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Managing a Medical Device Project with an Embedded Software Component

  
  
  
  

By Rick Sabourin, Senior Software Engineer

Meet Jim Szabo, Lead Strategist, Healthcare Delivery Solutions

  
  
  
  
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We are pleased to welcome Jim Szabo to Ximedica and the Healthcare Delivery Solutions team.

Research Tips for Conducting In-Home Interviews by Lindsey Messervy

  
  
  
  

At Ximedica, we prefer to conduct consumer interviews in people’s homes, rather than in a facility, when we are seeking rich and deep insight into their context and experiences.  Crossing the threshold into into a person’s home can be a delicate matter for both you and them. Here are a few tips that will help you navigate through planning, conducting, and following up on in-home research.

View from the China Medical Equipment (CMEF) show in Shenzhen by Aidan Petrie

  
  
  
  
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Nine halls and a parking lot full of devices that look a lot like yours…

Know Thy Stakeholder: How vested interests drive product development & optimal delivery systems

  
  
  
  
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By Beth Werner, Sr. Research & Product Strategist

Ximedica Hosts 3rd Annual Introduce a Girl to Engineering Day

  
  
  
  
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With females representing less than 11% of the engineering workforce in our country and the knowledge that gender diversity is often linked to corporate profitability and employee satisfaction, Ximedica is committed to educational outreach opportunities targeting young women.

Meet Beth Werner, Sr. Research and Product Strategist, Healthcare Delivery Systems

  
  
  
  
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We are pleased to welcome Beth Werner to the Ximedica Research and Strategy team. 

What if Usability Wasn't Part of the Design Process? How a new pill splitter might look...By Benjamin Beaugh

  
  
  
  
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Ximedica honors World Usability Day!  For more information on today click here:  http://www.worldusabilityday.org/

How to Determine if a Risk Needs Mitigation By Kristy Bell and Albert Sanford

  
  
  
  

A risk management plan documents how a project team will identify and evaluate potential risks with a product. The plan outlines the process and the criteria the team will use to determine if mitigation is required for a particular risk. This document becomes part of the complete Design History File (DHF). This activity is an integral part of Ximedica's product development process to satisfy the requirements of HE-75, 21 CFR 820.30(g), and ISO 14971:2007, (i.e., the guidelines and regulation published by the FDA and the international standard for risk management in the medical device industry).

Perspective: How one medical device found its way to Honduras by Juris Grauds

  
  
  
  

As an electrical engineer at Ximedica, I derive much personal satisfaction from solving difficult problems, something we do every day. But “I think, therefore I am” does not fully convey the sense of positive being I find here. Ultimately, I work in the medical field because it contributes to a greater good:  helping others. These two important aspects of medical device design recently converged at Ximedica in the form of a wireless dental polishing tool for hygienists.

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