News and Insights

Reshaping R&D

In Search of the Silver Bullet: The Illusion of Big Data


While big data by definition captures a large amount of detail for a large number of patients, what it can’t do is provide a company with the big picture, “the wide angle view.”  While big data sets such as SharedClarity, formed by UnitedHealthcare and several large provider systems, can be…

Impact of the Changing Reimbursement Landscape


Recent legislation and growing anxiety about debt have put healthcare in the spotlight, where it’s likely to stay for an indefinite period. Payers and providers are under enormous pressure to reduce costs and improve quality, manifested in the increasing experimentation with ACOs, bundled pricing, and other alternative delivery models. As…

The Medical Voice — From Product Development to Post-Market Surveillance

Numerof Brief

The medical device industry is in the midst of a redefining transformation, posing both opportunities and threats to manufacturers’ current business model. Global device companies must address significant operational challenges to ensure that monitoring and safety surveillance practices address growing concerns about the safety of products introduced to the market.…

Orphan Drugs — Niche Strategy, Mainstream Potential

BioPharm International

While historically on the margins of R&D spend, orphan drug development increasingly looks like a strategy whose time has arrived for delivering value in drug development. The blockbuster model is wearing thin — the pressure for lower cost drugs with better outcomes flies in the face of the “one-size-fits-all” approach…

510(k) Clearance: Change is in the Wind

MX: Medtech Executive

Over the past several years the medical device industry has been rocked by product recalls, Department of Justice investigations into improper marketing practices, and incidents that highlight the potential conflicts of interest with physicians. Product safety concerns are especially predominant, given FDA reports that nearly 2,500 medical devices were recalled…