I think management should already have a good understanding of the resources needed to uphold their QSR. As we learned this week in lecture Management oversees the subsystems: i. Design Controls, ii. Corrective and Preventative Actions, iii. Production and Process Controls, iv. Equipment and Facility Controls, v. Records Documents and Change…[Read more]

I agree with @tme3 that the ambiguity of GMP’s could actually be beneficial to a startup because it allows for a little more flexibility to create their own quality system and since each company is different with different products there would inevitably be different manufacturing processes. I also agree how others have stated that for a start-up…[Read more]

You could monitor progress by looking at EV and SV.
Earned Value-the value of the work you have completed so far. Earned Value=Percent complete*original budged cost of task
Schedule Variance (SV)= EV- Planned Value (PV)
If you have a positive SV, that means you are ahead of schedule. If you have a negative value, that means you are behind schedule.

I would add to this, contingency plans. At the beginning of each project we usually have clearly defined plans with assigned responsibilities and then the inevitable happens when something unforeseen happens that falls out of the detailed plan and its unclear of what the next steps would be and who is responsible to address. This falls in line…[Read more]

My office is a little unique in which we have a lot of products that we ultimately out-license to larger device companies. We develop the products and file patents on them and in some situations the market just isn’t there. Most of our products fail because there is a competitor in the market and our product isn’t differentiated enough to induce…[Read more]

We usually use passive marketing techniques where people come to us for a license and we usually have consistent sales. However in the last year in order to increase sales, we have created a catalog of all of products available for licensing and instituted a one-click license. The one-click license allows the licensee to select the product from…[Read more]

I agree with the posts above that its important to have both business and interpersonal skills, but I believe its essential to have interpersonal skills to get deals done. Sales is all about not just getting a deal done, but relationships. As seen with this week’s simulation, you want to not just make one deal, you want to have and maintain a good…[Read more]

Over a year ago I was assigned to manage the development of a robotic device. We had a prototype and since it is now first to file, we filed a patent so we could further the development while also pitching to outside companies to see if we could get a collaborator. At the time, the device did not have the resources or funding available that it…[Read more]

I personally think the planning phase is the most important phase during a project. It sets the tone for the project and as Dr. Simon mentions if you fail to plan, you plan to fail. For instance if you have gone through the proper steps in planning and have a great plan, if something happened at the company and you could not move forward to the…[Read more]

As @cdj24 mentioned SV=EV-PV. Where EV is the percent complete* original budgeted cost of task and PV is the vale of the work you are supposed to have on a certain date. I agree as others have mentioned that in order to have a positive SV which means you are ahead of schedule, you need to have have a larger percent complete than planned. The…[Read more]

Just to provide another perspective, at MSK we file patents on technologies like medical devices in order to protect IP and to ultimately outlicense. Before we file a patent, we evaluate the technology and the market. Once we move forward with patent protection, in parallel, we work on a technology development/marketing plans. Depending on the…[Read more]

As most have mentioned like @asmibana and @sanam funding in a major role. I work at MSK in the Office of Technology Development so we constantly have new invention disclosures, but unless the PI has resources/funding available-it is hard to innovate. If an MSK employee comes up with an invention, like a surgeon, and they do not have their own…[Read more]

The Discovery and Innovation phase as many have mentioned is the part of the life cycle that identifies customer needs, market, and competitors the “Climbing the Hill” phase where we search for ideas, unmet needs and look at how we can do better than competitors. You need to have a target market, understand and segment the market. In this phase…[Read more]

I think @smithshah sums it up well above.
Design Verification Inputs=Outputs
Design Validation Outputs=user needs and intended use

Design Verification is- did you design the device correctly? Does your device meet the design requirements you set out in DID? Whereas Design Validation is-did you design the right device? Does this device satisfy…[Read more]

Hopefully if the user needs are not met as @hc255 mentions above, they would go back to the spec and make sure the output meets the user needs and intended use. I really don’t think there is any room for compromising during Design Validation, because if you end up releasing the product without addressing all these user needs, then that may cause…[Read more]

So for this particular example to plan on selling a medical device in US and then decide in executing phase to sell in Japan, this would be a big scope creep in my opinion. I agree with the comments above, but I also think a major concern would be patent protection. When you want to commercialize a medical device you file a provisional patent…[Read more]

If you’re in the Executing Phase it is the Project Manager’s responsibility to make sure that the team is performing their tasks on schedule and to deal with a team member’s vacation, or absence. As @cdj24 mentions, it should be communicated in the planning phase if a team member is planning to take a big vacation or be absent from work. However,…[Read more]

The PMBOK guide provides an overview of the Project Integration Management processes. I. Project charter as mentioned above II. Project Management Plan the process of performing the work defined in the project management plan to achieve the project’s objectives. III Direct and Manage Project Execution performing the work defined in the project…[Read more]

I also think its important to identify what the new PM considers the error in the Scope to be. I agree with the above posts, but I think if the key Stakeholders had signed off on the scope of the project-they would need to be included and determine if there indeed is an error with originally laid out scope and if they want to use the resources to…[Read more]