A comprehensive medical device commercialization process divides the product development into distinct phases. Regardless of the phase your product is in, your supply chain strategy should be tailored to suit your specific needs. In this blog post, I will describe strategies useful for each product development phase.
Medical device commercialization is typically broken into Four Phases: Phase Zero Product Definition, Phase One Engineering Design and Development, Phase Two Transfer, and Phase Three Manufacturing. This blog covers Phase Two Medical Device Transfer to Manufacturing tips and examples from our employee experts.
This blog compares a traditional Vector Network Analyzer (VNA), the HP 8753, with a NanoVNA for use by the budget constrained engineer developing a medical device.
A Vector Network Analyzer or VNA injects a known signal into a circuit, and determines what changed about the signal after it leaves the circuit. VNAs are used during the development process of a device, to characterise and verify the performance of circuits such as amplifiers, filters, antennae, cables, etc. This is very common, especially if a given device operates at higher frequencies, where nonidealities can play a bigger role and are harder to predict.
Choosing a medical device contractor is one of the most important decisions a medical device start-up can make.
In today’s distributed workforce environment, finding a medical device development partner that will enable collaboration and innovation without actually physically being together is possible if you know what questions to ask.
Visual rhetoric and emotional interaction in Medical Devices
Frequently in the medical device industry, the tangible importance of the aesthetic design of an object can be downplayed. It can be considered dressing or fluff and not important in the development of the device. However, aesthetic personality, visual rhetoric or emotional interaction with a medical device influence the experience that an operator and a patient have with the device.
Clinical investigations are defined within both FDA and EU MDR as the systematic investigation involving one or more human subjects, undertaken to collect data and assess the safety or performance of a device. Using the clinical data to demonstrate that the device meets the safety and effectiveness considerations is an important step in the device lifecycle.
Here, we will look at some of the differences between FDA and EU MDR process and requirements for clinical investigations.
The US Food and Drug Administration (FDA)’s voluntary Qualification of Medical Device Development Tools (fda.gov) is intended to encourage use of innovative technologies and novel approaches to medical device development and create a favourable regulatory framework to expand the availability of entirely new medical devices to patients.
This blog includes an overview of MDDT program, its categories, history, benefits, Centre for Devices and Radiological Health (CDRH) Qualification Process and Decision Framework.
As you gear up to face your impending FDA inspection, we’re here to lend a helping hand with five crucial tips for a smooth and successful FDA inspection.
Navigating the intricacies of regulatory compliance can be daunting, but fear not! Our expert advice will guide you through this difficult process, so your organization is well prepared to meet the FDA’s requirements.
When thinking about the roles of Quality Assurance (QA) and Regulatory Affairs (RA), I like to use the metaphor of the trail blazer and the guide, RA is there to blaze the trail and find the path, QA is there to keep the team on that path and away from pitfalls and hazards.
RA does this by monitoring and reviewing the regulatory landscape, understanding the applicable laws and regulations, but also knowing about recent decisions by regulatory bodies and how interpretations of these directives and guidances can vary. QA keeps projects on track by being fully engaged in the Quality Management System (QMS) and knowing what needs to be done to ensure that the project is successful as well as compliant.
Our employee experts share their best tips and examples for each phase of the commercialization process in a four-part series on Medical Device Commercialization. This blog covers Medical Device Phase One Product Development engineering, design and development. For Phase Zero tips, check out our blog on Product Definition.
Medical device commercialization is typically broken into Four Phases: Phase Zero Product Definition, Phase One Engineering Design and Development, Phase Two Transfer, and Phase Three Manufacturing.