Showing all posts written by Kregg Koch
In addition to his educational background in mechanical engineering, Mr. Koch spent several years working as a mechanical design engineer on the Space Shuttle's rocket engine program for The Boeing Company. In particular, he worked as a conceptual design and manufacturing support engineer. While working on this program, Mr. Koch received NASA’s Space Flight Awareness Award for engine safety related contributions.
Mr. Koch joined the firm in 2007.
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.
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.
Medtronic acquires Intersect ENT, sells Fiagon to Hemostasis LLC as required by FTC
On May 13, 2022, Medtronic, Inc. announced that it completed the acquisition of Intersect ENT, Inc. The transaction was only able to gain approval of the Federal Trade Commission (FTC) upon the agreement that Medtronic sell the assets of Fiagon NA Corp., a key subsidiary of Intersect ENT. Medtronic sold Fiagon to Hemostasis LLC and was thereupon able to finalize the acquisition of Intersect ENT.
As a result of the transaction, Medtronic acquired Intersect ENT’s PROPEL™ and SINUVA™ (mometasone furoate) sinus implant product lines and technology, intellectual property, and Intersect ENT’s facility in Menlo Park, CA. Intersect ENT employees joined Medtronic as a result of the acquisition.
SINUVA is an FDA-approved biosorbable, steroid-eluting implant that, according to Intersect ENT, is clinically proven to reduce polyps and symptoms of nasal congestion. PROPEL is also an FDA-approved biosorbable, steroid-eluting implant, indicated for patients with chronic rhinosinusitis (CRS). The PROPEL implant, which has reportedly also received CE mark clearance in Europe, is designed to keep sinuses clear after an endoscopic sinus procedure, while the SINUVA device is inserted to treat nasal polyps that develop after ethmoid sinus surgery.
Medtronic reports that acquiring Intersect ENT’s product lines and customer base will further Medtronic’s efforts to help patients who suffer from chronic rhinosinusitis, reported to be one of the most common health care problems in the U.S.
The FTC’s Bureau of Competition investigated the planned acquisition of Intersect ENT and determined that Medtronic, Inc., a wholly owned subsidiary of Medtronic plc, and Intersect ENT violated Section 7 of the Clayton Act, as amended, 15 U.S.C. § 18, and Section 5 of the Federal Trade Commission Act, as amended, 15 U.S.C. § 45.
An agreement was reached between Medtronic, Intersect ENT, and the FTC, pursuant to which Fiagon was sold to Hemostasis LLC.
Fiagon makes ear, nose, and throat navigation systems and balloon sinus dilation products. According to the draft Complaint prepared by the FTC, without this divestiture, the acquisition of Intersect ENT by Medtronic would pose a threat to future competition in the United States for both ENT navigation systems and balloon sinus dilation products.
The press release by Medtronic is available here.
FDA: Approval for Novel Medical Devices Remains a High Priority, Despite COVID-19
According to the FDA’s Center for Devices and Radiological Health (CDRH) Annual Report, in addition to its significant efforts to fast track the approval of COVID-19 related devices, the CDRH has also maintained its high priority focus on supporting innovation of new medical devices in the United States.
As provided in the Report, according to CDRH Director Jeff Shuren, M.D., J.D., the FDA has now granted emergency use authorization (EUA) or full marketing authorization to over 2,000 medical devices intended to prevent, diagnose, or treat COVID-19 and more than half of CDRH’s workforce has been directly involved in the COVID-19 response. The Report further states that the CDRH moved quickly with respect to COVID-19 treatment devices to ensure the availability of the wide range of related products shown below, including diagnostic tests, personal protective equipment (PPE), ventilators, and other critical devices and supplies for health care providers and patients.
As one example in the Report, CDRH authorized 15 additional over-the-counter (OTC) COVID-19 tests for at-home use during 2021. According to CDRH Director Shuren, these were authorized in record times—in some cases in less than a week—highlighting CDRH’s devotion to providing a rapid response to the COVID-19 pandemic.
The report also states that CDRH’s pandemic-related efforts have not brought its other authorizations to a grinding halt, and that the CDRH also managed to clear or approve 13 devices with breakthrough designation and granted market authorization for 103 novel devices during 2021. “One way that we are measuring the success of our efforts is through tracking the number of innovative medical technologies being brought to the U.S. first so that patients have access to the safest and most innovative devices available,” says Shuren. “A decade ago, the U.S. was too often behind in this regard. But we are gratified to see our efforts have resulted in 103 novel devices receiving marketing authorization in 2021, despite the unprecedented demands of our pandemic response,” continues Shuren. “Spurring innovation in developing safer, more effective devices is key to improving patient care and quality of life.”
Giving marketing authorization to 103 novel devices is touted by the Report as “an incredible achievement” in light of the increased demand on CDRH staff resulting from the COVID-19 pandemic. “This highlights the commitment and dedication of CDRH staff to strengthen public health by bringing innovative devices to patients,” comments CDRH.
In the past ten years, according the Report, the CDRH has issued four times as many approvals, authorizations, and clearances of novel technologies as a result of the innovative policies and approaches developed and implemented by CDRH. Novel technologies include those brought to market through the Premarket Approval, Humanitarian Device Exemption, and De Novo pathways, as well as a subset of those brought to market through Emergency Use Authorization (EUA), or the Breakthrough Devices Program.
The Breakthrough Devices Program is another program available for emerging companies that provides device manufacturers with an opportunity to engage directly with CDRH’s experts through several different program options to address topics as they arise during device development, evaluation, and premarket review.
NeoChord Announces Successful Completion of First-in-Human Procedure with its Mitral Chordal Repair Technology
NeoChord, Inc. (“NeoChord”) announced on October 4, 2021 that it successfully completed a first-in-human procedure with the NeXuS Transcatheter Mitral Chordal Repair (TMVr) device NeoChord is developing. NeoChord also reported that the patient has been discharged from the hospital and is back to a normal lifestyle.
In a press release David Chung, President and Chief Executive Officer of NeoChord expressed enthusiasm for their achievement. “On behalf of our entire organization, I want to thank the collective team of physicians for bringing this first-in-human procedure to success. Coupled with our successful, clinical experience with the transapical device, this transcatheter milestone further establishes NeoChord as the leader for beating heart, off-pump mitral chordal repair, providing another tool for the Heart Teams to offer patients a surgically-proven technique with an interventional approach.”
Mitral regurgitation is believed to affect more than 2 million individuals and to be the most common valvular disorder in the United States. According to some studies, mitral regurgitation is prevalent in more than 10% of adults over the age of 75. NeoChord notes that, if left untreated, mitral regurgitation may lead to chronic heart failure – the leading cause of hospitalization in the U.S. and Europe.
This first-in-human procedure was performed at the University Hospital of Bordeaux in France in collaboration with the Universitätsmedizin Mainz Germany. According to Thomas Modine, MD, University Hospital of Bordeaux and Ralph Stephan von Bardeleben, M.D., Universitätsmedizin Mainz, who both co-led the procedure, “the ability to replace a ruptured native chord by precisely placing suture in the mitral leaflet and securing with an anchor contributed to a very safe procedure.”
Azeem Latib, M.D., leading cardiologist from New York USA closely involved in the development of the TMVr device and procedure believes that “minimally invasive transcatheter chordal repair offers the promise of driving surgical-like results by maintaining the physiologic construction of the mitral valve, translating to better long-term outcomes.”
NeoChord is a privately-held medical technology company focused on beating heart mitral valve repair in patients suffering from mitral valve regurgitation.
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