FEATURED EDITORIAL

3 Challenges To The Orthopedic Biomaterials Market In 2019
3 Challenges To The Orthopedic Biomaterials Market In 2019

Despite declining prices, technological innovation and other developments in the orthopedic biomaterial product market have maintained the market’s growth, drawing in patients with easier-to-perform and more efficient procedures.

  • Take The Narrow Path To Wide Adoption — Here’s Why And How
    Take The Narrow Path To Wide Adoption — Here’s Why And How

    Segmenting patients, providing physicians with guidance on which ones your technology suits best, and clearly stating expected outcomes helps to drive use, preference, and — eventually — increased adoption rates.

  • How To Write An Effective Validation Master Plan
    How To Write An Effective Validation Master Plan

    A validation master plan (VMP) outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility. Master plans are written to assist an organization with validation strategies or to provide control over a specific process.

  • Back-Door De Novo? FDA Accepts Real-World Evidence For Expanded Use
    Back-Door De Novo? FDA Accepts Real-World Evidence For Expanded Use

    Obtaining early clearance with a narrower claim enabled this company to enter the market earlier, as well as use its own product as a predicate to collect real-world evidence — all while obtaining broader clearance and avoiding the requirement to document patient-informed consent during trials, since the device already had been cleared.

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INDUSTRY INSIGHTS

  • Improving Health Outcomes With Personalized Apps
    Improving Health Outcomes With Personalized Apps

    Advances in sensors, smartphones, communications, and analytics give developers new tools to build creative and powerful applications that promise to improve health outcomes and reduce healthcare costs.

Micro-MIM Succeeds At Making Precise Micro Metal Parts

As component sizes for medical devices shrink to micron size, conventional machining may not be the most efficient or consistent method for manufacturing. Learn why Micro-MIM is preferred for components with tight tolerances at high volumes.

Plan For Success With Sustaining Engineering In Medical Device Development And Manufacturing

Sustaining engineering enables the developer to plan ahead, getting the development and design of the device done right the first time, and smoothing the transition to manufacturing. KMC's executive director of engineering, Scott Leon, weighs in on the subject.

How To Uncover The Hidden Value Of Culture In Supplier Selection

The business pain of switching suppliers, both in terms of costs and revalidation time, heightens the importance of making the right decision the first time.

Taking Micromolding To the Next Level

Micromolding requires a high level of intimacy and attention to detail to be successful over the long run, so it’s important to work with micromolder with the capability, scalability, and sustainability to get a product from the design stage all the way to high-quality mass production. 

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SOLUTIONS

Medical Micromolding Medical Micromolding

MTD Micromolding is solely committed to providing the highest quality micromolding services of advanced medical products. MTD offers their innovative skills in exploring and producing very small, delicate, and intricate components required for advanced medical applications and products such as specialized surgeries, bioabsorbable devices, and implant devices. With a constant demand for newer, smaller, never-before-seen micro medical devices, MTD is also prepared to assist their strategic partners in the development of new solutions.

In Silico Simulation For Enhanced Device Performance: 3DEXPERIENCE® Platform In Silico Simulation For Enhanced Device Performance: 3DEXPERIENCE® Platform

SIMULIA’s solutions for medical device development provides a framework for engineering teams to integrate the tools they use into re-usable, deployable processes. This reduces time-consuming and error prone tasks to improve productivity and consistency, while enabling design exploration studies to find better designs and democratization to expand the user-base for simulation. Lastly, capturing these processes in the 3DEXPERIENCE® platform provides the traceability organizations need when making critical business decisions.

Motion Control Products: Coreless Motors Motion Control Products: Coreless Motors

Canon’s coreless motors are part of the family of dc-motor products that are custom manufactured to achieve the exact speed, power, and currents required for OEM applications. These motors feature a small footprint, high power output, and a low moment of inertial that provides quick response rates and high controllability. They are ideal for many applications including cameras and pumps. Customization and other options are available on request.

Medical Device Prototyping & Design Services Medical Device Prototyping & Design Services

Carclo's product engineers have multiple years of experience with medical device prototyping and design. They address your medical device design needs by getting involved as early in the product prototype and design cycle as possible.

Manifold Technologies and Techniques Manifold Technologies and Techniques

For over three decades, the Lee Company Electro-Fluidic Systems Group has been an industry leader in electromechanical valve and pump technology. Their expertise in fluidics is drawn from a complete understanding of the application and components involved. Using a manifold technique, it is possible to incorporate solenoid valves, pumps, passive components and active components into a complete assembly that has been functionally tested per the application requirements.

Glass Micro Bonding Benefits And Applications Glass Micro Bonding Benefits And Applications

SCHOTT Electronic Packaging and Primoceler Oy have joined forces to expand current hermetic packaging portfolios with pioneering glass micro bonding technology. This process enables the manufacture of vacuum-tight, ultra-miniature electronic and optical devices with superior reliability. This bonding method is based on laser technology and can be completed without any heat or added materials.

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FEATURED SUPPLIERS

Alconox, Inc. Alconox, Inc.

With more than 60 years of experience in formulation of quality aqueous cleaners, Alconox Inc. understands the cleaning needs of the medical device manufacturing industry including stringent FDA regulations and GMP compliance.

FLIR Systems, Inc - Research & Science FLIR Systems, Inc - Research & Science

The largest commercial infrared company in the world, FLIR has nearly 50 years of experience building and integrating high-performance infrared cameras. FLIR cameras play pivotal roles in a wide range of industrial, commercial, and government activities in over 60 countries.

 EVENTS

PAP 2019 March 5 - 6, 2019
Baltimore, MD
IVT's Statistics in Validation March 6 - 7, 2019
Philadelphia, PA
Medical Device Validation Week March 12 - 14, 2019
Minneapolis, MN
Life Sciences Accounting and Reporting Congress March 20 - 22, 2019
Philadelphia, PA
15th Annual Pharma Forum 2019 March 24 - 27, 2019
New York, NY
20th Annual Computer and IT Systems Validation April 23 - 25, 2019
San Diego, CA
6th Annual FMV Congress May 1 - 2, 2019
Philadelphia, PA
5th Annual Endpoint Adjucation May 1 - 2, 2019
Philadelphia, PA
UDI Conference June 11 - 12, 2019
Baltimore, MD
More Events...