Week 9: Putting in the (Paper)work

Several weeks ago, I had a conversation with Dr Richardson about the different types of activities typically done within manufacturing engineering. At the beginning of the conversation, he said something like “Well first there’s sustaining, which is frankly a lot of paperwork.” Well this week at Boston consisted of a lot of sustaining engineering.

The 25 Non-Standard Production Requests (NSPRs) I managed this week

In my Week 7 blog post, I described a project that I’ve been working on involving data collection to start validating a new piece of equipment. The step we are currently trying to take is to conduct an experiment that should tell us which process parameters are most critical and a range of values for those parameters that would yield the best process outputs. I finished my data collection that helped us to define the values used in this experiment, as well as the full experiment plan, last week. At the start of this week, all that was left to do in order to start the experiments was to give the experiment to the production team. (It was important for the validation process that product builders use the machine to fabricate the parts and not interns.) I can definitely say I underestimated what would be involved in this request.

What I initially thought would be done on Monday to hand over this experiment ended up being completed a couple hours after I left work on Friday. The two main reasons it took so long were that there were several different documents that had to be consecutively approved by different people, and that we were trying to run 25 separate “non-standard orders,” which meant 25 iterations of every document. We couldn’t expect each document approver to respond as soon as we sent them what we needed, so it just took a while to get through everyone’s hands.

As I mentioned, the paperwork was completed after I left on Friday. Our goal was to start some of the runs on Monday, so we pushed hard to ensure everything was ready before everyone left for the day. I got to experience a taste of the high energy workstyle of manufacturing Friday as we were rushing around making sure all the paperwork was done and everyone had what they needed to start the orders early Monday morning. Having to leave with the rest of the Rice interns kept me from being able to stay until all the work was completed.

In my conversations with some of the Boston Scientific employees, I’ve learned that a major value offered by Boston Scientific (and most big medical device companies) is the reliability of their products.  This experience showed me a lot of the people and structure involved with the robust quality system that ensures their products’ high reliability. While it’s always possible to make mistakes, I saw how Boston’s system made it difficult to accidentally compromise the quality of the products that go out the door. I also noted how difficult it would be for a smaller company to attain these high reliability standards.

Another exciting thing that happened this week was the assignment of our implementation projects (see Week 8 post for background). I was given my first choice of the projects, an app that will improve hospice care for patients in Brazil. I’m excited for both the challenge this project will be and the impact it will have. Most of my coding experience is in Matlab, while the app that I will be improving was done in a completely different language. There will be a significant learning curve moving from a language as high level as Matlab to one used for app development, but I purposely chose this project to gain more hard programming skills. Furthermore, the work I’ll be doing won’t just be a learning exercise, but will have a real impact on people who are in a difficult yet meaningful part of their life! I’m overjoyed I will get to work on a problem I care about!

We can all feel the summer drawing to an end with only 8 days left at Boston. I will be working hard to finish this internship strong and getting ready for the Fall back in Houston.

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Week 9: Pivotal Week

Back in the Groove

I had a short week this week (due to an extended holiday weekend), and so we (Ryan and I) had to continue working on our projects without skipping a beat. For this week, we specified that it would be most important to work on the raw material characterization project. Just to recap, here were some of the deliverables that we had set out to accomplish by the end of the internship:

  1. Conduct Observations of Parameters Used in the Tip Forming Process of Catheters
  2. Conduct Tensile Pull-Tests to Find Optimal Parameters
  3. Develop a Compelling Argument for Tightening Process Controls for Raw Materials Coming into Coyol

The reason of interest behind this project is to create a better performing product, and one possible cause as to why there is unwanted variation can be traced to the raw material coming into Coyol.  The polymer extrusions come from a sister site, and there are several different indexes used to validate the material. However, there is a belief that some of these index parameters may have too wide of a tolerance. This issue seems like an easy fix, right? Perhaps the solution is to tell the sister site to ‘tighten the fence’, however, the proper method in handling this situation requires thorough research and justification (I sense a noticeable theme going on here).  The raw material is formed through a machine called an extruder (as seen in the figure below).

Extruder

Feedstock in pellet or powder form is fed into an extrusion barrel where it is heated and melted and forced to flow through a die opening by means of a rotating screw. It is in this process in which a multiplicity of variables exist, and so changing even one requires solid reasoning. For more visual learners, this is a good video simply explaining the process:

  • https://www.youtube.com/watch?v=WaB-dsB1Kfk

On the Clock

With only 8 days left in our internship, the sense of urgency to start thinking about concluding our current projects has been creeping up on us. I have learned so much in my last few weeks at Boston Scientific, but now, it is time to start putting what I’ve learned into a cohesive format. Although I know I have a lot of work left to complete, due to the various projects I’ve been working on, I am truly excited in having my first true test in the Industry.

This upcoming week will be one of the most challenging of the summer. At the beginning of the internship, we emphasized that” SMART” goals should be set. Although I set weekly objectives within projects, it is now time to start concluding projects as a whole. Dr. Van Kleeck mentioned that it is important to have a mindset beyond the internship and to focus on things such as exit interviews and make sure that the post-internship transition goes smoothly. These are all aspects to consider and make sure are conducted effectively going forward.

Implementation Project

This week, our cohort was informed of the implementation projects for the upcoming year. We were given a list of potential projects and asked to rank them to gauge our interest. Fortunately, everyone got projects that they were interested in (Dr. Richardson working his magic yet again). I was given the opportunity to work on a teledermatology project in conjunction with Barretos Cancer Hospital in Brazil. Teledermatology is a field in which telecommunication technologies are being used to transfer medical information through varying media. In Brazil specifically, there is a need for nurses to transfer images of skin conditions of patients in a secure and effective manner. Although this project is a little bit out of my area of expertise, I think this will be a great learning experience and chance to expand my understanding!

Barretos Cancer Hospital, Brazil

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Week 9: As One Project Ends, Another Begins!

A lot has happened this week! Project 1 successfully reached its goal and ended. Because of this, I’ve been assigned a 3rd project! In this project there have been issues with a device used in colonoscopies recently- a wire loop with a mesh net used to collect samples for biopsy has a tendency to delaminate or break. Not good!

This type of background information for Project 3 is called qualitative information- typically found by identifying problems through a market analysis. After market analysis, R&D engineers had to take the qualitative information and turn it into quantitative information. In what position does the device break? How much force can the device withstand before it breaks? Is one side of the loop stronger than the other side? R&D engineers are basically science detectives, and are trying to identify the areas of concern within the medical device. Once questions like I mentioned above are given the proper numerical specifications, the process engineers step in to make the solution happen.

This is where my project begins: I have the test protocol, and I need to develop a validation method to verify the way the test is run wont affect the data. It’s basically testing the test that checks to see if something passes or fails. This is important because we want to make sure our test is repeatable and reproducible with little variation in our results.

I began to write the test-checker, aka the VTMV (Variable Test Method Validation) document, but I soon realized I lacked some foundation and structural information behind these complex tests. Thankfully, one of my managers Felipe helped me out and gave me some great resources from Six Sigma.

I spent a day reading all I possibly could, and have a much better understanding of the “Hows and Whys” behind a variable test method validation system. Variation in performing the test is undesirable, and Six Sigma gave great insight on identifying and eliminating variation. For example, variation can come from operator error(for example, a test favors those who are right handed). This type of variation is a more straightforward fix in the design of the test. Other types of variation are more difficult to pinpoint, and that is why statistical software like Minitab is awesome.

On Friday I was able to do a dry run of the test method- the numbers aren’t official, but they give me a good idea of what I’m working with. Next week I anticipate a finished protocol so I can later submit it to a board for approval. After that, my test method validation protocol will be used to test the colonoscopy devices here at Coyol! See you next week- Pura Vida!

Pictured above is the setup for the test on a machine called an Instron. It measures the maximum tension used to break the mesh holding the metal ball (metaphorical biopsy sample) when pulled through a tiny hole symbolizing a catheter.

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Keep Pushing

The exhaustion has finally set in. I found myself feeling exceptionally tired the last several days this week, which made it difficult to concentrate on my work. Luckily, I was able to continue plowing through my tasks and complete all of my goals for the week. Having a lot of tasks that can be completed in small amounts of time has helped a lot with keeping my motivation high and my progress on track.

For the DOT checklist project I am working on, I completed all of the sections of the Document Review that we aimed to finish this week. I read Design Verification Master Plans (DVMPs) for two of the product models, as well as the Design Validation (DV) Plans and Reports for those models. DVMPs are documents that describe the methods that the company will use to verify that the design of the product meets the requirements that were previously outlined in the design inputs. DV Plans and Reports are documents that outline the tests that the company will use to validate that the device meets the user needs and intended uses and then documents that these tests have been completed and whether or not certain specifications are met. I also spent some time this week summarizing my notes on these documents, so that they are more organized and easier to read. Next week, I will complete this project after reading the Design Change Logs, Use and Design Failure Modes and Effects Analyses (FMEAs), and the Usability Engineering Plan and Reports for the different models of this catheter product. This project has really taught me the importance of documenting your work. In a large company like BSC, there are thousands of employees all over the world that need to be able to understand all of the components of the projects they are working on, so having good documentation is crucial to company success. Documentation is also important for traceability of a project and being able to sustain products on the market. Although paperwork may be the least exciting part of the process, I am glad that I have had the opportunity to see its importance and learn to appreciate it.

Along the lines of documentation, BSC recently switched to a new system for storing their documents, and the DA team has a Value Improvement Project (VIP) open to help organize this system. They are creating Design History File (DHF) summaries in order to make it easier to find documents for specific products. Guiselle gave me the task of completing these summaries for five different products while she is on vacation. So far, I started the summaries for four of these devices (all of which are guidewires), and I finished the summary for one of the products that I discussed last week, which is the device that requires changes be made to the Directions for Use (DFU). In addition to the DHF summary for this product, I got to do a manufacturing line tour at the Coyol site this week to see how it is made. This was definitely the best part of the week for me, because the device is really neat and extremely beneficial to patients. It is used during interventional cardiology procedures to catch plaque and clots in the arteries to prevent them from traveling into the bloodstream and potentially the brain.

Another new task that I was assigned this week is to help get feedback from the DA team about working at BSC. A few months ago, the team took a survey in order to give the company feedback from their employees. My manager wants to get additional feedback about some of the answers to the survey in order to make improvements within the department and potentially within the company. I will be conducting one-on-one meetings with each member of the team in order to learn more about what BSC offers its employees and what aspects of their work life could be changed in order to make them happier. Once I have conducted these meetings, I will present what I hear to the entire team so that we can brainstorm solutions to improve the aspects of the job that the team feels are lacking. Guiselle and I are hoping that the team will be more willing to tell me some of the things they would like to see changed, since I am impartial in this situation and can present the findings anonymously. This is another project that I am excited to be a part of, because I get to use my unique situation of short time here at BSC as a benefit to the team and hopefully help make an impact and help my coworkers. They have been so wonderful to me, so I am glad that I have a chance to do something for them.

Last week, Guiselle taught me the basics on how to conduct a complaints analysis for a product already on the market. This is important for sustaining, because if your users are complaining about one of your products, you need to find out why and how it will affect the product’s life cycle and, more importantly, the patients. Complaints analysis utilizes a scale for severity and occurrence of a potential harm to the patient in order to determine a risk index that is then compared to the risk index indicated in the FMEA. If the indices match, there is no need for the company to do anything, but if they don’t, the company will have to take action. I will get the chance to practice what I was taught by doing a complaints analysis for one of the guidewires produced by BSC.

While I am excited that I have gotten to do all of these new tasks, I am a little bummed about two of my projects that have hit a standstill. For the Innovation Culture project, I completed a presentation for the Needs Finding lecture that I planned to present with Guiselle, but unfortunately, our goals were set back because of meeting rooms being completely booked. It seems that I won’t be able to give this presentation with Guiselle before I leave Costa Rica, but hopefully she and Jorge can use the presentation that I started to give the lecture. Additionally, my project focused on writing a scoping draft has not made any new progress this week. On Monday, I will be meeting with the project lead to determine the status of the project and will hopefully get some new tasks to complete. After discussing the project with my boss, she wants me to come up with a list of concerns and questions that I have about what this project could require, especially in terms of time and money. One of the biggest concerns is not knowing whether or not the project will require a clinical trial, which is expensive and takes a long time. I will also be looking into any predicate devices that the company may have that we could leverage for the new proposed device. Hopefully the project will start to gain some momentum next week, but regardless, I have learned that goals aren’t always met and that’s OK. The important part is that I am still learning.

On the bright side, I finished my portion of the onboarding project this week! Now, I can say that one of my projects is complete, and that is a great feeling. This week, I reviewed the website links that are provided to new hires to learn more about the company and the resources they have as an employee at BSC. I also estimated the time it took me to complete different portions of the onboarding process and gave more feedback about the process to the project lead. Hopefully the team will be able to use my work to continue to make improvements. I have noticed that the DA team is really proactive about improving their department, which is something that I find inspiring.

Lastly, on Thursday, Chandler, Callie, and I met with one of the engineers from the Neuromodulation Hardware team. He showed us the circuit boards they use inside their devices, as well as the machines they use to test the circuits before they put them in the casing. It is amazing how much information can be controlled in such a small amount of space.

Tuesday of this week was a Costa Rican holiday, so we got the day off to relax and catch up on some sleep (although, “sleeping in” now refers to waking up at 6:30am instead of 5:30am). In the evening, we had a BBQ out by the pool at our place, and some of our Costa Rican friends joined us.

On Saturday, we traveled to Manuel Antonio to kayak through mangrove trees and relax on the beautiful beaches in the national park.

With only two weeks left in Costa Rica, I am excited to go home to visit with my family and friends, but at the same time, I am sad that the summer is coming to a close. I look forward to making the most out of the next two weeks. Pura Vida!

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Week 9: Taking Charge

This week was a little slower for me! Because my supervisors are out of town, I was, unfortunately, unable to do much hands-on work at the office. Instead, I had to be more proactive in finding things to do. I took this extra time to speak with other employees in my department to see if they had any ideas on what the next steps of the project should be, and I received very valuable feedback from a few process development engineers. One engineer suggested that I acquire some of the research done by marketing that would allow me to more clearly articulate the market for the project, so I acquired some of these documents to read and incorporate into my findings. I even brought some work home with me, and spent time reading and writing about my project after work hours.

I also was able to create a comprehensive presentation that summarized my research findings and recommendations. In our short courses, Dr. Richardson emphasized how helpful it is to create presentation slides as you work through a project, rather than waiting until a final presentation or deadline to do so. I have been trying to keep up with this suggestion throughout my time at Boston Scientific, and it has been really helpful for me. Not only does it allow me to keep track of key project milestones, but it also helps me contextualize the work I’m doing and clarify my next steps. It also is a great way to quickly get other employees up to speed on the project, and will definitely be useful when I meet with my supervisors this week after they return.

Additionally, I have been working on creating documentation that summarizes the progress I have made thus far into my project. Documentation is one of the necessary evils of working at an engineering company – it’s not the most exciting thing to do, but it’s incredibly important. Documenting progress makes it easy to share work with others and ensure continuity of a project. The continuity aspect is especially important for a short internship. Once I leave, it’s important that the team be able to easily follow my research and findings, and clear, well-written documentation will make this possible.

Last week, I discussed the importance of holding myself accountable to my work, and this week made that sentiment more important than ever. With the absence of my supervisors and a temporary halt on my project, I was a little lost at the beginning of the week. It took me a while to regain some direction, but once I did I was able to find productive things to do. I am excited about the return of my supervisors this week, and hope that I’ll be able to really get going on my project this week!

This past Tuesday was Guanacaste Day, a Costa Rican holiday celebrating the annexation of the Guanacaste province! Because of this, we had the day off from work, and the GMI team decided to host a barbecue for some of our friends in Costa Rica. We spent a good chunk of the day cooking, but it was definitely worth it – the food turned out delicious! We were joined by some of our collaborators, including Luis, Jorge, Guiselle, and Guiselle’s newly adopted puppy, Daisy! It was a really fun way to celebrate the holiday and show our appreciation for our Costa Rican friends.

Our team also took a trip to Manuel Antonio this weekend, which is a national park on the Pacific coast of Costa Rica. This area is beautiful, with gorgeous beaches, green rainforests, and tons of wildlife (sloths, monkeys, and birds) to observe! We kayaked through a mangrove forest and spent some time on the beach. With the end of our time in Costa Rica coming closer and closer, I’ve been feeling especially appreciative of all that this country has to offer – I’m really going to miss it!

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Week 9: Anticipation and Preparation

Everyone knows that when you wear white, you are only bound to get something on it- whether it’s a pen mark or food stain. Well on Wednesday this week I wore a white shirt, with this mentality of course. But instead of a little pen mark or food stain, I dropped an ENTIRE mocha on my shirt during lunch because of cap mix-up (it was the wrong cap, I promise). If you can imagine that chocolatey, milky, coffee mess on a white shirt, then you can imagine the embarrassment. Luckily Sanjana came to the rescue with water to flush out the stain! Despite the clean-up, I smelt (and felt) like a walking hot cup of coffee all day- giving me the name Coffee Girl.

Beyond my coffee escapades, this week was spent anticipating and preparing for my experiments and prototype builds. As a recap:

Project one: Optimizing the use of a new material for urethral stents.

Project two: Building or preparing a build for prototypes based on an R&D engineer’s design plans.

(New) Project three: [A continuation of a mini side project I did on Week 1&2] Advisement on the characterization of a new material for guidewires (for the Coyol and Heredia sites), using a submitted business proposal.

Project One, testing the material and equipment!

Project one got the green light once I was able to arrange a time and day to use the equipment in the clean room. So Friday afternoon I ran a test drive with the equipment and the material I am investigating. This experiment was helpful as I could configure how to use the equipment and note the material’s characteristics. These were all important factors to consider before I moved on to the next step involving the urethral stents and how I seek to optimize the use of it.

Project two is still in the preparation stage as I gathered most of the supplies I need to build the prototypes this past week. During my preparation, I have been meeting with Manufacturing engineers to determine what equipment I can use for my prototypes and finalizing the build plans little by little.

Project three is currently in the research stage. Since this project wasn’t one of my main or prioritized projects, I mostly hope to make progress on it for my team to continue carrying it out at the end of my internship. During week one of the internship I had begun this project by requesting FTIR testing of the guide wires to obtain solidified confirmation of the material. Throughout my research, I have compiled as much information as possible and documenting it in order to make it easier when moving forward. I am learning about a lot of new characterization tests, but the next step is seeing what is possible to do on site, since the main point behind this project is to bring the manufacturing of guidewires with this material to Coyol and Heredia.

While juggling these three different projects, I began to understand the undercurrents that fuel a medical device industry and the responsibilities of the engineers concerting these projects. Unlike research, where you can focus on one sub-aspect for years, in the industry it is important to multitask several sub-aspects as efficiently as possible. You have to work quickly but thoroughly in responding to stakeholders’ needs and collaborate with others to complete all the tasks.

To end the week, the GMI team made a trip to Manuel Antonio for a day trip on Saturday. Along the way we stopped on Crocodile Bridge, a bridge that overlooks a river bed where several enormous crocodiles tend to congregate. We also made a trip to the mangroves and explored this unique ecosystem through a kayak tour. And last but not least, we spent the afternoon at Manuel Antonio Park, which was by far the most beautiful beach we have visited so far!

Kayaking through the mangrove forest.

Looking down from Crocodile Bridge.

 

One of the beaches in Manuel Antonio Park.

 

 

 

 

 

 

 

 

Until next time! Pura Vida.

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Week 8: Accountability

We are halfway through the internship! This week, I spent more time on the production floor. We were performing a confirmation build for one of Boston Scientific’s new catheters. Our goal was to test different curing conditions in order to establish high, low, and nominal temperatures and cooking times for specific steps of the manufacturing process. I got a chance to see how this process works, including all of the preparation and documentation that leads up to the tests themselves. In order to run the test, the manufacturing team had to produce enough catheters ahead of time so that the test could be run without hindering production output. This meant running a shift overnight to produce three batches of catheters, that could then be tested continuously. Once this was completed, our team was able to test our product under the different conditions. The entire process involved a lot of coordination and communication between different departments.

One of the most interesting things I learned this week was how detailed and precise the documentation process is for manufacturing. As I learned last week, most of the production is done by hand. For each step, there is an instruction document that outlines how to do it in extreme detail. Many of the steps are followed by quality control tests, in which the user can access whether the device has been successfully assembled thus far. If a device doesn’t pass the quality test, it goes into a scrap pile. Each time a device is scrapped, the engineer who scraps it must document why the device couldn’t proceed to the next step. Every step is tracked so that the engineers who handle the device are held accountable.

At any successful company, accountability is key. Over the past few weeks, I’ve noticed the ways in which Boston Scientific incorporates methods to hold their employees accountable. At the end of every week, the Process Development department holds meetings in which one project team gets the floor and walks the whole department through what they have accomplished. There is a huge rolling whiteboard on which they list their goals, ideas, and deliverables. This is a really cool way that not only forces teams to monitor their work as their project progresses, but also gets the entire department involved.

One of the biggest things I’ve focused on this week is holding myself accountable. At a big company like Boston, and especially as an intern, a lot of the work that we are assigned is very open-ended. There’s no one keeping an eye on me to make sure I’m being productive, and I don’t have someone checking my work at every step to ensure I’m heading in the right direction. It’s my responsibility to make sure I’m taking the right steps, asking the right questions, and utilizing my resources. This week, with my boss out of town, I knew I had to make sure I was keeping on top of my goals. I delved deeper into my research, and asked for more opportunities to learn. At the end of the week, I was able to provide my recommendations for the next steps on the project, which I will get the chance to test out next week!

This weekend, we went to La Fortuna to see the Arenal Volcano! We relaxed in some hot springs, went on a hike through an inactive volcano, and took a boat ride through the lake. Arenal is one of the biggest tourist attractions in Costa Rica, and after hearing so much about it from many of the locals, it was exciting to experience it firsthand.

We only have three more weeks left at Boston Scientific, and in this beautiful country – I’m ready to make the most out of it!

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Week 8: The Intersection of R&D and Manufacturing

Being a part of the Exploratory Phase team in Process Development has exposed me to a diversity of topics and projects happening on the Coyol site, making these past three weeks at Boston Scientific fly by! Although I have done a lot during my time, I still have much more work to do. I am also beginning to realize that Process Development engineers need to be very dynamic as they collaborate with both R&D and Manufacturing engineers A LOT, which I really enjoy piecing together each side’s perspective into a project.

Last week I spoke about my exploration of methods to utilize a new material for urethral stents and this week I hoped to solidify these methods in order to test it out. Fast forward to this week- I spent the beginning of the week reaching out to Manufacturing engineers to better understand the current processes they use. First off, I learned that Manufacturing engineers are very busy on the production line! Second off, these discussions led me to take one step back to focus on how to prepare the material because I found out the equipment I needed did not exist in our site. So I had to make it work somehow, but ideally with the tools I did have at my disposal. My meeting with one Manufacturing engineer set up how I will approach this preparation technique next week.

Regarding my other project in developing an R&D engineer’s design ideas into build plans, we were able to establish which configurations of the factors were most representative. This allowed me to formulate a document describing what parts were needed and the necessary parameters to build the prototypes. Following my planning, I reached out to a couple Manufacturing engineers who would be able to assist me in obtaining the materials for the prototypes. It was exciting to finally create my first draft of a deliverable in my project, as it meant I was one step closer to assembling the prototypes.

Working on prototypes in the engineering lab.

Both my projects were briefly put to a pause on Tuesday because for the next few days I worked with my team and a visiting R&D engineer from the Boston Scientific headquarters to complete a new project dealing with rotatable snares. This project has been in progress since I started three weeks ago and now it was being executed in order to carry out benchmark tests. Typically, a Process Development engineer will “rent” out a production line to carry out the assembly of a prototype they are working on. On Tuesday, we made our first attempt at carrying out the assembly of these rotatable snare prototypes on the production line, although a few logistics and the learning curve for the new product delayed the start of manufacture. Therefore, the next day my team and the visiting R&D engineer spent the whole morning and early afternoon building the first part of the prototypes in the engineering lab. It was important to have different people working on the assembly to simulate the variability on the production line. I was thrilled to have the chance to work with my hands and bring an idea to life! Through this process, I unfortunately learned about the strength of Loctite (a gap filler adhesive) and that it’s not the most enjoyable thing to get in between your fingers! We eventually formed over 100 prototypes that were later, on Wednesday and Thursday, completed on the production line. To finish up the project, on Friday I drafted up a document with instructions and pictures on how to form the main part of the prototype for future iterations because it was a bit of a finicky process. While I was not able to focus on my own projects this past week, in reality it would have involved a lot of waiting for responses and materials delivery. I also had the opportunity to converse more with an R&D engineer and learn more about their daily work schedules at Boston Scientific in the United States. It is very interesting to hear comparisons between different sites’ work culture and environments, even within the same company.

This weekend was not only a big weekend because it was our halfway point through the internship, but it also was our first whole weekend trip and we spent it at Arenal Volcano. Arenal is the mecca of ecotourism and it is absolutely crucial to make a trip out to one of the beautiful (and active!) volcanoes of Costa Rica. We took a 5 km hike around the lava beds surrounding Arenal Volcano and saw some small glimpses of Arenal Volcano itself, but for the most part it was covered by clouds. Even in its half covered state, you could only imagine its grandeur and fear-invoking presence on the town of La Fortuna. Not only did we visit for the volcano, but the La Fortuna area is also known for its multitude of hot springs- all the way from transformed and developed to natural and rugged. We got to experience both sides of the spectrum of hot springs, and I would say the natural ones were truly unique.

Arenal Volcano, all that you can see of it at least!

Rio Chollin, natural hot springs.

Until next time. Pura Vida.

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Continual Learning

Wow! We are half-way through our internship, the time is flying! This week, I was able to work more on my project and made some significant progress, so that made the week go by even faster than normal. Aside from working on my project, I got to attempt to insert a urinary catheter, learn about neuromodulation, and come to some significant insights about biomedical engineering.

Where I work (and eat, a lot).

Let’s start with the insights: First, while reminiscing about my previous internships in the oil and gas industry, which is a world away from the medical realm, I realized that at the heart of it, most engineering jobs are extremely similar. All involve processes accompanied by paperwork, meetings to collaborate and share progress updates, various projects that must be balanced, information gathering to understand possible solutions, and most importantly, sound decision making based on technical knowledge. All external factors aside like company culture and coworkers, the thing that differentiates between engineering jobs is the projects themselves. So it is extremely important to be interested in the products that you are working on. Currently, I’m not sure exactly what products I’m most interested in, but I do know that they reside in the medtech industry. My second insight involved quality systems. Basically, a quality system is a framework of checks and structured processes that guide all work in a company. Initially, while reading through my mountain of training paperwork, I thought that quality systems only slowed work down and made everything more laborious due to extra paperwork and hoops to jump through. However, I realized this week that quality systems are extremely important in the medical industry because patients’ lives are at risk. A quality system ensures that patient safety is safeguarded as best as possible. It catches small details that tend to fall through gaps (like new FDA standards or recently identified risks from products) that can have terrible consequences. It helps to maintain the company’s reputation by only allowing the highest quality of work. It also provides a way to track work to improve products and processes through good documentation. So although complying with a quality system can be frustrating, I am now convinced that it is absolutely necessary.

A diagram of a guidewire (similar to the ones I’m working on). From http://massachusetts.all.biz

Honestly, I have been surprised at how much I have been learning in the past three weeks. I expected the learning curve to more or less level off at some point during my internship, but it hasn’t, a fact for which I am extremely grateful. The difference is that while I was learning just facts, now I am actually understanding by piecing the facts together to create a full picture. For example, I learned about quality systems, good documentation, and the product development process during training. But it was only this week that I understood that all three are actually inseparably intertwined. My project centers around ensuring FDA compliance to new guidelines, which was caught by the quality system. But without the product development team documenting their choices and specifications, I would not be able to learn about the products enough to even start my project. So it all comes full circle. I am coming full circle by understanding what the trainings I read actually mean in real life.

Spearing the sample again and again in vain.

Trying to insert a urinary catheter into rubber organs.

Speaking of learning, this week I was also privileged to participate in a urology clinical training. I learned about the different parts of the urinary system (kidneys, bladder, etc.) and how kidney stones are removed. Then, as always with the clinical trainings, I got to try my skills with real devices on a dummy setup. I was really glad that it was a dummy because I speared it about ten times until I hit the kidney stone while simulating the percutaneous (through the skin) approach to removing kidney stones. I wasn’t even able to get the catheter in the ureter tube in the other simulation with rubber organs and a scope camera. This is especially significant because I was “cheating” by using the shadow of the device to help me, moving the fake organs around in an attempt to succeed, and watching the screen that actually showed some contrast. All three of these are advantages that surgeons do not have in real life. So my respect for surgeons skyrocketed that day. They have skills beyond anything I can imagine; I tip my hat to you all.

An implantable device and controller to stop Parkinson’s disease tremors.

Another highlight of my week was talking with the head of R & D neuromodulation (aka Chandler’s boss). He gave us a high-level view of neuromodulation which consists of sending electrical signals to nerves to decrease symptoms. It is absolutely amazing what they can do. With an implant, the tremors of Parkinson’s disease are stilled, crippling chronic pain fades to background noise, and the deaf can hear. It is an amazing field that I am looking forward to seeing what it has to offer in the next twenty years because they are just scratching the surface.

 

 

Here are more fun facts about Costa Rica:

  • Holding the door open for others is common courtesy
  • Costa Rica sits on the intersection of two tectonic plates, so small earthquakes are frequent
  • Speed limit signs are rare in the city because traffic and speed bumps are the main speed regulators

To wrap up our week, we took a trip to Arenal volcano. It was a blast! We hiked the active volcano, swam in the clear lake, soaked in the natural hot springs, browsed local art, and enjoyed the ever-shifting weather.

Hiking at Arenal volcano this weekend, 360 view!

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Week 8: Full Steam Ahead

Reviewing Progress

Our team made it a key point to review progress weekly, this ultimately ensures that we stay on target with our specific objectives. On Monday, I had presented the previous week’s work, detailing the research I had done. Although the information was useful, one thing that my supervisor suggested I improved on was the general detailing of the problem. At Boston Scientific, they use “problem-solving” and “fish-bone” diagrams. The reason behind these diagrams is to show the step-by-step process in tackling an issue. Being that I am only at Boston Scientific for three more weeks, I think I wanted to jump ahead and propose solutions to problems without taking a tiered approach. Although it may seem that a solution that could fix a problem relatively fast is a great approach, in reality, it can be ineffective for a few reasons:

  1. The solution does not solve the root problem
  2. The solution is not the most-effective option
  3. The solution can add cost in the long-term
  4. The solution may not be validated

Fish-bone Diagram

As an Engineer, my first instinct when seeing problems is to immediately fix them, but as this internship is teaching me, sometimes being patient and thorough can be the only way in addressing problems.  There are three main driving principles in correctly defining a problem:

  1. Data-Driven
  2. Team-Based
  3. Right the First Time

These three principles help ensure that the problem is first understood at a fundamental level, and that you have the necessary justification to further pursue solutions. Boston Scientific emphasized that “a correctly defined problem is 50% solved” and after going through the process of problem-solving, that statement makes perfect sense.

Weekly Objectives

After we reviewed last week’s progress, we also discussed what was on the agenda for this week.  Some of the objectives I had included the following:

  • Designing an Experiment to Justify a Machine
  • Conduct Daily Chemical Testing of Coating
  • GEMBA Walks (Internal Audits)
  • Begin Joint Raw Material Characterization Project

Justifying L&D Machine

For Boston’s Stents and NVI, they needed a more controlled process for lubricity and durability (L&D) testing. With the variability in testing (various French sizes, material composition, etc.) it was difficult for them to validate a specific L&D machine as they were unable to get the same tolerances across their varying products. With that in mind, I did some research on finding an alternative machine capable of adjusting to that variability. After contacting some sister plants that had used similar equipment, we found that it may be viable to implement a specific machine, but further testing needed to be done. This requires that we send samples (using a “design of experiment” method) for testing. The samples must be representative of the wide range that would be seen in the Stent and NVI product lines.

Coating Testing

An important aspect in improving the shelf-life of a coating is to look at humidity saturation over time to see what might be improved. Typically, these humidity tests were only done on a weekly-basis and so it was difficult to pinpoint exactly where a problem with the humidity was occurring. As of recently, there have been more efforts in conducting daily-testing to help in the process of identification. With that, I analyzed the conditions of the room in which the dip-coating was done and tried to see if instances of lost conditions in the room affected the coating humidity. Records of room conditions from the last year were given to me to analyze. This is just a step in data collection that could help us get closer to a solution.

An ongoing project by a colleague involved improving the tank in which the dip-coating was done. An idea was proposed to better enclose the coating to prevent any external factors from adversely affecting the coating. This of course had some overlap with what I am currently working on, and by pitching and brainstorming ideas together, we perhaps can propose an efficient solution later down the road.

GEMBA Walks (Internal Audits)

Another objective we had set out this week was to go on a “GEMBA” walk. Essentially, this is an observatory walk around the production room to see if there are any improvements that could be made and ensure that non-conforming events are not occurring. This is referred to as an informal audit of sorts and keeps a system of accountability between coworkers. Internal audits are especially helpful to a company such as Boston Scientific in that it prepares everyone for external audits (where the ramifications are much more significant) and keeps the company running smoothly from a regulatory perspective.

Joint Raw Material Characterization Project

As an additional project to work on, Ryan and I began the preliminary research on the raw material characterization project. Our objectives were the following:

  1. Understand the specifications required from the Coyol-Spencer transfer
  2. Evaluate the variation in values
  3. Try to control parameters to get better pull-test results
  4. Receive process parameters from Spencer

Boston Scientific’s Spencer location provided the raw materials needed for extrusions and among the specifications required, among the most relevant to our project revolved around us understanding the melt-index and molecular weight of the raw material received. We need to further analyze the effect those specifications have on extrusions, and then as an output, meet with Spencer’s plant and see if we can tighten the parameters of specification on the raw material coming into Coyol.

Weekend Fun

As our time in Costa Rica is winding down, we wanted to see one of the most popular destinations in Arenal. After a 3 hour drive, we were able to relax some at the Baldi hot springs and of course, have impromptu photoshoots (which I am sure Tasha and Sanjana will provide pictures for). To start the next day off right, the group went on a hike near the Arenal Volcano and got some amazing views!

Hiking Views of Arenal

And if those views weren’t stunning enough, Lake Arenal is another great place to get in tune with Mother Nature. Still in awe of Costa Rica after 8 weeks!

 

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