Process development, optimization and control using statistical methods and tools is useful to demonstrate that processes are stable and capable. We queried an industry expert to gain insight on the benefit of statistical analyses.
"Orthopedic knowledge and surgical skills have grown in many separate silos over the years, and there will be significant advantages to integrating these areas, both for the patient and the profession," says Patrick Sweeney, M.D. "The possibilities created by this will be extensive."
Resources are being dedicated to harnessing the potential of additive, and while many are making progress, others lack the knowledge and support to make measurable headway. The Tech Center will host one and a half days of education provided by more than 20 additive manufacturing specialists hailing from organizations such as SME, ASTM, FDA and GE Additive. Join us!
Over the last 100 years, orthopaedic surgery has migrated from therapies based on limb removal to joint replacement to tissue repair, and now clinical solutions for tissue regeneration. Today's orthobiologic market is exciting and full of promise on one hand, but also filled with uncertainty and critical challenges on the other.
Packaging is an integral part of product commercialization. Millstone Medical's study of the heat sealing process reveals that variability in peak peel strength of nylon pouches can be reduced by making sure that the sealing interface temperature remains stable.
Your supplier scorecard has a two-fold purpose. First, it is intended to be an objective rating system to identify suppliers that are not performing well so that corrective action can be taken. Second, it provides evidence to auditors and inspectors that your company is evaluating supplier quality.
Prudent manufacturers know that the deployment of human factors and usability engineering go beyond meeting regulatory requirements. Manufacturers can leverage their programs to cut costs, mitigate risks and understand how they stack up to competition.