The FDA’s Medical Device Innovation Challenge: A New Approach to Combat the Opioid Epidemic

On May 30, 2018, the U.S. Food and Drug Administration launched an innovation challenge as a way to combat the fight against opioid addiction. The challenge was issued to “spur the development of medical devices, including digital health technologies and diagnostic tests that could provide novel solutions to detecting, treating and preventing addiction, addressing diversion and treating pain.”

FDA Commissioner Scott Gottlieb stated that “[m]edical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in tackling the opioid crisis.” Medical devices can be used to address opioid addiction by, for example, effectively addressing local pain syndromes in order to supplant the use of systemic opioids and reduce the use of opioids. “New digital technology products and diagnostic tests could help in the opioid addiction fight by detecting, treating, and preventing addiction; addressing diversion of the opioid supply chain to illicit use; and treating pain,” the FDA said.

According to Bloomberg, “accepted companies will get to work more closely with the FDA’s review offices than usual to help get their products approved. Products that qualify as breakthrough devices under food and drug law will receive that designation without the sponsor needing to submit an application, the agency said. A breakthrough device designation can reduce the time and cost to get a product to market that addresses life-threatening or irreversibly debilitating diseases.”

The innovation challenge is open to any product in any stage of development. The challenge also is open to developers of currently marketed devices who can show that their devices have an improved benefit-risk profile compared to opioid use in pain management. The FDA anticipates “that applicants will eventually submit one or more formal applications to the FDA, such as an investigational device exemption, De Novo, premarket clearance (510(k)) or premarket approval application.”

This innovation challenge is part of the FDA’s plan to aid in the opioid crisis and supports several overarching goals of the U.S. Department of Health and Human Services’ Five-Point Strategy to Combat the Opioid Crisis. On April 20, 2018, the agency also released the first of two new draft guidances intended to aid industry in developing new medications for use in medication-assisted treatment (MAT) for opioid dependence.

J&J Accepts Platinum Equity’s $2.1B Offer for its LifeScan Subsidiary; Receives Offer for Advanced Sterilization Products Subsidiary

On June 12, 2018, Johnson & Johnson announced acceptance of an offer from Platinum Equity, a private investment firm, to acquire its diabetic monitoring unit, LifeScan, for approximately $2.1 billion. In response to the acquisition, Platinum Equity Chairman and CEO Tom Gores said

We are committed to putting our financial resources and global operating expertise to work in support of the company’s core mission to improve the quality of life for people living with diabetes.

LifeScan offers blood glucose monitoring products to patients for the care of diabetes under the OneTouch brand. According to the press release, LifeScan business earned approximately $1.5 billion in revenue in 2017. Platinum Equity previously reported that LifeScan President Valerie Asbury would continue leading the business.

In February 2018, Bloomberg reported that Johnson & Johnson was seeking to sell off its sterilization products division for as much as $2 billion. The selling price has increased as Johnson & Johnson announced on June 6, 2018, receipt of a binding offer from Fortive Corp. to acquire Advanced Sterilization Products (ASP), a division of Ethicon Inc., for approximately $2.8 billion. If accepted, Johnson & Johnson indicated it expects the proposed transaction to close no later than early 2019.

ASP sells sterilization products under the STERRAD and CYCLESURE brands. ASP’s high level disinfection products are sold under the EVOTECH brand. Johnson & Johnson reported that ASP earned approximately $775 million in revenue in 2017.

 

FDA Unveils Update to Software Precertification Program

The U.S. Food and Drug Administration (FDA) recently updated its software Precertification Program. A working program was originally rolled out in April 2018, but the program was updated in response to requested public input. The FDA expects to roll out a finalized version of the program by December 2018 and to have a pilot test available in 2019.

With the precertification program, the FDA hopes to streamline the certification of “mobile apps” and other software that is used to “treat, diagnose, cure, mitigate, or prevent disease or other conditions,” or so-called software as a medical device (SaMD), according to the updated program description. While software in a medical device (SiMD) is not currently part of the program, the FDA hopes to include SiMD and software that is an accessory to hardware in the future. The program will allow certain organizations that can demonstrate a “culture of quality and organizational excellence” to streamline their oversight of SaMD.

The update clarifies that not all software is subject to regulatory review even if it has some connection to the medical industry. In particular, the update notes that non-device software is exempt, such as software that is intended for (1) for administrative support, (2) for maintaining or encouraging a healthy lifestyle, (3) to serve as electronic patient records, (4) for transferring, storing, converting formats, or for displaying data, or (5) to provide certain limited clinical decision support.

According to the update, organizations “of all sizes” can qualify. The FDA makes clear that startups and smaller companies can apply and receive precertification. Two levels of precertification exist. Level 1 precertification allows an organization to develop and market “lower risk” software without review while also streamlining review of higher risk software. This level would be awarded to an organization that demonstrates excellence in product development but may have a “limited track record” in “developing, delivering, and maintaining” products in the healthcare market. Level 2 precertification allows “lower and moderate risk” software to be developed and marketed without review and allowing streamlined review of other software. This level is awarded to those organizations with a track record in demonstrating high quality software products.

In determining what amount of review is required for “lower risk” and “moderate risk” SaMD, the FDA looks at (1) the risk category of the product, (2) the level of precertification of the organization, and (3) the extent of the changes the software relative to an existing device. Under either level of precertification, “minor changes” require no review by the FDA.

The FDA is looking to update additional aspects of the precertification program, including how it relates to substantially equivalent device review. The FDA is currently requesting comments on the program.

Medical Device Connectivity Market Reported to Top $2.6 Billion by 2023

The market for medical device connectivity is projected to reach about $2.6 billion by the year 2023, according to a report published in April 2018 by several publishers.  The report states that the connectivity market for 2018 is expected to be about $940 million.  This equates to a compound annual growth rate (CAGR) from 2018 to 2023 of 23.2%.

According to news articles, the report states that “[t]he growth in this market is attributed to the increasing penetration of [electronic health records] and health information exchange systems in healthcare organizations, growing focus on care quality and patient safety, healthcare IT initiatives driving the integration of medical devices with hospital information systems, and the growing need to curtail healthcare costs through a connected healthcare environment.”

From 2018 to 2023, the medical device connectivity market CAGR is estimated to be 23.2%

The report further states the medical device connectivity services segment, as opposed to the device connectivity solutions segment, is anticipated to grow at the maximal CAGR during the “outlook period” from 2018 to 2023.  The report divides the technology sectors into wired, wireless, and hybrid technologies.  The wireless segment is projected to register the highest CAGR during the outlook period.

The report also breaks down the relevant markets into hospitals, home healthcare, ambulatory care settings, and imaging & diagnostic centers.  It finds in 2017 hospitals controlled the medical device connectivity market.  The report also finds that North America is expected to grow at the highest CAGR during the outlook period, followed by Europe.

The increase in the market is attributed in the report to “growing funding towards innovative projects in the medical market, [the] need to curtail the escalating healthcare costs in the USA, the presence of a big number of healthcare IT firms, rising investments in the healthcare sector by top market players, and increasing awareness about advanced technologies.”

The report is made available for purchase from several publishers, for example by Report Linker and Markets and Markets.

First Prosthetic Iris Approved

On May 30, 2018, the Food and Drug Administration announced the approval of the CustomFlex Artificial Iris. According to the FDA, this is the first approved artificial iris. The approval was granted to Clinical Research Consultants, Inc., and the device is marketed and developed by HumanOptics AG.

The HumanOptics website describes the CustomFlex Artificial Iris as a prosthetic iris used to treat adults and children whose iris is completely or partially missing due to congenital or traumatic aniridia, or other conditions with iris defects. Patients with aniridia experience compromised vision and also suffer from aesthetic defects of the eye. As stated by Dr. Malvina Eydelman, the approval of the CustomFlex Artificial Iris:

provides a novel method to treat iris defects that reduces sensitivity to bright light and glare. It also improves the cosmetic appearance of the eye in patients with aniridia.

HumanOptics website notes that the CustomFlex Artificial Iris is made of pigmented silicone, and is customizable in size and coloration to fir the needs of each individual patient. It further describes that the artificial iris is inserted into the eye by making a small incision and inserting the folded iris into position, the iris is then unfolded and held in place by the structures of the eye, or by sutures, and mimics the function of the natural iris.

Approval of the CustomFlex Artificial Iris was performed under the compassionate use exemptions of the FDA. The approval proceeded through the premarket approval application (PMA). PMA is the FDA review of Class III medical devices, which include high-risk medical devices. Because the CustomFlex Artificial Iris was classified as a high-risk medical device according to the FDA, it required a PMA pathway in order to obtain marketing approval. This is the most stringent type of device marketing under the FDA, and according to the FDA, approval indicates that the CustomFlex Artificial Iris was shown as safe and effective for its intended uses. In addition, the CustomFlex Artificial Iris was granted Breakthrough Device designation. This program is intended to help patients have more timely access to breakthrough technologies that provide treatment for diseases for which no approved treatment exists or which offer significant advantages over existing treatments.

Cyberdyne Bringing HAL Cyborg Exoskeleton to US Market

Cyberdyne, a Japan-based robotics technology company, recently announced its collaboration with Brooks Rehabilitation and the Brooks Cybernic Treatment Center to bring its Hybrid Assistive Limb (HAL®) exoskeleton to the U.S. market.  According to the companies, the device is designed to help patients rehabilitate from conditions leading to lower limb disorders, including spinal cord injuries and strokes.  There are currently about 200,000 people in the United States that have such injuries.

According to Cyberdyne, HAL® is the world‘s first cyborg-type robot, by which a wearer‘s bodily functions can be improved, supported and enhanced.  Cyberdyne explains that wearing HAL® leads to a fusion of “man,” “machine,” and “information.”  HAL works by detecting small electrical signals in the patient’s body through the use of small sensors placed on the skin.  The signals are detected by HAL®, which responds with a movement at the joint.  Dr. Robert McIver, the director of clinical technology at Brooks Rehabilitation, commented that patients using HAL® have seen greater functional changes in a shorter amount of time than with any other intervention method tried in spinal cord injured patients.

The press release notes that HAL® received approval and marked clearance from the U.S. Food and Drug Administration in 2017.  The device was previously only available in the EU and Japan, but has been in use in Japan since 2011.  In 2011, the suit was estimated to cost approximately between $14,000 and $19,000, down from the $50,000 cost for the first prototypes unveiled in 2006.  The monthly rental for a HAL® suit is expected to be $1,000.

According to USPTO public records, Cyberdyne is a listed assignee of a number of U.S. Patents, including, 9,943,458 and 8,773,148, as well as design patents D749,227, and D786,446.  Cyberdyne notes that the International Patent Application relevant to HAL® was accredited as a Notable Invention by the World Intellectual Property Organization (WIPO).

Teleflex to Acquire QT Vascular’s Coronary Products for Nearly $100 Million

According to the Straits TimesQT Vascular, a Singapore-based medical device company, reached an asset purchase and option agreement to sell its intellectual property rights to some of its non-drug coated coronary products, such as its Chocolate XD® and Glider™, to Teleflex Life Sciences Unlimited Company and Teleflex Incorporated (“Teleflex“).  The agreement gives Teleflex the option to purchase QT Vascular’s drug coated product, the Chocolate Heart, which is still being developed.

Under the agreement, Teleflex may pay up to $98.4 million in cash—$26.2 million for the non-drug coated coronary products, $65.6 million for the drug coated coronary product, and up to an additional $6.6 million upon the achievement of certain sales revenue milestones.  According to the Straits Times, the total value of the deal may be greater than $100 million, which exceeds QT Vascular’s market value of $36.3 million as of May 23, 2018.

Eitan Konstantino, CEO of QT Vascular, stated:

We are excited that Teleflex, one of the world’s leading medical device companies, chose to acquire our coronary products and to obtain a license to our extensive coronary IP portfolio.  We will work closely with Teleflex’s team to bring our pioneering drug coated coronary product, Chocolate Heart™, to the US market.

According to QT Vascular’s press release, the deal is pending approval by its shareholders.  As reported in the Straits Times, QT Vascular and Teleflex are also negotiating other business agreements, including supply agreements related to the products QT Vascular is selling to Teleflex.

The press release states that QT Vascular will independently continue its development of other products, such as a planned Investigational Device Exemption clinical trial of its differentiated drug coated percutaneous transluminal angioplasty balloon (Chocolate Touch®) in the U.S.

This deal follows the January 2018 announcement of QT Vascular’s sale of its non-drug coated Chocolate® PTA balloon catheter to Medtronics for $28 million.

First Thrombectomy Device Cleared for Pulmonary Embolisms

The FDA announced 510(k) clearance for Inari Medical’s FlowTriever device for the treatment of pulmonary embolism (“PE”).  According to Inari, the FlowTriever system is the first thrombectomy device cleared for the treatment of PE.  The FlowTriever had previously been cleared for treatment of the peripheral vasculature.

Inari announced that the PE specific clearance was based on the results from the FlowTriever Pulmonary Embolectomy (“FLARE”) study.  Principal investigator Dr. Thomas Tu presented the results of the FLARE study at an April 27, 2018 Scientific Session of the Society for Cardiovascular Angiography and Interventions in San Diego, CA.  In a press conference, Dr. Tu stated that the FlowTriever “potentially has the chance to reduce bleeding complications, [and] to reduce total hospital and ICU length of stay.”  Dr. Tu also emphasized that the FlowTriever compared favorably with other techniques for treating PE and that FlowTriever employs a “purely mechanical approach which avoids the use of thrombolytic drugs and [the] resulting risk of of bleeding complications” associated with other techniques.  Co-principal investigator Dr. Victor Tapson touted the results as “an exciting advancement in the treatment of acute pulmonary embolism patients” because “[u]ntil now, there has not been an approach to rapidly restore flow to reverse right heart strain without the use of thrombolytic drugs and their inherent risk of bleeding complications.”

A recent article from the American College of Cardiology estimates that approximately 100,000 hospitalized patients each year die of causes related to PE.  The article discusses other treatments for PE, including anticoagulants and inferior vena cava filters.  The article also discusses other percutaneous approaches for treatment of PE such as “1) thrombus fragmentation with a rotating pigtail catheter; 2) aspiration thrombectomy; 3) rheolytic thrombectomy; and 4) suction embolectomy.”

The FlowTriever is a mechanical device designed “to treat vascular occlusions due to an embolis[m].”  The FlowTriever catheter has a self-expanding retriever with three “disks” for engagement and retraction of clots.  The retriever is designed to self-expand with a clot, engaging the clot and trapping it between the disks.  The clot is retracted into an “aspiration guide catheter,” allowing for synchronized aspiration and mechanical retraction of the clot.  Additional information on the FlowTriever is available in the video below from Inari Medical.

DePuy Synthes Acquires Medical Enterprises Distribution LLC’s Orthopedic Assets

DePuy Synthes, a part of the Johnson & Johnson Medical Devices Companies, announced recently that it has signed a definitive agreement to acquire the assets of Medical Enterprises Distribution, LLC, which includes the automated ME1000™ Surgical Impactor tool used in hip replacement surgery.  The two companies had previously formed an exclusive agreement to co-market the hip application of the ME1000™.  The financial terms of the acquisition are not being disclosed.  The transaction is expected to close in the second quarter of 2018.

According to Medical  Enterprises, the ME1000™ delivers constant, stable energy that is designed to automate bone preparation, implant assembly and positioning in total hip arthroplasty (THA).  DePuy Synthes said that the company plans to develop and broaden the surgical impactor technology for a range of orthopaedic surgery procedures.

“The acquisition of assets of Medical Enterprises Distribution is a key example of going beyond the implant to provide complete solutions to achieve better outcomes.” – Ciro Roemer, Company Group Chairman of DePuy Synthes

The hip replacement global market was $6.5 billion in 2015 and is predicted to reach $9.1 billion by 2025.  The global market for all joint replacements is expected to reach $30 billion by 2025.  Other companies in the joint replacement markets include Zimmer Biomet, Smith & Nephew, and Stryker.

In the recent press release, DePuy Synthes also announced an exclusive marketing agreement with JointPoint Inc. to co-market a hip navigation system for  analysis of implant selection during THA.  Earlier this year, DePuy Synthes announced the acquisition of Orthotaxy, a privately-held developer of software-enabled surgery for total and partial knee replacement.  In discussing the Orthotaxy acquisition, Ciro Roemer, Company Group Chairman of DePuy Synthes, said “Our goal is to bring to market a robotic-assisted surgery technology that is an integral part of a comprehensive orthopedics platform, delivering value to patients, physicians and healthcare providers across the episode of care.”  Other companies in the joint replacement market are likely seeking to create comprehensive orthopedic platforms as well.

Apple Releases Electronic Health Record Aggregation Tool in iOS 11.3

According to an Apple press release, iPhone users will now be able to store and view their medical records on their phones as part of a new feature found in iOS 11.3.  Although many patients are already familiar with clinic-specific patient portals, Apple’s new Health Records feature is said to allow patients to download their medical records from a variety of hospitals and clinics, and consolidate those records on their iPhone.

According to Apple, the Health Records feature can be found in Apple’s Health app on updated devices.  The Health Records feature allows participating hospitals and clinics to transfer medical information to a users device. The patient’s medical record data will be stored along with their own patient-generated data in the consolidated Health app.  Users will be able to view recorded allergies, clinical vitals, conditions, immunizations, lab results, medications, procedures, and similar information.  Users will also be notified whenever their data is updated, such as when lab results are received.

Apple notes that in the past, patients’ medical records were held in multiple locations, requiring patients to log into each care provider’s website and piece together the information manually.

The press release notes that data within the Health Records feature will be encrypted and protected with the user’s iPhone passcode.  Moreover, no health record data passes through Apple’s network.  Instead, Apple relies on Fast Healthcare Interchangeability Resources (FHIR) and related application programming interfaces (APIs) to transmit the data from a hospital or clinic’s electronic health record (EHR) system directly to a user’s device over an encrypted connection.

As a result, Apple maintains that it does not create, transmit, or receive any protected health information for or on behalf of a covered entity or business associate.  Nevertheless, if a user chooses to sync their health data with iCloud, the data will be encrypted in transit and for storage on Apple’s servers.

With the push to provide patients with their digital health information comes a push for FHIR, solidifying the technology’s viability as a solution to the federal mandate that providers allow patients to access electronic versions of their health records

Apple notes that at this time, around 40 hospitals and clinics are participating, including Johns Hopkins, Cedars-Sinai, Penn Medicine, UC San Diego Health, and Geisinger Health System.

 

 

 

 

 

 

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