Software can be an essential component of the medical device, whether it is designing a new product or improving the functionality of an existing one. When it comes to the software in medical devices, one seemingly minor change can have drastic implications for device function and clinical performance. reliance on software functionality and the…[Read more]

There are several factors that must be considered when determining the appropriate sample size including risks associated with the product, costs associated with producing the product, and costs associated with inspection, measuring, and testing. It is very important to consider the risks associated with the product. The Bayes Success-Run Theorem…[Read more]

Feedback plays a critical role in the design process. In order to make sure the review meetings go smoothly, the attitude of the team needs to be in order. The meetings should not devolve into firing lines where the team members are giving criticism without any basis. It should not also be where the lead is giving an elaborate presentation to win…[Read more]

A successful validation program brings together engineering, manufacturing, regulatory compliance, and quality assurance to develop test solutions that are unique to each application. Developers of medical devices must validate the product design to ensure that it meets the user’s requirements. Design validation should be more than bench testing.…[Read more]

Adding to the previous posts, the format of the Design Verification is equally important. Although, format of the DV is not as important as the quality of information it contains. However, if the data does not flow correctly in the document then the readability diminishes. Having a standard format promotes better communication between the…[Read more]

Multiligamentous Ankle Supports (L1906)

A multiligamentous ankle support provides control of the ankle joint between the medial and lateral malleoli while allowing for dorsiflexion and plantar flexion.

Medicare announced an additional verification for the ankle supports to
1. Include a rigid stirrup and foot plate which provides functional…[Read more]

An important tip in creating a Gantt Chart is defining a critical path. It is a method of looking at all of the activities in the Gantt chart, considering the timing and dependent relationships of each, and calculating the longest path from start to completion of the project. The critical path is a quick way of looking at the progress and critical…[Read more]

One thing to point out about a DHF is that every team member who is involved in the planning/development of a particular medical device should have access to the DHF. Sometimes, new recruits might not be given access just to prevent any mistakes. However, that actually might lead to some missing information that was relayed from the new recruit…[Read more]

Defining user needs are extremely important as in the future you definitely need to demonstrate that the product you develop addresses the User Needs you define. FDA doesn’t really define User Needs in the 820.30 regulations per se. User Needs are usually displayed in the beginning of the Design Controls as in the waterfall diagram. User Needs a…[Read more]

The most obvious advantage of a clinical trial is that you have access to a new treatment that you wouldn’t have otherwise. People are likely to go through regular testing which is in most cases very beneficial to the patient. The risk always involves that the treatment may not work and instead have side effects. Sometimes the side effects can be…[Read more]

I would opt for the Clinical Quality Assurance Auditor (CQA). CQA inspects the documents and processes of the clinical trial to make sure that they comply with certain guidelines, known as the good clinical practice (GCP). They make sure the trial is adhering to SOP’s as well since that can change over time. The reason this role appeals to me is…[Read more]

From a little bit of research, it seems very apparent that prior experience is required for applying for a role in clinical research. I agree with amandaally1029 thoughts that it varies for different roles. However, a sponsor actually requires the company to keep all its clinical researchers CV’s on file because they request to see the…[Read more]

“EI refers to our ability to understand moods, behaviors and impulses, and control them to match a particular situation.”

This concept is extremely important to understand as there are very few companies who understand the emotion of their buyer. It is a concept where a business has to understand the emotions of their customer at the right time…[Read more]

Stryker

Mission: “Together with our customers, we are driven to make healthcare better”

Vision: They do not have a clear vision statement however, in the company description is states, “Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better.”

Stryker products…[Read more]

The most popular way of marketing these days is using social media. There is an increasing use of social media everyday. Popular social media channels include Facebook, Twitter, Instagram, Pinterest, Reddit, LinkedIn, Google Plus and Snapchat are all different unique in their own ways of engagement. One of the common way I have come across…[Read more]

A tech startup can incorporate in many different forms, but an LLC, C-Corp, or S-Corp are most common. Each form has its pros and cons and your choice can therefore help or hurt you as your company grows. For this reason, it is important to understand and weigh these pros and cons and determine which form is best for your company.Generally…[Read more]

Apple financial findings as of July 2017(Quarterly) are as follows:

Gross Profit Margin: 38.51%
Net Profit Margin: 19.20%
Net Income: 46.65B
ROE: 35.68%
ROI: 18.39%
ROA: 14%

The gross profit margin is quite high and has been improving with every quarter. This is reflected in Net Profit margin since Apple sales have been increasing rapidly every…[Read more]

I worked for a software company where part of my job was to test the upcoming applications and softwares that would be used by the financial tower of my client. There are many tools depending on the type of application involved. For an instance,you would test a java based application with testing the UI by having a login screen and running…[Read more]

Based on my past work experience, I have repeatedly encountered a hesitation/resistance to any kind of new processes from the quality department. If an engineer is coming up with a new and innovative approach to tackle a problem, the quality department resists it strongly and always tries to dissuade into going back to the old process. The part of…[Read more]