Tools for EMS manufacturing quote pricing analysis - Optimize total landed cost savings for your contract electronics outsourcing programs

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Tools for EMS manufacturing quote pricing analysis - Optimize total landed cost savings for your contract electronics outsourcing programs

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Fast product launch new medical devices: 510(K) and FDA cleared v FDA approved

By VentureOutsource.com Staff

Barriers for bringing new medical devices to market can be challenging. Balance between medical product outsourcing activity with contract manufacturing partners and medical device manufacturers is key. But FDA Cleared medical devices not only undergo less scrutiny than FDA Approved devices, they also require no proof the medical device actually works.

FDA Cleared devices can legally promise more than they deliver. The way most medical devices become cleared (v approved) is through a loophole in the FDA’s system called the 510(K) pathway. This can be good for medical device manufacturers wanting to get product to market quickly.

Find med device product development
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In your search results you can further target other Industries and/or Services plus, you can add more geographies to your search.

The Food, Drug and Cosmetic Act Section 510(k) mandates OEMs marketing medical devices need to register / notify the FDA at least 90 days in advance of the date the OEM intends to bring its medical device to market. (Read more at fda.gov)

 

SEE ALSO
How to cut 5% to 15% from your EMS manufacturing fees
MedTech device and equipment trends

 

Technically, medical device companies bringing a new product to market are not required to go through a strenuous testing process if the new device being brought to the market is substantially similar to one that had come before. This way, innovation would not be stifled.

 

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Contract service agreement for medical device design services
Contract service agreement for medical device manufacturing services

 

But abuse has taken hold, and as more consumers come to understand this, device manufacturers may want to take the extra steps when deciding which path to take when launchin med device new product introductions.

FDA Cleared or Approved devices (2017)

Surprisingly, today, more than 80% of medical devices are cleared through the 510(K) loophole. See below.

But first to market does not guarantee market share stability. Comedian John Oliver speaks to this on HBO’s ‘Last Week Tonight with John Oliver’.

Find providers of med device design and manufacturing services

Search the Venture Outsource directory of contract electronics solutions providers for med device design and manufacturing services here.

Use 72+ advanced search criteria in our massive, worldwide directory for all contract electronics solutions providers. Search multiple geographies, multiple services offered, and numerous different end markets, combined, right here.

Medical Electronics New Product Launch and NPI Management in EMS Manufacturing

Learn more about medical electronics new product NPI program launch and cost management with the Venture Outsource 30-page handbook you can request here.

Designed for non-traditional electronics OEM companies, our handbook is divided into the primary topics below, with several topics going deeper, with detailed industry examples and clear suggestions and checklists for readers to consider:

  • OEM Outline for Electronic Prototype and New Product Development
  • EMS Manufacturing Request-for-Proposal (RFP) Terms
  • EMS Manufacturing Request-for-Quote (RFQ) Best Practices
  • EMS Manufacturing Industry Quote Pricing Drivers
  • EMS Manufacturing Program Workflows, Flowcharts
  • EMS Manufacturing NPI Systems Integration (Box Build) Checklist

Our handbook can help guide medical electronics OEM manufacturers when formulating and benchmarking their new product launch roadmap and pricing strategy. Request this handbook.

Get a list of EMS manufacturers matching your program needs (Its free)

Venture Outsource has the largest, global database of contract electronics capabilities. Get a free list of contract EMS manufacturing companies matching your program needs.

“Was able to very quickly find details on the important elements of setting up EMS and ODM partnerships, talked with an advisor for personalized info on quality providers matching our requirements while getting up to speed quickly about the industry and connect with key staff from like-minded companies and potential partners. Great resource.”

— Jeff Treuhaft, Sr. Vice President, Fusion-IO

Advisors have access to detailed information on listings in our global database and can help you compare provider service capabilities to better match your program needs. Speak with a Provider Advisor. This free service is for electronic professionals working in OEM brand companies.

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