Why in the world would the president of a well-established, $2-billion spinal device powerhouse leave his post to join a yet-to-be-launched challenger in the same space? This was one of the many questions I put to Keith Valentine, president and CEO of SeaSpine, during a recent phone call. In this Q&A, Valentine discusses why he left NuVasive to join SeaSpine, how SeaSpine navigated its recent spin-off from Integra LifeSciences,...  Continue Reading..

The U.S. is on track to spend about $3.2 trillion in healthcare in 2015 (more than the entire GDP of France), and a projected $5.5. trillion by 2024. Yet, life expectancy in the U.S. is actually lower than in countries spending far less. It’s too early to say whether systemic improvements like the Affordable Care Act will be able to reverse this trend, but while we wait around to find out, medical technology has become a popular...  Continue Reading..

Pulse Therapeutics has developed a mechanical thrombolysis technology that accelerates the delivery of clot-busting drugs to a clogged artery. The Magnetically Enhanced Diffusion (MED) System consists of intravenously administered nanoscale iron particles and a patient-side workstation, whose rotating magnet induces the particles to spin within the bloodstream. This activity creates flow towards the clot in otherwise stagnant vessels, bringing...  Continue Reading..

What factors should you consider before designing your next medical device? What capabilities will end users request (or demand?) from new devices in the coming months? What design approaches are your peers taking? What types of designs will be successful in the future?  Continue Reading..

TransEnterix has taken a most unconventional approach to the design of its SurgiBot platform for laparoscopic surgery. While traditional systems are controlled via a console located outside the sterile field, TransEnterix decided to return the surgeon to the patient’s bedside. The result is a robotic surgery system that is quite literally just what the doctor ordered — and that costs a fraction of existing platforms. Med Device...  Continue Reading..

With its novel, laser-based technology, this early-stage company hopes to displace lumpectomy as the standard of care for eliminating breast tumors after early detection.  Continue Reading..

3D printing has fundamentally changed the way medical devices are prototyped and tested; however, the technology can carry a product only so far into the development process, primarily due to material constraints. Injection molding (IM) can generate highly accurate prototypes in final production materials, but the process is not without its own drawbacks. Now, a hybrid prototyping process has emerged, offering medical device developers the best...  Continue Reading..

It wasn’t so long ago that the world was in an absolute panic over Ebola. One company that found itself smack in the middle of the global healthcare industry's response to Ebola was Cerus Corporation, maker of a technology that inactivates pathogens in transfused blood components. I recently had the pleasure of speaking with William “Obi” Greenman, the company's president and CEO. We discussed the Intercept system,...  Continue Reading..

Nearshoring has become a major buzzword in recent years. But despite all the hoopla, nearshoring is not the right approach for everyone, warns medical device manufacturing consultant Mark Bonifacio, a 25-year veteran of the industry. During a recent conversation, Mark shared four questions medical device companies need to answer before making the decision to nearshore or offshore production of their products.  Continue Reading..

The U.S. healthcare sector is currently engaged in a bizarre game of musical chairs. Traditional participants are snatching up seats they haven’t historically occupied, while still clinging desperately to their own, and new players are constantly jumping into the fray. When the music finally stops, will medical device incumbents still have chairs to sit on?  Continue Reading..