As I spoke recently with colleagues at a conference in Florence, Italy, about healthcare innovation, a fundamental truth resurfaced in my mind: the U.S. healthcare industry is just that. An industry, an economic force, Big Business.

You’re listening to customers. You’re combining their feedback with those bread crumbs of data that they leave with every transaction and interaction with your brand.

Put in the terms of this article’s title, most of us would run a mile, whatever the proposition.

As a cucumber plant grows, it sprouts tightly coiled tendrils that seek out supports to pull the plant upward. This ensures the plant receives as much sunlight exposure as possible.

The FDA has announced an end to the alternative summary reporting (ASR) program for medical device manufacturers and will make the data publicly accessible.

A recent family biking vacation in the Dolomites region of Italy had my family and I all swept up in the charms of Northern Italy.

There’s a lot of bad press out there about journey mapping. And there’s a lot of bad journey mapping (or what people think is journey mapping).

This story was originally published by Knowable Magazine.

Although the “new approach” to regulating medical devices has always given more urgency to higher-risk medical devices, this is not the case for the European Medical Device Regulation (MDR).

This notion of risk-based processes within quality systems is something that has become part of our formal lexicon following the release of ISO 13485:2016, the globally harmonized standard for medical device quality management systems (QMS).