Senior quality leaders and the FDA agree quality organizations supporting pharma manufacturing often fall short of providing the support necessary to maintain and increase regulatory compliance and product quality. At the same time, some do not understand their actions and believe they are obstructionist and reflective of a strict compliance mentality with little regard for the business and its success.
At most medical device companies, mere utterance of the word recall is akin to mentioning the Dark Lord’s name in the Harry Potter series of novels: it’s simply not done, unless one wishes to invite misfortune upon oneself. In Harry Potter’s world, the Dark Lord (Voldemort) is referred to as “He-Who-Must-Not-Be-Named,” a moniker easily coopted by “recall”-averse medical device companies into “That-Which-Must-Not-Be-Said.”
As a child and student, I was mostly an academic. I got report cards with lots of “A’s” on them, but they didn’t hand out trophies for that. I did earn two small trophies for being on the first place team in kickball tournaments (it would have been way cooler if that was dodgeball instead). I did win a “Louie” as the guitar-player in the high school jazz band. I still have the little trophy for my Louis Armstrong Jazz Award and every time I lay eyes upon it – I think to myself, what a wonderful world!
Instead of focusing on FDA-regulation as the driving force in product development, compliance should instead be an outcome of a streamlined process that ensures a safe and reliable product is delivered to market. Achieving compliance, and creating the documentation, is an outcome of the focus and rigor required for regulated product development. This article discusses how Jama Software can simplify FDA processes by improving development and production.
Discover the 9 elements of a predictable quality system when evaluating CMO partners. Predictable quality shortens your time to market, reduces your compliance risk, and reduces risk to the patient.
When OEMs choose an outsourcing partner, they need to trust the effectiveness of the supplier’s CAPA program, and they need to trust that the supplier’s culture sustains quality each and every day, for every device.
As an OEM, it is your responsibility to ensure the parts supplied to you are compliant with ISO regulations. Ideally, your supplier’s quality systems are strong enough to identify risks, prevent defects, and to catch defects quickly if they do occur. This requires a robust quality management system.
How development teams need to engage in the holistic, programmatic risk management necessary for a predictable development program.
How do you design a usability test that mimics the panicked, stressful situation that a user may be in when he or she is using your medical device in the real world?
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.
Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, recently announced it has received CE Mark for its self-expanding CENTERA valve for severe, symptomatic aortic stenosis patients at high risk of open-heart surgery.
Arterys Inc., the leader in intelligent, cloud-based medical imaging software solutions, recently announced its fifth 510(k) clearance from the U.S. Food and Drug Administration (FDA).
Empatica Inc has received clearance from the FDA for Embrace, its award-winning smart watch. Embrace uses AI (advanced machine learning) to monitor for the most dangerous kinds of seizures, known as "grand mal" or "generalized tonic-clonic" seizures, and send an alert to summon caregivers' help.
Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced it has received U.S. Food and Drug Administration (FDA) clearance for the Sidus® Stem-Free Shoulder system as a total shoulder arthroplasty solution for patients with good bone stock that have either osteoarthritis, post-traumatic arthrosis, focal avascular necrosis of the humeral head or who had previous surgeries of the shoulder that do not compromise the fixation.
K2M Group Holdings, Inc.(NASDAQ:KTWO) (the "Company" or "K2M"), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced that it received a CE Mark for its CAPRI® Cervical 3D Expandable Corpectomy Cage System* featuring Lamellar 3D Titanium Technology™, and the successful completion of its first surgical case.
Cianna Medical, Inc. has received FDA clearance of the SAVI SCOUT® reflector for long term implant. The SAVI SCOUT reflector is an integral part of the SCOUT system for wire-free breast tumor localization.
CardioFocus, Inc. today announced the European CE Mark approval of the HeartLight Excalibur Balloon, a next-generation technology designed for the treatment of atrial fibrillation (AF).
Acutus Medical® today announced that the U.S. Food and Drug Administration has cleared the AcQMap® High Resolution Imaging and Mapping System and the AcQMap® 3D Imaging and Mapping Catheter for use in patients for whom electrophysiology procedures have been prescribed.
The injury and surgery recovery technology leader, Game Ready®, announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its revolutionary orthopedic rehabilitation device, the Med4 Elite™.
The U.S. Food and Drug Administration today approved a new treatment option for patients who have been diagnosed with moderate to severe central sleep apnea.