Clinical and commercial adoption are interrelated, but not identical. Successful medical device acquisitions are predicated on a thorough understanding of how these components fit together. Before acquisition, both target and acquirer must first understand the core scientific and clinical support for the technology, as well as anticipate ongoing hurdles in front of commercial acceleration.
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.
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.
Many medical device project development teams either ignore sterilization challenges until confronted with failed tests late in development, or adopt conservative guidelines that increase cost and lead times. More deliberate, proactive efforts applied to the sterilization topics discussed here can lead to improved outcomes.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
