Blog Tag: Medical Devices
The United States is the world’s largest medical device exporter, according to reports accounting for $45 billion of over $140 billion in global exports in 2014. This is not surprising since it also produced the largest share of medical devices in the same year, contributing to nearly a fifth of the $340 billion global industry. Yet, the United States and other large markets are largely saturated with annual growth rates of only 3 to 5 percent.
For these reasons, Cuba displays a potential high-growth opportunity for American medical device manufacturers, according to a recent report in the Cuba Journal. According to the report, Cuba’s expenditures on healthcare in 2014 were nearly 10 percent of its GDP. Yet, Cuba’s domestic production of medical devices is limited largely to low margin goods such as surgical dressings, optical lenses, and dental supplies. Thus, Cuba is greatly dependent on medical device imports, including both low-end goods such as syringes and catheters as well as high-end goods like imaging equipment and orthopedic devices.
However, the share of imports to Cuba from the United States is dwarfed by other countries. According to the report, Europe makes up over 40 percent of Cuban imports while China and Japan combine for nearly 30% of the country’s imports, as of 2014. The United States, on the other hand, provides less than 1 percent of Cuba’s medical devices. Even Mexico exports twice the share of Cuban medical devices the United States does.
Meanwhile, similarly sized markets received far greater attention from U.S. manufacturers. For most of the period from 2005-2014, U.S. exports to regional countries with a per capita GDP comparable to Cuba’s, such as the Dominican Republic and Colombia, have been more than 200 times greater than that of Cuba, according to the report
Fortunately, medical device exports to Cuba from the United States are on the rise. In 2015, U.S. exports to Cuba jumped by more than 600 percent compared to 2014 even though exports to Cuba dropped overall by 40 percent in the same period.
Notwithstanding the above, few companies have taken advantage of the Cuban market. This may be due in part to unfamiliarity with the law as well as delays and difficulties in complying with it. However, the U.S. Office of Foreign Assets Control has relaxed some of the barriers, and an exception for medicines and medical devices to the general policy of denial for exports already exists. This, combined with a greater awareness of the trade opportunities in Cuba and the greater openness between the United States and Cuba, have made Cuba a potentially attractive destination for U.S. medical devices. But, at present, the Cuban market remains largely untapped.
ESDs have been used to reduce or eliminate self-injurious or aggressive behavior by applying an electric shock to the skin. According to the proposal, FDA determined that ESDs “present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling.” The proposed rule also cited ethical concerns, as many people exhibiting aggressive or self-injurious behavior are among a vulnerable patient population due to intellectual or developmental disabilities. Such patients may have difficulty communicating pain or consent, and may be unable to make their own medical treatment decisions.
FDA’s “primary concern is the safety and well-being of the individuals who are exposed to these devices,” according to William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, in an April 22 press announcement.
“These devices are dangerous and a risk to public health–and we believe they should not be used.”
FDA research indicates that only one facility is using ESDs to treat aggressive and self-injurious behavior in the United States, treating an estimated 45-50 people. Although medical practice has largely evolved toward positive behavioral treatments, sometimes combined with medication, the proposed rule “would ultimately remove these devices from the marketplace completely.”
FDA medical device bans are rare and typically used only when necessary to protect public health. However, the proposed ESD ban follows just one month after a March proposal to ban powdered gloves. The only medical device ban currently in effect was issued in 1983, covering implantable prosthetic hair fibers for concealing baldness.
The proposed rule is available online for public comment for 30 days.
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to the PROLIFT Expandable Interbody System of Life Spine. Accordoing to its website, Life Spine is a medical device company based in Huntley, Ill., that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders.
According to press releases, the PROLIFT system is the latest addition to the company’s platform of expandable interbody technologies. According to Life Spine, PROLIFT is an all-titanium system restores disc height, in-situ, for minimally invasive Posterior Lumbar Interbody Fusion (PLIF), Transforaminal Lumbar Interbody Fusion (TLIF) and oblique approaches. Once implanted, the system can expand cephalad to caudal to accommodate disc height ranges from 8mm to 16mm for varying patient anatomy.
According to Life Spine, “When paired with the CENTERLINE™ Midline Thoracolumbar Screw System, PROLIFT creates the optimal hyper-minimally invasive solution.” “The PROLIFT Expandable Interbody System allows for simplified, contracted insertion with minimal anatomical disruption and retraction,” said Rich Mueller, Chief Operating Officer of Life Spine.
Life Spine plans to launch a limited release of the PROLIFT system in the second quarter of 2016, and full product release is expected later in the year.
According to a press release from the Israeli company BioLineRx, their novel polymer for treating Celiac Disease has been confirmed as a Class IIb medical device in the European Union (EU). According to the company, the polymer, called BL-7010, is “a novel, non-absorbable, orally available co-polymer intended for the treatment of celiac disease. It has a high affinity for gliadins, the immunogenic proteins present in gluten that cause celiac disease. By sequestering gliadins, BL-7010 effectively masks them from enzymatic degradation and prevents the formation of immunogenic peptides that trigger the immune system. This significantly reduces the immune response triggered by gluten.” The company is also investigating use of the polymer as a food supplement to target patients with non-celiac gluten sensitivity.
According to BioLineRx, the celiac co-polymer BL-7010, was invented by Prof. Jean-Christophe Leroux from the Department of Chemistry and Applied Biosciences, Institute of Pharmaceutical Sciences, ETH Zurich, Switzerland, and is being developed by BioLineRx under a worldwide exclusive license agreement with Univalor.
According to their website, BioLineRx is a “clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates. The Company in-licenses novel compounds primarily from academic institutions and biotech companies based in Israel, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.”
U.S. Senators Cory Gardner (R-CO) and Joe Donnelly (D-IN) recently introduced the Rare Device Innovation Act and the FDA Regulatory Efficiency Act. The bills, if passed, would streamline the U.S. Food and Drug Administration (FDA) approval process for a number of medical devices. A press release from Senator Gardner states that “this legislation allows the FDA to spend more time reviewing new breakthrough technologies and expedite them to the market for patients who need them.”
According to the press release, the Rare Device Innovation Act makes it easier for medical devices to qualify for expedited approval. In order to qualify for the expedited approval process under the current Humanitarian Use Device (HUD) program, medical devices must treat diseases that exist in fewer than 4,000 patient cases, annually, in the U.S. The Rare Device Innovation Act proposes to increase that number to 8,000, which according to the press release will “create an incentive for manufacturers to develop medical devices for rare diseases to help people with rare conditions gain access to technologies they would not otherwise.” Devices covering diseases like ALS, cerebral palsy, Hodgkin’s lymphoma, mesothelioma, and tuberculosis would qualify under the bill, according to Senator Gardner’s press release.
As outlined in the release (and as a major departure from present FDA practice), the FDA Regulatory Efficiency Act seeks to allow accredited third-parties to perform initial reviews of 510(k) medical devices. Medical devices that qualify under 510(k) are low-risk medical devices that are substantially similar to those already approved by the FDA. Examples of qualifying devices include powered wheelchairs, shunts, and CT scanners.
Regarding the proposed FDA Regulatory Efficienty Act, Senator Donnelly’s press release states: “The legislation would still hold companies accountable for their quality systems, while also helping to alleviate the overwhelmed FDA.”
The proposed third-party 510(k) review appears to have some degree of industry support. In fact, AdvaMed (the “Advanced Medical Technology Association”) recently commended Senators Donnelly and Gardner on introduction of the FDA Regulatory Efficiency Act. JC Scott, senior executive vice president, government affairs, for the Advanced Medical Technology Association stated:
This legislation would create a voluntary program under which medical technology companies could have their quality system certified by an FDA-authorized third party. This certification would allow companies to self-certify certain low-risk changes to currently marketed devices. These changes would be limited to minor alterations to an existing product or manufacturing process currently covered by 30-day notices for PMAs [pre-market approval applications] and ‘special 510(k)s’ for 510(k) products . . . . This new program will helps ensure that companies are accountable for this minor changes while lessening the burden on FDA, allowing the agency to focus on higher-priority activities . . . . We look forward to working with members of Congress, FDA and other key stakeholders to move this important legislation forward.
On April 15th, the U.S. Food and Drug Administration (FDA) began its Expedited Access Program (EAP), which is designed to get certain medical devices to market sooner. Under the EAP program, device sponsors collaborate early with Center for Devices and Radiological Health (CDRH) staff to put together a Data Development Plan with the agency.
Jeffrey Shuren, director of the CDRH, states that the EAP is a way “to speed qualifying devices to patients with life-threatening or irreversibly debilitating conditions without compromising FDA’s high standards for safety and effectiveness.” Shuren goes on to say that “Under the EAP, FDA may accept a greater degree of uncertainty if it is sufficiently balanced by other factors, including the probable benefits to having earlier access to the device.”
To participate in EAP, a device sponsor must submit to the FDA a request for EAP designation. Factors the FDA considers when making benefit-risk determinations for devices subject to premarket approval applications (PMA) are discussed here.
To receive EAP designation, a device must meet three criteria:
(1) the device is intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition;
(2) the device meets at least one of the following criteria: (i) no appropriate alternative treatment or means of diagnosis exists, (ii) the device represents a breakthrough technology that provides a clinically meaningful advantage over existing legally marketed technology, (iii) the device offers significant, clinically meaningful advantages over existing legally marketed alternatives, or (iv) the availability of the device is in the best interest of patients; and
(3) the sponsor submits an acceptable draft Data Development Plan.
The FDA recently issued a draft guidance document regarding its policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical devices. In view of the “increasingly global” nature of clinical research, the FDA issued the guidelines to clarify the standards under which foreign clinical data will be accepted.
Under the FDA’s existing framework, and in particular for Premarket Approvals (PMA), the FDA will accept foreign clinical data if it conforms with the 1983 version of the Declaration of Helsinki, or the local rules of the country in which the clinical study was conducted. If using the local rules, the sponsor must detail any differences between the local rules and the Declaration, and explain why the local rules are more protective of human test subjects. One of the proposed rules would require that foreign clinical studies used to support PMAs, Investigational Device Exemptions (IDEs), Humanitarian Device Exemptions (HDEs), and 510(k)s be conducted according to good clinical practice (GCP).
The FDA also states that, for many device premarket applications, like 510(k)s, PMAs, and de novos, foreign clinical data “can be used to support clearance or approval of the application” as long as the data constitutes valid scientific evidence under 21 CFR 860.7. The FDA encourages sponsors to submit the foreign clinical studies for review through the FDA’s Pre-Submission process, before using the studies to support an application.
The draft guidance document further lists three special considerations that may be applied to foreign clinical studies to ensure that they satisfy FDA standards, namely (1) differences in clinical conditions, (2) differences in study populations, and (3) differences in regulatory requirements. These special considerations are intended to identify whether the results of a foreign clinical study can be generalized to apply to US clinical practices, the US population, and FDA requirements, respectively. To illustrate application of these special considerations, the FDA has provided 7 examples and explains the outcome of applying the special considerations to the examples.
According to the Federal Register, public comments on the draft guidance document must be submitted to the FDA by July 20, 2015. Comments may be submitted online to Regulations.gov, or mailed to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
HD Medical, Inc. announced today the launch of its business operations in the United States and its flagship product, the “ViScope Visual Stethoscope.” According to the press release, the stethoscope features:
a high-resolution visual display plus high-fidelity sound amplification of body sounds by a factor of 30 . . . . [M]edical professionals are able to perform “dynamic auscultation(TM)” and see the heart beats they hear in real-time waveforms on an integrated visual display.
The press release states that HD Medical, Inc. will unveil the stethoscope at the American College of Cardiology’s 62nd Annual Scientific Session & Expo in San Francisco on March 9-11, 2013.