Cambridge-based Surgical augmented intelligence company Cydar Medical has recently announced its strategic collaboration with medical device company Medtronic. Under this pilot agreement, EV Maps software, previously exclusive to Cydar, will be applied to approxmately 40 new global sites, fusing Cydar’s flagship augmented intelligence tech with the services and case support which Medtronic can provide, the aim being to collectively improve patient care. The Cydar-owned EV Maps software is built to harness the latest in GPU (cloud graphics processing) computing, machine learning, and computer vision tech, to improve visualisation and decision making in surgical theatres and across the care spectrum in general. This tech is designed to enable clinicians to create advanced, patient-specific 3D maps in detail, to be used for image-based navigation, procedure planning, and post-op review, resulting in a reduction of radiation exposure to both the patient and clinical team, as well as providing increased delivery confidence. The pilot collaborative programme should also inform the future development of procedure planning, supported by the use of predictive analytics, and doing so by assessing risk factors such as endoleaks, sac regression probability, along with myriad other inidustry-related concerns. This collaboration marks a first for a medical tech company entering into a public, strategic partnership with digital endovascular technology in order to progress advanced aortic treatment decisions for the patient, and is representative of Medtronic’s continued commitment to innovative solutions within aortic care for both physicians and service users. Carolyn Sleeth, Vice President and general manager at Medtronic, had this to say regarding the merger: “Medtronic aims to revolutionise endovascular aortic treatment with digital solutions with this phased approach. By collecting data across the patient journey—before, during and after procedure—our goal is to provide analytic support to make our endovascular stent grafts ‘smart’”.

The Joint Replacement Division of medical device company Stryker recently announced the introduction of their Insignia® Hip Stem at the 2022 Annual Meeting of the American Academy of Orthopoaedic Surgeons, which took lace in Chicago. It has been designed to optimise patient fit and ease for the surgeon during implantation in muscle sparing approaches when conducting hemiarthroplasty and total hip procedures. Using Total Hip 4.1 software (allowing surgeons to capitalise on 3D CT-based data to capture the unique anatomy of each patient), the Insignia Hip Stem is compatible with Mako SmartRobotics™. Capitalising on Stryker’s SOMA database (Stryker Orthopaedics Modelling and Analytics), the company analysed data from more than 1,300 patient CT scans, and strived to design a device which effectively re-creates biomechanics for procedures in patient total hip replacement. A unique Tri-Stage™ Broach is offered by Insignia, which features 3 different tooth geometries, along with unique collar lengths (specific to size) and a superlative range of femoral offsets which have been designed to provide advanced fit and function over a wide breadth of of femoral morphology. Additionally, Insignia has a low profile shoulder and short stem lengths, which have been engineered to ease lateralization and insertion for use in muscle-sparing approaches such as direct anterior. Katherine Truppi, the Vice President as well as General Manager for Hips at the Stryker corporation, had this to say: "We're excited to now offer surgeons a collared, fully HA-coated hip stem designed for muscle-sparing approaches like direct anterior. Insignia joins Stryker's family of market-leading hip stems to complement our primary hip portfolio. Compatible with Mako SmartRobotics, Insignia delivers patient-specific fit, function and flexibility, allowing surgeons to further enhance patient outcomes." The Stryker company is is generating insights by enabling innovative products with digital capability, which help to drive improved operational, financial and clinical outcomes across the care profession. Stryker has called this Advanced Digital Healthcare. It includes the capability extension of Mako SmartRobotics™ to procedures which utilise the Insignia Hip Stem. Stryker’s digital technologies are striving to make healthcare operations more personalised, precise and efficient, by using simple and secured connected platforms. Throughout the 2022 Annual Meeting, the company will also be holding live demonstrations, as well as exhibitions, and a lunch symposium which features Insignia and Advanced Digital Healthcare. © Stryker Corporation © American Academy of Orthopaedic Surgeons

Many companies are currently struggling with disruptions to supply chains, and stock shortages. Highly regulated sectors, such as the medical device industry, have been majorly impacted by these supply disruptions. Many unprecedented challenges to the medical device industry were brought about by the COVID-19 pandemic. These included demand for respirators sky-rocketing, as well as a drastically increased need for PPE (Personal Protective Equipment), colossal staff shortages and disruptions to supply chains. Because each device needs an extensive review process, longer lead times are necessary within this sector for the approval and delivery of products, meaning even minor disruptions can cause major delays. When China was first hit by the virus, many component suppliers closed, meaning parts for essential devices, such as ventilators, were practically impossible to locate. The pandemic caused critical cash-flow issues, affecting SMEs (Small and Medium sized Enterprises) the most, although larger companies also faced an impact regarding the supply-demand ratio. More so than other manufacturers of electronics, medical device manufacturers need to work past an abundance of red tape in order to ensure regulatory compliance, meaning that if a component is lacking in supply, it can’t just be replaced with a similar device, as each component needs to be separately approved by a regulatory board. There are, however, various ways to lessen the impact of disruptions to supply chains. When a medical device is being designed, the creator should aim to be as vague as possible regarding the specs of the device’s components. This makes it easier to locate spare requirement-approved components without compromising safety or efficiency. Once the design stage has been passed, one way of combating the negative results of shortages is to keep track of stock, while increasing inventory wherever applicable – for example, if a component becomes popular and available, buy as much as possible within budget. As many companies were forced to close due to the pandemic, some component lines have become obsolete. As a result of regulatory measures set by organisations such as EMA, obsolescence issues are tough to avoid when dealing with the manufacture of medical devices. However, manufacturers are able to take certain steps to minimise the impact, such as studiously researching the predicted lifespan of potential components, along with keeping tabs on how long they’ve been available on the market. Manufacturers can also mitigate the risk of potential obsolescence by sourcing a vendor who can help in sourcing obsolete parts. Considering the ongoing pandemic, manufacturers are cautioned to implement good obsolescence management plans, and failure to do so could lead to losses of millions in down-time and replacement parts.

Having cleaved off its spinal and dental businesses to nascent independent company ZimVie, medical device company Zimmer Biomet is now focusing all its energy towards the remaining orthopaedic segments, which include the hip and the knee. The first move post-spinoff covers the knee and hip surgical businesses, and the company has launched its first software offering based on artificial intelligence. It’s called the WalkAI tool, and is built to analyse the patient’s progress in the first few months following hip or knee surgery, with the aim of making a prediction on whether or not they’re recovering at the expected pace. It has already been offered to some current users of Zimmer Biomet’s care management platform Mymobility, and will extend to a wider release by the end of the month. WalkAI connects to Mymobility, which constantly collates data from the Apple Watches and iPhones of post-op patients regarding their gait, along with numerous other physiological metrics. An AI algorithm then analyses this mobility data to predict the walking speed of the patient as far as 90 days following surgery. If these daily predications are falling short of the real-world data kept in Zimmer Biomet’s database, WalkAI is built to send an automatic notification to the healthcare providers of the patient through Mymobility, which can only be accessed by the clinician-facing side of the platform. WalkAI alerts them to the possibility that the patient may not be on target for recovery, giving the clinicians the option of tweaking the recovery before it veers too far off track. “Using a proprietary, Zimmer Biomet-developed artificial intelligence algorithm, WalkAI is the orthopedic industry’s first and only AI-based model to create daily, personalized predictions and identify patients who may be exceptions to typical recovery curves in an effort to help surgeons mitigate or minimize poor outcomes,” said Liane Teplitsky, president of global robotics and technology and data solutions at Zimmer Biomet. “WalkAI is built from our wealth of anonymized ZBEdge data and is the first model to demonstrate our unique capability to deliver actionable predictions by connecting real-world data and AI through ZBEdge products and experiences,” Teplitsky said. The software is going to be included in Zimmer Biomet’s ZBEdge suite, which launched last year. It combines digital health, robotic surgery, and app solutions for smartphones, which collaborate to form a highly comprehensive platform for digital surgery.