Adding to previous posts, one other factor to consider are the regulations about supplier selection and management in 21 CFR 830.50. FDA scrutiny on supplier selection, criteria used, and more importantly how sponsors control their supplier has increased in the last few years. It is one of the first topics discussed during audits. Contracts should…[Read more]

Design verification means confirming by objective evidence (i.e. testing) that the design outputs meet design inputs. Design Verification is one of the most important activities in the development phase of a medical device. It is a rigid rule as there are predecessor and successor activities that happen prior and after design verification. For…[Read more]

I agree with previous posts to contact the vendor to identify the problem and a solution. However, this is not an unusual issue and typically the way that companies control these problems is by establishing specifications for which the vendor must produce against and quality agreements that vendors agree to. This way the vendors have testing to…[Read more]

There are many factors that can affect schedule variance (SV) such change requests, issues with suppliers of materials/ components to mention a couple. These factors can impact in the timeline of a project and increase project spending. For all problems there are solutions, as such pre-investing in early phases of the development and ensuring the…[Read more]

The different kinds of changes, as mentioned in previous posts, are Non-Essential Design Change (NDC), Design Change Number, and Engineering Change Order. Each one of these carry a workload in order to implement the change. All of them require following company procedures, although some such as engineering change order may also impact regulatory…[Read more]

It will be prudent to include buffers in the project plan to account to the unexpected. This is a practice in two companies I have worked for developing medical devices and combination products. I always include buffers in my timeline and DDP. Your example of marketing department going off and doing their own thing and impacting the project team…[Read more]

Change control is another well-know concept that focuses on managing change to prevent unintended consequences. The regulations provide for change control primarily through the assigned responsibilities of the quality control unit. Certain major manufacturing changes (e.g., changes that alter specifications, a critical product attribute) might…[Read more]

Echoing several responses above, the PM has many important responsibilities. However, I believe that these responsibilities would not be as challenging as communicating effectively amongst all department/ functional areas working together on the project. There needs to be a great deal of transparency which can only be achieved through clear timely…[Read more]

This type of scenario was part of the mini-sim this week in which we were asked to deal with delays in timeline which happened due to incorrect task duration. Creation of WBS and task duration is a critical activity that occurs during project initiation. The one key aspect of this activity is to include the actual SMEs (Subject Matter Experts)…[Read more]

One of approaches to take would be to look “easy” fixes first (e.g. improve packaging configuration first, then propose modifications to the device, then propose modifications to the combination product) so we can try to identify the root cause, followed by quick lab tests that can provide objective evidence about the root cause identification and…[Read more]

Risk/ Benefit Ratio is an assessment of the risks against their benefit. Ideally the benefit has to outweigh risks in order for the company to accept the risk. Typically, risk analysis has a qualitative component and the result feeds into the assessment. According to PMBOK, there are several ways to approach how risks are assessed. Probabilistic…[Read more]

A successful project will include risk management as part of planning phase. As stated by the professor, “if you fail to plan, plan to fail”. Risk management will help the company anticipate issues/ problems and identify mitigations ahead of time so there are preventative actions that can be taken even in the early phases of a project. For…[Read more]

It seems the company has a lot to worry about and updating the Gantt Chart may be the last of their worries. The balloon pops immediately instead of lasting for days could be a catastrophic issue and could result in termination of a program if the problem is not resolved. Unfortunately the link provided at the starting post is no longer working so…[Read more]

I think another great example of process group within medical device are product complaints and change control that fall under monitoring and controlling process group. This continuous monitoring provides the project team insight into the heath of the project and identifies any areas requiring additional attention. According to PMBOK, in…[Read more]

As mentioned in today’s lecture, often companies disregard project management with design controls thinking they are one and the same. This leaves gaps that can implicate the success of the project. The PM would ensure the planning phase of a project is composed of processes performed to establish the total scope of the effort, define and refine o…[Read more]

The marketing team typically identifies the need based on market evaluation for a new product to be developed and often provides design inputs mostly from VOC (voice of customer). However from my experience if the project depends solely on marketing team’s design inputs, there is likely chance the project will be unsuccessful. Other sources must b…[Read more]

Selection of the members of the project team is extremely important in several ways. Obviously you desire the project team to be composed of people a high level technical knowledge/ skills from all functional areas that will support the program (engineering, marketing, etc.), but also it is important and desirable that people are compatible with…[Read more]

Based on the PMBOK, there are five phases of project management.
Phase 1; Project Initiation – This is the start of the project, and the goal of this phase is to define the project at a broad level. This phase usually begins with a business case. This is when you will research whether the project is feasible and if it should be undertaken. If…[Read more]

In my opinion, it is very important that projects are properly prioritized and that every member of the team understands the details around priority that the project holds. Ultimately, successfully prioritizing tasks in each project will impact the success of the team and success of the project itself. The skill required from project managers is…[Read more]

In agreement with some of what was described in previous posts, if the manufacturer is not the one claiming that the TJA total joint arthroplasty can be used while performing high intensity or extreme sports then it would not fall within the manufacturer responsibility to retest their device (actually they may have legal rights to sue the hospital…[Read more]