Contributors' Corner Guest contributors submit their opinions and knowledge about the Medical Design space en Issues and Challenges in Protecting Personal Health Information <div class="node-body blog-body"><div></div>Authentication and authorization issues are a classic mix of the human element and poor implementation. If you have been to a hospital lately, your eyes quickly are drawn to the amount of identification and security cards attached to each employee. Establishing identity is clearly a complex problem...</div> <p><a href="" target="_blank">read more</a></p> Design-Engineering information medical devices security software Contributors&#039; Corner Fri, 19 Dec 2014 16:04:00 +0000 13721 at Security Risks Inherent in the Medical Device Lifecycle <div class="node-body blog-body"><div></div>We must consider the extra wrinkle in this health security story: the numerous medical devices that collect and store PHI. These devices often lack security controls because they were built before security became a consideration...</div> <p><a href="" target="_blank">read more</a></p> Electronics Design-Engineering data healthcare medical device security software Contributors&#039; Corner Wed, 29 Oct 2014 17:50:00 +0000 13651 at Effective Design Partnerships: Understanding the Manufacturer’s Profile and Objectives <div class="node-body blog-body"><div></div>In the most effective partnerships, the manufacturer and outside firm begin with research (see the second column in this series for why this is so). But by the time the partners reach the design phase, they need to be able to define more than just the product concept. </div> <p><a href="" target="_blank">read more</a></p> Design-Engineering design manufacturing medical device partnership product Contributors&#039; Corner Mon, 20 Oct 2014 19:04:00 +0000 13611 at Protecting Sensitive Data in a Sensitive Industry <div class="node-body blog-body"><div></div>A breach of personal health information carries an emotional component quite unlike the breach of credit-card information. Credit cards can be cancelled and reissued, but personal health information can’t be voided after being compromised in a data breach. </div> <p><a href="" target="_blank">read more</a></p> Electronics data healthcare protection security software Contributors&#039; Corner Mon, 22 Sep 2014 16:44:00 +0000 13411 at Effective Design Partnerships: Understanding the Critical Partnership Research Stage <div class="node-body blog-body"><div></div>Few markets rival the medical market for complexity. Most product sales involve a long line of people who can influence the decision: doctors, patients, nurses, technicians, IT engineers, accountants, safety managers, regulators, administrators, auditors, and more. Each has a slightly--or radically--different calculation of the holistic value of the product. </div> <p><a href="" target="_blank">read more</a></p> Design-Engineering design manufacturer marketing medical device research Contributors&#039; Corner Sun, 07 Sep 2014 22:42:00 +0000 13291 at Steps to Jumpstart Your UDI Program <div class="node-body blog-body"><div></div>The recent observation is that many companies--especially those without class III devices--are in a “wait and see” mode, or at best, have delivered an informal communication to the obvious UDI stakeholders and had a loose planning session or two. </div> <p><a href="" target="_blank">read more</a></p> Materials Design-Engineering compliance FDA regulatory UDI unique device identification Contributors&#039; Corner Mon, 25 Aug 2014 21:23:00 +0000 13241 at Using Oscilloscopes for microVolt Biomedical Measurements <div class="node-body blog-body"><div></div><p>Measuring electrical phenomena presents a number of challenges to biomedical signal measurement systems. The tiny, microVolt-level electrical pulses that signal a firing neuron or a muscle response, are often obscured by high-amplitude noise or accompanied by significant DC potentials. Quite often, the signal of interest is a small transient pulse that either occurs intermittently, or only once.</p></div> <p><a href="" target="_blank">read more</a></p> Design-Engineering Contributors&#039; Corner Thu, 31 Jul 2014 19:43:00 +0000 13111 at Finding the Right Fit for Effective Design Partnerships <div class="node-body blog-body"><div></div>One of the most powerful combinations in business is a partnership between a product manufacturer and an outside product design firm. It’s an opportunity for two complementary organizations to work through a complex process – with a huge number of variables – and produce something much greater than either could produce on its own. </div> <p><a href="" target="_blank">read more</a></p> Design-Engineering Contributors&#039; Corner Tue, 29 Jul 2014 01:21:00 +0000 13071 at Building a Foundation on Security and Compliance <div class="node-body blog-body"><div></div>Recent high-profile security breaches in the retail, finance, and insurance industries underscore the need for organizations to keep data secure across a wide network of devices and systems accessed by customers, vendors, and remote workers. In the healthcare industry particularly, concerns over protecting...</div> <p><a href="" target="_blank">read more</a></p> Electronics computer medical device security Contributors&#039; Corner Tue, 15 Jul 2014 17:03:00 +0000 12981 at Looking to Automated Compounding Systems to Remove Human Error <div class="node-body blog-body"><div></div>The 2012 meningitis outbreak linked to contaminated steroid injections continues to be a tragic reminder of the risks inherent in manual medication compounding. Unsanitary conditions at the Massachusetts compounding pharmacy that made the injections, resulted in fungal contamination of the drugs. </div> <p><a href="" target="_blank">read more</a></p> Materials Components Contributors&#039; Corner Tue, 01 Jul 2014 19:51:00 +0000 12901 at