MedTech Strategist Issue: Vol. 5, No. 12 - September 14, 2018


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Orthobiologics/Sports Medicine - "Orthobiologics at a Crossroads”

Sidebar: “KOA Clinical Trials May Soon Provide Some Insights”

By Wendy Diller, Senior Writer/Market Analyst

As the use of orthobiologics in orthopedic surgery booms, the FDA and leading surgeons are concerned about the lack of good clinical trial data to support their widespread use for some of the most common musculoskeletal diseases. Surgeons are tackling the problem by building a consensus around good clinical trial design, terminology, and best practices in medicine. Amid a changing FDA environment,  Vericel is one of a few companies to achieve success in this field based on high-quality clinical evidence.

Diabetes Devices - “CGM on the Upswing: A Three-Month Implantable Enters the Fray”

By Mary Thompson, Executive Editor

After struggling for years to gain traction, the US continuous glucose monitoring market has finally found its footing. Now growing at double digits, CGM adoption is being driven by more accurate, patient-friendly devices; vastly improved payor coverage; and recently launched direct-to-consumer marketing campaigns. Although DexCom, Abbott, and Medtronic dominate the space, Senseonics has what could be a game-changer for some patients: the first fully implantable 90-day sensor, offering greater convenience without sacrificing real-time functionality.

Executive Interviews - “Senseonics Expands the CGM Toolbox with a 90-Day Implantable: CEO Tim Goodnow Charts the Path Forward”

By Mary Thompson, Executive Editor

In this Q&A, Senseonics President and CEO Tim Goodnow discusses the US launch of Eversense, a first-of-its-kind 90-day implantable continuous glucose monitoring system, as well as the company’s well-stocked product pipeline, and the challenges it faces in the rapidly expanding and fiercely competitive US CGM space.

Perspective - “Is Medtech Too White?”

By Kwame Ulmer, Contributing Writer

The medical device industry has a diversity problem. MedTech Color aims to fix it.



Start-Ups To Watch: Otolaryngology - “Neuromod Devices: Targeting Tinnitus Discreetly and Effectively”

By Colin Miller, Contributing Writer

Tinnitus affects approximately 15% of people globally, ranging in duration and impact from a short-term discomfort to a lifelong hardship. Current solutions only manage symptoms without fully treating them and patients dislike them for aesthetic reasons. Neuromod Devices is introducing a home-use, non-invasive bimodal neuromodulation therapy device which re-habituates the nervous system for prolonged relief from tinnitus.


Start-Ups To Watch: Structural Heart Disease - “Transverse Medical: Total Protection for the Brain During TAVR”

By Mary Stuart, Senior Writer/Market Analyst

With a new cerebral embolic protection device that completely protects the brain, Transverse Medical is getting ready to serve an expanded and younger population of transcatheter aortic valve replacement patients, where the high rates of perioperative stroke that accompany these procedures are even less tolerable. 

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Companies Covered in this Issue:  Abbott Laboratories Inc., Alerje,Beta Bionics Inc., Boston Scientific Corp., Cochlear Ltd., Danaher Corp., DexCom Inc., Emboline Inc., Experien Group, Filterlex Medical Ltd., Histogenics Inc., Innovative Cardiovas­cular Solutions LLC, Johnson & Johnson, Key­stone Heart Ltd., Medtronic PLC, MemStim, Neuromod Devices, Protembis GMBH, Roche, Sanofi, Schipper Design, Senseonics Holdings Inc., Transverse Medical Inc., Vericel Corp., Zimmer Biomet Inc.

Topics Covered in this Issue:  Cardiovascular/Vascular; Diabetes; Ear, Nose & Throat; Executive Interviews; Medtech Business Strategies/Development; Neurology/Neurovascular; Orthopedics/Spine; Perspective/Commentary; Regenerative Medicine/Cell Therapy; Start-Ups