The CURES Act: What it is and what it means to Life Sciences Companies

Author: oswaldcompanies | Date:February 28th, 2017 | Category: Blog, Life Sciences

The 21st Century CURES Act, was signed by President Obama in December 2016 and will impact medical device development, pharmaceutical companies, FDA enforcement and approval processes including the way clinical trials may be used. The law was designed to increase the speed at which new medical treatments get to market by hastening some of the […]

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Your Life Sciences Business: Guidance, Updates and Resolutions You Can Keep

Author: oswaldcompanies | Date:January 27th, 2017 | Category: Blog, Business Risk, Life Sciences

Fresh starts and new beginnings. That’s how we seek to approach each new calendar year. Personally we proclaim resolutions and set goals for ourselves: to read more, exercise or eat healthier. Professionally we build business plans, and set sales or production goals. While there’s plenty to plan and prepare for in 2017, take note of […]

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medical device fdaMedical Device Violations: FDA Launches Portal to Report Regulatory Misconduct

Author: oswaldcompanies | Date:December 7th, 2016 | Category: Blog, Business Risk, Life Sciences

The FDA recently launched a portal for individuals to report allegations of regulatory misconduct of a medical device manufacturer or individuals marketing a medical device. An allegation in this manner is any claim that a medical device manufacturer may be operating in a manner that violates the law and circumvents the FDA’s ability to monitor […]

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cyber riskCyber Security: More Than Meets the Eye For Individuals and Businesses

Author: oswaldcompanies | Date:July 13th, 2016 | Category: Blog, Business Risk, Life Sciences

A quick Google search of the phrase “cyber security” will result in more than 19,000,000 results in less than a second. If that’s not an indicator that this is a hot button issue, I don’t know what is. Based on my experience personally, and professionally in the medical device and insurance industries, cybersecurity (and the […]

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Life Sciences | How to Respond to an FDA Investigation [WEBINAR]

Author: oswaldcompanies | Date:September 12th, 2014 | Category: Blog, Life Sciences

Michael Cremeans, Life Sciences Practice leader at Oswald hosted a webinar to discuss how to respond to an FDA investigation.  Joining him was Drew R. Barnholtz, Attorney at Law at Schneider, Smeltz, Ranney & LaFond, P.L.L. During the presentation, the team addressed how to respond if you were faced with an investigation, whether it be […]

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Cyber Security Risks for Medical Device Manufacturers: Expert Panel Discussion [VIDEO]

Author: oswaldcompanies | Date:August 4th, 2014 | Category: Blog, Life Sciences

Michael Cremeans, Life Sciences Practice leader at Oswald, hosted a panel discussion to talk about cyber security risks for medical device manufacturers, as well as the preparation for possible FDA regulations and the changing landscape. In the discussion, the presenters addressed several questions surrounding cyber security specific to the medical device industry. They covered what […]

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Michael Cremeans to Host Panel on Risk Management for Orthopedic Companies

Author: oswaldcompanies | Date:February 19th, 2014 | Category: Blog, Life Sciences

CLEVELAND – February 19, 2014 – Michael Cremeans, Life Sciences Practice Leader at Oswald, will present the panel event “Fully Exposed: Managing Your Risks in 360 Degrees” to discuss the risks that plague orthopedic companies. He’s invited industry experts Kim Schmid, Esq., Executive Managing Partner at Bowman and Brooke; Mark DuVal, President of DuVal & […]

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Medical Device Companies: ROI and “Doing the Right Thing”

Author: oswaldcompanies | Date:August 12th, 2013 | Category: Blog, Life Sciences

Most medical device companies want to “Do it right”. They typically do the right things when developing a world class device.  They take all the right steps. No shortcuts. As a matter of fact, some of the most successful companies ” work closely with the enemy” (i.e. the FDA) and even seek advice from the meanest […]

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Your Top Questions About Life Sciences Insurance

Author: oswaldcompanies | Date:June 21st, 2013 | Category: Blog, Life Sciences

Since “you don’t know what you don’t know” and most people are not insurance experts, many ask more about the strategic portion of insurance for their life sciences business. You want to know that you are covered if your product fails and that a policy is in place to respond to these kinds of claims. […]

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FDA Shutdown Insurance

Author: oswaldcompanies | Date:May 13th, 2013 | Category: Blog, Life Sciences

What do you do to protect your company in the event the Food and Drug Administration (FDA) has ordered or demanded a product that your company sells be sequestered, banned, recalled or withdrawn from the stream of commerce? You may need an insurance product to cover your financial loss as a result of your company […]

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