Medical devices used in the United States must comply with federal regulations established to ensure that specified requirements have been met. A high-level overview of these design control requirements is provided to increase awareness of the device development process and…   Read more»

Investment in artificial intelligence (AI) and digital health technologies has increased exponentially over the last few years. In the United Kingdom, the excitement and interest in this space has been supported by NHS policies, including proposals in the NHS Long…   Read more»

As a MS student working in research right now, from my short experience, the IRB is in charge of reviewing all research protocols. Whatever test is being run in the lab, the IRB is the ruling factor in deciding if…   Read more»

The FDA does give some guides to how the test should be run but the general rule of thumb is to have a test for every claim that your product proposes will happen to the human using the medical device….   Read more»

Design controls were made so that companies have documentation for every step of their design process, and so that these documents can be reviewed to consistently find any design and technical errors. This saves companies from any flaws in their…   Read more»

Most of the time, each medical device has a standard guideline for testing which is followed by the engineers to design the appropriate test for the appropriate device. These guidelines are known as ASTM (American Society for Testing and Materials)…   Read more»

Gantt charts are extremely helpful in Industry. This resource allows the team to lay out a specified timeline of objectives and the resources that are allocated to each of the objectives. This is a very powerful tool which allows the…   Read more»

Design controls designates the application of a formal methodology to the conduct of product development activities. It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries. One of the aspects that I think design…   Read more»

From my experience, the IRB document is what you want. The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of…   Read more»

I don’t have any industry experience, but I have some ideas about creating Gantt charts. In my opinion, first of all, we need to have a clear purpose. When making Gantt chart, it needs to be concise and clear. Adding…   Read more»

@traceymrawI believe this article explains the expanding role academia now has on the medical device development process, as shown in this picture below. This “paradigm shift” explains that the role of academia in recent years has taken on more responsibility…   Read more»

Verification is a constant process for devices such as computer-assisted surgical systems (CASS). Initially CASSs were approved for use in minimally-invasive surgery such as hysterectomy and prostatectomy. As the market grew for CASSs, the case to use these devices in…   Read more»

@as934This is a good idea to consider for future studies, especially ones that incorporates physical activity. With the growing smart wearable market upon us this is becoming increasingly affordable over time. For a project that includes an ECG in their…   Read more»

From my experience working on a Gantt Chart, the most important thing to consider is the relationship between tasks. Many tasks depend on other tasks completion before they can be finished, or even started. This is a crucial aspect of…   Read more»

Design verification and validation are very similar, and I struggled to grasp why they needed to be separated into two distinct phases as well, when they seem be almost the same thing. What I have learned is that verification checks…   Read more»

Design Controls organize everything about a product, and the product development stages. The importance of proper design controls stems back to the importance of communication. Design controls play a major role in every aspect of product development because it is…   Read more»

Posted by: @la82 As mentioned in other discussions, design control is an integral part of any medical device design, and its benefits are clear. However, what are some of the issues that arise of the process and if it is…   Read more»

Posted by: @amandaally1029 Verification is an important part in developing medical devices or products, and can really help in making sure the products set out to do what they are supposed to. For instance, take tylenol for example; the purpose…   Read more»

Posted by: @smk45 While watching this week’s lecture on design control, I tried to figure out the main difference between Design Verification and Design Validation. Both are used to make sure that the design outputs align with the design inputs….   Read more»