Newsletter | May 9, 2019

05.09.19 -- What To Do AFTER Your FDA Inspection | How Hospital Consolidation Impacts Medtech Pricing

Featured Editorial
Impact Of Hospital Consolidation On Pricing Strategies In Medical Technology
By Matthew Majewski and Kira Gordon, CRA

Reimbursement rates have not risen as rapidly as device and medical supply costs, putting cost pressures on hospitals. This, in turn, increases pricing pressure on device manufacturers, as consolidated health systems have more negotiating power.

What Should You Do After An FDA Inspection?
By Mark Durivage, Quality Systems Compliance LLC

The FDA inspected your firm, and one or more FDA Form 483 inspectional observations were noted by its team. This article provides guidance on how to minimize or avoid additional enforcement actions.

Industry Insights
Shorten Time-To-Market By Thinking About Protective Parts Early
Article | Caplugs

Partnering with a trusted supplier of protective plugs and caps can save money, ensure your medical device is ready to ship on time, and protect your device from damage.

Using Microcurrent High-Voltage Leak Detection Technologies For Challenging Drug Products
Article | By Oliver Stauffer, PTI Packaging and Inspection Systems

Using HVLD in the pharmaceutical industry: Leverage test method development on some products to validate other products.

Medical Micro Molding: Complex Problem-Solving
Article | MTD Micro Molding

Problem solving is what drives the medical device industry. For OEMs to successfully produce medical solutions, they often need to overcome manufacturing challenges. Whether manufacturing a micro component in-house or working with another molding supplier, sometimes OEMs hit roadblocks.

Parylene’s Role In Pain Management Technology
Article | Specialty Coating Systems

The use of nerve location technologies has become more common due to the accuracy that can be achieved during medical treatments and procedures. This article discusses such technologies and is helpful for understanding the role parylene plays in pain management technology.

Choosing A CM: Find The Best Match By Asking The Right Questions
White Paper | By Mike Fritschy, SMC Ltd.

When selecting a contract manufacturer (CM), it’s important to look carefully at organizational alignment, senior leadership engagement, program management, commitment to projects large and small, and processes in place to manage risk. 

Cultural Audits: What Are They And Why Are They Essential?
Article | B. Braun OEM Division

The medical device industry is familiar with quality audits, but is less familiar with the benefits of having a cultural audit to assess the competence, dedication, and passion that each party brings to the table.

Med Device E-Book: How To Avoid Four Common Labeling Product Recalls

Labeling errors are a recurring reality for medical devices. This e-book discusses the four most common scenarios in recalling labeled medical device products and solutions for each of them.


The 18th Medical Device R&D Summit is the premium forum bringing together medical device R&D executives with leading solutions providers. The summit offers an intimate environment for focused discussion on cutting-edge technology, strategy, and implementation of solutions to forward-thinking medical device companies interested in staying ahead of the market. Find out more here.

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Ultra-Miniature 2-Port HDI Solenoid Valve
The Lee Company
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