Global orthopedic sales increased by +3.8% to $53 billion in 2019. We’re planning for a disruption to orthopedic procedure volumes and day-to-day business to last through 2020 and into 2021.
PEEK and titanium dominate the spinal fusion market. DiFusion received FDA 510(k) clearance to market a spinal interbody made of ZFUZE, a new polymer engineered specifically for orthopedics.
An equivalency study comparing the properties of Ti64 ELI powder produced by plasma atomization and Electrode Inert Gas Atomization (EIGA) found that EIGA proved superior in terms of chemistry and flowability and exhibited no statistically significant differences in morphology or density.
When speed to market is vital, design and prototyping of any project carries heavy weight. Collaborating with suppliers from the onset and communicating throughout yield a better chance of being successful.
Altering team culture can be a long journey, but organizations that are successful in this approach benefit from harmonious and productive environments.
A recent panel including FDA, Stryker, Mayo Clinic and the Advanced Regenerative Manufacturing Institute discussed developing a quality system, validating/verifying processes and working with FDA.
The innovations revealed by challenge entrants have the potential to assist orthopedic patients during and after the COVID-19 pandemic, and help reduce risks during an operative procedure.
Partners have similar challenges, including forecast visibility and stability, relevant capacity plans and unified response to unexpected market events. We hosted a roundtable with device companies and contract manufacturers to offer advice on overcoming these obstacles.
GMP/QSR and ISO 13485:2016 are similar with respect to medical device manufacturing and design quality systems. However, the interpretation and approach of the investigator or auditor makes the experience very different.
