Articles By Jim Pomager

1. The Ideal (If Uncommon) Way To Launch A New Medical Device Company 12/1/2015

   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, what he sees as the biggest market opportunities in the spine space, and more.

2. Unhealthy Healthcare Economics: Medtech Innovation As The Cure, Not The Cause 8/26/2015

   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 target for criticism and proposed spending cuts. What if the way out of this mess was to devote more resources to medical technology, not less?

3. Companies To Watch: Pulse Therapeutics 7/8/2015

   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 medications to the clot site 40 times faster than normal. The company has filed an early feasibility investigational device exemption (IDE) with the FDA, and anticipates beginning clinical trials to evaluate the device for stroke treatment later this year.

4. 3 Top Trends Driving Medical Device Design In 2015 — Experts Weigh In 6/22/2015

   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?

5. Developing A Surgical Robotics System That Doctors Really Want — And Hospitals Can Afford 4/1/2015

   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 Online recently spoke to Todd Pope, the company's president and CEO, about the rigorous process TransEnterix used to incorporate stakeholder feedback from across the healthcare system in SurgiBot’s design.

6. Companies To Watch: Novian Health 2/23/2015

   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.

7. 3D-Printed Injection Molding: The Future Of Rapid Prototyping? 2/2/2015

   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 of both worlds — the speed and economy of 3D printing combined with the material and accuracy advantages of IM.

8. Development Of A Pathogen Inactivation System To Stop Ebola And Other Deadly Outbreaks 1/26/2015

   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, the factors behind Cerus’ recent public stock offering, the modular premarket approval (PMA) pathway it used for Intercept, the story behind its Ebola involvement, and why it is uniquely positioned to help stop future infectious disease outbreaks.

9. Nearshore Or Offshore? How To Decide Where You Should Manufacture Your Medical Device 1/16/2015

   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.

10. Google, Apple, & Other New Medtech Players: If You Can’t Beat Them, Join (Or Copy) Them 1/7/2015

    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?