Having worked for two different device contract manufacturers, and having made decisions to outsource manufacturing to other contract manufacturers, I’ve had both good and bad experiences. Reflecting on one of my best experiences in outsourced medical device manufacturing, I reconnected with Tim McGinnis, VP of quality assurance and regulatory affairs for Sanmina’s medical division, to gain insight from his successes.
Because FDA requirements focus heavily on usability issues related to safety, device developers can fall into the trap of assigning less meaning to usability problems that won’t cause harm. But, it is not always possible to catch all unanticipated use errors during validation, and usability problems not directly related to safety risks can still affect purchasing decisions and device acceptance.
Given that Republicans hold only a simple majority in the Senate, it is expected that their power to dismantle the ACA will be limited to those provisions that are tied to the budget. This article — the first in a two-part series — will discuss how repealing certain parts of the ACA will impact the medtech industry.
In recent years the U.S. Food and Drug Administration (FDA) and the European Commission (EC) have increased their surveillance on medical device manufacturers and their suppliers. This article discusses how to evaluate audit readiness for a medical silicone molding company, as well as preparing to move toward global quality standards.
As the FDA’s next deadline for the unique device identification (UDI) of Class II devices draws closer, medical device manufacturing companies are looking to further their UDI implementation, whether they are well on their way to success or they haven’t even started. Barcoding, or identifying products via GS1 regulatory standards, is essential for companies wishing to be up to date on UDI implementation. Unfortunately, companies may be delaying UDI implementation because they view the new regulations as something an organization can address quickly. This is not the case. This article discusses the importance of viewing UDI implementation as process that encompasses the entire company rather than just as a “quick fix.”
Labels often are an afterthought, because they don’t directly affect the capabilities of a medical device. However, they certainly affect the functionality of the device and users’ ability to effectively utilize all of its features. Consider these factors — and their importance — as you design your medical device overlay or inventory stickers.
Global spending on healthcare medicines is expected to reach $1.3 trillion by end of year 2018. While many of these medicines may be developed in the traditional dosage forms, companies are increasingly developing more and more drug delivery devices, in order to deliver patient convenience, more effective routes of administration through targeted therapies, and value to the global payors. As the world’s second largest medical device market, China offers a significant opportunity for drug delivery companies to expand their global footprint in Asia.
Creating a successful drug delivery device requires the seamless integration of the biological or pharmaceutical regulatory requirements with the device regulatory requirements. There are several factors that need to be considered in order to do this, all while ensuring the patient is kept at the center of the design.
The drug-device combination product market is growing at a rapid pace. By 2019 it is expected that the global market for drug device combination products will reach $115.1 billion. This is nearly double its worth from $66 billion back in 2012. This burgeoning market will likely bring in a flood of product submission applications to the FDA at a time when resources are already strained.
Medical devices, from ideation to post-launch assessment, are regulated in the United States by the U.S. Food and Drug Administration (FDA) under the Medical Device Regulation Act of 1976 an subsequent amendments to the Federal Food, Drug and Cosmetics Act of 1938.
The FDA’s medical device regulatory pathways — for premarket review, clearance, and approval — are based on three classifications, which indicate the degree of regulatory control necessary to ensure a device’s safety and effectiveness. Class I devices are considered low-risk, and many are exempt from the regulatory process. Class II devices require special controls for “labeling, guidance, tracking, design, performance standards, and postmarket monitoring,” and most require premarket notification 510(k) to demonstrate substantial equivalence (having the same intended use and technological characteristics) to a legally marketed device. Class III devices usually sustain or support life, are implanted, or present a significant risk of illness or injury. Most class III devices require premarket approval (PMA), which examines a variety of factors in weighing the probable health benefits from intended use of a device versus the probable risks.
Medical device makers must adhere to Current Good Manufacturing Practice (CGMP) regulations, which FDA inspectors use to determine if a manufacturer has the facilities, skills, and equipment to produce and pack its product. In addition, the FDA recently decreed that all medical devices must carry a unique device identifier (UDI), readable by both machines and humans, to “improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.”
Medical device makers competing in international markets must monitor and adhere to the policies of foreign regulatory bodies, which can vary greatly, depending on the nation. For example, countries in the European Union all recognize CE-Mark approval, while the regulatory framework applicable to imported devices still is being built in growth markets like China and India.
Many global regulators require manufacturers to be certified by the International Organization for Standardization (ISO). ISO 13485 compliance, confirmed through third-party (notified body) audits, demonstrates a medical device manufacturer’s procedures and products meet or exceed international quality standards.
Efforts are also underway to standardize international regulations to ensure the safety, effectiveness, and quality of medical devices. The International Medical Device Regulators Forum (IMDRF) — composed of regulatory agencies from Australia, Brazil, Canada, China, Europe, Japan, Russia, and the United States — is building upon previous work by the Global Harmonization Task Force on Medical Devices (GHTF) to speed this harmonization and convergence.
Top officials of the U.S Food and Drug Administration (FDA) testified before a Senate HELP (Health, Education, Labor, Pensions) Committee to stress the rationale for re-authorizing user fee programs designed to streamline regulation and speed access to innovative and lifesaving medical products.
BioStable Science & Engineering, Inc. announced recently it has received FDA market clearance for the HAART 300 Aortic Annuloplasty Device, the first commercially available internal annuloplasty device designed for aortic valve repair. BioStable expects the HAART 300 Aortic Annuloplasty Device to be available to select U.S. heart centers in the summer of 2017.
The U.S. Food and Drug Administration (FDA) is suspending the effectivity of its final rule on off-label promotion for another year.
Medtronic plc recently announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of the CoreValve Evolut PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at high or extreme risk for open heart surgery.
Johnson & Johnson CEO Alex Gorsky says pharmaceutical, medtech, and healthcare companies should continue to have the ability to innovate amid challenges brought about by impending changes to United States healthcare policy and legislation.
The United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) has released initial recommendations for pre-market and postmarket clinical evaluation of leadless cardiac pacemakers.
The Trump administration has released its budget proposal for fiscal year 2018 that will more than double the user fees collected from drug and device companies for U.S. regulatory review of medical products.
Cardiologists can now access the advanced ultrasound imaging technology needed for fast and confident diagnoses with Toshiba Medical’s Aplio i900.
The Republican-led Senate has voted 55-43 to confirm Seema Verma, President Donald Trump's nominee to head the Centers for Medicare and Medicaid Services (CMS), the federal agency that administers major healthcare programs to over 130 million Americans.
DJO Global, Inc. (“DJO” or the “Company”), a leading global provider of medical technologies designed to get and keep people moving, today announced that its Exprt® Revision Hip portfolio received market clearance by the U.S. Food and Drug Administration. Exprt® Revision Hipis the latest addition to DJO Global’s Exprt® portfolio – a platform defying conventional approaches to total joint implants by improving outdated designs, focusing on patient outcomes and reinventing traditional price points. The