EdgeOne Medical - Blog

Our platform for fostering conversation on product development and product lifecycle management topics of interest with the community.

The MedTech Conference = AdvaMed + Industry + Hipster, Hacker, and Hustler Mindset

published on August 17, 2017 by Jim McGough

The next 25 years will present incredible opportunities for innovators in the MedTech industry.  In my opinion, individuals and teams who learn to operate with the “Hipster, Hacker, and Hustler” mindset will be in the best position to create game-changing innovation and become sought-after partners in future MedTech innovations.   Unfortunately, this mindset is a bit foreign to many folks who have already been in the MedTech industry for a while---and professional investors “know it when they see it”. 

Keys to Avoiding Common Pitfalls in the Development of Product Requirements for Drug Combination Products

published on March 03, 2017 by Jerzy Wojcik

This article was originally published in the March 2017 Issue of Drug, Development, and Delivery

Key Takeaways from Drug Delivery Partnerships 2017

published on March 01, 2017 by Lilli Zakarija

Earlier this month, I attended the Drug Delivery Partnerships (DDP) Conference in Florida.   The conference covered a wide range of topics impacting the combination product sector including digital health, mixed reality, risk management, new technologies in manufacturing and molecular development.

How to Approach Off the Shelf (OTS) devices for your Combination Product

published on August 10, 2016 by Lilli Zakarija

This article originally was published in the Combination Corner featured article in  Drug Development & Delivery magazine on May 3, 2016 

Doctor, Your "Future" is waiting to see you now

published on May 10, 2016 by Jim McGough

Your "Present" is not feeling well

You will not find your "Future" while rapidly inputting patient information into an electronic health record system portal every Friday night while sitting in close proximity to your spouse who is also a physician and doing the same thing while you both enjoy a bottle of wine, a pizza, and intermittent conversation (now known as Physician couple date night and unfortunately a true story). It is no wonder that the U.S. Surgeon General, Dr. Vivek Murthy, recently proclaimed that improving the “emotional well-being” of physicians has become one of the top priorities for the entire healthcare ecosystem.

The Art of the Early Exit (in Regulated Medical Technology Product Companies)

published on September 29, 2015 by Jim McGough

You don’t plan to do it (an early exit)—but rather you design your venture to be able to do it in a win-win-win way (entrepreneur/investor/strategic acquirer) at every milestone.

Happy Wife = Happy Life ?

published on September 18, 2015 by Jim McGough

Someone years ago shared with me the principle of "a happy wife leads to a happy life". I chuckled, acknowledged the sage advice, and stored the catch-phrase somewhere in my brain.  It wasn't until I started working with my wife Lilli as co-founder of EdgeOne Medical that I realized how true this saying was.  But it wasn't just about "happiness"--it was about something more.  It was about significance.  Her life's significance and what I could do to support and enable her pursuit of significance.

Combination Product Firms: The Good, Bad, and Ugly

published on April 30, 2015 by Jerzy Wojcik

Today's Therapeutic-focused Combination Product (Drug/Biologic & Device) Companies:  The Good, The Bad, and The Ugly.  Which one are you?

Device Selection Tips for your Drug or Biologic

published on March 02, 2015 by Lilli Zakarija

You are a drug/biologic developer and the time has come to select a delivery device (auto-injector, pump, etc.) that will be feasible for clinical trials and ideally commercialization.  More than likely you are not interested in developing this device in house and you need to decide whether to develop a custom delivery device or leverage an existing “off-the-shelf” device.  The points listed below serve as a guideline to facilitate the decision making process and to assist in selecting the best device for your specific needs.

The Empire Strikes Back: Sabre rattling between the FDA and Third Party Combination Product (CP) device developers?

published on February 28, 2015 by Jerzy Wojcik

FDA’s final rule on combination products (21 C.F.R. Part 4) set forth current good manufacturing practice requirements that must be met for the entire product (drug/device or biologic/device), regardless if the device design occurs internally or externally to the Marketing Authorization Holder (MAH).  Although many elements of CP cGMPs are well understood, it appears many are focused on understanding design control and supplier evaluation in the context of the new regulation and guidance.