PDBI (Product Development in Biomedical Industry) is a core course in MBE program. It is the longest course we have and it goes from December until February covering Christmas. Since it contains so much information, I want to separate the course reflection to two parts.
The foremost important assignment of this course is the CTMH project. We went to Ki Huddinge to listen to the presentation from the CTMH groups working in KI hospital. The groups introduce the unmet needs of medical device in the hospital, and we choose the topic of interest to propose our solution. This project is the implementation of the knowledge we have learnt during lectures and seminars. In the end, we will go through all steps necessary from a business idea to the complete business plan.
Up till now, we have learnt the two major topics in product development, patent strategy and regulatory affairs. For the first three weeks, we read the required reading Patents and strategic inventing : the corporate inventor’s guide to creating sustainable competitive advantage written by Nissing, Nicolas J. We discuss the book in depth and present our learning by conducting a Freedom to Operate analysis (FTO). The purpose of FTO is to ensure that our product don’t infringe other patents and thus we have the freedom to operate.
After we come back from Christmas, we start the intensive learning about regulatory affairs. We have literature seminars and case workshops regarding all the necessary regulatory issues, such as 510k from FDA, MPA in Sweden, ICH and Medical Device Directives. These might be the ‘boring’ part as there are tons of documents to read and analyze, but it is the essential part to get your product approved and then it can be released in the market. We need to do a risk management plan for our project as well.
As a check-point, we have a case-essay exam which examines our ability to integrate all the knowledge we have learnt so far to analyze the case. Personally, I enjoy case exam because it is to provide argumentation and not memorizing the facts. You are never certain what to write, but it is a good way to present your learning.
Currently we are listening to guest lectures held by experts from various positions in the industry, such as project manager, quality assurance consultant and research scientist. Their experience is very valuable for us to have an insight on the actual responsibilities of different jobs.
We are busy with the project as we need to develop a comprehensive business plan and incorporate all parts we have done so far. I will talk about the last learning block and project in PARTII.