The FDA is unable to conduct medical device plant inspections in China because of the U.S. State Dept.’s travel advisory amid the coronavirus outbreak, the agency said in a statement today. While the FDA is unable to conduct inspections, it plans to rely on tools such as import screening, examinations, sampling and import alerts, along […]
Bonifacio Consulting Services
The U.S.-China trade war: Here’s what it means for medical device industry suppliers
If the tariffs actually make a country great again, it might be Malaysia, Vietnam or Costa Rica, global medical device industry suppliers say. The U.S.-China trade war is certainly affecting where U.S. medical device companies decide to make their products. But don’t expect a bunch of manufacturing to come back to the United States. “They […]
Can AI take medical device manufacturing to the next level?
Artificial intelligence could improve medical device manufacturing efficiency and reduce risk, but it’s still a work in progress. Artificial intelligence is driving the world and our habits. Some of the world’s most well-known companies are using AI: Apple in Siri, Tesla in self-driving cars, Amazon in Alexa and even Netflix. Now medical device companies including […]
What does the U.S.-China trade war mean for medical device companies?
The ongoing trade war between the United States and China affects everything from tooling and mold-building to commodity medical devices when medtech is concerned, according to Mark Bonifacio of Bonifacio Consulting Services. Bonifacio, though, thinks China is too big for medical device companies to ignore: Even if the labor costs savings aren’t as attractive, there is simply […]
4 ways medtech contractors are evolving (and why)
The present and near future for medtech contractors will rely on specific strategies such as tiered partnerships and consolidation, an emphasis on speed, and owning therapeutic and technology spaces. Andrew Potter, Bonifacio Consulting Services, and Christopher Delporte In the first article in this series, we examined some of the important trends during the last 10–15 years […]
These trends have made medical device manufacturing what it is today
About 10 years ago, there were a number of notable trends and market forces which began to, once again, change how the medical device manufacturing sector brought its products to market. They’re still shaping the market we have today. Andrew Potter, Bonifacio Consulting Services, and Chris Delporte Perhaps the true measure of a forward-thinking industry […]
Medical device tax: Consultant calls offshoring concerns ‘horse hockey’
Mark Bonifacio, founder of the medical device contract manufacturer APEC and an industry consultant, said medtech companies shouldn’t be concerned about the medical device tax that’s part of the Affordable Care Act.