Regulatory Articles

61. Assessing The FDA's Cybersecurity Guidelines For Medical Device Manufacturers 2/17/2016

    In practically all matters of cybersecurity within the health sector, the United States Food and Drug Administration (FDA) seems to be in a constant state of offering subtle suggestions where regulatory enforcement is needed. The argument against enforcing cybersecurity standards typically centers on the idea that a regulatory presence stifles innovation. Due to the industry’s continuous lack of cybersecurity hygiene, malicious electronic health record (EHR) exfiltration and vulnerabilities in healthcare’s Internet of Things (IoT) continue to be a profitable priority target for hackers.

62. Two Essential Steps To Protecting Your Global Supply Chain From UDI Disruption 10/2/2015

    For most medical device companies, compliance with the Class III FDA UDI final rule already has been addressed, and most project stakeholders probably have started to develop a compliance strategy for FDA UDI Class II. What UDI-impacted stakeholders may not be considering is how FDA UDI could impact their company’s global inventory management strategy. In this article, we provide two steps companies should take to ensure their global supply chain maintains continuous flow of product. 

63. Medical Device Registries: Recommendations For Advancing Safety And Public Health 8/12/2015

    Recent high-profile failures of medical device technologies, including metal-on-metal hips and implantable cardiac defibrillators, are a reminder that this country lacks a robust system for assessing the safety and effectiveness of medical devices once they enter the market.

64. Cleanliness Validation For Medical Devices 8/12/2015

    Residues on the surface of medical devices can cause implant failure and poor device performance. The main source of these residues is from materials used in the manufacture of the device, although contamination during the storage, cleaning and handling of the device is also known to occur.By Chris Pickles, Ph.D.

65. UDI Impact on Medical Device Labeling: Lifting The Lid On Pandora's Box 7/24/2015

    Medical device companies are striving to capitalize on market opportunities while simultaneously dealing with increasing regulatory compliance requirements. One of the newer mandates, the FDA ruling on Unique Device Identification (UDI), requires action in three main areas.

66. Beyond Compliance: Medical Device Product Development 7/24/2015

    Increased regulatory scrutiny is a reality in today’s medical device industry. Over the last several years many of the industry’s leading companies have been hit with an injunction, undergone a product recall, or found themselves operating under FDA consent decree. At the same time, the pressure for growth on these companies has never been greater. Driven by Wall Street, the pace of new technology, emerging market opportunities, and competition from well funded start-ups, medical device executives find themselves in an environment where they must continually innovate with flawless execution to survive.

67. CYA 101: 4 Tips to Help You Cover Your Audit 7/23/2015

    Audits are a part of doing business for most life sciences companies, but that doesn’t make them any less stressful. If an audit goes badly, it’s a black eye for your company. You could be looking at long product delays, warning letters, consent decrees, recalls, or even a plant shutdown. So, what’s the secret to walking into an audit with confidence? It takes proper planning and the right tools. Here are a few tips to help you be better prepared, so you no longer have to fear the auditor.

68. Due Diligence On Your Medical Device Manufacturing Partner 7/10/2015

    A number of healthcare market forces – from cost pressures and global competition to strong demand from emerging nations – have converged to drive increasing use of design & manufacturing services companies to design, engineer, manufacture, package and distribute a wide range of medical devices.

69. Software Development For Medical Devices 7/10/2015

    Software is fast becoming the differentiator for manufacturers of medical devices. The rewards of software innovation are balanced by the risks and challenges of regulation, stringent quality requirements, market pressures, and significant complexity.

70. The Multiplier Effect Of Drug-Device Convergence 6/23/2015

    First-generation drug-device pioneers could not have envisioned today’s landscape. The growing convergence between medical devices, pharmaceuticals, and biologics is transforming these once-separate market sectors, not to mention the state of health care and our quality of life. The global market for drug-device combinations is on track to generate $115 billion in market value by 2019. Thus, opportunity — and demand — abounds for effective treatments combined with innovative drug delivery methods.