My perspective is that the various artifacts such as Design input Document, Design Specification Document and/or Design Output Document are important to document the robust process of gathering information, analysis and decision making. As the Professor indicated each organization may…   Read more»

Having been a project manager, I can say the Gantt Chart is extremely valuable in the initial stages to better communicate relationships between tasks especially when team members think there are nol dependencies. The ability to create a common view…   Read more»

My view of design controls is to provide a complete product lifecycle to medical devices. In the early stages of project definition to the ultimate regulatory approval and post market surveillance, we need to fully understand reasons for change and…   Read more»

Design controls are an elemental piece of getting a well-thought out idea on a piece of paper to a manufactured reality. Design controls include nine parts: planning, input, output, review, verification, validation, transfer, design changes and the design history file….   Read more»

From my experience in industry I would echo everyone who has said that you need to consider delays/setbacks and build that into your timeline. I worked on one particular project that had a very ambitious timeline with little to no…   Read more»

Outsourcing your Device to another manufacturing company, there are a lot to consider before making such a decision. It comes with it’s Pros and Cons of doing this. Choosing the right outsourcing partner or company can pose a challenge unless…   Read more»

Although I have not had the opportunity to prepare a Gantt Chart for the company I work at in industry, I did have to include this in my senior design capstone proposal and got a brief introduction into what should…   Read more»

Outsourcing the design transfer can be beneficial in many ways, such as cost efficiency or a shorter time to market. However, and possibly bias because I am currently a supplier quality intern at a medical device manufacturing company, I believe…   Read more»

The purpose of the design and development plan section is to provide investors with a description of the product’s design, chart its development within the context of production, marketing, and the company itself, and create a development budget that will…   Read more»

It is important to understand couple of things when it comes to design transfer that is Inability to transfer a design effectively can prompt circumstances in which determined parts are either unavailable or higher in cost than expected, production workflow…   Read more»

While design control is not required for all medical devices, it applies to nearly every medium- and high-risk device. And this isn’t just for new devices – in the US, FDA requires design controls for all Class II and III…   Read more»

Yes. it is important that you design and develop a medical device that is safe. FDA and EU and all other regulatory bodies throughout the world will want some assurances that your medical devices is safe before you bring the…   Read more»

Posted by: @orleron We have begun learning about the Design History File (DHF) this module. We are more than halfway through the course, so congrats for making it this far! This module deals with the DHF contents and how to…   Read more»

Posted by: @rv347 In design controls, there is the DID and DSD documents. DID is design input and gives a broad description of the product (ex, “red knob”), whereas the DSD is design specification and gives a very specific description(ex,…   Read more»

With the ISO Adopting the Design Control, the EU regulatory which follows ISO regulation will have to accept ISO 13485:2016 for Design Control into their Development process of a Device.  That being said, they will definitely have to look into…   Read more»

Randomization is used to reduce the bias in assigning patients to study treatment groups and it provides unbiased assessment of the effects of different medical treatments. Both randomization and blinding are important tools in determining the effectiveness of a clinical…   Read more»

In most circumstances, I advocate the “Right to Care” act due to the simple fact that this may be the last resort for terminally ill patients. Rather than focusing on the pros of this act, I would like to focus…   Read more»

I understand that placebo studies may provide the necessary research in order to advance technology and healthcare, however I believe they can sometimes be unethical. For example, if a patient is battling a vigorous disease and they believe they are…   Read more»

As of January 2020, it has been reported that one patient with amyotrophic lateral sclerosis, or ALS, has received an investigational drug from BrainStorm Cell Therapeutics and seven patients have received an immunotherapy vaccine under evaluation for glioblastoma under the…   Read more»