Industry Perspectives - Design & Development

  1. The Impact Of Health Technology Assessments On Reimbursement
    8/8/2016

    Within the medical device industry, companies may use HTAs to focus on future product development, and investors may look at HTAs to guide funding decisions for promising innovations. This article will define HTAs and examine how they performed, by whom, and the implications for reimbursement and coverage.

  2. Coming Home: Designing For Medical Device Use Environments
    7/28/2016

    Understanding a product’s use environment is as key a building block to designing a usable and useful medical device as understanding the end user. Where a product is used, and who is using it, are inseparable factors, and anticipating how they interplay in device use is a critical and complex task.

  3. First-In-Human Studies - What's The Rush?
    7/27/2016

    Today's medtech developers seem intent on getting to actual use -“first-in-human” (FIH) - as soon as possible. But, what motivates the race to FIH? Why is it so important and meaningful to quickly achieve that first actual use case of a new medical device? Furthermore, are the motivations guided in a way that aligns with safety and efficacy?

  4. Your Device Is Safe And Effective, But Is It Desirable?
    7/25/2016

    It is possible -- and encouraged -- to transition from design inputs that help create useful and usable devices to inputs that make a product desirable. Desirability transforms a product from merely acceptable to a solution that encourages adoption and long-term brand loyalty, achieves differentiation in a crowded marketplace, and helps support better medical outcomes.

  5. Market Cannibalization Underlies Cardiac Output Monitoring Market
    7/10/2016

    Cardiac output (CO) is regarded as a fundamental component of hemodynamic monitoring in critically ill patients. Demand for less-invasive technologies is just one of the factors driving change in the CO monitoring market. 

  6. Medical Plastics: Material Selection Based On Feel
    7/5/2016

    From prioritizing material properties to establishing desired values for each property, selecting plastic materials based on feel is a complicated undertaking. To elicit the most desirable user response from the device, it can be helpful to consider the what, rather than the how.

  7. How To Effectively Evaluate Instructional Materials and Labeling Before Development Is Complete
    6/30/2016

    How do we ensure that the instructional materials are going to facilitate safe and correct product use, and not introduce the potential for error? Ideally, we want to take the same approach that should be taken for device design: Incorporate human factors evaluations early and often. However, understanding the best way to do this is not always simple. 

  8. Med Device Rosetta Stone: Translating User Needs Into Design Inputs
    6/24/2016

    Designing optimal solutions means taking into consideration all of the influences on the user, including technology strategies, market trends and opportunities, and even regulatory and reimbursement systems. The comes the tough part: How do you translate user needs into specific and actionable design inputs?

  9. Cybersecurity For Not-Yet And Never-To-Be Connected Medical Devices
    6/20/2016

    Any device that uses any kind of code — in other words, practically all modern medical devices more complicated than a basic scalpel — can potentially be hacked or otherwise compromised, even if they are not directly connected to the internet.

  10. Advancing Medtech Development: Metal 3D Printing’s Expanding Role
    6/5/2016

    Meeting patient needs in challenging medical circumstances requires patient-specific implants and specialized surgical instruments. These implants and instruments can require such small, intricate parts — often with features, geometries, or enclosed channels — that they would be impossible to produce without the industrial 3D-printing process of direct metal laser sintering (DMLS).