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Medical Silicone Molding Blog

OEMs: Do You Trust Your Medical Device Supplier’s Quality?

Posted by Leo Gelera, Quality Manager

8/7/17 11:30 AM

Meeting the New ISO Deadline & Risk Management For Supplier Realization

OEMs: Do You Trust Your Medical Device Supplier’s Quality? 

As an OEM, it is your responsibility to ensure the parts supplied to you are compliant with ISO regulations. That is no easy task. Ideally, your supplier’s quality systems are strong enough to identify risks, prevent defects, and to catch defects quickly if they do occur. This requires a robust quality management system.

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Topics: Quality, OEM and Supplier Partnerships

OEMs: DISCOVER THE HIDDEN COSTS AND RISKS IN YOUR COMPLEX SUPPLIER NETWORK

Posted by Mike Huiras, Vice President of Sales & Marketing

5/17/17 11:26 AM

Are your customers willing to pay for the cost of complexity in your supplier network?

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Are your customers willing to pay for the cost of complexity in your supplier network? I think we both know the answer to that question.

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Topics: OEM and Supplier Partnerships

Are You Gambling With Medical Device Compliance?

Posted by Harold Sant, VP Operations, FMI

4/18/17 12:35 PM

8 Reasons To Ditch Paper Device History Records

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What is the probability thousands of handwritten records created by production employees are error free? That’s the gamble OEMs make when they accept handwritten device history records (DHRs) from their contract manufacturing organizations (CMOs).

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Topics: Medical Device Compliance

Understanding Silicone Molding for Implantable Medical Devices

Posted by Harold Sant, VP Operations, FMI

6/22/16 10:00 AM

Medical device manufacturers rely on the biocompatibility of silicone for a wide range of devices that come in contact with the body, ranging from long-term orthopedic surgical implants and cardiovascular devices to one-time-use devices.

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Topics: Implantable Silicone

The Growth of Biocompatible Silicone in Implantable Medical Devices

Posted by Harold Sant, VP Operations, FMI

6/2/16 10:00 AM

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After more than 50 years of using silicone rubber in medical implants, the number of applications for the material’s use in both short- and long-term implantable medical devices just keeps growing. With its long track record
 of biocompatibility, medical-grade silicone is being used in a range of implantable devices with critical functions, such as defibrillators, heart pumps and surgical reconstructive components.

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Topics: Implantable Silicone

Cleaning Comes First in Sterilizing Medical Silicone Molded Components

Posted by Harold Sant, VP Operations, FMI

10/15/15 8:00 AM

The sterilization of medical devices – particularly reprocessed medical devices – has been in the news in recent years, as healthcare associated infections have soared as the result of improper sterilization of medical instruments, such as scopes, by the end user. Whether a device will be reused or not, sterilization is a significant concern for the manufacturer, who is ultimately responsible for shipping a safe, sterile device.  But is sterilization enough?

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Topics: Cleanroom Manufacturing

Is Your Medical Silicone Molding Company FDA Ready? Why It Matters.

Posted by Harold Sant, VP Operations, FMI

8/28/15 7:00 AM

FDA-ReadyFollowing the scandal in France, where a company was caught substituting industrial silicone for medical grade in breast implants, which led to a higher rate of ruptures, both the European Commission (EC) and the U.S. Food and Drug Administration (FDA) have increased their surveillance on medical device manufacturers and their suppliers. As U.S. and European regulators have stated their intention to conduct surprise audits, it is imperative that all suppliers, including the medical silicone molding company, be ready for an audit at any time, in any facility, whether domestic or international. The consequences of failing an FDA or EC audit can be devastating to the OEM and its suppliers alike.
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Topics: Quality

DFM Key to Scale-up and Commercialization of Medical Silicone Molded Components

Posted by Harold Sant, VP Operations, FMI

8/4/15 10:00 AM

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Getting a new medical device to market quickly is the goal of every manufacturer, but hurdles appear at every step of product development, which can involve myriad parts from multiple suppliers.

For medical silicone molded components, three phases are critical to the part’s success in the long run, with rigorous DFM a crucial first step:

  1. Design for Manufacturability (DFM)
  2. Process Capability and Validation
  3. Production Planning for Scale-up and Commercialization

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Topics: Part Validation, Design for Manufacturability

Five Steps to Ensuring Bond Strength in Silicone Overmolding Applications

Posted by Harold Sant, VP Operations, FMI

6/23/15 10:00 AM

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Medical device manufacturers have relied on silicone overmolding to produce parts for a wide variety of applications that come in short- or long-term contact with the human body, such as surgical blades, orthopedic handles and wire insulators for pacemakers and other implantable devices.

In overmolding or insert molding, silicone is bonded to a substrate, which is typically made of metal or plastic.

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Topics: Silicone Overmolding

Automated Assembly and Inspection of Medical Silicone Molded Components

Posted by Harold Sant, VP Operations, FMI

6/3/15 7:30 AM

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Medical device manufacturers often inquire about automated assembly and inspection of medical silicone molded components when submitting a request for a quote for a new part. However, OEMs may be surprised to learn that automated systems are not always the most cost-effective solution for silicone molding and may not even be possible for a particularly complex component or assembly.

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Topics: Part Validation, Part Assembly