On September 26, 2017, the FDA announced that it has chosen nine tech companies to participate in a pilot program (FDA Pre-Cert) to help tech companies bypass some regulations that have hindered health software and products release, Bloomberg reports. According to the Bloomberg article, this program operates as a “fast track” for these technology companies, which amongst others include Apple, Fitbit, Samsung, Johnson & Johnson, and Verily Life Science (an arm of Google parent Alphabet Inc.), and is said to allow them to develop technologies rapidly, while allowing the FDA to maintain oversight over those projects.
This program is said to signal a broader trend at the FDA to streamline regulation since FDA Commissioner Dr. Scott Gottlieb was appointed in May. Bloomberg reports that as technology companies have entered the healthcare and medical device arena, questions arose of whether these companies were required to seek FDA approval on their products. For example, in 2013, the consumer gene-testing company 23andMe Inc. was ordered by the agency to temporarily stop selling its health analysis product until it was cleared by regulators. “We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate,” Commissioner Gottlieb said.
As Fortune reports, the pilot companies can potentially get their products pre-cleared in lieu of undergoing the FDA’s traditional medical device regulatory framework. Under FDA Pre-Cert, the FDA will instead primarily examine the software (rather than the tech device itself) and inspect facilities to ensure it meets the FDA’s rigid standards. If the companies pass the audit, the companies will attain pre-certified status. The FDA Pre-Cert was launched as part of the agency’s Digital Health Innovation Action Plan. The press announcement states that the “plan seeks to outline the agency’s vision for fostering digital health innovation while continuing to protect and promote public health by providing clarity on medical software provisions of federal legislation passed in 2016 (21st Century Cures), adding expertise to the digital health unit and initiating the FDA Pre-cert pilot program.” The FDA plans to share public updates via the pilot program webpage as well as through stakeholder meetings, including a January 2018 workshop.
For more information on the FDA’s Pre-Cert press release, please visit the site here.
According to Medtronic news release, the company recently received 510(k) clearance from the U.S. FDA and a CE mark from the E.U. for its StealthStation™ ENT surgical navigation system. The system will assist surgeons performing procedures within the ear, nose, and throat (ENT) anatomy.
Medtronic explains that the StealthStation™ ENT works by generating an electromagnetic field within the ENT anatomy during surgery and allows surgeons to track the locations of instruments during procedures, much like a GPS system used for cars. The surgeons can view 3-D structures on a 27-inch, high-resolution touch-screen monitor. Medtronic already markets a similar system, the StealthStation™ S8, for use in neurosurgery and spine procedures.
The press release reports that StealthStation™ ENT system provides surgeons with enhanced visualization during procedures and also includes several software and hardware innovations such as Virtual Endoscopy. Virtual Endoscopy gives surgeons a simulated view of a patient’s sinus cavities that have previously been unavailable using traditional endoscopy. Thus, Medtronic explains, a surgeon can load a Virtual Endoscopy with a patient’s pre-operative data and practice that patient’s surgery prior to setting foot in the operating room.
The StealthStation™ ENT system should enhance patient outcomes and provide a valuable tool to surgeons. Dr. Joseph Raviv, director of endoscopic sinus and skull base surgery at NorthShore University HealthSystem commented:
The intraoperative use of computer-aided surgery is very helpful to assist the surgeon in clarifying complex anatomy during sinus and skull base surgery . . . . It provides an added level of assurance and may allow for a more thorough sinus procedure.
A voluntary agreement (link in Dutch) was consummated by the Dutch Ministry of Health, industry, and hospitals. According to an Emergo blog post, under the terms of the agreement, the Netherlands will adopt the US Food and Drug Administration’s Unique Device Identification (UDI) system.
According to the post, Dutch hospitals agreed to use UDI codes exclusively for identification and traceability of medical devices, and industry promised to place only UDI codes on device labels. According to the Emergo post, this means that every manufacturer that wants their devices used in Dutch hospitals now needs to provide UDI codes on those devices.
An article from Securing Industry cites to the the Dutch Ministry of Health as saying that the decision to use the FDA’s UDI system was made to avoid adding complexity for manufacturers by requiring a separate system. According to the article, the Netherlands is the first in the EU to adopt the FDA’s UDI system, a decision that some believe may increase the chances of the UDI system being adopted elsewhere in the region.
In 2013, the US published the rule requiring UDI codes to be assigned by device manufacturers to each version or model of a device. Under the published rule, the codes must be in both human and machine readable formats. According to the FDA, implementation of UDI codes improves patient safety, modernizes device postmarket surveillance, and facilitates medical device innovation.
The reSET® mobile app, developed by Pear Therapeutics, is approved to assist individuals undergoing outpatient therapy for alcohol, cocaine, marijuana, and stimulant addictions. The application is not intended for use in treating opioid dependence, however.
The reSET® application is designed to provide a form of treatment called cognitive behavioral therapy. It teaches SUD patients practical skills that help them abstain from using drugs and stick with their rehab programs, and provides a series of reward-based incentives. reSET® is not approved as a standalone treatment. Instead, it is designed to be used in conjunction with outpatient addiction therapy.
“This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment,” said Carlos Peña, Ph.D., M.S., director of the Division of Neurological and Physical Medicine Devices in FDA’s Center for Devices and Radiological Health. “More therapy tools means a greater potential to improve outcomes, including abstinence, for patients with substance use disorder.”
reSET® was reviewed through the FDA’s de novo premarket review pathway, a regulatory scheme for low- to moderate-risk devices for which there is no legally marketed predicate to which the device can claim substantial equivalence. The FDA reviewed data from a multi-site, unblinded 12-week clinical trial of 399 patients. In this trial, patients with alcohol, cocaine, marijuana, and stimulant SUD who used reSET® demonstrated statistically significant greater adherence to abstinence (40.3 percent) compared to patients not using reSET® (17.6 percent).
We believe that prescription digital therapeutics hold promise in improving patient outcomes across a wide range of central nervous system disorders including psychiatry, neurology and pain, and will become a vital part of tomorrow’s treatment paradigm across all disease areas.
Regulatory approval of reSET® may represent an important step forward in the use of mobile applications to treat people with psychological, neurological and substance abuse disorders.
Kalytera Therapeutics, clinical-stage pharmaceutical company, recently announced plans for clinical trials focused on the treatment of Graft versus Host Disease using Cannabidiol (CBD), a compound found in cannabis. This development highlights the expanse of continued research—and potential—of CBD-based medicines and methods of treatments being pursued by companies globally.
Cannabis is a flowering plant that has long been recognized for its uses in fiber production and hemp oils, recreation, and medical applications. According to Project CBD, CBD is one of a diverse class of chemicals called cannabinoids found in the cannabis plant. CBD was first identified in the early 1940s , but more than 20 years would pass before researchers identified the more famous cannabinoid, tetrahydrocannabinol (THC). Likely because of its psychoactive effects, THC would go on to dominate research studies of cannabis. However, the classification of marijuana as Schedule I substances under the Controlled Substances Act of 1970, federally sponsored medical research into CBD and its effect dwindled.
Both CBD and THC interact with the human body through the CB1 receptor of the endocannabinoid system, a system of receptors found in the central and peripheral nervous systems and many other organs of the body. The endocannabinoid system is involved in the regulation of, for example, appetite, pain, mood, and memory. By binding more weakly with the CB1 receptor than THC, CBD invokes a different response within the endocannabinoid system. Unlike THC, CBD tends not to cause psychoactive effects. Instead, as a growing body of research suggests, CBD plays a role in moderating the effects of THC and reducing inflammation, nausea and pain. Multiple studies suggest that CBD has therapeutic applications for a wide variety of conditions, and companies across the world are researching medical treatment for specific maladies. A few notable projects evaluating potential uses for CBD include:
- GW Pharmaceuticals has commenced FDA-authorized clinical trials for Epidiolex®, a CBD-based drug for treating a rare genetic epileptic encephalopathy called Dravet syndrome. GW reports to have fourteen distinct patent families with claims directed to treatment of epilepsy. Other GW patent filings for CBD include treatments for constipation and cancer.
- Zynerba Pharmaceuticals is developing a synthetic CBD-based gel that is absorbed through the skin and aimed at treating adult epilepsy, osteoarthritis, and fragile-X syndrome. Zynerba has patents directed to transdermal CBD compositions and other CBD delivery systems.
- Insys Therapeutics, Inc. is in Stage 2 clinical trials for a CBD-based drug to treat severe pediatric epilepsy and applications directed to stable formulations of CBD for oral administration.
- Kannalife Sciences Inc. licenses a U.S. government-owned patent for cannabidiol-based drugs for the treatment of diseases caused by oxidative stress. Kannalife is developing CBD-based drugs for the treatment of Hepatic Encephalopathy and Chronic Traumatic Encephalopathy, a type of brain damage.
- Kalytera reports to have filed composition and method-of-use patents on its CBD treatments.
The science of CBD medicine is still being developed. To date, no CBD-based drug has received FDA approval. According to the DEA, CBD is still considered a Schedule I Controlled Substance by the Drug Enforcement Agency (DEA). As such, the future for CBD producers and researchers is uncertain. Pharmaceutically, CBD presents many challenges to delivery into the body. For example, with a half-life of only 18-32 hours CBD is difficult to stabilize and deliver to a target location within the body. As explained by Kalytera, when taken orally, CBD must pass through the liver, which significantly reduces the bioavailability of CBD. Moreover, CBD is lipophilic and accumulates in the skin when using transdermal delivery. As such, effective delivery of CBD is a significant hurdle.
Despite these challenges, the potential relaxation of legal constraints on cannabis cultivation and sales across the United States and the promise of an entire new field of pharmaceuticals continues to drive innovation in CBD medicine.
According to data published by business intelligence firm Cutting Edge Information, the majority (73%) of pharmaceutical marketing teams expect to use or continue to use the popular social media forum Facebook to facilitate their digital marketing strategies over the next one to two years.
According to Cutting Edge Information, “[i]n these strategy meetings, teams consider several factors, including the target patient population, therapeutic area and geographic region.” For example, “region can affect strategies because each country has its own pharma marketing rules and regulations.”
The survey, which included marketing teams from companies such as GlaxoSmithKline, Johnson & Johnson, Chiesi, Janssen, Mallinckrodt, and Takeda, also revealed that YouTube (64%) was the second most popular among the pharmaceutical marketing teams, while LinkedIn (55%) and Twitter (45%) rounded out the top four.
Not as popular, but still commonly used social networking sites include Instagram (18%) and Vimeo, Google+, Tumblr, and SlideShare each with 9% of pharmaceutical marketing teams utilizing them. Interestingly, additional data from the study show that no surveyed pharmaceutical or medical device companies reported using Pinterest, Vine, Flickr or Reddit.
On August 29, the FDA announced a recall of 465,000 implantable pacemakers, citing concerns that hackers may be able to take control of the pacemakers’ settings. This would open patients up to danger from improper pacing or rapid depletion of the devices’ batteries, according to the FDA’s statement. Instead of removing and replacing the pacemakers, the recall is designed so that doctors will install a firmware upgrade that removes the vulnerability.
Newsfactor reports that there have been no reported exploits of the vulnerability and no devices have yet been compromised.
The recall highlights that medical device manufacturers are beginning to take a more focused approach to cybersecurity. Mac McMillan, CEO of privacy and cybersecurity firm Cynergistek, told Modern Healthcare that “If devicemakers didn’t already have developers sitting around looking at cybersecurity, they now have to incur the costs of making sure their devices stay current. In the past, they’ve developed devices and put them on the market and moved onto the next device. This is a new thing for them.”
Mike Kijewski, CEO of medical device security company Medcrypt, also suggested that the FDA should update its regulations to help medical device companies stay on top of cybersecurity threats. “If the FDA can say you’re just doing the update for cybersecurity and the changes are minimal and the functionality of the device isn’t changing, they can make the update happen faster,” Kijewski suggested.
Canada’s equivalent of the FDA, Health Canada, is still looking into the vulnerability and its proposed solution, and has set a target of 75 days to resolve the situation.
Recently, digital currencies, such as bitcoin, have greatly increased in popularity. Some of this popularity may be attributed to digital currencies’ many purported advantages over traditional currencies, such as that blockchain technology allows for a distributed and cryptographically secure ledger without the use of traditional banking institutions. Newer and more advanced digital currencies have recently been introduced with the added advantage of smart contracts, which are said to be self-executing contractual clauses that may be programmed into a digital currency transaction. As such, many new digital currencies have been appearing with individuals investing in Initial Coin Offerings (ICOs), which are somewhat akin to the Initial Public Offerings (IPOs) of a traditional corporation.
Even more recently, a few companies have begun to make use of digital currencies and blockchain technology in the medical arena. Many have found blockchain technology uniquely suited to secure patient records, and have found that the smart contracts of digital currencies may allow individuals greater control of their medical data. Below is a summary of a few fields of medicine and companies within those fields in which digital currencies and blockchain are already being developed.
Medical Records and Health Data
According to The Merkle, Bowhead Health is the first medical device company using their AHT digital currency tokens with smart contracts to create a new medical data market. The company plans to allow individuals with Bowhead’s digital currency to control the dissemination of their medical data, and also to compensate those individuals if and when they choose to share with research institutions. Bowhead’s AHT tokens are said to allow 70% of research fees to be distributed to users with the other 30% going to token holders.
According to Blockchain News, Medicalchain is a UK-based company using blockchain technology to allow patients to securely store and send their medical records to their healthcare professionals. Medicalchain is said to allow patients to have a centralized medical record accessible from anywhere in the world, and allow individuals the ability to control medical institutions’ access to their records.
The Medical Society of Delaware has partnered with the company Medscient, and they are using blockchain technology to create a proof-of-concept platform to allow insurers and medical care providers to access patient records, according to The Cointelegraph. The article further states that this partnership was made possible when the state of Delaware became the first state to pass a law allowing the use of blockchain technology in business for stock trading and record-keeping.
The Illinois Blockchain Initiative has partnered with Hashed Health to create a pilot program to streamline the process of issuing and tracking medical licenses, according to The Cointelegraph. The goal of this partnership is said to give patients and healthcare providers a transparent license registry system that uses smart contracts to automatically update information.
Medicine and Artificial Intelligence (AI)
According to news sources, Doc.ai is a collaboration between developers from the universities of Stanford and Cambridge, and is said to be creating a platform built on blockchain technology and using AI to create a resource to answer patient’s specific questions regarding their personal health records and their physician’s analysis.
According to Reuters, The Bitfury Group and Insilico Medicine, a Baltimore-based medical AI firm, have formed a partnership to study and develop blockchain technology and AI solutions in the medical industry for healthcare data.
On August 22, 2017, Emerging Implant Technologies GmbH (EIT) announced the acquisition of 22 patents and pending applications relating to 3D printed expandable spinal fusion cages based on living hinges from Dr. Morgan Lorio, a spinal surgeon based in Nashville, Tennessee. A recent published application relating to the subject matter can be found here. FIG. 3 of that application, said to illustrate a 3D model printing method, and FIG. 7 said to illustrate an intervertebral cage apparatus are reproduced below.
EIT describes itself as a German medical device manufacturer specializing in implants for spinal alignment. In July 2017, a news article noted that EIT received approval from the U.S. Food and Drug Administration (FDA) to commercialize its spinal interbody product offerings. Regarding EIT’s acquisition, Guntmar Eisen, co-founder and CEO of EIT, stated:
“This IP is our platform to take fully 3D printed fusion cages to the next level by adding functionality to our EIT cellular titanium® cages. This will give the surgeon more options intraoperatively, reduce inventory and support MIS techniques – and at the same time reduce cost of expandable cages.”
According to PRWeb, the first functional spinal fusion cages based on this patent acquisition will be launched in 2018.
Takeda Pharmaceutical Company, a Japan-based global pharmaceutical company, recently announced an agreement with BioSurfaces Inc., a small Massachusetts research company, to research the development of medical devices for the treatment of gastrointestinal (GI) diseases. According to the announcement, Takeda will contribute its GI expertise to the development of medical devices to be designed by BioSurfaces using BioSurface’s biomaterial nanotechnology. Takeda’s GI drug Entyvio has recently been predicted by gastroenterologists to see significant growth. Fittingly, BioSurfaces touts its nano-fibrous materials, said to be formed by electrospinning FDA-approved polymers, as superior platforms for drug-delivery. Vincent Ling, Ph.D., senior director of the Materials and Innovation, Takeda Pharmaceutical Sciences, commented:
Our research collaboration will lead to the development of cutting-edge use of biopolymers and device fabrication technology. Application of developed technology has the potential to help prevent strictures and promote healing of fistulas, which are common manifestations of GI diseases.
The partnership continues a trend for Takeda, which has entered into at least 50 other new partnerships over the past 20 months, according to Life Science Leader. A little over a year ago, the 236-year old pharmaceutical company announced its plans to restructure the R&D organization by focusing on three therapeutic areas – Oncology, Gastroenterology (GI), and Central Nervous System (CNS) – as well as on Vaccines. As reported by Life Science Leader, the partnerships reflect the “restructuring of the R&D organization around the idea of increasing external collaboration on a global scale.” BioSpace notes that Takeda’s new strategy also includes splitting-off several assets outside of its new R&D focus as well as investing in strategic acquisitions, with the Financial Times reporting in 2016 that Takeda had allocated $15 billion for U.S. acquisitions.
Takeda’s partnership with BioSurfaces is not the first time it has teamed up with a nanotech partner to complement its drug discovery with drug delivery modalities. “Takeda is devoting itself to the idea of spinning off companies based on new technologies, including those discovered outside. As a pharma designed for drug discovery, at times it’s best to fund an alternate modality, so it can grow externally, before integrating it into our pipeline. I think that’s a view of nanotechnology we can entertain for the future” said Ling in 2016.