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OMTEC 2019 Reading Resources


Attending OMTEC? Seeking more information on an agenda subject?
Want to share additional resources with your colleagues? 
We've compiled a list of articles that were written by or feature OMTEC speakers.


Knee Innovation Focused on Materials, Design and Computer-Assisted Improvements
By Robert A. Poggie, Ph.D.


The past 20 years of innovation in knee replacement have led to increased durability and clinical longevity of implants, reduced early complications, decreased surgical time from incision to closure and better targeting of clinical indication.

The primary drivers of innovation are patients’ and healthcare providers’ desire for long-term clinical survivorship and a return to normal, healthy function without pain. This is measured by the rate of revision surgeries caused by early- to mid-term failure of the implant, infection, loss of fixation, significant pain or unacceptable functional outcomes. In short, surgeons and patients alike want one surgery to restore normal function without pain for the life of the patient. While total hip replacement is nearly “there,” and many of the materials, instrumentation and surgical innovations are common to both hip and knee, industry continues to grapple with the estimated 20% of patients who are dissatisfied with their knee replacement. Read more | Attend the session
  


Be Prepared When Suppliers are Acquired
By David Finch


When considering changes to your supplier base, you must include regulatory and supply disruption concerns, the time and resources required to complete your supplier approval process and other associated costs and risks in the decision process. Given these hurdles, a number of potential suppliers never make it past the due diligence phase.

But what do you do when an important supplier is merged with or acquired by another that isn’t approved to supply specific components, instruments or implants previously supplied by the acquired company? If the decision is forced on you, the concerns and risks remain the same but without the benefit of time or ability to decide not to proceed. With the recent M&A activity in the supplier space, all OEMs should prepare for this scenario. Read more | Attend the session

  


Orthopedic Stakeholders Talk Coating Standards
By Carolyn LaWell


Back in November 2018, about 125 people packed into a hotel conference room for a one-day ASTM workshop on medical device coatings. Professionals from coating manufacturers, device companies and universities listened to two dozen presentations that reviewed coating applications, the success they’ve experienced and the challenges that remain with assessing their performance. FDA and ISO representatives were among the first presenters of the day.

The makeup of the room was significant in that few standards and guidance documents exist for coatings today. The workshop was designed to discuss and strategize needs in the development of coatings, with an intended outcome being a strategy for developing coatings standards and specifications that will serve as extensions of the recently published ISO standard, ISO 17327-1. Read more | Attend the sessions

  


Finding Your Way in a Post-Lean/Six-Sigma World Using Operations Science
By Edward S. Pound


Industry has lost its way—maybe industry never had it. Performance efforts almost always have to navigate a maze of conflicting opinions and methods. The results of this approach have not been good. It’s easy for managers chasing performance improvement to get disoriented, and more than a few have moved on to different jobs because they got lost in the maze at their previous job.

Consider the following: Lean failure rates are regularly quoted as being between 50% to 98%, depending on the expert. An Industry Week survey in 2007 (433 anonymous respondents) reported that only 24% of Lean implementations achieved significant results.1 On the other hand, it is curious that so many companies and consultants tout Lean, yet there is no verifiable data that links it to financial success. I think a primary reason Lean is so popular is because it’s easy to communicate “Eliminate Waste!” as a slogan and management needs a good, simple rallying cry to help focus workforce efforts. Read more | Attend the session