As a means to save time and money and still hit the product launch, I agree with @cdj24 to get as much research done as possible so that you don’t spend as much time and money on experiments that might ultimately fail. For this week’s simulation our group had many rounds back and forth with having a plan to use a particular carrier and then…[Read more]

I agree with what most of said that determining the main cause of the equipment failure and to add to the discussion, I would say based on this week’s Simulation, the importance of logging these incidences. In case there is a pattern and something else on the factory floor may be playing a role or other environmental causes. I think running a…[Read more]

As @merzkrashed mentions the FDA “results of a process cannot be FULLY verified by subsequent inspection and test” and ISO “processes for production and service provision where the resulting output cannot be verified by subsequent monitory or measurement”. So if you can’t verify every requirement or verify every single item produced, process…[Read more]

Since the previous devices’ IQ, OQ, and PQs have been explained in great detail, what would the IQ, OQ and PQ look like for other devices? For example a femoral implant?

IQ- Femoral molding equipment meets the specs, working parts, can be installed, operated and maintained, has a maintenance schedule. Includes limitations and tolerances that a…[Read more]

I agree with @asimbana that ISO provides more flexibility with their definition “processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measuring. Whereas the FDA has a stricter definition of “results of a process cannot be fully verified by subsequent inspection and test”. As…[Read more]

I work at a non-profit hospital so for our more robust medical devices that we are unable to develop in-house, we use outside contractors to develop the devices. So the company will come and meet with surgeon that invented the device and work closely with the surgeon to understand the problem its solving and how best to improve the original…[Read more]

The Project Planning Phase is extremely important and crucial to the project’s success. Going off what @ks629 mentioned, its necessary during the planning phase to mitigate risk and to have contingency plan in place for as you mentioned, having integral team members not around for the implementation. I however disagree with the notion that not…[Read more]

I agree with @ks629 that the Project Planning Phase is extremely important and crucial to the project’s success. going off what @ks629 mentioned, its necessary during the planning phase to mitigate risk and to have contingency plan in place for as you mentioned, having integral team members not around for the implementation. I however disagree…[Read more]

I agree with @srg36 that even if you use project management tools like Pert charts, Gantt charts, there will still inevitably encounter pitfalls, but you will be able to more effectively manage these scenarios with these management tools. As Dr. Simon mentions in lecture, it is important not only to schedule the tasks but to account for costs and…[Read more]

I agree with @hm243 that although it would be time consuming to update the document every time a new revision is made, it would be necessary to update all the relevant documents. So as @hm243 mentions that if the Work Instructions reference a SPEC document and you revise the SPEC document you would need to update the Work Instructions where it…[Read more]

I haven’t worked at company that directly deals with this, but I think you can call any document anything so the importance is the content of the documentation. I think the necessary documentation/titles would be what we encountered in this week’s simulation. With at the top of the Quality Manual (QM) which is the document that explains how the…[Read more]

When first reading this post, I thought yes SOPs should be used in the research phase as well as development phase. However, thinking more about it I think the research phase is when there is more creativity and you’re trying new things, so it might not make sense at that stage to have the detailed procedure on how to perform detailed tasks…[Read more]

Chapter 3 of PBOK goes into detail of the 42 management processes. Table 3-1 on page 42 is a great visual that shows the mapping of the 42 management processes into the 5 Project Management Process Groups (Initiating, Planning, Executing, Monitoring & Controlling, and Closing) and the nine Project Management Knowledge Areas (Project Integration…[Read more]

If I were a PM running a Risk Management meeting, I would ask the attendees of the meeting to have them familiarize themselves with with the ISO 14971 standard as @aij5 mentioned, and for them (i) come up with a list of risks (ii) analyze the potential risks using Failure Mode Effects and Criticality Analysis (FMECA) and Process (PMECA) to look…[Read more]

At Sloan we outsource the development so when we set up a Project plan we include a scope that clearly defines the deliverables, goals, and deadlines. Since it can be very expensive to develop a medical device we usually break it down into Phases (Phase 0, Phase Ia, Phase Ib, etc). Phase 0 is the planning phase where the scope is laid out for…[Read more]

I agree with @hm243 that SOPs should be very detailed and descriptive laying out the instructions on how to create a specific product. As Dr. Simon mentions in lecture it should be written at a HS level so that anyone can pick up the SOP and understand it and create the product. It should be written in such a way that you could just provide the…[Read more]

As @julienneviuya described Design History File (DHF) is created during the Design Phase during the product development stage of the device and is written before the production. Whereas the Design History Record (DHR)is produced during the Production Phase and is a record of everything done to a single device or a single lot/batch of devices,…[Read more]

In thinking about PMS and detection of problems, I thought about the process of notifying FDA and I cam across a NYT article. In the article, the director of healthy policy for the National Center for Health Research in Washington said “It often takes months or even years for the F.D.A. to detect patterns of failure, post-market surveillance o…[Read more]