Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Changing Times Raise Barriers to Device Innovation

Executive Summary

While legal considerations play a role in determining if or how soon use of a medical device is adopted, other factors are now just as important and in some cases more important in influencing a provider’s product selection process.

You may also be interested in...

Hospitals Up the Ante in Device Purchasing Decisions

In many US hospitals, materials, purchasing, and supply chain executives often have the clout to influence thumbs-up or thumbs-down decisions on most new products that enter the building. That is one major reason why medical device manufacturers are waking up to the fact that so-called "me-too" items and minor upgrades to existing products aren’t as acceptable to hospitals as they once were. But in the evolving market in materials office supplies, smart manufacturers with a clear path to working alongside materials executives offer products that keep costs down, add to patient safety, and enhance patient care.

Negative Innovation: Helping Reduce Health Care Technology Costs

At the recent Stanford Center for Cardiovascular Technology Annual Symposium 2010, hosted by Stanford University's Peter Fitzgerald, MD, PhD, and Alan C. Yeung, MD, one of the newest buzzwords in medical device development was "negative innovation". Increasingly, executives, particularly at big companies, are coming around to the notion that in the future, a product development model that posits that incremental device innovation will continue to be rewarded with premium pricing and wide adoption won't hold anymore. Instead, they argue, in a world in which health care costs are scrutinized ever more closely and initiatives like comparative effectiveness bring cost and quality into the same discussion, the US health care system will begin to favor a new kind of value proposition: devices that reduce costs, while delivering equivalent, and perhaps in some cases even slightly worse, outcomes.

FDA Gene Therapy Office Chief Prefers Flexibility With Accelerated Approval Confirmatory Trials

Ideally, the studies would be underway at the time of approval, as the US FDA’s new authority allows, but Office of Therapeutic Products Director Nicole Verdun sys there will be exceptions.


Related Companies

Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts