COMMERCIALIZATION SOLUTIONS FOR THE ORTHOPEDIC INDUSTRY
MAY 2020 | VOLUME 1

Roundtable participants from Wright Medical, Zimmer Biomet, Autocam Medical, NN Life Sciences and SITES Medical met virtually to discuss expectations in planning and forecasting in today's environment.

The shift of procedures to ASCs and scrutiny of implant utilization are two trends that will emerge from COVID-19, says Dr. Peter Althausen, trauma surgeon and chair of The Orthopaedic Implant Company.

The past six months have brought compelling M&A activity. We look at the status of three deals in light of unprecedented challenges to companies’ operating environments.

Shaher Ahmad of 4S Med-Device Consulting advises engineers to listen and observe with a sense of empathy to understand a situation versus immediately jumping in to fix it.

Industry should expect a rebound in the issuance of Warning Letters as the backlog of inspection reports is cleared, CDRH settles into their new structure and internal communications improve.

Preoperative planning, surgical instrumentation and bony ingrowth are advancements that surgeon Alan Davis, M.D. says are a must for future total ankles.

The redesigned NUVIS system reduces wires and equipment with a single-use, HD arthroscope.

Proceeds will support commercial launch and postmarket clinical studies of the Tapestry system to treat serious tendon and ligament injuries.

Correction: The last installment of the newsletter did not note that OrthoSensor's FDA's 510(k) clearance addressed alignment capabilities. VERASENSE Sensor-Assisted Technology is used to measure tibial coronal alignment and quantify soft tissue balance when used with Zimmer Biomet's Persona Knee.
From the archives:

For cost reductions and supplier relationships to be sustainable, you must address more than just the quoted price. You must attack real supply chain improvement and cost drivers at both the supplier and the OEM with the intent to reduce cost while maintaining or improving margins.
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There’s a difference between meeting quality regulatory standards and fostering a quality culture in your device company. Refining and improving culture pays off in many ways throughout your project lifecycle.

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