than ever before.”
New Tools, Technologies, and Approaches
Endoscopes are now being used in conjunction with tools to access parts of the body that were not easily accessed before, serving as “working channels” that go beyond the role of just carrying lights and cameras. For example, endoscopes can be used for procedures such as tissue removal for biopsies or suturing. Also, although they have traditionally been reusable, there is now a market for disposable endoscopes. Traditional endoscopes are expensive to reprocess, repair, and autoclave to make them ready for reuse. Disposables reduce cleaning and maintenance costs and time. They also reduce infections from inefficient cleaning. “Particularly with COVID-19, it has become important to use single-use endoscopes for bronchial procedures to avoid hospital-acquired infections in COVID patients,” said Treleaven. “I expect to see an increased demand in single-use endoscopes that are cost-effective to manufacture.”
Surgeons are working with smaller tools to help minimize incisions, which require more precise navigation systems. Using technology for visualization has existed for some time, but now that visualization tools are more sophisticated, the adoption curve is increasing. “Navigation solutions are definitely advancing,” said Oliver Buchert, director of R&D for Stryker’s Spine Division. “Workflows are improving, computing power is getting faster, and visualization on the screen is getting more refined. Also, with augmented reality, surgeons can visualize the surgical plan before starting difficult procedures, helping to reduce some of the strain during MI surgery.”
An important goal in MIS is to get patients on their feet and moving as soon as possible, which is easier to do when there is minimal soft tissue damage that resulted from the surgery. An MIS system that effectively manages soft tissue is MicroPort Orthopedics’ Anterior Path, a cannula-based approach for total hip arthroplasty.3 “The biggest benefit we have seen so far with this procedure is that it allows us to use less dissection in a more optimal position on the patient’s body, so there is less soft tissue damage and smaller incisions, which allow patients to get moving faster,” said Assini. “These technologies are getting patients out of the hospital faster.”
Robotic surgery also has a big impact on the MIS market, with a growing number of procedures that can be completed or enhanced with robotics. While some robot-assisted surgery platforms were originally designed to handle procedures in areas such as cardiology, gynecology, or head and neck, they are now becoming more market-specific, including eye surgery, lung biopsies, and joint replacements. The ultimate goal is for robotic-assisted surgery to become so advanced that the use of expensive magnetic resonance imaging (MRI) and computed tomography (CT) scans will not be required.
“We are seeing more platforms that require parts for robotic systems,” said Reese. “Tolerancing is tighter because of the interaction between robots and the software that controls the robots—for example, robotic end effectors, arrays, and other navigated instruments. That makes our DFM a critical contribution to ensure a cost effective and timely product launch.”
StereoTaxis is a robotic magnetic navigation system where the external robotically controlled actuators actually simultaneously track and guide the tip of an intravascular catheter.4 “This creates a platform for precision interventions with a single access port, and perhaps no external incision in cases where a catheter could be delivered through an existing orifice,” said Thielman.
Stryker’s allows surgeons to do lateral surgery in controlled and versatile ways. “Generally, in lateral surgery, numerous X-rays are taken and instrumentation may encounter significant force when holding or retracting anatomical structures out of the way,” said Rubin. “This means the instruments need to be rigid without interfering with the images that are taken. To resolve both issues, we utilized carbon fiber in the Niagara retractor, a material that is strong yet also radiolucent.”
Assini believes the next step from robotics will be more advanced augmented realities. “Most of today’s robotics have been around for quite some time,” he said. “Using them almost moves away from rapid recovery or minimally invasive surgery, due to all the adjunct things necessary to make the robotics work. Moving forward, I believe patient-derived augmented reality systems will allow us to accurately place implants during a minimally invasive surgery, without the need for CT scans or accessory pins, both of which can lead to longer OR times and increased surgical costs."
Augmented Reality (AR)
Augmented reality and navigation technologies continue to advance in orthopedics, sometimes adopted from other fields of practice. As sophisticated as MIS is, it does present a narrow field of view, which can slow down the procedure and add to surgeon fatigue. This is especially true for complex procedures that require three-dimensional visualization, such as placing a medical device or the removal (or avoidance) of sensitive or critical tissues.
“AR allows the user to see the real world overlaid with a layer of digital content,” stated GlobalData Thematic Research in a Medical Device Network article. “The integration of AR into MIS means surgeons will not solely rely on endoscopes. Instead, AR projections of scans can be superimposed on patients in real-time to aid planning and increase accuracy when placing devices. For patients, this could reduce the chances of trauma and scarring while also accelerating postoperative recovery.”5
“I recently had the opportunity to use a Mimic simulation platform for robotic surgery and was astounded at the level of simulation the company had achieved for training purposes,” said Thielman. “A notable collaboration between FundamentalVR and HaptX will add another layer of convincing realism to training simulations. Surgeons of the near future will be able to log more simulation hours easily and conveniently to hone their skills and conduct surgical planning.”
Royal Philips recently announced its ClarifEye Augmented Reality Surgical Navigation system for minimally-invasive spine procedures.6 By combining 2D and 3D visualizations at low X-ray dose with 3D AR, the system provides live intra-operative visual feedback to support accurate placement of pedicle screws during spinal fusion procedures. Four high-resolution optical cameras augment the surgical field with 3D cone-beam CT imaging, without the need for additional X-ray. “The system combines the view of the surgical field with the internal 3D view of the patient to construct a 3D augmented-reality view of the patient’s external and internal anatomy,” stated Fabienne van der Feer, communications director for Philips Image-Guided Therapy in the Netherlands.
In another accomplishment, in June 2020, Frank Phillips, professor and director of the Division of Spine Surgery and the Section of Minimally Invasive Spine Surgery at Rush University Medical Center in Chicago, completed an augmented reality minimally invasive spine surgery using Augmedics’ xvision Spine System surgical guidance system.7 Phillips, who performed a lumbar fusion with spinal implants on a patient with spinal instability, could “see” the patient’s 3D spinal anatomy through the skin using a transparent near-eye-display headset. This device determines the position of surgical tools, in real time, and a virtual trajectory is then superimposed on the patient’s CT data, with the highest precision. The 3D navigation data was projected onto the surgeon’s retina using the headset, allowing him to simultaneously look at the patient and see the navigation data, without having to divert his gaze to a remote screen during the procedure.
“Having 3D spinal anatomic and 2D CT scan images directly projected onto the surgeon’s retina and superimposed over the surgical field takes spinal surgery to another level,” said Phillips. “Being able to place minimally invasive spinal instrumentation extremely accurately and efficiently, reducing surgical time and complication risk, is critical to improving outcomes for spinal surgery. Traditional surgical navigation platforms have been shown to improve accuracy of implant placement, however, using augmented reality allows for the advantages of traditional (non-3D) navigation, plus the ability to visualize the patient’s spinal anatomy in 3D through the skin.”
Moving Forward
Size and scale is a big challenge in MI innovation. It is relatively easy to zoom in and design parts in computer-aided design (CAD) that cannot be easily be built. “One tool that our development teams leverage is large-scale prototypes at 2x, 5x, or even 10x the final design size,” said Thielman. “Obviously we don’t use a 10x scale prototype on a human, but these larger sizes can teach us a lot about kinematic feasibility and are much easier and faster to fabricate and work with, compared to a prototype of normal size.”
It is easy to get caught up in the drive to make devices, components, and instruments that are more complex, multifunctional, and smaller, that push the edge of innovation. However, there is also something to be said for simplicity. Products that are less complex, with one or two main functions or applications, are easier to make, have less potential for failure, are lower cost, and easier to use—especially for disposable, single-use devices.
“We need to adjust our thinking from providing surgical instrumentation that support multiple surgical techniques,” said Reese. “In doing so, instruments can be slimmed down and designs fine-tuned for a specific approach/technique. We need develop procedure kits that are best-suited for MI as opposed to redesigned versions initially developed for open procedures. It is also important to consider alternate materials and manufacturing processes that allow for the miniaturization and accuracy of instruments.”
Assini maintains that minimally invasive surgery will really accelerate when all the key factors are brought together: appropriate soft tissue management training, implant delivery, 3D printing, and regional blocks from an anesthesia standpoint. “Considering all the components of a minimally invasive surgery will make MIS become the standard of care,” he said.
Thielman believes the difference between the possible and the impossible depends on how well understood the problem is and whether or not the right team has been deployed to solve it.
“OEMs often task our development teams with very challenging problems because we are comfortable thinking about solutions at different levels and are not bound by assumed constraints their internal teams might have adopted,” said Thielman. “An outside perspective can lead to lines of beneficial questioning that help cross the boundary of feasibility. Even when these projects don’t finish in a marketable device, they generally result in valuable technology that may open up new opportunities in the near future.”
Santoro agreed.
A client came to MICRO years ago to design a revolutionary handheld articulating device for use in laparoscopic surgery. It was going to be the first to articulate in a way that imitated a specific hand motion, which had not been done previously. Although the product did not reach long-term market value, the company’s intellectual property signified a breakthrough in medical technology innovation and was a precursor to robotics applications for surgery.
This experience improved how MICRO approaches its business, noted Santoro. “As a result, we established and reinforced the project management and complex supply chain operations we still use today, which propelled us on a growth trajectory as a full-service contract manufacturing operation. This experience also led to even greater education on the assembly of minimally invasive, articulating devices, which ultimately opened the door to the robotic-assisted surgery market—something we would not have been able to do without this initial project presenting a valuable learning opportunity.”
References
- bit.ly/odt210721
- bit.ly/odt210722
- bit.ly/odt210723
- bit.ly/odt210724
- bit.ly/odt210725
- bit.ly/odt210726
- bit.ly/odt210727
Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. His clients range from startups to global manufacturing leaders. He also writes a variety of feature articles for regional and national publications and is the author of five books.
