Three speakers opened our ears, eyes, and minds at Healthegy’s Medtech Conference last month in Minneapolis. Two presentations provided input that reshaped my own long-held notions, while the third helped me to think about value-based outcomes from a more productive perspective.
In the final chapter of this series, we will discuss three key individuals who sustain a device from release until the device is retired.
The definition of a medical device in the Federal Food, Drug and Cosmetic Act (FDCA) is purposefully broad — some say too broad. It allows the FDA to reserve potential oversight of many healthcare products, including software, and some software development companies have bristled at the FDA’s potential to regulate their products.
The U.S. 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.
Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Philips BlueControl wearable light therapy device to treat mild psoriasis.
Stryker announced today that it has received FDA 510(k) clearance for its MultiGen 2 RF Generator. This product provides physicians with the efficiency, control and reliability they need when performing radiofrequency ablation, a minimally invasive procedure that can provide lasting relief to those suffering from facet joint pain.1
Medtronic plc recently announced the expanded U.S. Food and Drug Administration (FDA) approval of the self-expanding CoreValve Evolut transcatheter aortic valve replacement (TAVR) platform to include patients with symptomatic severe aortic stenosis who are at an intermediate risk for open-heart surgery.
Masimo announced recently the CE marking of the rainbow Super DCI-mini sensor, a reusable spot-check sensor that features Masimo SET Measure-through Motion and Low Perfusion pulse oximetry and rainbow SET technology with multiple physiologic measurements – including, for the first time, the ability to measure total hemoblogin (SpHb), carboxyhemoglobin (SpCO), methemoglobin (SpMet), and arterial oxygen saturation (SpO2) using the same noninvasive reusable sensor.
Cerus Endovascular Ltd. today announced that it has received CE Mark approval for the commercial sale of its Contour Neurovascular System™ for the treatment of intra-cranial aneurysms (IAs) across the European Union (EU).
Cardiologs Technologies SAS announced recently that it has received FDA clearance of its Cardiologs ECG Analysis Platform, a cloud-based cardiac monitoring-analysis web service powered by artificial intelligence (AI).
Edwards Lifesciences Corporation, the global leader in patient-focused innovations for structural heart disease and critical care monitoring, recently announced it received U.S. Food and Drug Administration (FDA) approval for its INSPIRIS RESILIA aortic valve, the first in a new class of resilient heart valves.
Varian Medical Systems (NYSE: VAR) has received FDA 510(k) clearance for its Halcyon™ system, its new device for cancer treatment. Halcyon simplifies and enhances virtually every aspect of image-guided volumetric intensity modulated radiotherapy (IMRT).
Royal Philips, a global leader in health technology, recently announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market IntelliSpace Portal 9.0 and a range of innovative applications for Radiology in the U.S.
Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology and endoscopy, today announced that it has received 513(f)(2) (de novo) classification from the FDA to expand indication for Merit’s Embosphere® Microspheres.