The four Ps of marketing—product, price, promotion, and placement—are especially relevant to medical devices because a successful product needs more than good engineering. Companies must consider the features of the device, its cost, how they communicate its benefits, and how…   Read more»

One concept that stood out to me from this lecture is that medical device marketing should begin with identifying a customer need rather than simply creating a product and trying to sell it. The slides explain that product development involves…   Read more»

This week’s discussion of financial statements and ratios showed me that a company’s success cannot be measured by revenue alone. For example, the current ratio compares current assets with current liabilities and helps evaluate whether a company can cover its…   Read more»

The lecture’s comparison of public and private companies made me think about how a company’s ownership can influence its decisions. Public companies must report financial information quarterly and are accountable to shareholders, while private companies generally have fewer public reporting…   Read more»

One thing I found interesting in this week’s lecture was how choosing a business structure can affect the risks involved in starting a company. For example, a sole proprietorship is relatively simple to establish, but the owner is personally responsible…   Read more»

One thing I found interesting was the difference between quality assurance and quality control. Quality assurance is more preventive and focuses on the methods and systems used to make sure a product meets requirements, while quality control evaluates the results…   Read more»

Before this lecture, I assumed Regulatory Affairs mainly handled paperwork after a product was developed. I was surprised to learn that regulatory professionals are involved from the beginning of product development by helping determine product claims, communicating with the FDA,…   Read more»

I thought the 510(k) pathway was interesting because manufacturers do not always have to prove that their device is completely new. Instead, they must show that it is substantially equivalent to a predicate device that is already on the market….   Read more»

One topic that I found interesting was how medical devices are divided into Class I, II, and III depending on the level of risk they pose to patients. It makes sense that a tongue depressor would not require the same…   Read more»

The section on ISO 10993 made me realize how important it is to have a structured approach to testing medical devices. The slides explain that devices should be evaluated based on factors such as the materials used, previous clinical data,…   Read more»

I found the idea that biocompatibility depends on the tissue especially interesting. A material may be considered biocompatible for one application but not necessarily for another because different tissues can respond differently to the same material. The slides also showed…   Read more»

One thing that stood out to me was how many things can go wrong during pre-clinical research, especially when there are time or budget limitations. The slides mentioned that animal studies can be delayed because suppliers may run out of…   Read more»

The part about not “reinventing the wheel” caught my attention. I liked the idea of looking at previous projects before starting a new one because there could already be useful Gantt charts, budgets, design documents, or meeting notes available. I…   Read more»

I think scope is one of those things that sounds simple until you actually think about everything that has to be included. The slides mention objectives, deliverables, milestones, technical requirements, limits, exclusions, and customer reviews. What stood out to me…   Read more»

Something I found interesting this week was how much emphasis was placed on the initiation phase of a project. I honestly would have assumed that the most important part was getting started with the actual work. However, the slides explain…   Read more»

One point from the first week that stood out to me was the idea that this course is meant to prepare us to function as a team member on a commercial medical device project. The course objectives include learning about…   Read more»

I was surprised by how many different career paths are available within the medical device industry. Before this course, I mostly thought about engineering and research when I thought about medical device development. However, the slides mentioned careers in clinical…   Read more»