Blog Tag: Medical Device

FDA Draft Guidance for Fostering Medical Device Improvement Using the Voluntary Improvement Program

On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s Voluntary Improvement Program (“VIP”). The draft guidance, Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program, can be found here.  According to the FDA:

“The VIP is a voluntary program facilitated through the Medical Device Innovation Consortium (MDIC) that evaluates the capability and performance of a medical device manufacturer’s practices using third-party appraisals, and is intended to guide improvement to enhance the quality of devices.”

The VIP draft guidance, is an extension of the 2018 pilot program Case for Quality Voluntary Medical Device Manufacturing and Product Quality (“CfQ Pilot Program”). According to the FDA, the CfQ Pilot Program assessed the “capability and performance of key business processes using a series of integrated best practices detailed in the Information Systems Audit and Control Association (ISACA) Capability Maturity Model Integration (CMMI) system.” The results of the pilot program can be found here.  Participants in the CfQ Pilot Program reported that “the appraisal had a direct value to product quality and over 90% reported a positive experience with the appraisal.”

As described in the draft guidance, the goal of the VIP is to “elevate and enhance manufacturing practices and behaviors through which quality and safety of medical devices can be improved.” As indicated in its name, this program is voluntary. Through use of the program, third-party appraisers visit participants to evaluate their practices in order to identify strengths and areas for improvement.

According to the draft guidance, VIP offers various benefits and opportunities for those manufacturing sites who demonstrate sustained capability and performance. Examples of opportunities from the draft guidance include:

  • FDA Consideration in Risk-Based Inspection Planning
  • Utilization of a Modified Submission Format for Premarket Approval Application (PMA) and Humanitarian Device Exemption (HDE) 30-Day Change Notices for Modifications to Manufacturing Procedures or Methods of Manufacture
  • Utilization of a Modified Submission Format for PMA and HDE Manufacturing Site Change Supplements
  • Utilization of a Modified Submission Format for PMA or HDE – Manufacturing Modules

The VIP has various participation and enrollment criteria for manufacturing sites, which can be found here.

The FDA requests comments on the draft guidance by July 5, 2022.

Pfizer Australia Announces Deal to Acquire ResApp Health

Pfizer Australia Announces Deal to Acquire ResApp Health

ResApp Health recently announced its planned sale to Pfizer Australia, a wholly owned subsidiary of Pfizer Inc.  Pfizer agrees it would acquire 100% of the shares for AUD $0.115 / share, for a total equity value of approximately AUD $100 million.  ResApp directors announced a unanimous recommendation to sell, and their intent to vote their own shares accordingly.  A shareholder vote is scheduled for June.

ResApp Health develops point of care diagnostics for telehealth that integrate with existing platforms.  Their algorithms can diagnose disease from sounds.  For example, one platform reportedly diagnoses respiratory problems based on the sound of a patient’s cough or breathing, and no physical contact is required.

The companies will also enter a Research & Development License Agreement to collaborate on products in the field of COVID-19.

In a statement, Pfizer Australia’s Lidia Fonseca stated that “this proposed acquisition and research collaboration add to our growing digital capabilities and bolster our efforts to pave a new era for digital health.”  ResApp CEO Tony Keating expressed excitement, stating “the material premium and certainty of an all cash consideration is an attractive outcome for our shareholders.”

This acquisition would be the second for Pfizer this year.  Earlier, it acquired ReViral, the developer of therapeutics for respiratory viruses, for $525 million.

Medical Device Cybersecurity Survey Report Released

Cybellum released a medical device survey report on April 20, 2022 entitled “Medical Device Cybersecurity: Trends and Predictions.”  The company’s website states that their “mission is to enable manufacturers and their suppliers to develop and maintain products that aren’t just safe, but are also secure.”

According to the company website, in preparing the new report, Cybellum “asked top security experts from hundreds of medical device manufacturers, about their main challenges and how they plan to solve them in 2022, and beyond.”

Cybellum lists the following key findings from the report:

Almost 90% admitted they need to improve on key areas, such as SBOM [software bill of materials] analysis and compliance readiness

Over 55% do not have a dedicated response team (PSIRT) in place

Almost 55% increased their cybersecurity budget by more than 25% in 2022

Other media outlets described the report as finding “widespread cybersecurity noncompliance despite rising investment,” and “[m]ore than half of medical device companies think they are noncompliant with cybersecurity regulations, standards and guidelines.”  Further, “compliance with requirements ranged from 54% for Food and Drug Administration premarket submissions to 37% for International Medical Device Regulators Forum (IMDRF) cybersecurity principles and practices.”

According to MedTechDive, the report states that “[m]ore than 80% of respondents see device security as a competitive advantage and almost every polled company increased its security budget this year. However, 78% of those surveyed indicated they are doing the minimum to achieve compliance and 80% view device security as a ‘necessary evil’ imposed by regulators.”

According to a press release by Cybellum, “[m]edical device cybersecurity has become an extremely complex challenge. With medical devices becoming software-driven machines, and the rapid pace at which cybersecurity risk evolves due to new vulnerabilities, complex supply chains, new suppliers, and new product lines, it has become seemingly impossible to keep the entire product portfolio secure and compliant at all times. It is now more important than ever to learn from peers and try to find the best way forward.”

The full text of the survey report can be found here.

Researchers Develop Blood Clot Test Based on Single Drop of Blood

Researchers Develop Blood Clot Test Based on Single Drop of Blood

The University of Washington announced that a team of researchers has developed a prothrombin time/international normalized ratio (PT/INR) blood clotting test that requires only a single drop of blood and a smartphone.  According to the team’s February 11, 2022 paper published in Nature Communications, the test uses a tiny cup containing copper, and a blood clotting agent that is attached to the smartphone below the camera, as shown in the figure below from the paper.

After adding a drop of blood, the smartphone vibrates, causing the blood to react with copper and the agent to form a blood clot, all of which is observed and measured by the camera.  A video of the device is here.

Blood clotting, also known as coagulation, is the process by which blood changes into a gel-like substance to prevent bleeding.  Excessive blood clotting within blood vessels can restrict blood flow, leading to serious conditions like deep vein thrombosis and pulmonary embolisms.  Blood thinners can reduce clotting, but patients must have their blood tested frequently to ensure proper dosage, as too much or too little blood clotting can be life-threatening.

Shyam Gollakota, a University of Washington professor and co-author of the paper, stated:

Back in the day, doctors used to manually rock tubes of blood back and forth to monitor how long it took a clot to form.  This, however, requires a lot of blood, making it infeasible to use in home settings.  The creative leap we make here is that we’re showing that by using the vibration motor on a smartphone, our algorithms can do the same thing, except with a single drop of blood.  And we get accuracy similar to the best commercially available techniques. … This is the best of all worlds — it’s basically the holy grail of PT/INR testing.  It makes it frugal and accessible to millions of people, even where resources are very limited.

The research team hopes its new test can be deployed in patients’ homes and resource-limited areas.  A public release of the team’s code can be found here.

FDA Proposes Changes to Medical Device Quality Regulations

The U.S. Food and Drug Administration (FDA)  published on February 23rd, 2022, a rule proposal to overhaul medical device quality control regulation.  According to the FDA, the proposed rule change would “amend the device current good manufacturing practice requirements of the Quality System Regulation to align more closely with the international consensus standard for devices by converging with the quality management system requirements used by other jurisdictions.”

The proposed rule, titled Medical Devices; Quality System Regulation Amendments, would incorporate by reference International Organization for Standardization ISO 13485:2016, which is the international consensus standard for medical device manufacturers.   The FDA claims that finalizing the proposed rule “will continue our efforts to align our regulatory framework with that used by other regulatory authorities to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients.”  The FDA is also proposing to amend other aspects of its regulations to more closely align with the Food, Drug, and Cosmetics Act, as well as clarify good manufacturing practice requirements for co-packed and single-entity combination products.

Since early 2018, the FDA has said it is considering how to harmonize its regulatory requirements for medical device quality systems contained in 21 CFR part 820 with ISO 13485:2016, amid the international standard’s three-year transition period. This proposal would become effective one year from the publication date of February 23rd, 2022, and would result in the replacement of its current inspection approach for medical devices, the Quality System Inspection Technique (QSIT), with an inspection approach that will be consistent with the requirements of the Part 820 as finalized.

Beyond the harmonization with international standards, the FDA estimates that this rule change will save between $439 million to $533 million over the next 10 years.  At the same time, it is expected that the expenditure for all companies to get up to speed with the proposed rule change will total $7.6 million.

The FDA had announced last week a March 2, 2022 meeting of the Device Good Manufacturing Practice Advisory Committee to “discuss and make recommendations on the current good manufacturing practice requirements for medical devices . . . to align more closely with an international consensus standard for medical devices used by other regulatory authorities.”

The text of the proposed rule change can be found here.

FDA Breakthrough Device Designation for Biology-Guided Radiotherapy (“BgRT”) Device

On December 1, 2021, RefleXion Medical, Inc. (“RefleXion”), announced that the U.S. Food and Drug Administration (“FDA”) has granted the company breakthrough device designation for its biology-guided radiotherapy (“BgRT”) for lung tumors.

The FDA breakthrough devices program:

is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.  The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.

Further details regarding the breakthrough devices program can be found here and here.

According to RefleXion, “the breakthrough potential of BgRT lies in its ability to detect and then immediately treat moving tumors.  It is the first and only technology to use injected radiotracers to produce active signals, called emissions, from each tumor to guide treatment delivery” and “aims to remove the uncertainty of guiding radiation delivery using images taken days before treatment.” Many patients with stage four cancer cannot use current forms of radiotherapy because existing technology is unable to efficiently track and treat multiple tumors.  “The unmet need in lung cancer is staggering,” said Todd Powell, president and CEO of RefleXion.  According to Cancer.Org, “[l]ung cancer is the most common cause of cancer-related death,” accounting for 25% of all cancer deaths in the United States.

As RefleXion explains, the use of PET emissions in BgRT to guide treatment makes the “cancer itself act as a fast, biological fiducial continuously signaling its locations even during motion.”  As the PET tracer collects in the tumor, “a series of positron annihilation events occur resulting in the emission of two photons almost 180 degrees to each other.”  The detector in the RefleXion X1 device finds these emissions and outputs images in real time.  A video of RefleXion’s X1 Machine (shown below), used for BgRT, can be seen here.

 

Federal Circuit Reverses PTAB’s Invalidation of Patent Claims for an Artificial Heart Valve (Snyders vs St. Jude)

Federal Circuit Reverses PTAB’s Invalidation of Patent Claims for an Artificial Heart Valve (Snyders vs St. Jude)

On October 5, 2021, the U.S. Federal Circuit reversed a finding of invalidity by the Patent Trial and Appeal Board (PTAB) for patent claims related to an “artificial valve for repairing a damaged heart valve.”  St. Jude Medical LLC (“St. Jude”) filed for an inter partes review (IPR) at the PTAB for U.S. Patent No. 6,821,297, entitled “Artificial Heart Valve, Implantation Instrument and Method Therefor,” owned by Snyders Heart Valve LLC (“Snyders”).

In invalidating the claims, the PTAB interpreted the patent claim limitation of a “frame sized and shaped for insertion between the upstream region and the downstream region.”  The PTAB found that the limitation also covers a frame that fits in place after removal of a damaged heart valve.  The cited prior art allegedly also disclosed a valve insert sized to fit the valve after the damaged native valve was removed.  Therefore, the PTAB found that the prior art anticipated the claims.

The Federal Circuit held that the PTAB erred in determining that the “sized and shaped” limitation “does not require the frame be sized and shaped for insertion into a damaged heart valve,” but “only that the frame is sized and shaped for insertion in a position between the upstream region and the downstream region.”  The Federal Circuit reasoned that the PTAB’s construction was incorrect because “it covers frames sized and shaped for installation with the native valve removed, rather than only with the native valve in place.”  The Federal Circuit cited language in the patent specification allegedly stressing that the disclosed artificial heart valve can be inserted without removing the native valve, an alleged express improvement on the prior art.

The Federal Circuit’s decision is available here.

Alpha Tau Receives FDA Breakthrough Device Designation for Alpha DaRT Treatment of GBM

Alpha Tau Medical Ltd. (“Alpha Tau”) is a medical technology start-up focused on the research, development, and commercialization of its Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) treatment for solid cancerous tumors.  On October 8, 2021, Alpha Tau announced that it received FDA Breakthrough Device Designation for using Alpha DaRT to treat recurrent glioblastoma multiforme (GBM).  GBM is an aggressive, often incurable form of cancer responsible for malignant brain tumors.

According to the FDA, the goal of its Breakthrough Devices Program is to “provide patients and health care providers with timely access to [] medical devices by speeding up their development, assessment, and review.”

In a press release, Alpha Tau CEO Uzi Sofer stated:

“As GBM is such a terrible disease, it is critical that we find new solutions for these patients, and we are thrilled that receipt of the FDA’s Breakthrough Device Designation will allow us to expedite our clinical collaborations with leading cancer centers in the U.S. and across the world, and to bring new hope for GBM patients.  I am very proud of our team and our collaborators who have worked hard to extend the use of Alpha DaRT to GBM and have already accomplished so many amazing things.  This is fantastic news for Alpha Tau and fantastic news for so many GBM patients around the world.”

Alpha DaRT works by first inserting a “seed” into a cancerous tumor.  The seed then releases high-energy alpha particles that destroy the tumor while sparing the healthy tissue around it.

This is the second FDA Breakthrough Device Designation Alpha Tau has received.  In June 2021, Alpha Tau announced the FDA’s designation of Alpha DaRT for treating squamous cell carcinoma, a type of skin cancer.

Medical Device Company Pleads Guilty to Dealing in Non-FDA Approved Devices

Medical Device Company Pleads Guilty to Dealing in Non-FDA Approved Devices

The United States Department of Justice announced that medical device company Affordable Healthcare Solutions, LLC has pleaded guilty to charges related to unapproved prescription hyaluronic acid medical devices, as reported by a press release dated September 28, 2021.  The devices are “intended for the treatment of pain in osteoarthritis of the knee that must be injected by a doctor or other qualified health care professional.”  The company was sentenced for “Receiving Adulterated Devices in Interstate Commerce and Delivery for Pay with Intent to Defraud or Mislead, in violation of 21 U.S.C. §§ 331(c) and 333(a)(2).”

21 U.S.C. § 331(c) prohibits “[t]he receipt in interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.” According to the facts admitted during the plea, special agents with the United States Food and Drug Administration (FDA) located and seized foreign-market Supartz, Euflexxa, Synvisc, Synvisc-One, and Orthovisc that were adulterated for lacking FDA approval for distribution and use in the United States.

According to the press release, a review of the devices seized from Affordable Healthcare Care Solutions confirmed various differences between the outer box and carton labels, patient information brochures, and instructions for use between the FDA-approved labeling for Supartz, Orthovisc, Synvisc, Synvisc-One, and Euflexxa versus the labeling included with the unapproved versions being distributed by Affordable Healthcare Solutions. While discussing the seizure, Special Agent in Charge, Justin C. Fielder, emphasized that the “FDA regulates the manufacturing and distribution of medical devices to help ensure the safety of American patients.”

As a result of the plea agreement, Affordable Healthcare Solutions pleaded guilty to a felony, was fined, and was ordered to forfeit $837,000 worth of devices seized by the special agents. Juan Antonio Gonzalez, Acting United States Attorney for the Southern District of Florida, announced the felony guilty plea and stated:

Medical device suppliers whose greed leads them to disregard FDA protocols and approval processes put the public in danger. . . . These are serious crimes and, in our district, companies that put profit over patient safety will be held accountable.

Boston Scientific To Acquire Blood Clot Removal Tech Company Devoro Medical

Boston Scientific Corp. has agreed to acquire Devoro Medical Inc. in a deal expected to close this year.  Boston Scientific previously held a 16% equity stake in Devoro Medical and now agrees to acquire the remaining 84% stake for $269M.  Boston Scientific also agrees to pay up to $67M more if Devoro Medical clears certain regulatory and clinical milestones.

Devoro Medical is the developer of the WOLF Thrombectomy® Platform–a technology platform that “targets and rapidly captures blood clots using finger-link prongs that retrieve and remove thrombi in the arterial and venous systems.”

According to Boston Scientific’s press release:

“The addition of the WOLF platform advances our efforts to ensure physicians have the right tools to improve procedural efficiencies,” said Jeff Mirviss, executive vice president and president, Peripheral Interventions at Boston Scientific. “Clot management remains a core focus of our business, and upon commercialization, this highly differentiated technology will complement and expand our offerings to a full suite of interventional strategies for thromboemboli, which also includes the EkoSonic™ Endovascular System (EKOS) and the AngioJet™ Thrombectomy System.”

Boston Scientific plans to accelerate development of the WOLF platform following its acquisition of Devoro Medical, according to Michael R. Jaff, D.O., its Chief Medical Officer and Vice President of Clinical Affairs, Technology and Innovation, Peripheral Interventions.

This deal is the latest in a series of acquisitions this year by Boston Scientific.  In January, Boston Scientific agreed to acquire cardiac wearables company Preventice Solutions for $925M.  In March, Boston Scientific agreed to acquire the global surgical business of Lumenis LTD for $1.07B.  And, in June, Boston Scientific agreed to acquire cardiac ablation device maker Farapulse for $295M.

IP Litigation Remains Active in the Orthopedic and Spine Industries

IP Litigation Remains Active in the Orthopedic and Spine Industries

The orthopedic industry traditionally sees significant levels of intellectual property litigation activity, and this year has been no different. One source of this activity comes from Conformis who has continued to assert patents directed towards surgical planning and patient specific instruments and implants. In 2021, Conformis filed three new complaints, settled one case, and continued another litigation. These cases have involved various companies, including DePuy Synthes, Exactech, Bodycad, Wright Medical, and Medacta.

Decisions and settlements have also been reached in several additional lawsuits relating to diverse technologies, such as bone plates, knee implants, and pedicle screws. TriMed, Arthrex, Medacta, and Zimmer are some of the companies that have been parties to these lawsuits. Alternative forums, including the use of Inter Partes Review, have also continued to play significant roles for both patent holders and challengers.

Several attorneys from Knobbe Martens – including Andrew Douglas, Jessica Achtsam, Michael Christensen, Kregg Koch, Christy Lea and Sabing Lee – presented a webinar on August 26, 2021, to discuss notable decisions from recent orthopedic and spine intellectual property litigations. The webinar was prepared in anticipation of the 2021 Annual Meeting of the American Academy of Orthopaedic Surgeons and the 36th Annual Meeting of the National Association of Spine Specialists and included topics such as:

  • an analysis of claim types asserted by Conformis against patient specific implant and instrument technologies and how these claims have been enforced against and challenged by many prominent orthopedic companies;
  • how statements made by a patent holder can limit the scope of their claims in litigation;
  • how small companies can leverage their patents to derive licensing revenue;
  • trade secret issues that can arise at industry meetings;
  • how prolific doctor inventors have built and enforced large patent portfolios;
  • remedies for IP disputes outside the United States; and
  • strategies for using patents defensively as part of a countersuit strategy.

The full webinar is available for viewing at this web link.

Researchers Develop Face Mask for Detection of SARS-CoV-2

According to an article published in Nature Biotechnology, Harvard and MIT researchers invented a face mask for detecting SARS-CoV-2, the virus that causes COVID-19, via a user’s breath.  Instead of relying on a lab, the personal device uses sensors that use wearable freeze-dried cell-free (wFDCF) technology.  This technology contains the same molecules that cells use to recognize and manipulate nucleic acids and proteins.  According to MedGadget, unlike previous iterations of this technology which store living cells in “tiny aquariums”, wFDCF technology prevents any issues with leakage due to breakage.

To use the mask, a user presses a button on the mask to release water onto reactive wFDCF sensors.  MedGadget reports that results are given within 90 minutes and can be displayed on the inside of the mask for privacy purposes.  According to the scientific article, the wFDCF technology first cleaves viral particle samples in order to release the viral RNA.  Next, target genes located in the viral RNA are amplified via reverse transcription–recombinase polymerase amplification, in order to amplify the sequence that encodes for the spike protein.  A lateral flow assay strip is then used to display visual results similar to a pregnancy test.

“We have essentially shrunk an entire diagnostic laboratory down into a small, synthetic biology-based sensor that works with any face mask, and combines the high accuracy of PCR tests with the speed and low cost of antigen tests,” said researcher Peter Nguyen.  “In addition to face masks, our programmable biosensors can be integrated into other garments [e.g., lab coats] to provide on-the-go detection of dangerous substances including viruses, bacteria, toxins, and chemical agents.”

MIT News reports that the device can also swap in sensors for other pathogens, including influenza, Ebola, and Zika, or sensors they have developed to detect organophosphate nerve agents.

Genetic Engineering and Biotechnology News reports that the research team is “actively searching for manufacturing partners who are interested in helping to enable the mass production of the face mask diagnostic for use during the COVID-19 pandemic, as well as for detecting other biological and environmental hazards.”  The article reports that the authors have already submitted provisional patent applications for the technology.

The original article was published in Nature Biotechnology on June 28, 2021, and is available here.

FDA Taking Steps to Prevent Future Medical Device Shortages

According to the FDA, the medical device industry experienced significant supply chain disruptions during the COVID-19 pandemic.  Such disruptions caused shortages of PPE, ventilators, diagnostic testing, and other medical devices.  As Janet Woodcock, M.D., the Acting Commissioner of Food and Drugs, acknowledges in her July 21, 2021 statement:

“the pandemic has exposed great weaknesses in the medical device supply chain and its dependence on foreign medical devices.”

Woodcock also explains the steps being taken by the FDA to avoid such shortages in the future.  One step includes a request for $21.6 million to fund a new Resilient Supply Chain and Shortages Prevention Program (RSCSPP).  This funding request is part of the FDA’s request for $97 million to support its core safety programs.  Woodcock explains “the funding will provide, for the first time, resources to establish a permanent program for U.S. supply chain resilience for medical devices.”  RSCSPP’s goal is to prevent and mitigate the supply chain issues like those experienced during the pandemic while reducing dependence on foreign medical devices.

Additionally, the FDA is looking to expand its authority to prevent future shortages.  The FDA seeks broader authority “to obtain supply disruption notifications for critical devices.”  Broader authority has also been requested to require manufacturers to develop and share risk management plans.  The FDA plans to work with Congress to ensure the FDA has the resources and authority needed to advance these initiatives.

Strategies for Protecting Intellectual Property (IP) on a Reduced Budget

Shutdown orders due to the COVID-19 virus pandemic have created economic disruption, causing companies to scale back on intellectual property (IP) expense. This creates an opportunity to move ahead of the competition. This is especially true because the U.S. patent system, and many others around the world, reward the first inventor to file.

Below are some suggestions for protecting your IP on a reduced budget. This is not an exhaustive list. It is also not right for everyone. You should consult with legal counsel about your IP and what is right for your company.

Further, obtaining the best protection for your IP may involve filing for a utility patent, which is a long process. It involves, for example, understanding the client’s business and its goals; studying the technology; meeting with the inventors; discussing the invention, its genesis, and design alternatives; identifying target concepts to protect; meticulously drafting the claims and the written description; preparing the figures; and reviewing and revising the draft documents many times until they are right, among many other tasks.

By most measures, a pandemic is not an ideal time for many things, including companies trying to protect their IP. Consider discussing the following options with IP counsel to see if any of these might be right for you. For fuller discussion of these and other techniques, see this webinar presented to the Association of Corporate Counsel.

1. Get your place in line – On a reduced budget

The U.S. and many non-U.S. patent systems reward the first inventor to file. It is therefore important to stake your place in line before the competition. Below are some suggestions for reserving your place in line – your “priority date” – while keeping expenses down.

A. Consider a U.S. provisional patent application filing.

A U.S. provisional patent application holds your place in line at the Patent Office for up to one year. The government filing fee is currently 280 USD (potentially discounted for “small entities” or “micro entities”).

Provisional applications do not require the same level of formality as a non-provisional application. For example, a sketch, a slide deck, or an informal set of notes from an inventor can be filed as a provisional application. While you will only get credit, for priority purposes, for the amount of detail you file, it may be beneficial to file something rather than nothing.

Within one year of the first provisional application filing, you can supplement it with one or more “follow-on” provisional filings. This may be useful, for example, to file a follow-on later when IP budgets are subsequently increased.

All of the filed provisional applications within that one year can then be “rolled up” into a single non-provisional application. If you ultimately decide to do nothing with the one or more filed provisional applications, they will never publish.

B. Consider “coaching” preparation of the patent application.

While ideally a patent attorney will draft your application, this involves additional expense. One option may be to have your attorney “coach” you through the preparation process.

Trademarks Require “Use in Commerce” – But What If You Need Regulatory Approval Before Selling Your Medical Device?

The U.S. Patent and Trademark Office (USPTO) allows for a trademark application to be filed on an “Intent to Use” basis to establish a priority date before the mark is actually “used in commerce.” However, such use in commerce must happen before the trademark application will register with the USPTO. If your company markets medical devices or related goods that require regulatory approval, the use in commerce requirement presents unique issues.

Typically, use in commerce is established when the goods affiliated with the trademark application are shipped between two states or to a foreign country, and with a label or packaging showing the trademark on the goods. For most industries, use of a trademark “in preparation” of sales will not suffice to satisfy the use in commerce requirement. Additionally, a trademark owner is only given three years to use the mark in commerce and provide evidence of such use after the USPTO determines the application is otherwise ready for registration. If the owner does not submit proof that it has used the mark by the deadline, the application is deemed abandoned. Three years seems like ample time for many trademark owners, but anyone who has needed regulatory approval for a product knows the process can stretch well beyond these three years. How does one deal with this conundrum?

You may think that you should wait to file your trademark application so that you don’t run out the three-year clock. But this may allow competitors to swoop in and file intervening trademark applications. If the USPTO believes your mark is confusingly similar to the mark in a competitors’ prior application or registration, it could prevent you from being able to register your mark.

With few exceptions, the best strategy is to file your trademark application as soon as possible. Fortunately, the law provides an accommodation for trademark registrants with goods and services that require regulatory approval. Legislators recognized the fact that “commerce” varies in different industries. For instance, while some companies can sell products as soon as they are ready for market, others must undergo testing to get a stamp of approval prior to marketing or selling their products. This latter group typically includes medical device companies. These and other devices may require pre-market approval (PMA) or a 510(k) clearance from the U.S. Food and Drug Administration (FDA), which can take many years.

Lawmakers revised the definition of “use in commerce” to state that such requirement:

be interpreted to mean commercial use which is typical in a particular industry. Additionally, the definition should be interpreted with flexibility so as to encompass various genuine, but less traditional, trademark uses, such as those made in test markets, infrequent sales of large or expensive items, or ongoing shipments of a new drug to clinical investigators by a company awaiting FDA approval (Senate Judiciary Committee Report on S. 1883, S. Rep. No. 100-515, p. 44-45 (Sept. 15, 1988))

This expanded meaning of “use in commerce” has been generally adopted by the USPTO and the courts.

FDA Issues Guidance on “Abbreviated” and “Special” 510(k) Pathways

The U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an “abbreviated” and a “special” approach to the typical 510(K) process for medical devices.

The FDA describes the usual 510(K) process as “a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device…that is not subject to premarket approval.”  According to the FDA, “Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) .”

Now, two recent guidance documents issued by the FDA allow for altered 510(K) approaches for certain medical devices.  The first guidance, issued September 13, 2019, is for a “Special 510(K) Program.”  The FDA describes this program as “an optional pathway for certain well-defined device modifications where a manufacturer modifies its own legally marketed device, and design control procedures produce reliable results that can form, in addition to other 510(k) content requirements, the basis for substantial equivalence (SE).”  The guidance is intended to clarify “the types of technological changes appropriate for review as Special 510(k)s.”  The new guidance also supersedes prior FDA guidance from 1998 regarding Special 510(k) policy in “The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.”

This MDDI article purports to offer a “handy checklist” to determine “if changes made to your medical device can be reviewed under the [Special 510(K)] program.”  Some of the questions listed on the article’s checklist include the following:

  • Is it a change to the manufacturer’s own device?
  • Are performance data needed to evaluate the change?
  • Is there a well-established method to evaluate the change?
  • Can the data be reviewed in a summary or risk analysis format?

The second FDA guidance, also issued September 13, 2019, is for the “Abbreviated 510(K) Program.”  The FDA describes the program as “an optional approach that may be used to demonstrate substantial equivalence in premarket notifications (510(k)s)” and that “uses guidance documents, special controls, and/or voluntary consensus standards to facilitate FDA’s premarket review of 510(k) submissions.”   The guidance is “intended to facilitate 510(k) submission preparation by manufacturers and review by FDA.”

A copy of the guidance for the Special 510(K) Program can be found here, and a copy of the guidance for the Abbreviated 510(K) Program can be found here.   The FDA currently states that comments on either guidance may be submitted at any time.  Public comments on the guidance for the Special 510(K) Program may be submitted here and for the Abbreviated 510(K) Program here.

Cook Medical Petitions for Inter Partes Review (IPR) of Medtronic “Jervis” Patent

Cook Medical Petitions for Inter Partes Review (IPR) of Medtronic “Jervis” Patent

On November 9, 2018, Cook Medical LLC filed a petition with the Patent Trial and Appeal Board requesting inter partes review (IPR) of U.S. Patent No. 6,306,141, assigned to Medtronic Vascular, Inc.  The ‘141 Patent is entitled “Medical Devices Incorporating SIM Alloy Elements.”  The ‘141 Patent states that it relates to “a medical device containing a shape memory alloy element.”

The ‘141 patent discloses using stress and temperatures below body temperature to restrain a metal alloy.  The alloy expands to its original shape after being released from its restraint and exposed to body temperature.  In one example, the ‘141 Patent describes that the disclosed device enables doctors to treat damaged or diseased heart valves with a less invasive transcatheter heart valve procedure.  Figures 3 and 4 of the ‘141 Patent, shown below, illustrate a “side elevation view of a partial section of a catheter” in stressed (Figure 3) and unstressed (Figure 4) configurations.

The petition seeks to review all claims of the ‘141 Patent.  Cook Medical’s petition submits two grounds on which the claims of the ‘141 Patent should be found invalid due to obviousness.  The status of the proceeding can be examined by searching for the patent on the Patent Trial and Appeal Board website.

This is not the first time that the ‘141 patent has been subject to a petition for inter partes review.  On January 17, 2014, Edwards Lifesciences Corporation filed a petition with the Patent Trial and Appeal Board requesting inter partes review of the patent for review of all claims of the ‘141 Patent.  According to a Medtronic press release, on May 20, 2014, Medtronic and Edwards reached a “global settlement agreement” to “dismiss all of the pending litigation matters and patent office actions between them.”

In May 2013, Lombard Medical filed a petition for inter partes review of Claims 1-10 and 18-22 of the ‘141 Patent.  Lombard Medical’s products, according to its website, include the AORFIX™ endovascular stent graft.  According to a Lombard press release, on October 17, 2013, Lombard was granted a non-exclusive license by Medtronic to the ‘141 Patent, and Lombard formally requested a withdrawal of its inter partes review petition with the USPTO.

The ‘141 Patent has also been previously litigated. The ’141 Patent, among others, was previously asserted by Medtronic against W.L. Gore & Associates, Inc. in 2006; Gore’s EXCLUDER® AAA, TAG, and VIABAHN SFA® endoprosthesis devices were at issue.  The parties entered into a confidential settlement in 2009.

Medtronic also previously asserted the ’141 Patent, among others, against AGA Medical in 2007.  AGA’s AMPLATZER® Septal Occluder, Duct Occluder, and Vascular Plug devices were at issue.  The parties entered into a settlement in 2010 in which AGA received a non-exclusive license to patents including the ’141 Patent in exchange for $35 million.  AGA Medical was subsequently purchased by St. Jude Medical in October 2010 for $1 billion.

FDA & DHS Coordinate Efforts to Address Cybersecurity

The U.S. Food and Drug Administration (FDA) announced an agreement with the U.S. Department of Homeland Security (DHS) to strengthen the partnership between the agencies and “stay a step ahead of constantly evolving medical device cybersecurity vulnerabilities.”

The agreement formalizes a long-standing relationship by developing a new framework for greater coordination and cooperation. As part of the new framework, specific responsibilities have been assigned to the FDA and the National Protection and Programs Directorate (NPPD), a component of the DHS. The following table provides a breakdown of the responsibilities outlined in the agreement:

FDA Responsibilities NPPD Responsibilities
1. Coordinate and participate in regular, ad hoc, and emergency coordination calls to enhance mutual awareness of vulnerabilities and threats 1. Serve as central medical device vulnerability coordination center
2. Provide NPPD with draft public releases to facilitate coordination of messaging 2. Participate in regular, ad hoc, and emergency coordination calls with FDA to enhance mutual awareness of vulnerabilities and threats
3. Comment in a timely manner on NPPD draft advisories and alerts 3. Confer with entities providing sensitive information prior to sharing any CCI, trade secret, or PCII-protected vulnerability or product information with the FDA
4. Assess the risk to health and patient harm when potential impact is disputed 4. Coordinate with FDA on the content of alerts and advisories to be published by DHS
5. Submit requests to NPPD for independent third-party technical assistance to analyze and test medical systems 5. Maintain technical capabilities to support requests for independent third-party analysis regarding the impact of vulnerabilities
6. Share non-trade secret information to resolve disputes of risk, impacts, and communication 6. Publish healthcare and public health related alerts and advisories

In summary, the DHS will serve as the central coordination center and interface with appropriate stakeholders, and the FDA will provide technical and clinical expertise regarding medical devices.

FDA Commissioner Scott Gottlieb, M.D., during his discussion of the new agreement, addressed the FDA’s continued commitment to confront cybersecurity risk, while also recognizing the need for increased coordination between government agencies:

The FDA has been proactive in developing a robust program to address medical device cybersecurity concerns . . . But we also know that securing medical devices from cybersecurity threats cannot be achieved by one government agency alone. Every stakeholder has a unique role to play in addressing these modern challenges. That’s why this announcement is so important.

This agreement is not the first time a government agency has reached out to the FDA in an effort to strengthen medical device cybersecurity. As previously reported on the KnobbeMedical blog, the U.S. Department of Health & Human Services (HHS) Office of the Inspector General recommended earlier this year that the FDA include cybersecurity review as a greater part of the premarket review process for medical devices (e.g., through the inclusion of a Refuse-To-Accept checklists). This new FDA-DHS agreement is another example of continuing attempts to address ongoing medical device cybersecurity risks.

FDA to Strengthen Cybersecurity Oversight

In a recent report, the U.S. Department of Health & Human Services (HHS) Office of the Inspector General (OIG) recommended that the U.S. Food & Drug Administration (FDA) include cybersecurity review as a greater part of the premarket review process for medical devices. In particular, the report suggests including cybersecurity documentation as a criterion in the FDA’s Refuse-To-Accept (RTA) checklist, using presubmission meetings to address cybersecurity questions, and including cybersecurity as an element of the FDA’s Smart template.

The FDA has been ramping up its cybersecurity review lately to deal with increased cybersecurity concerns. For example, a ransomware attack caused an Indiana hospital to shut down its system. Other cyberattacks may have gone undetected.

Currently, the FDA reviews documentation that manufacturers submit regarding cybersecurity as part of the premarket submissions. The FDA uses this information to consider known cybersecurity risks and threats when reviewing submissions that deal with networked medical devices. The FDA may request additional information from applicants when submissions require clarification or when cybersecurity documentation is lacking. In view of these requests, the FDA regularly approves manufacturers on cybersecurity issues when sufficient documentation is provided.

For example, in one review of a glucose monitoring system, an FDA reviewer did not find “any information on how the manufacturer included cybersecurity in the device’s design,” according to the report. “The FDA reviewer explained that the device relied heavily on users to protect against cybersecurity threats by using antivirus software and enabling firewalls. The FDA reviewer requested that the manufacturer update its hazard analysis to address the missing information. The manufacturer did so, and FDA found the update to be acceptable.”

Because of examples like this, the report suggests using cybersecurity documentation as an element in the FDA’s RTA checklist. The RTA checklist is a screen against incomplete applications. Were cybersecurity part of these checklists, failure by a manufacturer to provide adequate cybersecurity documentation could prevent the FDA to accept the submission for substantive review.

The report also suggests that the FDA use presubmission meetings to address cybersecurity-related questions. These meetings serve as a way for manufacturers to ask the FDA specific questions, such as whether the submission satisfies the FDA’s standards. During these meetings, the FDA can include cybersecurity as part of the discussion, which may reduce the amount of time for the FDA review.

Finally, the report recommended that cybersecurity be a stand-alone element in the FDA’s Smart template. A dedicated section on cybersecurity could allow FDA reviewers to explain the results of their review regarding cybersecurity in a standard format.

The FDA has agreed with these recommendations and has begun taking steps to implement them, such as by including cybersecurity in the Smart template. The FDA also said that it “intends to update the RTA checklist and the accompanying guidance to specifically identify cybersecurity as an item in the checklist during the next update of these items.” The FDA is also currently considering new rules that may require submission of software as part of a premarket submission.

Medical Device Market Returns and Recent Industry Activity

The medical device and related markets have shown some growth recently.  For example, IHI, an iShares U.S. Medical Devices ETF, has a total return of about 24% year-to-date in 2018.   In the same time period, the S&P 500 has a return of about 8%.  The IHI fund has an average annual return in the last ten years of about 14% compared to about 10.7% for the S&P 500According to MarketWatch, the IHI fund invests in “medical-products companies that deliver the tubes, pumps and tools that are necessary to make medical facilities function. . . .  While some of the products offered by these companies are indeed high-tech, such as artificial heart valves, many are less glamorous, such as catheters and blood-pressure cuffs. But despite their flash, these items are staples, and medical offices and hospitals nationwide remain big revenue sources for these companies.”

MarketWatch further reports that ETFs related to healthcare in general have “more than tripled the returns of the S&P 500 this year.”  For example, the largest healthcare ETF by funds, XLV, is reportedly up 10% this year, and the IBB fund is up about 330% over the last ten years. Other healthcare-related funds reported to be outperforming the S&P 500 year-to-date in 2018 include the following:

  • Janus Henderson Obesity ETF “SLIM,” up 20%;
  • iShares U.S. Healthcare Providers ETF “IHF,” up 22%,
  • Invesco DWA Healthcare Momentum ETF “PTH,” up 23%;
  • the Ark Genomic Revolution Multi-Sector ETF “ARKG,” up 23%;
  • the SPDR S&P Health Care Equipment ETF “XHE,” up 27%; and
  • the Invesco S&P SmallCap Health Care ETF “PSCH,” up 40%.

There has been some activity and forecasts in the medical device market recently reported.  Some forecasts include the market for medical device connectivity projected to reach about $2.6 billion by the year 2023.  The global market for “IoT” (internet of things) medical devices is projected to grow at a compound annualized growth rate (CAGR) of about 25% from 2018 to 2023.   For the same period, the market for anesthesia-related devices is expected to have a CAGR of about 6.4%.  The global market for retinal surgery devices is reported as “likely to exceed $3 Billion by 2025, almost double from its current level in 2017.”  The global market for brachytherapy devices is reportedly predicted to rise at 4.2% CAGR from 2017 to 2022.

Some examples of recent medtech funding and M&A activity have included: CytoSorbents, a critical-care immunotherapy company that specializes in blood purification, received a research award of up to $3 million from the NIH.  Irvine-based Endologix, provider of solutions for aortic disorders, reportedly recently took out a $210.5 million convertible loan facility.  Urotronic, developer of a drug-coated balloon catheter for treating urethral strictures in men, reportedly raised $20 million in an equity offering involving 7 investors.  410 Medical Inc. a Durham, North Carolina-based company focused on technologies for resuscitation of critically ill patients, reportedly recently raised $3.1 million in financing.