Showing all posts written by Chang Lim
On February 20, 2018, Johnson & Johnson Medical Devices Companies announced the acquisition of Orthotaxy, a privately-held developer of software-enabled surgery technologies, including a differentiated robotic-assisted surgery solution. According to Johnson & Johnson, this technology is currently in early-stage development for total and partial knee replacement, and the Johnson & Johnson Medical Devices Companies plan to broaden its application for a range of orthopaedic surgery procedures.
Orthotaxy was founded in Grenoble, France, in 2009 by robotics entrepreneur Stéphane Lavallée and has focused on surgical planning software that allows surgeons to plan implant placement on preoperative CT or MRI images. Orthotaxy has also developed patient-specific surgical guides that enable surgeons to insert surgical instruments and perform surgery in accordance with a planned strategy.
Orthotaxy currently has 3 pending published patent applications: U.S. Patent App. Nos. 14/667,623, 15/032,223, and 15/032,225. The ’623 application and the ’223 application are directed to methods for constructing a patient-specific surgical guide (e.g., element 1 in FIG. 4 of the ’623 application reproduced below) based on a patient’s 3-D medical image.
The ’225 application is directed to a method for planning a surgical intervention that comprises computing and displaying a pseudo-radiographic images along with the representation of an implant in a patient’s anatomical structure, as illustrated in FIG. 2 of the ’225 application reproduced below.
Regarding the acquisition, Company Group Chairman Ciro Roemer stated: “Our goal is to bring to market a robotic-assisted surgery technology that is an integral part of a comprehensive orthopaedics platform, delivering value to patients, physicians and healthcare providers across the episode of care. The team at Orthotaxy has significant expertise and passion in developing this platform, and we aspire to bring to market a differentiated technology that helps improve clinical outcomes and increases patient satisfaction.”
According to Johnson & Johnson, financial terms of the acquisition will not be disclosed.
On August 22, 2017, Emerging Implant Technologies GmbH (EIT) announced the acquisition of 22 patents and pending applications relating to 3D printed expandable spinal fusion cages based on living hinges from Dr. Morgan Lorio, a spinal surgeon based in Nashville, Tennessee. A recent published application relating to the subject matter can be found here. FIG. 3 of that application, said to illustrate a 3D model printing method, and FIG. 7 said to illustrate an intervertebral cage apparatus are reproduced below.
EIT describes itself as a German medical device manufacturer specializing in implants for spinal alignment. In July 2017, a news article noted that EIT received approval from the U.S. Food and Drug Administration (FDA) to commercialize its spinal interbody product offerings. Regarding EIT’s acquisition, Guntmar Eisen, co-founder and CEO of EIT, stated:
“This IP is our platform to take fully 3D printed fusion cages to the next level by adding functionality to our EIT cellular titanium® cages. This will give the surgeon more options intraoperatively, reduce inventory and support MIS techniques – and at the same time reduce cost of expandable cages.”
According to PRWeb, the first functional spinal fusion cages based on this patent acquisition will be launched in 2018.
The U.S. Food and Drug Administration (FDA) recently authorized the use of what it described as a “first-of-its-kind” medical device to treat infants for a birth defect called esophageal atresia, in which the upper esophagus is disconnected from the lower esophagus and the stomach. According to the FDA, babies with this condition require a feeding tube until surgery can be performed to connect the esophagus to the stomach.
According to Cook Medical, its pediatric esophageal atresia anastomosis device, called Flourish™, uses magnets to pull the upper and lower esophagus together, closing the gap and allowing food to enter the stomach. Dr. Mario Zaritzky, a pediatric radiologist at the University of Chicago Medical Center and one of the joint inventors listed on the patent on this technology (U.S. Patent No. 9,168,041), states:
“The idea was to create a minimally invasive procedure that could possibly be an alternative to surgery in selective pediatric cases. Any procedure that can potentially replace major thoracic surgery with a less invasive method should be considered before deciding to go to the operating room.”
Cook Medical’s press release notes that each of the 16 infant patients treated using this device had a successful joining of their esophagus with no remaining gap, within 3‑10 days after receiving the device.
According to the Cook Group, Cook Medical is a company that engages in “medical research and product development in minimally invasive medical device technology for diagnostic and therapeutic procedures.”
Sportbrain Holdings LLC (“Sportbrain”) is a company that was previously engaged in the business of selling fitness trackers. Sportbrain recently sued eight smartwatch manufacturers for alleged infringement of its U.S. Patent No. 7,454,002 (“the ’002 patent”), which describes a method of capturing and analyzing personal data of a user and providing feedback to the user based on the analysis. FIGS. 1B and 3 of the ’002 patent are reproduced below. These defendants included Jawbone, Frédérique Constant, Apple, Michael Kors, HP, BLOCKS Wearables, Razer, and New Balance. The complaint in each case identified a smartwatch or fitness tracker (having an accelerometer, motion sensor, pedometer, calorie counter, and/or gyroscope) and its companion app as the accused product.
A day after Sportbrain filed its most recent lawsuit, the Patent Trial and Appeal Board (PTAB) granted a petition for inter partes review (IPR) of the ’002 patent. The IPR petition had been filed on July 22, 2016 by Unified Patents. According to its website, Unified Patents is a member-based organization seeking to deter non-practicing entity activity in specific technology areas. Unified Patents argued in its petition that the claims of the ’002 patent were obvious over four different combinations of prior art references.
In instituting the IPR proceeding, the PTAB concluded that the petitioner’s evidence established a reasonable likelihood that the combinations of prior art references would render all of the claims of the ’002 patent obvious.
The ’002 patent is now the subject of over 40 active cases brought by Sportbrain.
The Food and Drug Administration has issued a statement announcing that the FDA and representatives from the medical device industry and laboratory community have reached an agreement in principle on proposed recommendations for the fourth reauthorization of the medical device user fee program (MDUFA IV).
Under the new draft agreement (to be published in the coming weeks), the FDA would be authorized to collect almost $1 billion in user fees over five years starting in October 2017. This funding would provide critical resources to the FDA medical device review program.
The director of the FDA’s Center for Devices and Radiological Health, Jeffrey Shuren, M.D., has commented:
This draft agreement represents a substantial investment in the future of the agency’s medical device program and reflects the efforts the FDA has made to meet or exceed its performance goals and to help speed patient access to safe and effective medical devices. This funding will also improve the collection of real-world evidence from different sources across the medical device lifecycle, such as registries, electronic health records, and other digital sources.
First established in 2002 to provide the FDA with the resources necessary to better review medical devices, device user fees have helped the FDA increase the efficiency of regulatory processes with a goal of reducing the time it takes to bring safe and effective medical devices to the U.S. market. These fees, which range from the thousands to hundreds of thousands depending on the type of review required, are paid by medical device companies when they register their establishments and list their devices with the agency or submit an application or a notification to market a new medical device in the U.S.
The current legislative authority for the medical device user fee program expires on October 1, 2017, and new legislation will be required for the FDA to continue collecting user fees for the medical device program in future fiscal years.
Details of the draft agreement will be published for public comment in the coming weeks, and the final recommendations are scheduled to be delivered to Congress in January 2017.
An international team of researchers has recently showcased a tiny origami robot that can be swallowed and controlled by external magnetic fields. According to Daniela Rus, an electrical engineering and computer science professor and director of the Computer Science and Artificial Intelligence Laboratory at MIT, the robot can remove foreign objects, patch wounds, or deliver medicine at designated locations. Ms. Rus further states:
It’s really exciting to see our small origami robots doing something with potential important applications to health care.
According to IEEE Spectrum, the new robot builds on the team’s previous work with origami robots that was shown at ICRA in 2015. The group’s paper explains that, like its predecessor, the robot consists of two layers of structural material sandwiching a layer of shrinkable material that shrinks when heated. ArsTechnica reports that the new robot uses biocompatible materials to maximize the potential applications inside the human body – indeed, numerous different materials were tested before the team settled on dried pig intestines (similar to that used in sausage casings) for the structural material and a biodegradable shrink wrap (Biolefin) for the shrinkable material.
The robot holds a permanent magnet that responds to changing magnetic fields outside the human body. According to TrendinTech, after being swallowed in a dissolvable capsule, the robot can be controlled to, for example, remove a swallowed button battery, an ongoing problem with about 3,500 reported cases per year in the U.S. alone.
Although the project is still in its preliminary stages, Professor Rus and her team explain in their paper’s Discussion & Conclusion that they intend to conduct in vivo experiments and eventually add sensors to the robot and redesign the robot so that it can control itself without the need of an external magnetic field. A video showing the robot in action can be found here.
The Food and Drug Administration recently issued a draft guidance for managing cybersecurity in medical devices. The guidance document provides the FDA’s postmarket recommendations for monitoring, identifying, and addressing cybersecurity vulnerabilities in medical devices. According to the FDA:
A growing number of medical devices are designed to be networked to facilitate patient care. Networked medical devices, like other networked computer systems, incorporate software that may be vulnerable to cybersecurity threats. The exploitation of vulnerabilities may represent a risk to the safety and effectiveness of medical devices and typically requires continual maintenance throughout the product life cycle to assure an adequate degree of protection against such exploits. Proactively addressing cybersecurity risks in medical devices reduces the patient safety impact and the overall risk to public health.
Recognizing that medical devices and the surrounding network infrastructure cannot be completely secured, the FDA encourages manufacturers to establish a defined process to systematically conduct a risk evaluation and determine whether a cybersecurity vulnerability affecting a medical device presents an acceptable or unacceptable risk. According to the guidance document, such a process should focus on assessing the risk to the device’s essential clinical performance (i.e., performance that is necessary to achieve freedom from unacceptable clinical risk, as defined by the manufacturer) by considering: (1) the exploitability of the cybersecurity vulnerability, and (2) the severity of the health impact to patients if the vulnerability were to be exploited. Recommendations regarding timely remediation and reporting of such vulnerabilities are also provided.
Comments on the draft guidance should be submitted by April 21, 2016 to ensure consideration. Instructions on how to submit comments can be found here.