MedTech IoT start-ups and early-stage innovators often launch with a minimum viable product, or MVP, a version with just enough features and stability to be used in clinical or field-testing. With the right MVP, companies can prove technical feasibility and position themselves for success with investors. Here is how to get there.
EU MDR has increased the regulatory burden for medical device companies, but it can also serve as a catalyst for innovation and an opportunity to streamline clinical evaluation workflows through the adoption of digitalization and AI-powered automation.
The 3M Medical Materials and Technology group is working on innovative applications such as wearables and lab-on-a-chip diagnostic products.
As medical device complexity grows, the product development process often needs to improve in order to maintain device quality and safety, foster innovation, and reduce costs. Yet teams looking to make improvements often encounter resistance from management. This Ask the Expert focuses on how you can overcome barriers to improving the medical device development process.
The way in which we deliver healthcare is changing rapidly. Technology and rapid adoption is enabling device and tech manufacturers to develop products that move the delivery of care away from the clinical environment. Having the option to stay out of hospitals could be extremely important from both a financial standpoint as well as a health perspective, and could essentially help low-risk patients avoid exposure to viruses. Our experts today provide information regarding the regulatory requirements for …
With the publication of IEC 60601 3rd edition, manufacturers have been scrambling to meet EU and Canadian deadlines and formally incorporate a risk management process in the quality management systems. Device electrical and mechanical safety continues to be a critical path on the road to regulatory approvals and ongoing compliance.
Micro molding is has been debated over last number of years, and while size certainly plays a part in defining what it is, other aspects like precision, complexity and details involved are more the drivers for micromolding techniques.
This column discusses two critical requirements involving silicone tubing for medical device applications.
“If you are doing a wound care dressing, what is unique about the product, what are you doing differently than what is already in the market, what is it intended to be used for, who is using it, and where is it being used… All of these pieces of information help you decide how to proceed.” – Jeff Kaminski , President of MBK Tape Solutions. Excerpts from an interview.
The medical market has evolved over the past several years and is facing unprecedented challenges that were unforeseen just a few years ago. Increased government regulation, heavy cost pressures from local competition in emerging markets, and increased public pressure to achieve sustainability is challenging companies to drive operational efficiency and revisit material selection in order to succeed in the future global medical marketplace. This week, Ask the Expert focuses on material selection that opt…