Posts categorized as“Eastern Region”

Sandy Gill

Visual Project Management Improves Manufacturing Performance

On-time medical device manufacturing builds are a crucial factor to meeting program and client needs. The type of builds can range from first-off prototypes for preliminary verification studies to clinical studies and first-to-market devices after having received FDA clearance. Ensuring builds are done in a timely manner requires coordinating across several teams including engineering, manufacturing, […]

Danika Wotten

Key Elements for Medical Device Development Project Review Meetings

Trial and Error Lessons From Recent Pilots There are many methodologies that can be used to conduct medical device development project reviews. I have explored various approaches, workflows, and tools, including a structured survey approach with Microsoft Forms, online collaborative whiteboards approach with Miro, and dedicated project review tools like TeamRetro. Each tool facilitated various […]

Disha Patel

12 Steps to Set up a Biomed Lab

Some lab managers get to manage a running lab, but others get a whole new challenge of being a lab manager where there is no lab yet. Each phase from having nothing to having everything in operational condition requires thoughtful decision making and involves professionals from various backgrounds.

Palash Jha

How Post-Market Surveillance Enhances Medical Device Safety

Understanding Post-Market Surveillance: In the fast-paced world of medical technology, the journey of a medical device doesn’t end with regulatory approval. It continues into the post-market phase, where vigilant surveillance becomes paramount. This blog delves into the significance of post-market surveillance (PMS) for medical devices, exploring its importance, challenges, and potential improvements.

Khaled Youssef

One Platform, Versatile Solutions: Introducing a Modular Platform.

Immunoassays are the heart of most bioanalytical techniques used in clinical and research settings, allowing for accurate detection and quantification of biomolecules. The detection and quantification of an analyte is achieved using capture reagents, usually antibodies or antigens. The binding interactions between the analyte and the capture reagent are highly sensitive and specific, allowing for […]

Gary Skarja

Powering Future Cell and Gene Therapy Manufacturing

Biomanufacturing tools providers play a vital role by developing novel technologies and products to drive down manufacturing costs. This blog discusses 3 areas of technology powering the future of cell and gene therapies (CGT) manufacturing with design and development insights for each area: decentralized manufacturing, closed & automated systems and single-use technologies.

Rodolfo Prata

How Gamification Transforms Healthcare Experiences

The healthcare industry is continuously evolving and innovative approaches are needed to address its challenges. Gamification, the integration of game-like elements in non-game contexts, offers immense potential to transform medical devices and healthcare. This article explores the benefits of gamification in the healthcare industry and provides tips on how to improve patient engagement, access to […]

Mike Loveless

How to Improve Emotional Interaction With a Medical Device

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 […]

Vinky Kohli

Qualifying Medical Device Development Tools (MDDT)

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, […]

Rodolfo Prata

Patient-Centered Design

Patient-centered design is designing healthcare with the patient in mind, a methodology that prioritizes the patient’s desires and requirements. This encompasses constructing medical facilities, procedures, and systems to enhance patient care. The concept of patient-centered has gained considerable traction in recent years as healthcare organizations worldwide strive to improve their quality of care. In this […]

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