4. Zimmer’s Manufacturing Pains and Dvorak’s Downfall
When Zimmer Holding’s Inc. acquired Biomet Inc., it gained a Biomet manufacturing facility in Warsaw, Indiana.
After the acquisition, the FDA inspected the Biomet-legacy North Campus facility and issued, in the words of one regulatory expert, one of the “longest and most serious” 483s ever encountered. The 483s were not just technical violations, but ones that potentially went to safety, e.g., whether products were properly sterilized, or steps adequately documented so that the safety is known.
Product ship holds were issued and Dave Dvorak, Zimmer Biomet’s CEO, made multiple management changes including a new SVP, Global Operations and Logistics and a new VP, Quality Assurance, in addition to several other positions.
But the financial damage had been done. Sales were disrupted. Wall Street investors sold.
On July 11, 2017 Dvorak fell on the sword and resigned.
Dvorak made his mark on industry and surgeon relationships after former U.S. Attorney Chris Christie threatened to prosecute device makers for providing improper inducements to surgeons to use their products. The company, by far, had the highest annual payment amounts ($134 million) to surgeons. But under Dvorak’s realignment, over 75% of those payments then went for royalties.
After Dvorak’s departure, Daniel Florin, the company’s CFO, took over as Interim CEO.
On December 19, 2017, the company announced the permanent appointment of Bryan Hanson, then Medtronic plc’s president of the Minimally Invasive Therapies Group, as the new CEO.
3. Best Sports Medicine Technologies for 2017
Innovation and fixing patients remained the main interest of readers of OTW as the third most read article for the year named the ten winning companies with the BEST new sports medicine technologies for 2017. The winners in alphabetical order were:
Arthrex, Inc. for its InternalBrace™ Ligament Augmentation System, which augments the repair of the native ATFL ligament. The system provides a “check-rein” or “internal seatbelt” to allow the ligaments to heal in a more physiologic manner, at appropriate tension.
Bioelectronics Corporation was named for its ActiPatch (Pulsed Shortwave Therapy), a wearable, low-power, pulsed shortwave therapy device for adjunctive treatment of osteoarthritis of the knee and plantar fasciitis. The device provides continuous, new information to peripheral nerves and is key to mitigating central sensitization, and this is accomplished by the ActiPatch.
Breg, Inc.’s Breg Flex is a first-of-its-kind remote therapy monitoring device. It is mobile and uses sensor technology to gather objective, real-time data. Incorporated into the system are iOS and Android software engines (one for the clinician and one for the patient). Breg Flex’s sensor tracks activity and range-of-motion within 5 degrees of accuracy for flexion and extension and then communicates that data via Bluetooth.
Freeze Sleeve, LLC developed a revolutionary cold therapy compression sleeve called the Freeze Sleeve, which provides 360 degrees of cold therapy and compression coverage to arms or legs. The sleeve is applied directly to the skin and will not burn so it is safe for use by children and adults.
MuscleSound, LLC’s MuscleSound is an ultrasound that looks inside the muscles, measures the rate with which the muscle stores, generates and replenishes energy and, therefore, can track rehabilitation following injury in novel and more effective ways.
NCS Lab SRL developed a surgical instrument called the Taylor Stitcher which allows the physician to create transosseous curved tunnels for treating lesions to the shoulder rotator cuff. It works in both an arthroscopic and mini-open surgical technique. The system uses a 1.9 mm diameter nitinol needle which is activated and in one single step the physician creates the transosseous tunnel and pass the suture/shuttle.
OrthoNOW introduced a mobile app which patients can use to notify an OrthoNOW Center that they are in route, the reason they are going, and what time they expect to arrive. The app also locates the nearest OrthoNOW Center and provides contact interface to the Center.
Smith & Nephew’s Meniscal Root Repair Instrumentation is set of instruments designed to arthroscopically treat meniscal root tears by locating the posterior meniscal root footprint and fixating them back to their native locations. Seven instruments were designed for this technique.
The company won a second award for its Suspension Fixation for Bone Graft Healing. The system is a new approach which uses the shortening of sutures to draw two structures together under tension. The technology uses sutures and extra-cortical endobuttons to approximate the graft to the host glenoid bone. It has not yet been cleared by the FDA for U.S. sale.
Suture Innovations LLC‘s SutureDart allows surgeons to perform bone sparing drilling and passage of sutures though transosseous tunnels in a single step. SutureDart can be used for soft tissue to bone (e.g., patella tendon rupture) or bone to bone (e.g., syndesmosis).
