12.10.20 -- Will Transcatheter Valves Continue Cannibalizing Surgical Aortic Valve Replacements?

Medical device manufacturers and designers must overcome various challenges to succeed in an expanding global marketplace, challenged along the way by aspects of design, research, validation, and bringing their devices to a competitive market in a cost-effective manner.

In this paper, Lindsay Mann, director of marketing for MTD Micro Molding, tells MD+DI that about 25 percent  of the micro medical device components they produce are for miniaturized devices. This article also gives an update on miniaturization, including recent advancements in materials and manufacturing.

For medical device manufacturers and FDA/ISO-registered facilities, the integrity of quality systems is critical. Ensuring the quality system is suitable, efficient, and effective for business needs and customers is a key focus. 

B. Braun’s OEM Division can help companies with packaging, sterilization, and regulatory compliance as an OEM partner. 

In countless applications, metals cannot perform the role of a polymer. It is between these two spaces that either a polymer or a metal could perform the desired functions at an acceptable manufacturing cost in commercially meaningful volumes. 

When beginning cleaning validation, a company must identify the residues to be tested and then select the best detection method.

Medtech developers are constantly looking for ways to save money without compromising a product’s performance. The industry also is under increased scrutiny in terms of quality, regulatory requirements, and environmental sustainability for not just the finished product but the entire supply chain. 

This article presents a single source of truth (SSOT) solution for all medical device-related information so that all stakeholders have access to relevant information at any time. By controlling information and making it accessible across an organization, teams can focus on quality, accelerate innovation, and improve operational efficiency while ensuring global regulatory compliance.