Many medical device developers pass cytotoxicity, irritation, and sensitization testing—only to hit a wall at the implantation stage.
In fact, one of the most common reasons 510(k) submissions face delays is a poorly designed ISO 10993-6 implantation study.
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3 Critical Mistakes EHS Professionals Make in Biological Risk Assessment (and How to Fix Them)
Most workplace biosafety programs fail for the same 3 reasons— and each one can expose your organization to unnecessary risk.
Why Your Irritation Study Got Rejected (and How to Fix It)
The #1 reason irritation testing gets rejected? You’re using the wrong exposure route. We’ve reviewed dozens of irritation studies that looked solid—until they reached regulators. The science was technically sound, but the contact model didn’t match the real-world use of the device. That mismatch? It’s an automatic red flag for the FDA and EU reviewers. […]
Stop Over-Testing Your Device: How Smarter Test Planning Saves Time, Samples, and $50K+
When it comes to medical device testing, more isn’t always better. One of the biggest mistakes we see? Teams defaulting to comprehensive test panels — even when the risk doesn’t call for it. I recently helped a client avoid six months of rework after the FDA flagged several redundant biocompatibility tests. Why? Their Biological Evaluation […]
About the Therapeutics for Rare and Neglected Diseases Program
The National Institutes of Health (NIH) Therapeutics for Rare and Neglected Diseases (TRND) program is part of a congressionally funded effort to encourage and speed the development of new drugs for rare and neglected diseases. The federal budget for fiscal 2009 dedicated $24 million to establish this initiative.
TRND will bridge the wide gap in time and resources that often exists between basic research and human testing of new drugs. The effort is grounded in, but aims to improve upon, existing processes for drug development in the pharmaceutical industry.
Secondhand Smoke and Cancer
Secondhand smoke (sometimes called passive smoke, environmental tobacco smoke, or involuntary smoke) is a mixture of sidestream smoke (the smoke from the burning tip of a cigarette or other smoked tobacco product) and mainstream smoke (smoke exhaled by a smoker that is diluted by the surrounding air) (1–3).
Major settings of exposure to secondhand smoke include workplaces, public places such as bars, restaurants and recreational settings, and homes (4). Workplaces and homes are especially important sources of exposure because of the length of time people spend in these settings. The home is a particularly important source of exposure for infants and young children. Children and nonsmoking adults can also be exposed to secondhand smoke in vehicles, where levels of exposure can be high. Exposure levels can also be high in enclosed public places where smoking is allowed, such as restaurants, bars, and casinos, resulting in substantial exposures for both workers and patrons
Formaldehyde and Cancer Risk
Formaldehyde is a colorless, flammable, strong-smelling chemical that is used in building materials and to produce many household products. It is used in pressed-wood products, such as particleboard, plywood, and fiberboard; glues and adhesives; permanent-press fabrics; paper product coatings; and certain insulation materials. In addition, formaldehyde is commonly used as an industrial fungicide, germicide, and disinfectant, and as a preservative in mortuaries and medical laboratories. Formaldehyde also occurs naturally in the environment. It is produced in small amounts by most living organisms as part of normal metabolic processes.
Hair Dyes and Cancer Risk
Hair dyes use chemicals to change the color of the hair. There are three main types of hair dye: permanent, semi-permanent, and temporary.
Permanent hair dyes, which make up about 80% of currently marketed hair dye products, use colorless dye intermediates and dye couplers. In the presence of hydrogen peroxide, the intermediates and couplers react with one another to form pigment molecules. Darker colors are formed by using higher concentrations of intermediates.