Integration of Usability throughout the Design Life Cycle
May 1, 2017 - Sarah Blair, Ph.D., Senior Usability Engineer
The task of creating safe and reliable medical devices is the primary responsibility of medical device designers. At Minnetronix, usability is fully integrated throughout the process, helping our customers avoid the pitfalls inherent in more piecemeal approaches.
Overview of Non-Exempt, Significant Risk Medical Device Clinical Studies
September 21, 2016 - Lael Pickett; and Liz Scheurer, Principal Clinical Research Scientist, Neurocritical Care
The white paper “Overview of U.S. Medical Device Clinical Trials” provided a brief overview of U.S. clinical studies regulations, types of clinical studies and how to determine if an Investigational Device Exemption (IDE) is required. This paper will focus on Non-Exempt clinical studies that present a significant risk to study subjects and require that an IDE be filed and approved by U.S. Food and Drug Administration (FDA) and an Institutional Review Board (IRB) prior to initiating the study.
A Survey of Changing Regulatory Requirements for Electronic and Electromechanical Medical Devices
September 17, 2016 - Dirk Smith, Co-founder
Medical devices in 2016 continue to benefit from dramatic technology developments across engineering disciplines. Electronic-based devices, in particular, are increasingly employing cutting-edge technologies to meet user demands for fast, multi-function, usable, safe and cost-effective products. As complexity in devices and technology rapidly evolve, regulatory requirements are following suit, with significant and comprehensive updates to requirements and methods for demonstrating safety and efficacy.
Medical Device Design, Development, and Manufacturing: Considerations when Selecting a Strategic Partner
August 21, 2016 - Jim Reed, Vice President, Business Development and Marketing
Historically, the typical approach to medical device start-up development was to build an internal team of employees. This team completed assigned major development milestones, and following this success, management downsized them. Known colloquially as the “Hire, Develop, and Fire Model”, this approach is not only tumultuous and expensive, but it results in a loss of continuity and key core knowledge and know-how. It also presents challenges in managing spiky, episodic workloads with a team of a fixed size.
Overview of Non-Exempt, Abbreviated Requirements Medical Device Clinical Studies
August 15, 2016 - Lael Pickett; and Liz Scheurer, Principal Clinical Research Scientist, Neurocritical Care
The white paper “Overview of U.S. Medical Device Clinical Trials” provided a brief overview of US clinical studies regulations, types of clinical studies and how to determine if an Investigational Device Exemption (IDE) is required (Figure 1). This paper will focus on Non-Exempt clinical studies that do not present a significant risk to study subjects and must comply with “abbreviated” FDA regulatory requirements. Non-Exempt/Non-Significant risk (NSR) studies do not require an IDE application be filed with the US Food and Drug Administration (FDA) prior to initiating the study.