International -
How to Succeed in the Diabetes Device Space

Diabetes presents a huge market for medical device makers, but challenges such as a tough competitive landscape and relatively low profit margins make it anything but a sure bet.

Last month, private equity firm Platinum Equity offered Johnson & Johnson $2.1 billion for J&J's LifeScan Inc. blood glucose monitoring unit. This comes after plans to shutter its Animas insulin pump subsidiary.

Although J&J plans to close the doors on its diabetes business, other companies thrive…or at least break even. Success in this competitive space takes flexibility, a commitment to the long game and a deeper commitment to the patients themselves.

Unfortunately, diabetes devices have plenty of potential customers. More than 100 million Americans now live with diabetes or prediabetes, and more than six million use insulin...

 

Latest news

USA -
AdvaMed Raises Questions With FDA’s Combo Product Proposed Rule

AdvaMed is taking issue with the US Food and Drug Administration’s product jurisdiction proposed rule, which the device group thinks strays from how the 21st Century Cures Act defined combination products, according to comments released Monday. Some of the proposed revisions run counter to the plain language and intent of Section 3038 of the Cures Act , AdvaMed said. The group is seeking to clarify that a combination product’s primary mode of action shall not be determined to be that of a drug or biologic solely because the product features “any chemical action” in or on the body. “Given the...

Study -
Stimulation of Brain’s Reward System Leads to Reduction in Cancer Tumors

Scientists at Technion – Israel Institute of Technology have come up with a surprising way of fighting tumors and in the process showed that our brains have a role in preventing the growth of cancers. The researchers, who reported their findings in journal Nature Communications , artificially stimulated the reward system of mice stricken with cancer. What the investigators showed is that over time, the mice that received stimulation had significantly smaller tumors than control mice that were not administered the therapy. The team believes that their stimulation affected the nervous system so...

UK -
Register as a manufacturer to sell medical devices

Register a manufacturer or authorised representative (agent) for a manufacturer, to sell medical devices, including in vitro diagnostic (IVD) medical devices. Overview If you place certain medical devices on the EU market you or your designated authorised representative must register with the competent authority (national health regulator) in the EU state where you have an office or place of business. In the UK, Medicines and Healthcare products Regulatory Agency (MHRA) is the competent authority for the registration of medical devices. MHRA will only register manufacturers or authorised...

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