The path to commercial success for device companies is fraught with complexity. Often developers of novel products do not consider the obstacles they will encounter as part of the commercialization of their product. Yet, reimbursement and payment are absolutely critical to their success. Not only do these companies have to obtain FDA market approval, they …

Let the Q-Sub (or Pre-Sub) be your first contact with the FDA Every medical device company entering the US market, comes in contact with the FDA. Even if only to register the company or a Class I device on the FDA database. If you have a product that’s Class II or III, the Q-Sub or …

Many years ago, I found myself in a foreign city at a conference, spending a few minutes on my company’s booth, when all over sudden a man walks up, grabs my hand, leads me to a display on our booth and starts asking questions about my company and our products. All the while, for the …

Meet Danielle Giroud, convener of the ISO expert group on clinical investigations, at the OCRA Orange County Regulatory Affairs Discussion Group, June 19th event on ISO:14155:2019   Register: https://lnkd.in/enqdjCd   Medical devices may only be placed on the market if their performance and safety have been clinically evaluated. The harmonized standard ISO 14155:2019 “Clinical testing of medical …

Presentation to OCRA – March 13th, 2019 – on EU MDR Implementation, at the Allergan Auditorium (Part 3)   Economic Operators   Most Medical Device companies understand the issues surrounding notified bodies. They have been well documented and are often discussed at MDR events. But I’d like to draw your attention to the multiple economic …

Presentation to OCRA – March 13th, 2019 – on EU MDR Implementation, at the Allergan Auditorium (Part 2) Costs associated with MDR implementation   Most of you have thoroughly read through the MDD and the MDR? In comparison the MDD is a small document. A mere 23 articles and 13 annexes. The MDR is a …

Presentation to OCRA – March 13th, 2019 – on EU MDR Implementation, at the Allergan Auditorium (Part 1) From MDD to MDR Over the past few years manufacturers paid a lot of attention to the new European Medical Devices Regulations and the challenges and opportunities created by the changeover from the Medical Device Directives to …

Many foreign companies are interested in offering their products for sale in the HUGE US market. Besides, the market is relatively uniform. Seemingly one language and one culture make it easier to localize a global product to the US market than localizing it for the 28 different countries of the EU for instance. But many …

Life Sciences Clusters Overview:   The Southern California Life Sciences Clusters are created by bringing together world-class academic institutions (UCLA, USC, Caltech, UCSD, UCI,), top-notch research facilities (Scripps Research Institute), a close-knit medical community and Human and financial capital.   1,796 medical device and equipment manufacturing firms, and 1,453 biotechnology and pharmaceutical companies in California …

Over the past few weeks I’ve had several conversations with manufacturers and consultants alike regarding the export of an Unapproved Investigational Device for use in a Clinical investigation to be conducted entirely outside the United States.   One of the first comments I get asked: does the FDA have jurisdiction? While the answer is easy, …