Supply chain experts from OEMs and 3PLs share their thoughts on which technologies and trends will cause the most evolution in orthopaedic logistics over the next decade. Their responses include a mix of developing trends, like cold chain, and older technologies, like GPS and RFID.
With many device manufacturers struggling to implement challenging UDI regulations, FDA has released a series of resources to help clarify GUDID submission, UDI labelling regulations and compliance schedules. The resources include slideshow presentations and video interviews with FDA.
The update cements FDA's stance that device manufacturers should consider human factors testing as part of a "robust design control subsystem." When risk analysis for a device indicates that customers could use a product incorrectly, in a way that could result in harm, your premarket submission should include human factors data.
For cost reductions and supplier relationships to be sustainable, you must address more than just the quoted price. You must attack real cost drivers at the supplier and the OEM with the intent to reduce cost while maintaining or improving margins. Protect your margins with these strategies on innovation, variance reduction, supplier selection and continuous improvement.
Concerns about availability, cost containment and quality will likely surface in conversations between OEMs and material suppliers in 2016, as uncertainties continue over supply and demand, top-down price pressure and enhanced regulatory scrutiny. BONEZONE reached out to the 27 raw material companies exhibiting at OMTEC 2016 to identify what you should be aware of as you embark on your R&D initiatives.
The M&A transaction process utilized by large and mid-size medtech companies typically comprises seven phases: develop a strategy that complements the strategic business plan, assess options, engage targets, evaluate the transactions and reach an initial agreement, conduct due diligence, negotiate final terms and achieve closure and finally, integrate.
Stick around for this special closing session that will bring together OEMs, surgeons and suppliers to discuss the future of additive manufacturing - one of the most-requested topics from your peers. Get all of your questions answered at expert-staffed, highly-focused discussion tables.