ARTICLES BY BOB MARSHALL

The Sweet 16 Of Medtech Madness
The Sweet 16 Of Medtech Madness What do basketball and biomedical engineering have in common? They both are areas where universities compete.   Continue Reading...
Cybersecurity: FDA Leads While CIA Leaks
Cybersecurity: FDA Leads While CIA Leaks Ethical Intruder CEO David Kane shared with me recently his perspective on security challenges for medical devices, health IT, and hospitals - as well as strategies to overcome those challenges.   Continue Reading...
Sanmina’s Culture A Template For Medtech Growth
Sanmina’s Culture A Template For Medtech Growth Having worked for two different device contract manufacturers, and having made decisions to outsource manufacturing to other contract manufacturers, I’ve had both good and bad experiences. Reflecting on one of my best experiences in outsourced medical device manufacturing, I reconnected with Tim McGinnis, VP of quality assurance and regulatory affairs for Sanmina’s medical division, to gain insight from his successes.  Continue Reading...
3 Bad Ideas For FDA Pre-Sub Meetings
3 Bad Ideas For FDA Pre-Sub Meetings The FDA currently handles about 1,500 pre-subs per year - a number expected to grow to about 2,350 in the next five years. Here I present three sure-fire ways to make your pre-sub meeting stand out for all of the wrong reasons.   Continue Reading...
A Life Sciences Lesson From Lake Oroville
A Life Sciences Lesson From Lake Oroville Over time, a steady trickle of water can result in a flood; similarly, a steady stream of investment and ingenuity can result in a flood of medtech innovation.   Continue Reading...
Medtronic’s CardioInsight, A Nanocoated Stent, And A Hug
Medtronic’s CardioInsight, A Nanocoated Stent, And A Hug Thinking about flowers, candy, and cards? (If not, your Valentine’s Day may be in jeopardy.) While you’re thinking, why not explore some good news for the traditional Valentine symbol, the heart?  Continue Reading...
50 Shades Of FDA: Some 2017 Guidance Documents Will Require Clarity
50 Shades Of FDA: Some 2017 Guidance Documents Will Require Clarity Among the dozen "A-List" guidance topics that FDA has slated for finalization in 2017, three already have been released. That's good progress. But, at least three of those guidance initiatives put forth directives that medical device companies may find difficult, if not impossible, to follow.  Continue Reading...
Qualcomm Partner Provides Telehealth Simplification
Qualcomm Partner Provides Telehealth Simplification Integron's president discusses how his company developed a growth strategy to approach companies with existing in-home therapies looking to connect their devices. The end result was remote patient monitoring and connected health offerings that have been deployed to 56 countries around the world.  Continue Reading...
Missed Diagnosis Motivates Entrepreneurial Response
Missed Diagnosis Motivates Entrepreneurial Response In his final year of medical school, Matt Kesinger realized that a clinical examination was never going to be good enough for early stroke detection, and he began to develop the technological solution that would become Forest Devices’ ALPHASTROKE.  Continue Reading...
More from Bob Marshall
Bob Marshall

Bob Marshall

Bob Marshall brings more than 20 years of experience in medical device product development, manufacturing, quality assurance, and regulatory affairs to Med Device Online. He spent the last seven years with medical device consulting firm Regulatory & Quality Solutions, and previously held leadership positions with Renal Solutions (now Fresenius Medical Care), Siemens Medical Solutions, Medrad (now Bayer HealthCare), and Respironics (now Philips Healthcare). He holds both a BS degree in electrical engineering and an MS degree in organizational leadership from Geneva College.