As we close out 2019 and focus our attention to the forecasts of 2020, here is a sneak peek into what's IT leaders have on their roadmaps for 2020.

Keep on reading: 5 strategic priorities for CIOs in 2020

COO, Chris Luttrell shares her wealth of information about the current state of fraud, what IDology research is revealing about patron's trust and the forecasted impact of recent privacy legislation on consumers and businesses.

Keep on reading: Quick Answers to Quick Questions: In Conversation with Chris Luttrell, COO, IDology

With 34 years of programming experience in various organizations, Cal shares what he's observed of leaders who are looking to be reinvigorated, what to do when job-inspiration is lost and taking an educated leap of faith.

Keep on reading: Quick Answers to Quick Questions: In Conversation with Cal Evans, Senior Consultant, E.I.C.C., Inc.

When evaluating public cloud providers on pricing, it is easy to get hung up on the differences. AWS and Google Cloud each have their own service catalog, terminology and purchasing variations. But do these differences actually impact the final bill?

Keep on reading: Google Cloud vs. AWS: Who Has The Best Pricing?

By Jennifer A. Davidson and Justine E. Johnson On February 21, 2020, FDA published a final rule that, effective March 23, 2020, amends the regulatory definition of “biological product” consistent with the statutory definition under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), as amended by the Further Consolidated Appropriations Act, 2020 (FCAA),

The post FDA AMENDS THE DEFINITION OF “BIOLOGICAL PRODUCT” AND PREPARES FOR THE CONCLUSION OF A DECADE-LONG TRANSITION PERIOD appeared first on Kleinfeld Kaplan & Becker LLP.

By Suzan Onel and Vanessa Fulton On March 19, 2020, FDA issued a guidance document communicating its policy regarding postmarket adverse event reporting during a pandemic (“Guidance”).  The Guidance provides recommendations that affect adverse event reporting obligations for drugs, biologics, medical devices, combination products, and dietary supplements. To summarize, FDA states in the Guidance that

The post FDA Waives Certain Adverse Event Reporting Deadlines Across Product Industries During Pandemics appeared first on Kleinfeld Kaplan & Becker LLP.

By: Stacy Ehrlich and Justine E. Johnson On March 18, 2020, the Food and Drug Administration (FDA) published a final rule (21 C.F.R. Part 1141) requiring textual and graphic health warnings to be included on all cigarette packages and advertisements.[1]  FDA simultaneously published two related guidance documents: (1) Required Warnings for Cigarette Packages and Advertisements,

The post FDA ISSUES FINAL RULE ON GRAPHIC WARNINGS FOR CIGARETTE PACKAGES AND ADVERTISEMENTS appeared first on Kleinfeld Kaplan & Becker LLP.

By: Suzan Onel FDA issued a Press Release on March 28, 2020, reiterating what we all have seen in the news, there is a severe shortage of personal protective equipment (PPE) in health care facilities across the country.  In response to the shortages, FDA has issued Emergency Use Authorizations (EUAs) for respirators, ventilators, ventilator tubing

The post Shortage of PPE and other Devices During COVID-19 Pandemic – Is 3D Printing the Answer? appeared first on Kleinfeld Kaplan & Becker LLP.

By: Daniel Logan and Justine Johnson The Coronavirus Aid, Relief, and Economic Security Act, or “CARES” Act (Pub. L. No. 116–136) makes numerous changes to the Federal Food, Drug, and Cosmetic Act (FDCA).  The CARES Act made substantial changes related to the regulation of over-the-counter (OTC) drugs (see KKB’s alert here dedicated to summarizing these

The post Changes Made to the Federal Food, Drug, and Cosmetic Act by the CARES Act appeared first on Kleinfeld Kaplan & Becker LLP.

Researchers at the University of Bath in the UK have developed a 3D-printed microscope design, called OpenFlexure, which is open-source and can be assembled for as little as $18. More complex versions of the design are possible, and the microscope can incorporate full automation and a Raspberry Pi computer. The research team hopes that the […]

As the COVID-19 pandemic continues, many healthcare facilities around the world are inundated with critically ill patients, and resources such as equipment and staff are stretched thin. Shortages of critical equipment, such as ventilators, can mean the difference between life and death for patients, and the need to keep critically ill patients comfortable and alive […]

Researchers at Purdue University have developed a new technique to dramatically enhance the resolution achievable when imaging intracellular structures with super-resolution fluorescence microscopy. The technique uses the distortions created by a specimen to pinpoint the location of individual molecules, and thereby infer the location of intracellular structures. The technique could be particularly useful in studying […]

According to the World Health Organization, 47% of childhood deaths worldwide occur in the first four weeks of life. This neonatal mortality rate is particularly prevalent in sub-Saharan Africa, where nearly one million newborns die every year. Many of these deaths can be prevented with medical devices that more developed countries often take for granted, […]

In the era of COVID-19, surgical masks are a necessity for all healthcare workers and an effective way to curtail the spread of the virus within the general public. Since surgical masks are still in relatively short supply, companies and researchers have been working on ways to make available masks last longer. Cleanbox Technology, based […]

Adhesives specialist Intertronics has launched the preeflow eco-DUOMIX, a system that mixes and dispenses two-part materials.

Medical device manufacturer, Boddingtons, has lately been resourcing fast-tooling and moulding projects in relation to emergency procurement for the Covid-19 crisis.

Since early February, custom material solutions provider, Compounding Solutions, has been working hard to meet material demands related to Covid-19.

Our editor Laura Hughes highlights her five must-read articles for this week.

Tom Hoover, senior medical business development manager – Americas, assembly technologies, at global technology and manufacturing company, Emerson, explains how ultrasonic plastic welding is improved through improved force control.

During Covid-19, magnetic separation, metal detection, and conveying products are essential because they support the plastics processing industry and protect plastic from metal contamination.

Ashley Philipp, marketing director, Injectech, explains the importance of considering barb styles when choosing a fitting for your medical device.

Thermoformed packaging company Lacerta has managed to ship over three million Personal Protective Equipment (PPE) face shields to healthcare and frontline workers, in response to the coronavirus pandemic.

Diversified Plastics (DPI), a custom plastic injection moulder and additive manufacturer of high-precision components, has increased the capacity of its Acceleration Station to meet the rise in demand associated with the Covid-19 pandemic.

Stephen Sanderson, group inspection product manager and Guven Turemen, group metrology product manager, both from manufacturer Vision Engineering, discusses how manufacturers can ensure the quality of plastic components.

Greenlight Guru, a Medical Device Quality Management Software (MDQMS) platform, has teamed up with Emergo by UL, a consulting firm specialising in global medical device regulatory compliance.

Ian Bolland spoke to Chris Risley, CEO at Bastille Networks, about medical devices at risk of being compromised by SweynTooth vulnerabilities, highlighting how hackers can be combatted from targeting devices and healthcare systems.

Olympus highlights two important standards for medical tubing, and explores inspection solutions that can help you meet them.

The European Medical Device Regulation (EU MDR) will come into effect on 26th May 2021, a year later than originally planned.

The UK government has announced it will be ending support for four devices in the Ventilator Challenge.

Röchling Engineering Plastics UK is supporting the medical and healthcare sectors with thermoplastic components and materials to assist the NHS and worldwide OEMs.

HealthBeacon, a medication adherence technology company, has launched a new Covid-19 support offering for patients on injectable therapies.

Our editor Laura Hughes highlights her five must-read articles for this week.

Chemicals company Lubrizol is helping with the pandemic by making materials used in Personal Protection Equipment (PPE) as well as hand sanitiser and products to help treat patients who are fighting the virus.

Engineers from the University of Glasgow are responding to the coronavirus pandemic by producing up to 1,000 pieces of Personal Protective Equipment (PPE) each day.