The FDA’s Breakthrough Devices and Safer Technologies (STeP) programs are designed to speed up innovation for unmet medical needs. It gives manufacturers earlier and more frequent interactions with reviewers and review timelines, helping unique promising technologies reach patients that need…   Read more»

The FDA’s classification framework works well for physical devices because risk is tied to how much contact the patient makes with the device. Software wouldn’t exactly work with that classification, due to the danger coming from inaccurate readings rather than…   Read more»

I think the classification that the project will be in can also affect how early or late creative freedom should be considered. Since different classes will have pathways with varying qualifications they need to follow, the classes that require fewer…   Read more»

Testing biocompatibility during the designing process is important, but biocompatible for the device has to be managed across its entire lifecycle. If a new method is used when making a product, like a different supplier, reassuring biocompatibility after is a…   Read more»

@krish I definitely agree with you that organ on a chip model are slowly reducing our dependence on animal studies. The FDA themselves have also pushed for this, as the FDA Modernization Act 2.0 allows for organ on a chip…   Read more»

I have just started working in the biopharmaceutical industry, and one of the things they really hammer down is following protocol in order to stay within federal regulations. If we slip out of compliance, production can be stalled or even…   Read more»

It’s fine to consider some innovation, as long you can differentiate something the project truly needs and is worth the potential extra time and resources to enact this change. In my experience working on a product, we make a list…   Read more»

I agree with having feasibility check at the initiation phase of the project. However, to add to that, maybe it would be good practice to hold a risk assessment meeting and come up with a certain condition where it becomes clear…   Read more»

Depending on the severity of the disagreement, it can be helpful to the team if you also bring an outside perspective, specifically someone who has faced an issue similar to the one causing the disagreement. This way, it feels less…   Read more»

I actually see the jack of all trades aspect of BME having some positive outcomes in my own experience. For me specifically, I wanted to focus on data analysis focus jobs, but because I also had experience working in biolabs…   Read more»

I’d lean more toward more co-ops or longer internships, due to the multiple years of experience employer often expect for a lot of jobs. For students, co-op can give the student the required experience while being able to juggle both…   Read more»

I also see myself drawn to industry. For me, it’s mostly because I feel more comfortable dealing with a defined problem with a set deadline rather than the more open-ended approach. I’ve noticed that tangible progress motivates me more, and…   Read more»

To make the team aware of risk on even smaller, simpler projects, you could incorporate short “Risk Sprints” in regular intervals of the planning cycle. In each of these meetings, the team will look for new risks that can possible…   Read more»

One way of convincing management to invest in more contingency planning is to remind them that it is a regulatory and compliance risk. If the primary supplier cannot meet quality standards post its approval, that can cause major delays in…   Read more»

For long-running clinical trials, there are many ways to maintain engagement and motivation among team members. One way is to celebrate small milestones, like completing a trial phase. Showing appreciation for these small victories allows the team to more easily…   Read more»

One obstacle that can complicate timeline planning for large scale clinical trials is the variability added by conducting trials across multiple countries. Global trials come with more complexity that can’t always be covered by traditional tools like Gantt Charts. Each…   Read more»

The first step should be to identify why the underperformance is happening, which can lead to visits to monitor process or talking to the team themselves to find the root cause. Then the necessary changes can be made to see…   Read more»

One strategy that can be used for keeping clinical research teams motivated is to create and celebrate short-term wins. It was mentioned in this week’s slides that one motivator for people is team based praise, so breaking the project into…   Read more»

@ms3548 I think the way to managing the transition from broad to bottom-up estimating is to treat it as a planned-hand off. For example, scheduling a formal review point once enough detail is available, like a completed WBS or when…   Read more»

In addition to balancing detail and simplicity for the WBS, I think it’s also important the WBS structure has clear traceability between work and regulatory paperwork, like design inputs, outputs, verification and validation. If the WBS is too high-level, it…   Read more»