Week 5: Manufacturing Knowledge

My grandparents often ask me what I like designing as an engineer, but what they don’t realize is all the behind-the-scenes work that goes from conceptualizing a device idea to bringing it to market. I can understand their confusion, though. In my undergraduate studies, we cultivated and applied our engineering minds to prepare us for our capstone project, which ultimately highlighted our creative, design-driven side to improve upon a medical technology. Yet what we covered briefly in lecture, but often results in 80% of the engineering process and jobs in the market today, is the regulations, quality, IP, clinical trials, marketing & sales, and reimbursement of medical devices that makes it all possible. In other words, we only scratched the surface of what engineering truly had to offer. While people may get a kick from the image below, it does a good job at capturing the essence of engineering in the world: it’s perception, it’s reality, and all in between.

This past week we took part in an Implementation Short Course, created and taught by Dr. Richardson. Learning alongside several other professionals from nearby medical device companies, we dove into aspects of engineering that are crucial for translating a design to a marketable product. Each day was broken up into sections to give us the entire spectrum of requirements needed to implement our device in the medical industry, as follows:

  • Monday: Product Development Processes (PDPs), Intellectual Property (IP)
  • Tuesday: Quality, Manufacturing
  • Wednesday: Regulatory, Clinical Trials
  • Thursday: Sales & Marketing, Reimbursement
  • Friday: Presentation Showcase

As you can see, this all led up to our final presentation on Friday, where we analyzed and presented a medical device currently on the market using the criteria above (you can check out my presentation here!). To easily sum it up, it was a fascinating introduction into each of the disciplines that is required to implement a product, but it was also helpful to identify which types I would be interested in pursuing if I went down this path in the future.

 

Team Breast We CAAN, changing the game in breast biopsies

 

Being the gung-ho type of person that I am, I really resonated with the manufacturing and marketing topics this past week. I enjoy understanding the value associated with a product, and more importantly, how customers will value the product when they use it. A reason I decided to pursue medical devices is because of the customer-driven style of thinking that it brings. Not only do these devices interface with the consumer, but it was also built with their needs in mind, even if they may not realize them. It is an extremely dynamic way of learning, as you need to understand the vision of your product while adapting it to what the customer wants. From a manufacturing perspective, if the product is too difficult to assemble because of number of parts or complexities in the design, then we missed our goal. From a marketing perspective, if the product is revolutionary but no one understands how to use it, then we missed our goal. It is our job as engineers to simplify the connection between the product and the consumer, and I think that is pretty cool.

As a quick example of what I mean, look at the image below. Is this the best way to manufacture the device below? The answer could be yes, but it could also be no. How would you simplify the design (i.e. reduce number of parts, change the assembly process)? Check the bottom of this post to see how it could be simplified to make it easier to manufacture.

 

 

A phrase that keeps popping up throughout a process like product implementation is “Verification & Validation.” Though they seem to be interrelated, they reflect two vastly different goals. Verification is recognized as an internal process, which focuses on whether your product meets your specifications. Validation is an external process, or whether your device actually meets the needs what the customer wanted. Both are crucial for an implementation process to design a successful product, and that was really the ultimate mantra of the week. There are several steps taken to achieve these two goals, which is where things such as quality and clinical trials come into play, but in the end this constant checking and feedback cycle is what allows us to deliver a safe and effective device to the world. There is minimal room for error in the medical device industry, and this feedback cycle is how we as engineers can ensure that.

 

How the FDA looks at a medical device design process

 

Looking forward, I am excited to jump into my R&D position with Boston Scientific these next 6 weeks. Up until this point we have taken classes about innovation and implementation, as well as visiting hospitals to gather clinical needs. Now this is truly my opportunity to apply that knowledge and make the impact I emphasize so much about. I am looking forward to sharing my insights next week (to whatever extent possible) and I hope you’ll be back to hear my thoughts. Pura Vida.

 

Small side note, have you ever really thought about how a pencil is made? It’s much more complex than you might think. If you don’t believe me, check it out here.

 

 

Only 2 parts!? Crazy…

 

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