Blog Tag: Medical Device
Medical device innovations and IP: A strategy is everything.
Bringing a medical device to market relies on a broad understanding of IP, explain Sabing Lee and Kregg Koch of Knobbe Martens.
The original version of this article was published by Life Sciences IP Review. Click here to view that article.
The medical device industry is driven by innovation, where great ideas are developed into successful businesses and products to improve patient care and outcomes. As patent attorneys, we witness many different pathways to innovation and guide IP strategies for innovators of all types. From garage start-ups that become global industry leaders to incubators and university-funded research programs, innovation has no common starting point.
One certainty exists, though. A properly executed IP strategy, tailored to the medical device industry, is critical for protecting innovation, creating company value and ultimately supporting the commercialization of products that will benefit patients.
Sources of Medical Device Innovation
One common starting point for medical device innovation is the physician. Many new innovations start from individual practitioners, such as a surgeon or other specialist who works first-hand with the types of devices that he or she improves upon.
Whether orthopedic, cardiovascular, neurological, or other, physicians with first-hand experience in the causes of medical conditions, the outcomes from devices and treatments, and the implementation of the devices and treatments are often the best equipped to recognize a need for improvement and to foster innovation. This is the reason why a significant number of medical devices come from or are developed in consultation with physicians.
Medical device innovation is an iterative process, and a significant amount of engineering work is needed to translate an initial concept into a viable product. Some physicians are garage inventors themselves, building prototypes using household parts or buying and assembling components into something that can be tested in trials.
Frequently, physicians seek out partnerships with engineers who can assist in this process, and many important medical technologies have resulted from the physician-engineer collaboration. Engineers themselves are also often inspired by new medical ideas and will seek out the clinical perspectives of a physician to refine and improve upon these ideas.
Protecting IP is especially important to the solo inventor, who often starts with only an idea and needs to secure some degree of protection, typically with a provisional patent application, before disclosing the idea to others.
Solo inventors and early-stage companies should also take care in securing ownership rights to their inventions when seeking the help of others. Non-disclosure agreements, while helpful in maintaining confidentiality, do not typically include IP assignment clauses. Without an IP assignment agreement, the solo inventor runs the risk that one of their collaborators improves upon the invention and claims ownership of the improvement for themselves.
While many innovations are the result of spontaneous inspiration, incubators, who form another important group of innovators, follow a more structured process. Incubators are organizations, including university-sponsored entities (sometimes called biodesign programs), that usually comprise individuals having orthogonal skill sets and backgrounds that form a multi-disciplinary team.
Incubators often include physicians, engineers, scientists, and business professionals.
BIOCORP Receives FDA 510(k) Clearance for Smart Injection Sensor
French medical device company BIOCORP announced in a press release that it received FDA 510(k) clearance for Mallya, a device that according to the company allows insulin pen injectors to capture and transmit injection data such as dose, date, and time of injection to a mobile app via Bluetooth.
According to the Mallya website, the device allows users to keep track of their doses as well as share dosage information with family members and medical professionals. BIOCORP offers three models of the Mallya, one for each type of disposable insulin pen. The device, shown below on a pen, comes in two pieces that clip on to the insulin pen and can be removed and reused with new pens.
Mallya first launched in France on April 13, 2021. Since then, it has expanded to several countries, including Japan, Nambia, Netherlands, Romania, South Africa, and Taiwan.
On the recent FDA clearance, Eric Dessertenne, CEO of BIOCORP, commented:
This approval is a major achievement for BIOCORP and all of our employees who have been heavily involved in this regulatory process. This approval marks a historic achievement for BIOCORP as it allows the commercial launch of our Mallya device in the United States and illustrates BIOCORP’s ability to meet the highest regulatory requirements.
Other companies have also expressed interest in integrating insulin technology with Mallya. In March, Diabeloop, a company focused on artificial intelligence-driven insulin systems, announced a partnership with BIOCORP to integrate Mallya into Diabeloop’s automated insulin pumps.
The full BIOCORP press release can be found here.
Developments in Patent Disputes Between Apple and AliveCor
Earlier this year, AliveCor, Inc., a medical device and AI company producing electrocardiogram (ECG) hardware and software for consumer mobile devices, succeeded in convincing an International Trade Commission (ITC) judge that Apple Inc. infringed multiple, valid claims of three AliveCor patents on ECG technology. By December 12, 2022, the full ITC is expected to issue a final decision in that investigation (337-TA-1266).
With the final ITC decision just days away, Apple filed suit against AliveCor, Inc. in the Northern District of California on December 2. Apple alleges that the ECG functionality of several AliveCor products, including KardiaMobile, KardiaMobile 6L (pictured below), KardioMobile Card, and the related Kardia App, infringe one or two Apple patents: U.S. Patent Nos. 10,076,257 and 10,866,619. Apple also alleges that AliveCor’s KardiaPro service and Kardia App, in conjunction with various Kardia devices, infringe one or two additional patents: U.S. Patent Nos. 10,270,898 (titled “Wellness Aggregator”) and 10,568,533 (titled “User Interfaces for Health Monitoring”).
Less than a week after Apple filed suit, a panel of Patent Trial and Appeal Board (PTAB) administrative judges found that the three AliveCor patents asserted in the ITC investigation were invalid. According to Law360, an AliveCor spokesperson explained AliveCor is “deeply disappointed and strongly disagrees with the decision by the PTAB and will appeal.” Regarding whether the PTAB’s findings should impact the ITC’s decision, the AliveCor’s spokesperson added:
The PTAB and ITC are two, separate independent bodies and will make their own separate independent decisions. We look forward to the separate final determination from the ITC expected December 12 and are cautiously optimistic.
Report: Medical Device Market Expected to Grow Over Next Seven Years
An article from October 2022 states that the global medical device market is projected to jump by seven billion dollars in 2022 and leap to $223 billion over the next seven years, to reach a valuation of around $719 billion by 2029. A report by consulting firm Fortune Business Insights anticipates a 5.5% compound annual growth rate (CAGR) over this period.
The report identifies several factors contributing to the industry’s growth. These factors include a global rise in prevalence of chronic diseases, increased healthcare spending in developed and emerging countries, and a new emphasis on early detection and treatment by healthcare agencies. This is reported to be resulting in more and more patients undergoing diagnostic and surgical procedures.
According to AdvaMed, the U.S. occupies about 40% of the global medical device market. In segmenting the U.S. market share, Fortune Business Insights found that in-vitro diagnostics (IVD), cardiovascular devices and orthopedic devices are the largest segments. The report expects the IVD segment will grow at a higher CAGR due to the increased use of real-time diagnostics tests for the diagnosis of diabetes, cancer, and HIV/AIDS. The report also notes an uptick in the market for portable and wearable devices for treatment of chronic conditions due to a shift in preference among the elderly for home healthcare services following the COVID-19 pandemic.
The report also states the European market is anticipated to grow at an increased CAGR, due to the region’s increased spending on healthcare, well-established infrastructure, and increased adoption of advanced diagnostic devices. As with the U.S., Europe is reported to have seen a shift in focus to at-home medical care that suggests portable equipment will play a large role in their anticipated market growth.
Increased prevalence of cardiovascular disorders, diabetes, infectious disorders and dental diseases are all demand factors contributing to the forecasted growth in Asia Pacific, according to the report, causing more global medical device players to expand their presence in the region.
The three top-earning medical device companies globally in 2021 – Medtronic, Abbott, and Johnson & Johnson – are among those companies set to benefit highly from the industry’s predicted growth. However, the increasing demand for the medical device market as a whole guarantees that the future is looking bright for many companies in the space.
The report by Fortune Business Insights is available here.
FDA Approves LimaCorporate’s 3D-Printed Reverse Shoulder Replacement System
The FDA recently approved LimaCorporate’s fully 3D-printed glenoid baseplate and humeral stem for use in reverse shoulder replacement.
The shoulder includes the glenohumeral joint, which is the ball-and-socket joint where the head of the humerus (i.e., the ball) joins the glenoid (i.e., the shoulder socket in the scapula). However, when the associated tendons are damaged, reverse shoulder replacement or arthroplasty may be used to repair the joint. In reverse shoulder replacement, the ball and socket of the glenohumeral joint are replaced in opposite positions. As such, the ball is placed on the socket side of the joint and the socket is placed on the ball (i.e., arm) side where it is typically supported by a stem that is implanted in the humerus. LimaCorporate reports that its new PRIMA TT Glenoid system includes a 3D-printed convertible short stem and a fully 3D-printed glenoid replacement for Reverse Shoulder Arthroplasty.
According to a press release, LimaCorporate’s PRIMA TT Glenoid system uses trabecular titanium (TT), which is lightweight biomaterial containing titanium and having a regular three-dimensional hexagonal cell structure that imitates trabecular bone morphology, which is designed to encourage strong primary fixation and secondary bone ingrowth. In response to the FDA’s approval of the PRIMA TT Glenoid system, LimaCorporate’s CEO Massimo Calafiore stated “Today’s FDA approval for PRIMA TT Glenoid represents an exciting opportunity to accelerate our market growth in key regions. The new PRIMA shoulder platform will support our surgeons to bring the emotion of motion to even more patients!”
LimaCorporate states it is planning to launch the PRIMA TT Glenoid shoulder replacement system in 2023.
FDA to Collaborate with Veterans group on Medical Device Innovation
On September 28, 2022 the FDA announced a collaboration with the Veterans Health Administration (VHA), in particular the VA Ventures Innovation Institute. According to the FDA, the intent of the collaboration is to “help accelerate American medical device innovation to further improve and benefit public health. One goal of the collaboration is providing innovators with “straightforward, reproducible, and cost-effective testing methods throughout the product development cycle.”
Jeff Shuren, M.D., J.D., the director of the FDA’s Center for Devices and Radiological Health stated in the FDA’s announcement of the collaboration that:
This strategic alignment between our organizations creates a unique environment to achieve shared objectives for accelerating patient access to safe, innovative and effective medical devices.
The VHA will host staff from the FDA at the VA Ventures Innovation Institute in Seattle. According to the announcement, the FDA staff will be focused on the regulatory science while the VA staff will provide “clinical context for test development and provide hands-on training and other immersive experiences.”
The initial collaboration is described by the FDA as focusing on systems which can “exchange health information automatically for the diagnosis and treatment of patients.” While future areas of collaboration may include “the development of test methods for devices that can be used at a distance through, for example, 5G networks.”
Dr. Shereef Elnahal, the VA’s Under Secretary for Health, stated in the FDA announcement:
By working side by side, VA and FDA will leverage our combined strengths and expertise to bring the most promising health care technology innovation to Veterans – and Americans at large – faster than before.
The announcement by the FDA is available here.
FDA Publishes Draft Ethical Consideration Guidance to Protect Children Participants in Clinical Trials of Medical Products
On September 23, 2022, the Food and Drug Administration (FDA) published a draft guidance aimed to protect children who participate in clinical trials, titled Ethical Considerations for Clinical Investigations of Medical Products Involving Children. The draft guidance describes the FDA’s current position regarding ethical considerations for clinical investigations of drugs, biological products, and medical devices involving children. The guidance explains the fundamental concepts for the ethical framework that institutional review boards (IRBs), sponsors, and the industry should consider when reviewing or conducting clinical trials involving children.
Of note, the guidance outlines additional considerations and recommendations IRBs should assess when enrolling children in clinical investigations of medical products. The guidance explains that, in principal, the risk of the clinical investigations must be balanced by the prospect of direct and potential benefits and must at least be as favorable as any available accepted alternative treatment. Accordingly, the guidance suggests medical product developers need to use a dose or treatment level expected to be effective for the child which should also have a positive impact on the child’s life.
The FDA’s Office of Pediatric Therapeutics noted that “the best way to provide children with safe and effective treatment options is by including them in clinical research.” The Office of Pediatric Therapeutics further noted that children are afforded additional safeguards when participating in a clinical investigation since they are a vulnerable class who cannot provide informed consent for themselves. The FDA’s guideline comes at an important time. By way of example, although 48.2% to 72.6% of parents are willing to vaccinate their children against the COVID-19 virus, a lower rate of parents allow their children to participate in clinical trials.
The FDA’s draft guidance is available here, and is available for comments until December 27, 2022.
FDA Publishes New Monkeypox and Medical Devices Web Page
The FDA has published new web pages about Monkeypox and medical devices. The new web page, titled Monkeypox and Medical Devices, includes information on diagnostic testing, Laboratory Developed Tests (LDTs), and information for test developers. With more than 22,000 confirmed Monkeypox cases in the U.S., the new Monkeypox Medical Devices web comes as FDA takes significant actions to increase Monkeypox testing capacity nationwide following the Secretary of Health and Human Services’ August 9th announcement of public health emergency.
The FDA’s guidance issued for test developers under Policy for Monkeypox Tests to Address the Public Health Emergency describes, among other things, review priorities of Emergency Use Authorization (EUA) requests for monkeypox diagnostic tests. And, on the same day as the FDA guidance was issued, the FDA also issued the first EUA to a commercially available monkeypox test in the United States to Quest Diagnostics for its Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR device. “With this FDA emergency authorization, Quest is positioned to complement the response of public health laboratories and help fight the spread of the virus,” said Jay G. Wohlgemuth, M.D., Senior Vice President, R&D, Medical and Chief Medical Officer, Quest Diagnostic.
Quest Diagnostics is not the only company that has been working on monkeypox diagnostic test kits. Earlier in June, Becton Dickinson announced partnership with CerTest Biotec to collaborate on molecular diagnostic test for monkeypox. Several other healthcare and pharmaceuticals companies have also been linked with this effort. This comes at a time when many of these companies are preparing for a drop in revenue from COVID-19 testing as the threat of COVID-19 reduces.
Boston Scientific Acquires Embolization Gel Developer Obsidio, Inc.
Boston Scientific announced on August 15, 2022, that it acquired Obsidio, Inc. for an undisclosed fee. Obsidio has technology called the Gel Embolic Material (GEM™), which is used in minimally invasive blood vessel embolization. According to its press release, Boston Scientific intends to expand its interventional oncology and embolization portfolios.
An embolization treatment procedure uses a material to obstruct or reduce blood flow through a blood vessel. The treatment may be used to stop hemorrhaging, to stabilize blood vessel malformations, or to reduce blood flow to tumors, which are often highly vascularized.
Founded in 2019, Obsidio initially sought to commercialize technology relating to NIH-funded research on hemorrhage control and aneurysm treatment. Obsidio subsequently obtained FDA approval for GEM™ on July 1, 2022, claiming equivalence to Biosphere Medical’s EmboCube™ Embolization Gelatin. According to Obsidio, GEM™ is a semi-solid made up of bioresorbable gelatin, layered silicate, and tantalum powder. The material is delivered to a target vessel via catheter. As a semi-solid, the material is supposed to conform to the shape of the target vessel. Additionally, GEM™ is supposed to be shipped in a ready-to-use form, which, according to Boston Scientific, may save some preparation time relative to other embolization materials.
Boston Scientific is a multinational biomedical engineering company. In 2021, Boston Scientific spent over $4 billion across five acquisitions. Obsidio is the second of Boston Scientific’s acquisitions in 2022, the other being a $230 million deal for Synergy Innovation’s majority stake in M.I.Tech, a developer of a conformable, self-expanding metal stent called HANAROSTENT®.
USPTO Issues Notice Regarding Patent Examinations and FDA Submissions
On July 29, 2022, the United States Patent and Trademark Office (USPTO) issued a Notice by Director Kathy Vidal that may be relevant to those seeking or holding patents on medical devices that require Food and Drug Administration (FDA) approval. The Notice relates to certain duties owed to the USPTO with regard to statements and documents submitted to the FDA and other government agencies. The duties include a duty to disclose certain information and a duty of reasonable inquiry.
The Notice states “[t]he duty of candor and good faith in dealing with the USPTO includes the duty to disclose to the USPTO information material to the patentability of a claimed invention.” Further, “[e]ach party submitting a paper to the USPTO has an additional duty to perform an inquiry that is reasonable under the circumstances, including reviewing documents to identify information that is material to the patentability of a claimed invention.” The Notice states it “is intended to clarify the duties, including as to materials or statements material to patentability or statements made to the USPTO that are inconsistent with statements submitted to the FDA and other governmental agencies.”
The Notice was issued against the backdrop of an Executive Order by President Biden regarding competition in the economy, specifically in the pharmaceutical industry. Additionally, U.S. Senators sent a letter to the USPTO requesting “that the Office ‘take steps to reduce patent applicants’ making inappropriate conflicting statements in submissions to the [USPTO] and other federal agencies.'” Regarding the letter, the Notice further states:
The letter provided a specific example in which “inconsistent statements submitted to the Food and Drug Administration (FDA) to secure approval of a product—asserting that the product is the same as a prior product that is already on the market— can then be directly contradicted by statements made to the [USPTO] to secure a patent on the product.” The Letter noted that such inconsistent statements “should be cause for rejecting the application and, when made knowingly and with bad intent, potentially other sanctions.”
Against this background, the Notice states it “is part of the USPTO’s efforts to put into effect the Administration’s goals and address the Senators’ concerns.”
The Notice thus discusses which parties have a duty to disclose information to the USPTO in various patent examinations and proceedings, and what material information must be disclosed. For example, the duty to disclose “applies to positions taken by applicants or parties involving the claimed subject matter. For instance, in PTAB proceedings, parties should not take a position about the patentability of challenged claims that is inconsistent with positions taken in submissions to other Government agencies regarding the same subject matter.” An example PTAB proceeding is cited which resulted in “suspending a practitioner for four years for failure to correct the written record after learning of inaccuracies in a declaration the practitioner had filed.” The Notice discusses similar duties in the context of patent examination and prosecution.
In addition to the duty to disclose, the Notice discusses the duty of reasonable inquiry and when these two duties arise in dealings with other government agencies besides the USPTO.