Blog Tag: Medical Device
Medtronic recently announced that its Melody® Transcatheter Pulmonary Valve (TPV) is the first transcatheter pulmonary valve to receive FDA approval for implantation in patients with failed surgical bioprosthetic pulmonary heart valves. Medtronic touts the Melody TPV as providing these patients with a minimally invasive treatment option as an alternative to additional open-heart surgery.
The Melody TPV was previously approved under the FDA’s Humanitarian Device Exemption (HDE), a program for technologies that may treat fewer than 4,000 patients a year, subject to additional regulations, without meeting all of the traditional pre-market approval rules.
Commenting on the approval, Dr. Jeremy Asnes of the Yale School of Medicine said:
As the 1st commercially available transcatheter heart valve, the Melody TPV brought a breakthrough non-surgical option to treat failing pulmonary valve conduits. Thousands of congenital patients globally have benefited from this therapy in the past decade. With this expanded indication, we can further reduce the need for obtrusive open-heart surgery and allow even more patients to benefit from this minimally invasive treatment option.
Grand View Research predicts that the global transcatheter valve market is expected to reach a worth of $8.62 billion by 2024. According to the Centers for Disease Control and Prevention, congenital heart defects are the most common birth defect in America and the top killer of infants with birth defects. An estimated 40,000 babies are born with congenital heart defects in the United States every year.
The Food and Drug Administration (FDA) recently identified a list of Class II Medical Devices that, when finalized, will be exempt from premarket notification (510(k)) requirements. This publication was made by the FDA pursuant to the 21st Century Cures Act, signed into law on December 13, 2016.
Premarket notification (510(k)) is one of several alternative procedures that medical device manufacturers must undergo before being able to market their medical devices intended for human use. The 510(k) notification is required for medical devices that do not need to receive premarket approval (PMA) from the FDA and are not exempt from the 510(k) requirement. The FDA explains that medical devices are classified into three classes (Classes I, II, and III) based on based on the level of control necessary to assure the safety and effectiveness of the device. Most Class I and II devices and a few Class III are subject to the 510(k) requirement. Although a 510(k) applicant does not need to provide scientific evidence of safety and effectiveness for the intended use of its device, the applicant must demonstrate that the device is at least as safe and effective (“substantially equivalent”) to a legally marketed device (“predicate device”).
The FDA may exempt devices from 510(k) requirement. A list of factors that the FDA use to determine whether the device is exempt from 510(k) requirements includes: (1) whether the device does not have a significant history of false or misleading claims or of risks associated with inherent characteristics of the device; (2) whether characteristics of the device necessary for its safe and effective performance are well established; (3) whether changes in the device that could affect safety and effectiveness will either (a) be readily detectable by users by visual examination or other means before causing harm or (b) not materially increase the risk of injury, incorrect diagnosis, or ineffective treatment; and (4) any changes to the device would not likely to result in the device’s classification.
Section 3054 of the 21st Century Cures Act amended sections 510(l) and 510(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The amended sections 510(l) and 510(m) of the FD&C Act require the FDA to publish any Class I and Class II devices that the FDA determines no longer require premarket notifications under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness. The FDA is required to publish initial lists for Class II devices and Class I devices within 90 days and 120 days, respectively, after the enactment of the 21st Century Cures Act and then to update the lists at least once every 5 years.
A list of 510(k)-exempt Class I devices is expected to be published in about 30 days.
BodyCap, a France-based company said to be dedicated to the development of miniature wireless electronic sensors, recently announced that its e-Celsius® device has earned CE mark approval and is now commercially available for hospital use. The device will be available in the European Economic Area, Iceland, Liechtenstein and Norway.
According to BodyCap, the e-Celsius® device is a disposable electronic capsule coated in a biocompatible medical grade plastic and allows for the continuous and non-invasive monitoring of a patient’s core temperature. The pill wirelessly transmits temperature measurements to a monitor viewable by a health care professional and exits the body in about 1 to 3 days. Sébastien Moussay, co-founder of BodyCap stated:
“The e-Celsius device is a true alternative method to the current use of rectal or eosophageal probes, which are invasive, uncomfortable, generate stress and limit the patient’s mobility.”
“Our device is less intrusive and requires less from the medical staff, while at the same time increasing the well-being of both patients and healthcare personnel by lightening the workload. With the internal memory embedded in each capsule, e-Celsius ensures the monitoring of the patient’s temperature kinetics in real time or deferred time, whatever the measurement conditions.”
BodyCap’s website indicates that the broad medical applications of the e-Celsius® capsule ranges from general diagnostic to monitoring of patients during surgery or chemotherapy. Related e-Celsius® capsules have already been used outside the hospital setting, particularly in the monitoring of athletes. The device has previously been used during athletic events including the New York Marathon and the 2016 Summer Olympics.
Persistent Market Research estimates the market for global ingestible e-pills will reach almost $1.5 billion by the end of 2024. The e-Celsius® capsules reportedly will be sold for a unit price of $42 to $63, depending on volume, according to a MedGadget article.
Other ingestible sensors on the market include products by Proteus Digital Health.
According to public databases, BodyCap is the listed Applicant of U.S. Pat. No. 9,559,290.
Positive Clinical Results for Using Myriad’s BRACAnalysis CDx® for Identifying Breast Cancer Patients for Treatment with Lynaparza
Myriad Genetics recently announced clinical results showing that its BRACAnalysis CDx® test was able to identify patients with HER2-negative metastatic breast cancer who had improved response with Lynparza (olaparib), AstraZeneca’s PARP inhibitor. The results are based on a collaborative effort between Myriad Genetics and AstraZeneca for identification and treatment of patients with metastatic breast cancer and underlying BRCA 1/2 mutations.
In 2014, the FDA approved the use of BRACAnalysis CDx to identify patient with advanced ovarian cancer that would benefit from treatment with olaparib. Jonathan Lancaster, the chief medical officer of Myriad Genetics stated that, “we believe the results of the OlympiAD trial support use of BRACAnalysis CDx test to help inform treatment decisions in the metastatic breast cancer setting and will expand the patient population who can benefit from BRCA testing.”
The recent announcement is the first report of data from a Phase 3 Clinical Trial (the OlympiAD trial) that compares treatment options in Metastatic Breast Cancer Patients with Germline BRCA1/2 Mutations. The treatments compared the responses to Lynparza and so-called physician’s choice chemotherapy, where the investigators will choose Capecitabine, Vinorelbine, or Eribulin. Mydriad’s BRACAnalysis CDx test was used to identify patients with germline BRCA 1/2 mutations and these patients showed a statistically-significant improvement of progression-free survival when treated with olaparib compared to treatment with a chemotherapy of the physician’s choice. Information about the clinical trial can be obtained here: https://clinicaltrials.gov/ct2/show/NCT02000622.
According to Myriad, BRACAnalysis CDx is an in vitro diagnostic device that detects and classifies variations of BRCA1 and BRCA2 in both protein coding and intron/exon junctions regions of the genes. The device analyzes genomic DNA obtained from whole blood. Small genetic variations including single nucleotide polymorphisms (SNPs) are identified using PCR with Sanger sequencing. Larger genetic variations, including large deletions and duplications, are detected using multiplex PCR.
Republican lawmakers recently proposed a replacement of Obamacare known as the American Health Care Act (AHCA). One provision of the proposed legislation would permanently repeal Obamacare’s 2.3% medical device excise tax. Beginning in 2013, manufacturers and importers of certain medical devices were required to pay a 2.3% tax on sales of these devices. Although the medical device tax was suspended for 2016 and 2017, it was set for reinstatement in 2018.
Introduction of the AHCA is not the first time that lawmakers and industry lobbyists have attempted to permanently repeal the medical device tax. For example, in January 2017, a group of more than 220 Representatives introduced a bill in the House of Representatives that sought to repeal the tax. In introducing that bill, Rep. Erik Paulsen (R-MN) released a statement citing improvements in the industry after temporarily suspending the tax:
We are already seeing new American jobs and increased investment in research and development as a result of the temporary suspension of this tax. With over 200 cosponsors at the start of this new session, and with overwhelming bipartisan support, permanent repeal should be a top priority for Congress.
Beyond repealing the medical device tax, the Washington Post reports that the AHCA seeks to repeal a wide array of taxes that were expected to cost insurance, medical device, and other healthcare companies billions of dollars over the next decade. Indeed, according to the Joint Committee on Taxation the 2.3% medical device tax, alone, was expected to cost these companies $20 billion over the next ten years.
Repealing the tax will provide medical technology innovators with the long-term certainty necessary to support future job growth and sustainable, cutting-edge R&D that will ultimately lead to the next generations of breakthroughs in patient care and treatment. We urge the House and Senate to act expeditiously to pass this important legislation.
Voxello recently announced FDA 510(k) clearance of its noddle™ device, following submission of its application in October 2016. According to the press release, the noddle gives patients who are unable to speak a way to communicate through voluntary gestures. Voxello touts the noddle as allowing patient access to nurse call systems, environmental controls, communication apps, and speech generating devices with a touch or a click of the tongue.
Coralville, Iowa-based Voxello was founded in 2013 through the Iowa Medical Innovations Group (IMIG) at the University of Iowa. IMIG is an interdisciplinary program that includes students from the Colleges of Medicine, Business, Law, and Engineering. The noddle student team consisted of Vince Hahn, Zihan Zhu, Blake Martinson, and Ben Berkowitz, with Richard Hurtig serving as professor mentor.
At Voxello, our mission is to provide an effective and universal means to overcome communication barriers faced by hospitalized and long-term care patients. Today 3.9 million hospitalized patients each year are unable to communicate through traditional means, which results in an estimated three billion dollars in preventable adverse events. The FDA clearance of the noddle brings us one step closer to offering a solution for this urgent, unmet need.
The following video is provided on Voxello’s website:
Matthew A. Howard, Chair and DEO, Dept. of Neurology, University of Iowa Healthcare System, commented on his experience with the device:
The technology incorporated in the Voxello noddle has been extremely helpful in enabling us to provide the best possible care for neurosurgery patients with severe neurological injuries.
As the medical device market continues to grow, the medical device industry has strived to reduce costs through outsourcing. An industry report has found that the global medical device outsourcing market was valued at $33.2 billion in 2016, and is projected to continue to grow. The medical device industry is outsourcing not only the manufacturing of medical devices, but also associated services, such as regulatory consulting and contract manufacturing, to medical device service providers. Medical device manufacturers and outsourced medical device service providers should be conscious of the regulatory and legal ramifications of the delocalization associated with the outsourcing that is increasingly common in today’s global market.
While outsourcing has traditionally been linked to manufacturing, outsourcing of services has become a major growth engine in the medical device industry. Outsourced services include regulatory consulting, product design and development, testing and sterilization, implementation, upgrades, maintenance, and manufacturing contracts. Regulatory consulting, which in 2015 already commanded over 50% of the outsourcing market for services, is particularly expected to grow. Regulatory consulting includes services directed to compliance with national agencies that approve and continually monitor the safety of medical devices, including the F.D.A. in the United States and the E.F.S.A. in Europe. In addition, contract manufacturing is reported to be the fasted growing service in the medical device industry and is projected to grow at a compound annual growth rate of over 11.5% through 2025.
There are several benefits associated with medical device outsourcing. According to an MDDI article, outsourcing can help original equipment manufacturers (OEMs) accelerate time to market for a new product, and speed up return on investment. Furthermore, the article states outsourcing can provide specialized knowledge, expertise, and facilities without the significant resources required to acquire such expertise in house. Moreover, outsourcing can leverage the pre-existing large supply chain of the contractor.
However, outsourcing also carries potential risks. The issues associated with outsourcing so many aspects of services uniquely associated with the medical device industry may not be as well known or well understood as the issues presented by outsourcing manufacturing. According to another MDDI article, these issues may include an increased risk of civil lawsuits from consumers of medical devices. This is especially true as medical devices become increasingly digital, and cybersecurity vulnerabilities are found. The medical device industry may also face increased regulatory scrutiny from national agencies as more regulatory compliance is outsourced to consulting services. Consequently, the medical device industry and medical device legal community will increasingly face new challenges from a world in which more and more industry services are outsourced.
The European Council has released the final versions of its Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR). According to JDSupra, the Council of the European Union will vote on March 7, 2017 whether to adopt the MDR and the IVDR. That vote will be quickly followed on March 20, 2017 by a vote by the European Parliament. If adopted, the MDR and IVDR texts could be published by May 2017 and enter into force in May or June 2017. The MDR would be applicable by 2020 and the IVDR by 2022.
The final texts retain much of the same information of the current Directives released in May 2016. According to Regulatory Affairs Professionals Society (RAPS), an EU official stated that:
The content of the two regulations on medical devices and in vitro diagnostic medical devices is still the same as in the agreement reached between the Council of the EU and the European Parliament in May 2016 which has been approved by the Council on 20 September 2016… The difference between these ‘old’ documents and the ‘new’ documents is that the new documents have undergone a legal-linguistic review to make sure that the texts are coherent and equivalent in all 24 official EU languages. So in other words: the wording might have changed, but apart from corrections of some obvious mistakes and addition of necessary clarifications the new EU rules remain unchanged.
The regulations generally strengthen pre-market requirements and post-market surveillance, including establishment of a unique identification system. For example, some experts note that under the current IVD Directive, a manufacturer is able to self-certify about 80% of all IVDs on the EU market. However, when the IVDR becomes applicable five years after its publication, this ratio will flip so that approximately 80% of all IVDs on the EU market will require approval from a notified body.
JDSupra also reports that the two Regulations include transitional provisions that allow CE mark certificates issued in accordance with the current Directives to remain valid until the end of the period indicated on the certificates. According to the Emergo Group consulting company, CE mark certificates issued prior to final implementation of the new regulations in late 2019 or early 2020 will have a maximum validity of five years. CE mark certifications issued before implementation of the new regulations will expire automatically four years after the new regulations come into force.
As the Regulations will impact nearly every device manufacturer that sells products in the EU, device manufacturers are well-advised to consider their existing products and procedures in view of the Regulations to avoid future problems when marketing their devices.
Ethicon Inc. announced on February 17 that it reached an agreement to acquire Torax Medical, Inc. According to its website, Torax Medical is a privately held medical device company developing a minimally invasive surgical treatment for GERD acid reflux known as the LINX system. The website indicates that the LINX system supports the body’s barrier between the stomach and esophagus with a band of interlinked titanium beads. The beads are said to have a magnetic core, and the magnetic attraction between the beads helps close the division between the stomach and esophagus after swallowing.
Ethicon stated in its announcement that the transaction would “enable Ethicon to offer patients a safe and effective alternative to the anatomy-altering laparoscopic Nissen fundoplication surgical procedure.”
The financial terms of the deal have not been disclosed. A previous press release noted that Torax Medical completed a $25 million Series E financing round in August 2016, led by Johnson & Johnson Innovation – JJDC and existing investors including Sanderling Ventures, Thomas McNerney & Partners, Accuitive Medical Ventures, Kaiser Permanente Ventures, Piper Jaffray Companies, and Mayo Clinic Ventures.
Ethicon is a subsidiary of Johnson & Johnson, and has headquarters in Somerville, NJ, and Cincinnati, OH.
On February 14, 2017, U.S. District Judge Michael Mosman of the United States District Court, District of Oregon granted a Joint Stipulated Motion for Dismissal with Prejudice submitted by Plaintiffs Smith & Nephew, Inc. and John O. Hayhurst, M.D. (inventor) and Defendant Arthrex, Inc. subject to the terms of a Settlement and License Agreement. Information about the settlement terms is not publicly available.
This agreement ends a 12-year long dispute between Smith & Nephew and Arthrex over Smith & Nephew’s U.S. Patent No. 5,601,557, which is directed to a method and apparatus for anchoring cartilage within a joint.
In 2004, Smith & Nephew sued Arthrex and alleged that certain products of Arthrex’s SutureTak® and PushLock® suture anchor families infringed the ‘557 patent (case number 3-04-cv-00029). According to the United States Court of Appeals for the Federal Circuit’s opinion of March 18, 2015, the parties had gone through three jury trials and two previous appeals. The third jury trial in 2011 produced a verdict of willful infringement and damages awards. Arthrex moved for Judgment as a Matter of Law (JMOL) of noninfringement, which was granted by the district court without an opinion. The Federal Circuit reversed and remanded the JMOL and reinstated the verdict in its S&N II opinion in 2013.
We previously reported the district court’s entering of judgment in favor of Smith & Nephew on remand, awarding a total of $88 million in damages and granting a permanent injunction against Arthrex. The judgment was affirmed by the Federal Circuit in its March 18, 2015 opinion. In June 2015, Smith & Nephew reported receiving a $99 million patent infringement payment from Arthrex.
In 2008, Smith & Nephew also sued Arthrex and alleged that different products from the same SutureTak® and PushLock® families infringed the ‘557 patent (case number 3:08-cv-00714). Judge Mosman granted in-part Smith & Nephew’s motion for summary judgment of infringement and denied Arthrex’s motions for summary judgment as of non-infringement. He also granted Smith & Nephew’s motion for summary judgment as to reasonable royalty damages.
According to the court’s public record, a jury trial was set for February 13, 2017 for the remaining issues in the lawsuit filed in 2008. On February 10, 2017, Judge Mosman vacated the jury trial, followed by the parties’ Joint Stipulated Motion for Dismissal with Prejudice.
Smith & Nephew and Arthrex filed a similar Joint Stipulated Motion for Dismissal with Prejudice in the 3-04-cv-00029 case, and in another lawsuit in the Eastern District of Texas relating to Arthrex’s patents (case number 2:15-CV-1047). The motion was granted by the Eastern District of Texas court, but denied as moot in the 3-04-cv-00029 case, which was closed when the September 2013 judgment was entered.
With the upcoming Republican-dominated Presidency and Congress in 2017, the Affordable Care Act, or at least parts of it, look to be on the chopping block. One of the changes that may be forthcoming is a repeal of the 2.3% medical device excise tax. While currently being suspended through 2017, under the present law the medical device tax would be reinstated in 2018.
Some producers of medical devices hope that the tax is never reinstated. Mark Throdahl, president and CEO of OrthoPediatrics Corp., a northern Indiana based orthopedic company, has said that the suspension of the tax allowed the company to hire new workers and hopes for a full repeal after the Republican transition. According to Throdahl, the tax led to a hiring freeze, and suspension of the tax allowed for them to resume “an aggressive pace of hiring and investment.” Complaints from companies like OrthoPediatrics, as well as medical device associations like AvaMed, were what led to the initial temporary suspension of the tax.
The medical device tax has been a significant drag on medical innovation, and resulted in the loss or deferred creation of jobs, reduced research, spending and slowed capital expansion.
According to some lawmakers, lobbyists, and industry executives, Trump and U.S. lawmakers will likely repeal the tax which could help some of the larger medical device manufacturers such as Medtronic, Boston Scientific, St. Jude Medical, and Johnson & Johnson. Senate Republican Leader Mitch McConnell has stated that repealing the Affordable Care Act will be one of the first order of business starting in January. Senator John Barrasso (R-Wyoming) has also stated that the medical device tax would likely be repealed.
There are still a number of decisions on how to approach the repeal of the medical device tax, whether in one single bill to repeal the Affordable Care Act or a number of smaller bills removing different parts of the Act. We should be receiving more clarity once President-elect Donald Trump officially takes office.
Repeal of the tax may remove approximately $2.5 billion of annual federal funding.
The U.S. Food and Drug Administration announced the availability of a draft guidance for the clinical evaluation of software as a medical device (SaMD). The draft guidance was prepared by the SaMD Working Group of the International Medical Device Regulators Forum (IMDRF), an international group of medical device regulatory authorities including the FDA. When finalized by the IMDRF, the draft guidance will represent the FDA’s “current thinking” on SaMD clinical evaluation and will not be binding.
SaMD is defined in the guidance as software that functions as a medical device and can run on a general purpose computing platform, “without being part of a hardware medical device.” Unlike other medical device-related software, SaMD primarily has risks associated with incorrect output affecting clinical management of a patient, rather than risks resulting from direct patient contact. Thus, the guidance is intended to address the “uniqueness of indirect contact between patients and SaMD” and provide globally harmonized principles for establishing scientific validity, clinical performance, and analytical validity for a SaMD.
The FDA is seeking public comment on the draft guidance generally, and related to eight specific issues:
Does the document address the intention captured in the introduction/scope or vice versa?
Does the document appropriately translate and apply current clinical vocabulary for SaMD?
Are there other types of SaMD beyond those intended for non-diagnostic, diagnostic and therapeutic purposes that should be highlighted/considered in the document?
Does the document adequately address the relevant clinical evaluation methods and processes for SaMD to generate clinical evidence?
Are there other appropriate methods for generating clinical evaluation evidence that are relevant for SaMD beyond those described in the document?
Are the recommendations related to the “importance of clinical evidence and expectations” appropriate as outlined for the different SaMD categories?
Are the recommendations related to the “importance of independent review” appropriate as outlined for the different SaMD categories?
Given the uniqueness of SaMD and the proposed framework—is there any impact on currently regulated devices or any possible adverse consequences?
The draft guidance is available for comment until December 13, 2016.
Healthcare apps are becoming a greater part of everyday life. The increasing prominence and functionality of these apps has lead to the question of when healthcare apps should be regulated as medical devices. In the United States, the FDA has issued some guidance on how it will treat healthcare-related apps. However, the FDA’s guidance only provides a list of examples of what constitutes a medical device, leaving the app developers to try and analogize their new apps to the examples or interpret the statutory language.
The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has attempted to simplify the regulatory determination for app developers by updating its guidance on classifying health apps as medical devices. As part of the update, the MHRA published a”step-by-step interactive PDF” to assist app developers in determining whether their app will be regulated.
According to the press release, “[a]pp users can use this guidance to check if their health app is a medical device.” The goal of the update is to “aid developers in navigating the regulatory system so they are aware what procedures they need to have in place to get a CE mark which indicates acceptable safety standards and performance, and what their reporting responsibilities are when things change or go wrong.” John Wilkinson, MHRA’s Director of Medical Devices stated:
Where apps or stand-alone software make a diagnosis or recommend a treatment, people should check for CE-marking before using their apps and developers should make sure they are complying with the appropriate medical device regulations.
To further MHRA’s goal of assisting app developers with CE marking regulation, the interactive PDF provides a flow chart to help app creators determine whether their app could potentially be classified as a medical device.
The interactive PDF also provides additional flow charts for determining whether an app has a medical purpose and whether an app works directly with in vitro diagnostic (IVD) data. Additionally, the interactive PDF also sets forth the “essential requirements” that app developers must meet in the event their app is classified as a medical device. MHRA has inserted explanatory comments into these requirements section that give simple examples or a brief interpretation of the regulatory text. MHRA also provided links in the PDF where app developers can go for additional guidance.
OCTANe, an Orange County-based non-profit life sciences and technology accelerator organization, has announced the agenda for its 11th Annual Medical Device & Investor Forum (MDIF), which will be held on October 27-28, 2016, in Irvine, California. The speakers for this year’s MDIF include Mike Mussallem, Chairman and CEO of Edwards Lifesciences; Tom Burns, President and CEO of Glaukos; Jim Mazzo, Global President of Ophthalmology, Carl Zeiss Meditec; Brett Wall, Sr. VP and President of Brain Therapies, Medtronic; and Geoff Martha, EVP and Group President of Restorative Therapies Group, Medtronic. A number of companies will also present new strategies for maximizing funding options. The forum is expected to attract over 600 attendees.
According to its website, OCTANe fosters a successful ecosystem that accelerates the flow of ideas, talent, and capital by creating an infrastructure where entrepreneurs, academia, company executives, and business advisors build and grow sustainable organizations. OCTANe’s members include Orange County technology executive leaders, entrepreneurs, investors, venture capitalists, academicians, and strategic advisors, all working together to fuel innovation in the OC. OCTANe has helped more than 800 companies via the LaunchPad™ Small Business Development Center (SBDC) accelerator. LaunchPad™-certified companies are reported to have received more than $1.7 billion in investment and equity exits.
The agenda for this year’s MDIF includes a keynote address by Dr. Wallace Walrod, Chief Economic Adviser of the Orange County Business Council, and Herm Cukier, Sr. VP of Eye Care, Allergan, on Allergan’s economic impact on Orange County. A panel moderated by Clay Wilemon, CEO and Chief Strategy Officer of DevicePharm, will discuss using big data to improve patient outcomes and reimbursement. Sabing Lee, a Partner at Knobbe Martens, will host a panel discussing medical device security. And, U.S. Congresswoman Mimi Walters will address the importance of innovation in Orange County, and healthcare legislative and policy expert Jeff Kimbell will provide his views on the upcoming elections from a Washington D.C. perspective.
OCTANe annually welcomes more than 7,000 people to its programs and events, and more than 2,000 business leaders throughout the Orange County region are OCTANe members. Bill Carpou, CEO of OCTANe, describes the MDIF as “the most important event of the year when it comes to medical technology and Orange County.”
The FDA‘s planned National Evaluation System for Health Technology (NEST) will focus on new forms of clinical data, data sharing, and advanced analytics as the keys to optimizing the medical device ecosystem, says a new report issued by the NEST Planning Board. The Planning Board was convened by the FDA and the Duke-Margolis Center for Health Policy in order to outline the initial priorities for NEST.
The FDA plans for NEST to be the national evaluation system for medical devices and is aiming to evaluate evidence from the entire life-cycle of medical device products in order to more effectively monitor medical device safety and efficacy.
In July, FDA Commissioner Dr. Robert Califf and Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health (CDRH) stated that this system for evaluating health technology:
could quickly identify problematic devices, accurately and transparently characterize and disseminate information about device performance in clinical practice, and efficiently generate data to support premarket clearance or approval of new devices and new uses of currently marketed devices.
The Planning Board’s report explains that new standards for sharing medical data between multiple entities will be the focus of a planned NEST Coordinating Center. The proposed Coordinating Center will work to develop a network of experts which will aid NEST in collecting and evaluation clinical data, as well as data received directly from patients. According to the report, the Coordinating Center will foster the development of a NEST clearinghouse of analytical tools, methods, and standards for using linked real-world data collected through clinical and administrative workflows as well as from patients themselves to evaluate devices.
The Food and Drug Administration has issued a statement announcing that the FDA and representatives from the medical device industry and laboratory community have reached an agreement in principle on proposed recommendations for the fourth reauthorization of the medical device user fee program (MDUFA IV).
Under the new draft agreement (to be published in the coming weeks), the FDA would be authorized to collect almost $1 billion in user fees over five years starting in October 2017. This funding would provide critical resources to the FDA medical device review program.
The director of the FDA’s Center for Devices and Radiological Health, Jeffrey Shuren, M.D., has commented:
This draft agreement represents a substantial investment in the future of the agency’s medical device program and reflects the efforts the FDA has made to meet or exceed its performance goals and to help speed patient access to safe and effective medical devices. This funding will also improve the collection of real-world evidence from different sources across the medical device lifecycle, such as registries, electronic health records, and other digital sources.
First established in 2002 to provide the FDA with the resources necessary to better review medical devices, device user fees have helped the FDA increase the efficiency of regulatory processes with a goal of reducing the time it takes to bring safe and effective medical devices to the U.S. market. These fees, which range from the thousands to hundreds of thousands depending on the type of review required, are paid by medical device companies when they register their establishments and list their devices with the agency or submit an application or a notification to market a new medical device in the U.S.
The current legislative authority for the medical device user fee program expires on October 1, 2017, and new legislation will be required for the FDA to continue collecting user fees for the medical device program in future fiscal years.
Details of the draft agreement will be published for public comment in the coming weeks, and the final recommendations are scheduled to be delivered to Congress in January 2017.
Despite a drop in the second quarter of 2016, medical device funding is expected to finish stronger this year than in 2015. CB Insights has released a report on the funding and deal activity within the medical device industry since 2012. CB Insights reports that “after hitting a 4-year high of $1.5 billion in the second quarter of 2014, funding to medical device startups has sobered considerably.” Funding in 2014 was elevated by a $172 million Series G round secured by California based Proteus Digital Health. Overall, the medical device industry is on track for a modest increase in deals and dollars to private companies in 2016, after seeing a decline in both in 2015.
As of August 8, 2016, funding and deal activity have reached $2.1 billion and over 288 deals. At the current rate, total year funding would reach $3.5 billion and total year deal count would reach 476 deals. The funding has been bolstered by $75 million in Series C funding secured by California based Acutus Medical in March 2016 and recent funds raised by Minneapolis based CVRx, $93 million in August 2016.
The first and second quarters of 2016 are among 5 of the last 10 quarters to have 120+ deals. Funding in the first quarter of 2016 managed to break $1 billion, a feat that didn’t occur in 2015. However, the second quarter’s slip to $757 million saw the first sub $800 million quarter since the first quarter of 2015.
The deal and dollar share by stage for 2016 looks to be similar to those for the last four years with early-stage deals, including Seed/Angel and Series A, making up 29% of total deal share to-date. The top three “Most Active Early-Stage Medical Device Investors” are reported as Germany based High Tech Gruenderfonds, Memphis based ZeroTo510, and Philadelphia based Ben Franklin Technology Partners. Interestingly, “Other” funding rounds have been trending up and currently represent the largest share of deals at 42%. “Other” includes corporate minority rounds, VCs, and convertible notes. The top medical device investor overall is reported as New Enterprise Associates with Versant Ventures a close second.
CB Insights reports the top most well-funded medical device startup as Theranos, securing $400 million in total funding. Theranos was recently sanctioned by the U.S. Centers for Medicare & Medicaid Services (CMS) and banned from receiving Medicare and Medicaid payments.
Each of the top five has raised upwards of $250 million. However, the funding figures exclude debt rounds and lines of credit.
The U.S. Food & Drug Administration (FDA) issued a proposed guidance on August 8, 2016, regarding software changes to medical devices. The proposed guidance relates to requirements for submitting medical device software changes to the FDA for approval. The final document will provide assistance to medical device companies and the FDA for determining when changes to software or firmware for a medical device require FDA clearance. The medical devices covered include 510(k)-cleared devices and preamendments devices subject to 510(k).
The FDA’s proposed guidance explains that premarket notifications are generally submitted for commercially-distributed medical devices undergoing significant changes in design. Such changes include modifications that “could significantly affect the safety or effectiveness of the device” or a “major change or modification in the intended use of the device.” The proposed guidance relates to software changes and is an update to the original guidance issued in 1997 regarding changes to existing devices.
The “software” subject to the proposed guidance is defined as “electronic instructions used to control the actions or output of a medical device, to provide input to or output from a medical device, or to provide the actions of a medical device.” This includes software embedded in a device, software that is an accessory to another device, and “software that is intended to be used for one or more medical purposes that performs these purposes without being part of a hardware medical device.”
The FDA provides a flow chart for assisting with the determination, see below. Issues addressed in the determination include changes related to: strengthening cyber security; meeting specifications of the most recently cleared device; introducing or affecting hazardous situations; creating new risk control measures; and affecting clinical functionality or intended use of the device. Additional factors to consider beyond those in the flow chart and some examples of modifications are provided in the draft guidance as well.
The proposed guidance notes that in some cases a new 510(k) is not necessary, and that existing Quality System (QS) requirements may suffice. Such QS requirements mandate, among other things, that the manufacturer maintains records, for production upon request, regarding such changes and the processes used to determine the changed device meet the design specifications. Further, the proposed guidance does not apply to software for which the FDA has previously said it will not enforce compliance, including some mobile apps used with medical devices.
Some observers think the proposed guidance will help with improving cybersecurity of connected medical devices. The public may provide comments to the FDA on the proposed guidance until November 7, 2016: comments may be submitted electronically here.
The FDA has just released draft guidance for unique device identifiers (UDIs) tracking medical devices from their manufacturers to the end users. Specifically, the FDA is providing guidance to device the content and form of UDIs that was lacking (or at least unclear) in the original FDA UDI rule which was published on September 24, 2013.
UDI laws are currently listed under 21 CFR 801.20, and every medical device in commercial distribution is required to have a UDI, unless an exception or alternative applies (for example if the UDI is not technologically feasible). They must be given by an official UDI Issuing Agency that is in line with international standards for medical devices.
The UDI rule began applying to Class III devices in 2014 and implantable, life-supporting and life-sustaining devices in 2015. Class II devices will be in compliance this year, and Class I and non-classified devices will need to have them in 2018.
In this updated draft guidance, the FDA has clarified what forms that the UDI are required to be on medical device packaging. Specifically, the guidelines clarify that the UDIs must be present in two forms on the label and device packing: 1) “easily readable plain-text” and 2) automatic identification and data capture (AIDC) technology. The UDI then must be submitted to the Global UDI Database.
The guidelines provided further information on a number of other topics as well. For example, the guidelines clarified the AIDC technology should be read by a barcode scanner or similar technology, and the UDI may be split into multiple segments on medical device packaging. Moreover, multiple types of AIDC technology can be used on a device label, both representing the same UDI. However, if the UDI is not visible to the human eye, the packaging must disclose that there is the presence of AIDC technology.
The guidance further discussed the specific content of the UDIs, including device and product identifiers as well as data delimiters, and the particular ordering of such information on the packaging.
The FDA providing guidance to the UDI Rule is not uncommon, as a number of other guidances have been issued, such as the guidance issued on June 27, 2014 regarding the Global Unique Device Identification Database and the general guidance issued on August 20, 2014. As this is a complex and important issue, the FDA contains FAQ pages for any questions medical device manufactures may have.
The draft comments will be open for comment for 60 days, and both written and electronic comments are accepted.
The FDA recently approved the Medtronic Prestige LP Cervical System for treating degenerative disc disease at two adjacent vertebral levels (between C3 and C7). The device is said to be Medtronic’s third clinically-proven cervical implant and its first to be approved for use in both one-level and two-level procedures. The system was approved to treat single-level cervical disc disease in July of 2014, and approval for use at two adjacent levels was granted earlier this month. As described in Medtronic’s press release, the ball-and-trough design of the Prestige LP allows a variety of movements including bending, rotation, and translation.
According to Medtronic, the Prestige LP Cervical System serves as a complete replacement for one or two intervertebral discs. The human spinal column is composed of twenty four vertebral bones stacked on top of each other. The uppermost seven bones are referred to as the cervical vertebrae, and they are labeled C1 – C7. Flexible intervertebral discs (Fig. 2 below) act as shock absorbers between adjacent vertebrae. Each disc is composed of an inner jelly-like material called the nucleus pulposus and a tough outer wrapping called the annulous fibrosus. In addition to cushioning shock, the discs allow bending, twisting, and flexion of the spine.
According to the Arthritis Foundation, wear and tear on intervertebral discs is part of normal aging. As we grow older, the discs can dry out and lose their shock absorbing capacity. Stress from daily activities can cause tears in the annulous fibrosus resulting in herniation of the inner jelly-like core. Furthermore, because intervertebral discs have little blood supply, their ability for self-repair is limited. As a result, once a disc is injured, it may continue to deteriorate. Studies using Magnetic Resonance Imaging (MRI) show that nearly everyone over age 60 has at least some disc degeneration. However, not all people affected by disc degeneration will experience discomfort. According to the American Academy of Orthopaedic Surgeons, pain and disability due to cervical disc degeneration are often treated with physical therapy, anti-inflammatory medications, and steroid injections. When these options fail to alleviate symptoms, surgical options may be considered.
According to the UCLA Spine Center, the traditional surgical approach to treating cervical disc disease involves removing the affected disc (called discectomy) and using metal hardware to fuse the vertebrae above and below it. The preferred procedure is called Anterior Discectomy and Cervical Fusion (ADCF). During ADCF, the diseased disc is removed and replaced with bone graft or a plastic spacer. Adjacent vertebrae are then fused using a metal plate and screws. Because normal cervical discs are flexible and permit movement of adjacent vertebrae, cervical discectomy and fusion can restrict neck motion. However, compared to this traditional approach, replacing a diseased disc with an implant can allow for greater neck motion after surgery and reduce stress on remaining vertebral bodies (Fig. 3 below).
The Medtronic Prestige LP Cervical Disc joins others that are FDA approved for use at two vertebral levels. In August, 2013 the Mobi-C Cervical Disc (Fig.