Showing all posts written by Nathan Reeves
Mr. Reeves received his Bachelor's degrees from Walla Walla University, where he also conducted research in materials science. Mr. Reeves received his J.D. from Harvard Law School, where he worked as a clinical intern in the school's Cyberlaw Clinic and as Managing Editor of the Harvard Journal of Law & Public Policy.
Mr. Reeves joined the firm in 2015. He has experience representing clients in fields ranging from software and web services, to satellite communications, to media and entertainment. Click here to read full bio
The FDA has announced new goals to help modernize its procedures and respond to new technologies. In a blog post by FDA Commissioner Scott Gottlieb, M.D., the agency expressed new priorities to help modernize clinical trials for medical devices and develop standards for new technologies like artificial intelligence.
According to Gottlieb, clinical trials “are becoming more costly and complex to administer” while “new technologies and sources of data and analysis make better approaches possible.” In order to take advantage of these better approaches, Gottlieb pointed to the FDA’s Breakthrough Devices Draft Guidance, which proposes streamlined procedures to develop flexible clinical trial designs for important medical devices. This will allow the FDA to “evaluate . . . innovative devices more efficiently.” Six breakthrough devices have already been cleared using this program.
Additionally, Gottlieb discussed the FDA’s new goal of enabling the use of “real-world evidence” to support decisions to approve devices. According to Gottlieb, “[r]eal world evidence can help answer questions that are relevant to broader patient populations or treatment settings where information may not be captured through traditional clinical trials.” The FDA is helping to design several proof-of-concept trials that utilize real-world evidence.
Finally, Gottlieb discussed the FDA’s role in dealing with new and emerging technologies. In particular, Gottlieb discussed artificial intelligence, which “holds enormous promise for the future of medicine.” Medical artificial intelligence models are currently in development and the FDA recently approved an AI algorithm for detection and treatment of distal radius fractures. According to Gottlieb, the FDA is exploring ways to handle and evaluate the kinds of data that are relevant to AI performance and safety, hoping to “enable a transparent benchmarking system for AI algorithm’s performance.”
Gottlieb concludes that the FDA has “undertaken a comprehensive effort to make sure that our organization and policies are as modern as the technologies we’re being asked to evaluate, and that we’re able to efficiently advance safe, effective new innovations.”
The FDA has recently approved Embrace, a smart watch designed to monitor epileptic patients for seizures, according to a press release. According to the press release, the device uses machine learning to monitor patients for dangerous seizures, including grand mal or generalized tonic-clonic seizures. These seizures cause loss of consciousness and can cause a state of confusion in patients for periods of time after they finish. Embrace is said to allow medical professionals to gain information about when seizures happen with higher accuracy than was previously available and can also alert caregivers when patients are having seizures. During a seizure, the watch vibrates, LEDs light up, and an alert is sent via Bluetooth to the patient’s smartphone. An app on the phone can then send a distress signal via text or phone call to one or more caregivers.
The device was previously approved by the European Medical Agency in April 2017. According to articles, the technology was originally developed at MIT in 2007 and was funded by a successful crowdfunding campaign in 2014, which netted the maker, Empatica, more than $800,000. Embrace went on sale shortly after that campaign and has been available commercially but was not previously available as a medical device in the U.S.
The FDA’s approval was reportedly based on a clinical trial of 135 patients over 272 days. Each of the patients had epilepsy and were simultaneously monitored by EEG and using Embrace. The trial recorded over 6500 hours of data, including 40 seizures, which Embrace detected with 100% accuracy.
Matteo Lai, Co-Founder and CEO of Empatica, touted Embrace’s design and functionality, saying “We wanted to design the world’s first medical device that could win a design award, while being used as a lifesaving product.” Embrace is said to be the first smart watch to be approved by the FDA for neurological monitoring.
On August 29, the FDA announced a recall of 465,000 implantable pacemakers, citing concerns that hackers may be able to take control of the pacemakers’ settings. This would open patients up to danger from improper pacing or rapid depletion of the devices’ batteries, according to the FDA’s statement. Instead of removing and replacing the pacemakers, the recall is designed so that doctors will install a firmware upgrade that removes the vulnerability.
Newsfactor reports that there have been no reported exploits of the vulnerability and no devices have yet been compromised.
The recall highlights that medical device manufacturers are beginning to take a more focused approach to cybersecurity. Mac McMillan, CEO of privacy and cybersecurity firm Cynergistek, told Modern Healthcare that “If devicemakers didn’t already have developers sitting around looking at cybersecurity, they now have to incur the costs of making sure their devices stay current. In the past, they’ve developed devices and put them on the market and moved onto the next device. This is a new thing for them.”
Mike Kijewski, CEO of medical device security company Medcrypt, also suggested that the FDA should update its regulations to help medical device companies stay on top of cybersecurity threats. “If the FDA can say you’re just doing the update for cybersecurity and the changes are minimal and the functionality of the device isn’t changing, they can make the update happen faster,” Kijewski suggested.
Canada’s equivalent of the FDA, Health Canada, is still looking into the vulnerability and its proposed solution, and has set a target of 75 days to resolve the situation.
The FDA has announced that it will create a new unit responsible for overseeing digital health products. According to Bakul Patel, the Associate Center Director for Digital Health at FDA, the agency is working to define “what clinical validation looks like for software,” and will consider creating new premarket approval or clearance procedures for digital health products.
As Patel stated in an interview with Wired, the new unit will aim to keep up with emerging technology that uses artificial intelligence and machine learning to diagnose and treat patients. Patel noted that this kind of technology creates new and difficult challenges for regulators, who must figure out how to ensure that patients remain safe while keeping up with the increasing complexity and tighter release schedules that these new kinds of software bring.
“We’ve been trying to translate the current regulation paradigm for digital . . . [b]ut what we have today and what we’re going to have tomorrow are not really translatable. We need to take the blinders off, start with a clean sheet of paper.” –Bakul Patel, Associate Center Director for Digital Health, FDA
Wired reports that Patel is working to develop new models for testing and approving digital health products. Patel told Wired that “the idea is to get safe products to market faster, by having people compete on excellence rather than compliance.” One way the FDA might do this is by providing faster review with lower scrutiny for manufacturers with a long track record of safety and compliance.
According to FierceHealthcare that the new digital health unit will be part of the FDA’s Center for Devices and Radiological Health. While the new unit won’t be officially open until October, hiring of key staff is underway. Wired notes that the unit will be funded by the Medical Device User Fee program.
The Washington State Supreme Court recently released its decision in Taylor v. Intuitive Surgical, Inc. where it held that Washington law requires medical device manufacturers to warn hospitals that purchase their products of dangers associated with those products. According to Bloomberg BNA, Washington is the first state to impose such a requirement. As a result, the decision may have a significant effect on medical device manufacturers and their practices. SciPol reports that industry groups, such as the Medical Device Manufacturers Association and the National Association of Manufacturers, believe that the decision may increase the risk for device manufacturers to introduce new products and may lead to reduced innovation in the medical device space.
The case involved Intuitive Surgical‘s da Vinci robotic surgical system, which Intuitive explains enables surgeons to perform delicate and complex operations through a few small incisions. da Vinci is powered by robotic technology that allows the surgeon’s hand movements to be scaled, filtered and translated into precise movements of the EndoWrist instruments working inside the patient’s body.
The Plaintiff in the case, Mr. Taylor, claimed to have suffered complications during and as a result of surgery in which the da Vinci surgical system was used. As a result of those complications, Mr. Taylor sued his surgeon and his medical practice and Intuitive Surgical on various theories including “product defect, breach of warranty, breach of contract, violation of Washington’s Consumer Protection Act . . . , negligence, and product liability.” Mr. Taylor claimed that Intuitive Surgical had a duty to warn the hospital about the dangers that are associated with the da Vinci System. However, during trial, the court refused to instruct the jury that Intuitive Surgical had any such duty to warn the hospital. Mr. Taylor appealed the jury’s verdict for Intuitive Surgical.
On appeal, the Washington Supreme Court did not decide the merits of many of Mr. Taylor’s claims. Instead, it held that, pursuant to the Washington Product Liability Act (“WPLA”), manufacturers have a duty to warn hospitals about the dangers of their products and that, as such, the lower court erred when it did not instruct the jury on that duty. According to the Court, warnings must be provided to the purchaser of a product, which in Mr. Taylor’s case was the hospital. The Court vacated and remanded the case for further consideration consistent with its holdings.
The ruling has been met with mixed reactions. According to Mr. Taylor’s attorney, the decision “brings the law in line with the reality of modern medicine.” But, as Bloomberg notes, both the Medical Device Manufacturers Association and the National Association of Manufacturers cautioned that adopting a new warning requirement could chill medical innovation and harm patients overall. It remains to be seen whether other states will adopt similar rules.
According to the press release, in exchange for the Hospira division, which Pfizer acquired in September 2015, Pfizer will receive $600 million in cash and $400 million in ICU Medical stock. After the acquisition, Pfizer will own approximately 16.6% of ICU. Furthermore, Pfizer will have the right to nominate one director to ICU’s board as long as it holds 10% or more of ICU’s stock.
According to the Hospira Infusion Systems website, its products include IV pumps, solutions, and devices. Vivek Jain, ICU Medical’s CEO, explained that:
“By acquiring the Hospira Infusion Systems business, currently our largest single customer, we create a pure-play infusion business with the focus and scale to compete globally, eliminate our single customer concentration issue, and have a significant value creation opportunity as a much larger company.”
Jain further noted that Hospira has been using ICU’s licensed technology for more than 20 years.
Reuters reported that ICU Medical’s shares jumped 14 percent after the news.
The FDA recently approved INSIGHTEC’s Premarket Approval (“PMA”) application for ExAblate Neuro, a device designed to treat essential tremor. Essential tremor is the most common kind of tremor; it commonly affects the hands, but can also affect other parts of the body. The ExAblate Neuro uses magnetic resonance imaging (MRI) to guide a focused ultrasound beam to destroy a small part of the thalamus, a section of the brain thought to control some involuntary movements. According to INSIGHTEC’s website, the “revolutionary non-invasive treatment offers a life changing treatment to patients with essential tremor, tremor dominant Parkinson’s Disease and neuropathic pain.”
According to the FDA press release, the procedure works as follows:
To determine if the ExAblate Neuro treatment is appropriate, patients should first have MR and computerized tomography (CT) scans. Those undergoing treatment with the MRI-guided device lie in an MRI scanner that takes images to help a doctor identify the targeted area in the brain’s thalamus for treatment. Treatment with transcranial focused ultrasound energy is administered with incremental increases in energy until patients achieve a reduction of tremor. Patients are awake and responsive during the entire treatment.
As noted in the press release, the FDA relied on a recently-presented study of the device’s effectiveness. 76 patients exhibiting symptoms of essential tremor participated in the study. 56 patients received the ExAblate Neuro treatment, whereas 20 patients received a placebo treatment. Patients receiving INSIGHTEC’s ExAblate Neuro treatment showed a nearly 50% improvement after three months. However, Patients who received the placebo treatment exhibited no improvement, and some experienced a slight worsening in symptoms. Patients receiving the placebo treatment were able to “cross over” and join the treatment group after three months had elapsed. All patients (including the “cross over” patients) who received the ExAblate Neuro treatment retained about 40% improvement after twelve months. The study’s findings were presented at the 20th International Congress of Parkinson’s Disease and Movement Disorders.
Unfortunately, patients who cannot undergo an MRI, such as those with implantable metallic devices, are ineligible for the treatment.
A roundup of the FDA’s Quality System program for 2015 shows 2,104 inspections, compared to 2,213 in 2014, a decrease the FDA calls “slight.” The Quality System program began in the mid-1990s and is designed to ensure ongoing safety and quality in the design, manufacturing, packaging, labeling, storing, and servicing of medical devices. The FDA can inspect facilities used by medical device manufacturers as well as issue warning letters to potentially non-compliant manufacturers under the regulation.
Despite the drop of around 5% in inspections overall, inspections of non-U.S. manufacturers rose from 594 in 2014 to 620 in 2015. China and Germany accounted for most of the foreign inspections, with 126 and 90 respectively. No other country had more than 50 inspections last year. The FDA noted that it has “been working toward increased foreign inspections as foreign manufacturer inventory has been growing rapidly.”
The number of warning letters issued by the FDA under the Quality System program remained the same from 2014 to 2015, at 121 warning letters. The number of warning letters issued by the FDA had previously been decreasing by about 20 per year.
The FDA hopes that by releasing this data, industry can “improve device quality by sharing common observations from inspections” and avoid receiving warning letters.
The report was prepared by the FDA’s Center for Devices and Radiological Health, which promotes safety and innovation in the medical device field.