Design Controls: Design Transfer, Changes and the Design History File
Introduction and Review As you may recall from the first and second articles in this series, each manufacturer of orthopaedic medical...
Dec 31 2010,
Medical Device Packaging is Shaped by Increased Regulations
The Benefits of Capturing Product Data Are High – The Costs of Doing So Don’t Have to Be
Choosing the right data collection partner and process can help device companies differentiate themselves in the minds of surgeons....
Dec 31 2010,
Selective Retention: The Key to Keeping the People You Want
When you lose a “clutch player,” it hurts! Not only is it demoralizing to you, but it can have a...
Dec 31 2010,
3D Technology Improves Surgical Implants and Procedures
3D for improving orthopaedic implant design and surgical procedures has been hindered by the need for more accurate and usable...
Dec 31 2010,
Outcome Measures in Joint Replacement by Physical Activity Monitoring: Pre-pilot Study
Success rate figures for total joint arthroplasty are typically based on revision rates, and do not reflect patients’ satisfaction or...
Dec 31 2010,
2010 Orthopaedic Year in Review, Positive Signs for 2011
FDA regulatory changes, reimbursement and healthcare reform have created significant uncertainty regarding the ability to get new products approved and...
Dec 31 2010,
MDD Regulations: What I Wish I Had Known
Having worked in medical device research and development for over 20 years, I have contributed to many regulatory submissions for...
Sep 30 2010,
Change Management and S&OP
Some years ago, I spoke with a gentleman from Ford Motor Company’s Lean Supplier Institute whose job it was to...
Sep 30 2010,
A Supply Chain Manager’s Guide to Strategic Purchasing, OR How to be on top of things instead of having things on top of you!
Do your Supply Chain Management processes provide competitive advantage for your business?...
Sep 30 2010,
Design Controls: Design Verification and Validation
This editorial is the fifth in a series of six articles focused upon the design controls process from a standpoint...
Sep 30 2010,
Generation (Hire) ME
You are extremely lucky that this publication found out I was available for a writing project and that I am...
Sep 30 2010,
Injectable Hydrogel-based Medical Devices: “There’s always room for Jell-O”
Rigid materials have been very successful in total hip and knee replacements, in which the general strategy has been to...
Sep 30 2010,
Truth or Myth: Does an International Patent Exist?
Almost every inventor has asked, “Can I get an international patent?” The simple answer is, no. Let’s be clear, there is...
Sep 30 2010,
Industry’s New Customer: Hospital + Surgeon
Device companies are well positioned to play not just a role in technology, but also a pivotal part in the...
Sep 30 2010,
Design Controls: Design Review
This is the fourth in a series of articles focused on the design controls process from a standpoint of business...
Jun 30 2010,