Showing all posts written by Angela Dremann
Ms. Dremann practices in intellectual property law, with a focus on patent prosecution and client counseling, particularly in the area of medical devices.
Prior to joining the firm, Ms. Dremann worked at Brinks Gilson & Lione, a Chicago-based intellectual property law firm. She is admitted to practice before the Illinois Supreme Court, the U.S. District Court for the Northern District of Illinois, and the U.S. Patent and Trademark Office. Click here to read full bio
A report appearing in the December 2017 issue of Value in Health, (a journal of the International Society for Pharmacoeconomics and Outcomes Research) concluded that assessments of high-risk medical devices in the European Union were of low quality – based on evidence from studies that were methodologically inadequate.
The authors of the report reviewed 1,376 health technology assessment reports (“HTAs”) of high-risk medical devices (“MDs”) that were filed between 2010 and 2015. Of the 93 that were eligible for analysis, the researchers rated each of these studies on the following criteria:
- Evidence base
- Was the evidence in the HTA based on submissions by the manufacturer, data identified by an independent source, or both?
- Type of evidence
- Was the evidence in the HTA based on “direct” (e.g. head-to-head trials) or “indirect” evidence?
- Direct evidence from well-conducted randomized controlled trials were seen as providing the most valid estimates regarding the effectiveness of competing health care interventions.
- Level of evidence
- Further considerations of scientific evidence
- What were the total number of studies considered in each HTA report?
The report ultimately found that while almost all assessments considered “based their evaluation on direct evidence from independent systematic literature searches, good-quality data were scarce.” The report further stated that “our findings illustrate that even if systematic reviews and RCTs [randomized controlled trials] were available for assessment, most of these studies showed an unclear or high RoB [risk of bias] according to the specific tools used in their reports.”
The report ultimately concluded that:
In the EU countries, MDs are essentially regulated in the same way they have been since the 1990s. This means that high-risk MDs can enter the market and be used in humans without the requirement of evidence from robust clinical studies. As a consequence, scientific evidence prior to market approval of high-risk MDs is often based only on evidence from studies that were methodologically inadequate.
In summary, the report proposed that “additional changes are necessary, specifically with regard to the marketing authorization process of MDs, with stricter quality requirements based on methodologically robust trials, possibly in combination with other evidence sources.”
According to a regenerative medicine article published online on August 07, 2017 in the journal Nature Nanotechnology titled “Topical tissue nano-transfection mediates non-viral stroma reprogramming and rescue”, Researchers at the Ohio State University Wexner Medical Center and College of Engineering have developed a technology that has the potential to generate any cell type of interest for treatment within a patient’s body. According to the article, the researchers call their technology Tissue Nanotransfection (“TNT”), and state that a chip-sized device may be used to repair injured tissue or restore the function of aging tissue. This can include, for example, organs, blood vessels and nerve cells.
Dr. Chandan Sen, the director of Ohio State’s Center for Regenerative Medicine & Cell Based Therapies and the executive director of Ohio State’s Comprehensive Wound Center states that “by using our novel nanochip technology, injured or compromised organs can be replaced. We have shown that skin is a fertile land where we can grow the elements of any organ that is declining.”
Sen further states that “This is difficult to imagine, but it is achievable, successfully working about 98 percent of the time. With this technology, we can convert skin cells into elements of any organ with just one touch. This process only takes less than a second and is non-invasive, and then you’re off. The chip does not stay with you, and the reprogramming of the cell starts. Our technology keeps the cells in the body under immune surveillance, so immune suppression is not necessary.”
According to the Nature Nanotechnology article, the TNT chip-sized device has two major components – (1) a nanotechnology-based chip that sits on the skin, and (2) biological cargo contained within to affect the tissue underneath.
As illustrated in the figure above, the chip is said to deliver pre-programmed DNA or RNA non-invasively into living skin cells using a high-intensity, focused electric field and converting it into whatever type of cells chosen. “This technology does not require a laboratory or hospital and can actually be executed in the field,” Sen said. “It’s less than 100 grams to carry and will have a long shelf life.” “We are proposing the use of skin as an agricultural land where you can essentially grow any cell of interest,” Sen said.
According to the article, initial testing on mice has been promising. The researchers reported that they were able to reprogram skin cells into vascular cells on a mouse that had a badly injured leg with no blood flow. The article noted that as shown in the figure below, after one week of treatment, blood vessels appeared around the leg and within two weeks the leg had been completely restored.
Furthermore, the article noted that a mouse that suffered a stroke regained neurologic function, demonstrating that this technology could also be applied to organs and nerve cells.
According to researchers, the aforementioned technique is said to be unique as it skips the usual intermediary step of creating pluripotent stem cells. Furthermore, the article notes that because the process is non-invasive and the reprogrammed cells are part of the patient’s body, there are no concerns regarding immune suppression.
Since 2012, Inter Partes Review (“IPR”) has emerged as one of the most significant new procedures in patent law. An IPR is a proceeding in the Patent Office, and allows a party to challenge an issued patent on certain prior art grounds. If successful, the challenging party can invalidate some or all of the patent claims. IPRs can be an alternative to challenging a patent in court, although oftentimes IPRs are filed while a patent lawsuit is also ongoing.
Here at Knobbe Medical, we continue to track and identify Medical Device IPRs that have been filed.Below is a summary of the 315 Medical Device IPRs Knobbe Medical has identified between December 22, 2012 – November 30, 2016:
Cases Filed – 315
- Decision Regarding Institution Made – 222
- Pending Institution Decision – 63
- Instituted and Subsequently Settled/Patent Owner Terminated – 51
- Instituted and Pending Final Decision – 45
- Not Instituted – 73
- Final Decision Reached – 53
- Settlement/Patent Owner Termination Prior to Institution Decision – 30
- Average Time for Decision of Institution to be Reached = 181 days
- Average Time for Final Decision to be Reached = 529 days
As the number of IPR filings in the medical device industry continues to increase, this procedure is proving to be a powerful tool for companies and patent owners to challenge issued patents.
Please note that determining what is considered a “Medical Device IPR” was subjective and the data above is only intended to provide a general overview of medical device IPRs filed in the last couple of years, is based on public databases, and may not be accurate or complete.
Even if you are already familiar with IPRs, the following videos illustrate how actual IPR practitioners might approach some common issues.
Introduction to IPRs
Learn or refresh yourself on the basics of IPRs. Topics include:
- An overview of the patenting process and ways in which patent disputes can arise
- A description of how the Patent Trial and Appeal Board (PTAB) is structured and how IPRs function
- High-level strategic considerations for both patent holders and petitioners to help position themselves for success throughout the IPR process
Strategic Insights for IPRs
Hear insights into the process of successfully managing IPRs. Topics include:
- A clear description of the timeline associated with an IPR proceeding
- A walk-through of an IPR proceeding, including a trial
- What skills a successful IPR practitioner must possess to ensure the best representation at the PTAB
Security firm InfoArmor published a report in late July 2016 stating that a group of attackers infiltrated American health care institutions, stole at least 600,000 patient records and attempted to sell more than 3 terabytes of that associated data. In an interview with eWeek, chief intelligence officer Andrew Komarov noted that the hackers he investigated were able to compromise different health care institutions such as private clinics, vendors of medical equipment, and suppliers. Once inside the compromised systems, the hackers were able to take personally identifiable information and medical data, including imaging data (as shown to the right).
Komarov’s research should come as no surprise in view of a report issued by the Brookings Institute in May 2016 reporting that 23% of all data breaches occur in the healthcare industry. In fact, nearly 90% of healthcare organizations had some sort of data breach between 2013 and 2015, costing the healthcare industry nearly $6.2 billion.
According to a report done by Bloomberg BNA, while a number of legal mandates exist (e.g. the Health Insurance Portability and Accountability Act (HIPAA), the Health Information Technology Certification Program, and the Food and Drug Administration’s (FDA) premarket review), the existing guidelines are limited. Furthermore, medical devices face certain unique cybersecurity pitfalls. For example, while HIPAA applies to protect health information regardless of where it’s stored, protected health information that exists on disposed of or nonfunctional medical devices can be overlooked.
Connected medical devices (i.e., medical devices that can transmit information through the internet or a networked system) also pose unexpected risks and challenges. For example, the ability for hackers to remotely access connected medical devices can hypothetically result in significant threats to patient health and safety. A 2012 episode of the television show Homeland featured a character hacking into and manipulating the pacemaker of the fictional vice president. While such situations seem far-fetched, in an interview on “60 Minutes,” it was revealed that Vice President Dick Cheney’s doctor had actually disabled the wireless functionality of his heart implant, fearing that it might be hacked in an assassination attempt.
While such fears may seem fueled by paranoia, recent studies have shown that such security threats may be a real concern. Bloomberg Businessweek reported in November 2015 that the Mayo Clinic engaged a number of high-profile “white hat” hackers to conduct a study of cybersecurity vulnerabilities in their medical devices. These “white hat” hackers worked on a number of different medical devices, including things such as cardiac monitors, infusion pumps, and hospital beds. In one alarming example, one hacker was able to gain control of an infusion pump – the Hospira Symbiq Infusion System – and was able to remotely cause it to deliver a potentially lethal dose of medication. Shortly thereafter, the FDA issued a safety notice recommending a recall and the stopped usage of the aforementioned pump.
With increasing concerns about cybersecurity, as discussed on this blog previously, the FDA is currently seeking comment on proposed guidelines that outline when software changes to medical devices would require manufacturers to submit a premarket notification.
FDA’s MedWatch recently posted a voluntary recall issued by Cook Medical recalling 4.1 million catheters using Cook’s Beacon Tip technology. The recall was initiated after 30 Medical Device Reports were received by the FDA. A full list of affected catheters is provided here. Previously, a recall for the Beacon Tip was issued in July 2015, which was subsequently expanded in October 2015.
Cook Medical’s Beacon Tip is a sizing catheter with a radiopaque tip that provides visibility within the vascular system. The FDA’s recall notice states that the affected catheters suffered from polymer degradation of the catheter tip, which resulted in tip fracture or separation, in at least some cases.
The FDA recall explains that, the degradation could result in:
loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
According to Cook Medical, storage temperature, room humidity and the use of certain whole room decontamination products may contribute to the problem.
In a previous report, Cook found that complaints regarding the degrading tips were isolated to hospitals using new sterilization techniques. The sterilization techniques involved vaporized hydrogen peroxide that was used to clean operating rooms of patients infected with resistant bacteria, such as MRSA. According to the hospital, the affected catheters were left out in the operating room during the sterilization process. However, Cook states that there may be other undetermined contributors to the problem and will continue to investigate.
The California start-up Scanadu‘s website touts that a real-world and functional version of the famous prop is now available for those who backed it on the international crowdfunding site Indiegogo. The company’s website states that it began shipping its test version earlier this month and users have been posting images of the device on social media.
Designed by Walter De Brouwer, a Belgian entrepreneur, the device is called the “Scanadu Scout.” According to Scanadu’s website, this hockey puck-shaped device provides “valuable data about your body . . . just by placing it on your forehead.”
- US Patent Application No. 14/374,515 “Spatial Resolution Enhancement in Hyperspectral Imaging”
- US Patent Application No. 14/374,518 “Hyperspectral Imaging Systems, Units, and Methods”
- US Patent Application No. 14/350,798 “Automated Personal Medical Diagnostic System, Method, and Arrangement”
- US Design Patent Application No. 29/450,721 “Diagnostic Test Paddle”
In a speech in Cambridge on December 11, 2014 (which was reported on in an article in the Boston Business Journal), Dr. Bill Maisel– the science chief of the U.S. Food and Drug Administration’s center to oversee approval of medical devices – addressed long-standing complaints that the time to approve trials and new devices was too long.
According to the Boston Business Journal, Maisel spoke before members of MassMEDIC, Boston’s advocacy group for the medical device industry, and his speech was part of a daylong FDA Update event intended to give an overview on hot topics in regulatory approval in 2015.
The article reported that the FDA is on track to “meet or exceed” its own deadlines for approval and has worked in the past 2-3 years to cut half of its backlog of applications. As for the coming year, Maisel was quoted as stating that his priority is “strengthening the clinical trial enterprise.”
The article also stated that the FDA has cut down the average length of time of the submission of an application to conduct a clinical trial to decision by 75% in the past three years (from an average of 400 days to 2011 to 101 days this year).
According to the article, Maisel also remarked that the FDA was taking other steps to expedite approvals including:
- reviewing categories of devices considered high-risk to see if any of them can be downgraded; and
- the possibility of an “Expedited Access PMA” program – an accelerated approval program for companies developing products designated as high risk but in areas with significant needs.
More information for the FDA’s Monthly PMA (Premarket Approval)/PDP (Product Development Protocol) Decisions and Summary Statistics can be found here.
Butterfly Network, Inc. announced on November 3rd that it has raised over $100 million to commercialize a medical device designed to reduce the cost of real-time, three-dimensional imaging and treatment. Butterfly states that it is a start-up of healthcare incubator 4Combinator.
According to the press release, Butterfly Network aims to transform medical imaging and non-invasive surgery by leveraging advances in semiconductors, deep learning and cloud computing. Butterfly Network further states that, along with its founder Dr. Jonathan Rothberg, the company has assembled a group of physicists and engineers from MIT Lincoln Laboratories’ through-wall radar team.
“Spending 18 percent of our GDP, or $10,000 per person, per year, on healthcare is
unsustainable and out of touch with the needs of the rest of the world,” said Dr.
Rothberg. “At 4Combinator, our mission is to democratize healthcare by launching
companies, building devices, and combining advances in biology, semiconductors, and
artificial intelligence. We built Butterfly to transform the way we image the body and
Butterfly Network identifies itself as the sixth company founded by Dr. Rothberg, who previously worked on high-speed DNA sequencing technology.
According to USPTO records, Butterfly has filed a number of patent applications relating to portable imaging devices. These include:
- US Publication 2014/0300720 – “Portable electronic devices with integrated imaging capabilities”
- US Publication 2014/0180176 – “Image-guided high intensity focused ultrasound and related apparatus and methods”
- US Publication 2014/0243514 – “Transmissive imaging and related apparatus and methods”