May 2016 issue: Everything You Ever Wanted to Know about Starting a Medical Device Company + more

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In this issue:

43 Understanding nitinol implant design and manufacturing

48 Microneedle technology and transdermal drug delivery

54 Advances in lower limb prosthetics


 

Conquering the complex implant supply chain

By Heather Thompson

The supply chain for medical devices, particularly implantables, is very complex. Although a distributor often manages the inventory, manufacturers hold it in title, there are multiple parties involved at any given stage, and inventory changes hands quickly. The result is a high-value inventory battling competing interests, and high risks to the manufacturer – not to mention adherence to FDA regulations.

That’s why it’s hard to believe that many medtech companies still rely on antiquated logistics and inventory tracking. Some have decentralized systems that rely on a combination of ERP and spreadsheets. Others use manual entry systems into the ERP, shipping to either sales reps or hospitals. Both introduce risk to the process, by requiring recipients to confirm orders, or find missing information.

Seiyonne Suriyakumar, business development representative for Mobitor Corp., describes two orthopedic clients that were experiencing challenges:Orthopedic Device Company 1
A small company began experiencing rapid growth. As they grew, they struggled to continue using manual methods (calls, emails, faxes, whiteboards) to manage inventory. The manual nature of those requests meant the customer service team would often need to call reps back to confirm orders that they couldn’t understand or that were missing information. Orders were then manually entered into their ERP system and, if necessary, inventory was then shipped out to either the rep or hospital. Once a case finished, the rep would again send over consumption information, triggering another cycle of manual data entry, clarifications and questions. They had briefly looked at ome cloud-based systems, but were dissuaded because they were so much more than the company required and weren’t flexible enough to fit (and were also far too expensive).

Heather Thompson
Orthopedic Device Company 2
An established operation relied on a combination of their ERP and spreadsheets to track inventory. Without a centralized field inventory system, they had sub-par inventory planning, gaps in service, duplicative data entry and numerous discrepancies. The company made the decision to move away from that system to cut costs. It needed to ensure employees had the right systems in place to be sustainable, and positioned for growth. The companies looked at several systems in-depth, but outdated UX/UI, a challenging integration process, and the lack of some key features kept them from partnering with anyone.

Does any of this sound familiar? If it does, there is an outcropping of firms that are creating a better system to help medical device companies manage this complex process.

How do you know your technology is disruptive enough to break conventional wisdom?

textadimage Stan Rowe knows a little something about bringing disruptive technology to market. The current Edwards Lifesciences CSO was in on the ground floor of two of medtech's most disruptive treatments, stents and transcatheter aortic valve replacement.

On December 12th, Rowe will sit down with MassDevice editor Brad Perriello for a long ranging discussion about the inside story on how these technologies came to market and what Rowe learned along the way.


Register now with the code "TAVR" and save 15% today.

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