Week 5: Implementing and Implants

The Importance of Implementation

With the Medical Device Industry gravitating towards innovation, optimization and branching out into emerging markets, it is essential as engineers to understand the implementation of a product. We often get caught up in the R&D aspect of engineering, but in reality, about 80% of the time invested in a product is spent on the back-end in manufacturing, regulation and marketing. The GMI students spent the week working with professionals from various companies (Hologic, Allergan, Moog) at Establishment Lab’s facility to understand the implementation process through ‘project-based learning’. This practical approach in using a modern product as a template for analysis would help us get a real-world feel for how the current process in the MedTech industry works.

 

Choosing our Product

The course required that we split into groups and choose a product that is relatively new, moderately complex and discloses enough information for us to pursue. After some deliberation amongst our group, we settled on analyzing Medtronic’s Activa PC, which is a neurostimulator used to treat illnesses such as Parkinson’s, tremors, OCD and depression. Deep Brain Stimulation is a field that is emerging and piquing the interest of various medical device companies, and for this reason, this product seemed like an interesting case-study.

Medtronic’s Activa PC Neurostimulator

Intellectual Property Search 

The first step in assessing our product required us to analyze the IP landscape of Deep Brain Stimulation technologies. Being that research is relatively new in this field, there were some relevant patents that could pose a risk to furthering developing the Activa product-line. With many patents still active, we deemed that the product had a relatively high IP risk. One patent that proved especially interesting was the Brio IPG patent by St. Jude (now Abbott). This product is a direct competitor with the Activa, and so we needed to develop a strategy that could help theoretically put Medtronic’s device in a leveraged position when it comes to integrating future technologies to their product-line. An offensive-blocking strategy is what we deemed would best fit this specific product. With Medtronic being a larger company, they have both the resources and capital to buy-out smaller competitors and also put research into future integration possibilities. This would increase the hold Medtronic has in this market.

 

Manufacturing Process & Material Costs

 DBS implantation can cost upwards of $30,000. Being a Class III medical device, we knew that there would be higher material costs associated with the procedure. We decomposed the main components of the device into the following:

  • Impulse Generator (Battery, Electronics)
  • Titanium Housing
  • Polyurethane-coated Leads
  • Platinum-Iridium Electrodes
  • Extension Wires
  • Packaging & Labeling

While this list is not exhaustive, it provided a starting point in estimating what labor, burden and material costs would be for this product. Operating under certain assumptions, we estimated a total LBM cost of $4040.00. With Class III devices generally returning 70-80% margins on their product, the $4,000 estimation seemed appropriate.

From a product risk standpoint, our team brainstormed potential failure modes for the device and developed mitigation plans to account for higher risks. These potential problems and their mitigations plans are listed below:

  • Short-circuiting of the Device : Voltage-limiting
  • Incorrect Electrical Impulse Generation: Signal Calibration after Manufacturing
  • Battery Failure : Warning System for Low-Battery
  • Displacement of Leads and Electrodes : Use of Better Adhesive Techniques

With the device being an implantable, there is already inherent risk in regards to infection and improper surgical implantation, however to mitigate the problems above, the solutions needed to be adequate enough to be deemed acceptable by review.

There are ways to optimize the material costs of the product. We proposed three specific ways in which this could be accomplished:

  1. Look for opportunities to reduce device size (i.e. battery size)
  2. Look for alternate bio-compatible material
  3. Develop an application-based programmer

Not only would this decrease overall material costs, these solutions could potentially expedite the manufacturing process by a significant amount.

 

Regulatory & Clinical Strategy

As aforementioned, being a Class III device, a premarket approval (PMA) would be the most viable option in getting regulatory approval from the FDA. Although this pathway requires more resources invested (i.e. clinical trials), being such a novel device would allow innovation and trail-blazing in DBS technology. Our predicate devices would be the legacy Activa model as well as the Brio IPG.

In regards for the clinical trial that would be necessary for the Activa, a randomized controlled-blinded study (for both the patient and outcome assessor) would be most appropriate. The patient could press a button that would or would not stimulate the GPi/STN of the brain (for Parkinson’s in this case) in this clinical trial. The outcome assessor would also be blinded to prevent any bias in data collection. The primary endpoint in this study would be to see improvement in UPDRS testing. The UPDRS scale rates the severity of Parkinson’s in a patient, and measures parameters such as motor function, speech, and posture on a 0-5 scale (with 5 being the poorest performance). A secondary endpoint would be a behavioral evaluation both before and after stimulation to ensure no unwanted behavioral changes occur. 

Sales & Marketing

An essential question to ask before marketing a product is asking ‘who are our stakeholders’? By understanding the target demographic of a product, a tailored sales and marketing strategy can be implemented very effectively. In our case, we identified the key stakeholders to be:

  • Doctors
  • Patients
  • Family of Patients
  • Payers (Government, Insurance)

A value disposition analysis of the product helped us better define the particular sales strategy we wanted to pursue. From this, we determined that a ‘Direct-to-Consumer’ approach would provide the best return on investment being that the device has a higher cost and higher efficacy comparatively to the medical device market. Lastly for the marketing strategy, mediums such as television, magazines, publications and the Internet can all be used to advertise the product and it’s immense potential. Also providing free training to doctors could also encourage the use of Medtronic’s device over competitor’s.

Firsthand Experience

After spending a week learning about the various aspects of implementation, we were graciously offered a tour of Establishment Lab’s manufacturing process of silicone breast implants. Before we could enter the clean room, we had to suit up, wash our hands and understand the protocol of what is allowed. It was in this moment that I felt the most germaphobic  I had ever felt in my life. But, I was truly encouraged as to the measures the company took in ensuring that their product was high-quality.

A silicone implant made by Establishment Labs

What I’ve Learned

This approach of project-based learning helped me realize several aspects of engineering that are not necessarily the most glamorous, but are definitely the most integral in getting a product to market. As Engineers, it is an obligatory duty to continuously be improving and becoming more efficient and as a Medical Device Engineer, the duty is all the more necessary. Every improvement has the potential to improve the lives of many. As I prepare to Intern at Boston Scientific, I hope that I can translate what I have learned in the past week and make a positive impact!

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Week 5: A Sneak Peak Into Our Boston Scientific Internships

In the past five weeks in Costa Rica, we have taken three short courses that have delved into the entire product development process- covering the front and back ends. As a recap, the first class was taught by Paul Fearis during the first week we were in Costa Rica and explored the process of finding needs and developing solutions for issues we identify in the medical field- essentially the front end part of medical device design. A few key points that I took from that course was: how to craft needs statements, the importance of de-skilling certain processes, never to jump to solutions immediately after seeing an issue, and the potential to target an upstream issue when looking at the root cause.  The second course was taught by Dr.  Richardson and Dr. Wettergreen and emphasized the design and prototyping phase of medical devices. This course really opened my eyes to the importance of low-fidelity prototyping and the ability to mimic an idea through craft supplies, before investing a lot of time/money on an idea. And last but not least, the implementation course that we completed this past week taught by Dr. Richardson and Luis Diego (a former GMI graduate) tied it all together by covering the back end part of product development and most of all gave a great introduction to the parts we will be involved in during our internships at Boston Scientific.

One may ask, what is the back end of the product development process? A vital question indeed as it takes up about 80 – 90% of the entire process! Essentially it includes the following: quality management, manufacturing, regulations and reimbursement codes, clinical strategies, and sales and marketing. All of this was covered in just 4 days in the short course that we took at Establishment Labs. The class was made up of working professionals in the medical device industry in Costa Rica from all different companies and departments. On Monday we assembled into teams and chose a product that we would apply the aspects we learned about throughout the week.

Team Utrust! Pablo, me, Nicole, and Marco (left to right).

My team was made up of 2 RDI engineers (one who used to be a manufacturing engineer) and a civil engineer/manufacturing engineer working in the medical device industry. Our product was a based off a Hologic tissue removal device used in the uterus, called Myosure. Based off the intent of the device, my team was called Team Utrust (get it?).  The system worked by moving in axial and rotary directions to cut and suction out the tissue. It was inspiring to have different experiences and backgrounds in a group, as each person was able to bring their own expertise to the project. I would hope such efficient collaborations existed in the industry! I really enjoyed the structure of this short course because we typically had lectures and in-class exercises before lunch and group project work time after lunch. This really allowed us to develop our projects in the short week.

This course also brought to light a lot of factors that need to be taken into consideration when analyzing the back end of product development such as:

  1. The importance of design for manufacturing (DFM) principles (fun fact: engineers in the toy industry have the best strategies) and there should be a synergy between the R&D and manufacturing department.
  2. Take the trail that leads to money already instead of going through the long process of creating a new reimbursement code.
  3. Quality management systems are always in a state of flux and make up the nervous system of the product development process.
  4. Validation and Verification (V&V): Validation is made up of external feedback through clinical outcomes and is done at the end. Verification  happens within the internal processes.

    Presenting about our device Myosure.

On Friday, we had the opportunity to present our projects in a showcase where Establishment Lab and Hologic employees

Gowned up in the proper PPE before entering the clean room at Establishment Labs.

gathered to see the work we had done this week. After our showcase, we toured Establishment Lab’s clean room where the manufacturing of the breast implants occurred. It was really cool to see how the process worked and got me excited about my internship starting very soon at Boston Scientific. This week I found out that I will be in process development of urethral stents, so I will be taking on a project dealing with building prototypes of these stents!

Birthday cake surprise!

Looking back on this week outside of class- Tuesday was my birthday, so all the GMI’ers joined me for dinner and surprised me with a chocolate cake after dinner! Saturday was eventful as we experienced our first black out in Costa Rica! In fact all of Central America underwent a power outage for 5 hours because of a power overload in Panama. Upon further researching the event (once we actually had Wi-Fi), I learned that “the Central American countries are interconnected by an electricity transmission line of 1,820 kilometers, which extends from Panama to Guatemala”. A lot of

Fresh fruits and vegetables from the Feria del Agricultor.

businesses had back-up generators, while other businesses had to shut down during this time period and traffic was severely affected. On Sunday, we started off our morning by visiting the nearest Feria del Agricultor – which is a weekly farmers market that takes place all over Costa Rica in several towns. I got to stock up for the week with lots of fresh fruits and vegetables!

This next week we will begin our orientation to prepare us for our internship for the next six weeks at Boston Scientific! I am really looking forward to learning about the real-time medical device process in the industry. I am hoping to have a hand-on approach in the project I take on during my time there and learn about all the different aspects of process development, including the inlets and outlets of it.

Thank you for reading! Tune in next week for an insight on what I will be doing at Boston Scientific! Pura vida.

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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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Week 5: Final Short Course and Breast Implant Tour

This past week we began our final short course with Costa Rican professionals from various companies. I was looking forward to this course as it contained a broad overview of all divisions of medical devices: Research & Development, Legal, Manufacturing, Regulatory, Risk Management, Quality, Clinical, Reimbursement, and Marketing & Sales.

***Shout out to my mom who has a history in sales- entering this week I was extra interested in learning the Marketing and Sales behind medical devices!***

I found this image very useful as a reference to the broad scope of medical device implementation.

Every day in this short course we spent time learning these divisions of medical devices from lectures presented by Dr. Richardson and Luis Diego Gené, a Costa Rican and previous Rice GMI graduate. There was a unique twist embedded in our learning process that truly made this week extra fun. Each group (3 work professionals and 1 Rice student) picked one medical device on the market and applied our new skills deconstructing how this device traveled from ideas and concepts all the way to the market.

I enjoy these hands-on projects for multiple reasons. Project-based learning revamps a typical lecture format (sit down and listen, furiously write/type, try to remember info) and inserts real-life applications (a medical device on the market) through creative processes. At the end of the week each group would be expected to give an English presentation on their device to a panel of industry professionals. When I came to class on Monday, I knew each team would pick one medical device based on group interest and experience- so I came prepared with a rough list of medical devices with varying complexity.

~a very short and very rough list of medical devices which interest me~

Stent

Cochlear Implant

Thing that makes you less hungry, stomach clamp thing?

I wrote this list during breakfast on Monday morning, so I didn’t have time to learn what “stomach clamp thing” really was. I was looking forward to my other team member’s input, as I definitely only had interest and no expertise on these medical devices. On my team there was Salem, Pablo, and Maria who had 26, 7, and 1 years work experience respectively. Salem and Pablo had worked together in the past, so they suggested our team should work on their old project on NextGen LAP-bands. I had no idea what this device was, but valued the opportunity learning from 2 experienced minds on this device. After I agreed to work on this device, I flipped open my laptop and typed in LAP-bands. And look what popped up!

It was the stomach clamp thing!! Needless to say I was floored at this coincidence. It was a great start to such a productive week.

On Friday my team presented our “reverse engineering” project to a panel of industry professionals. I was very happy with our results, and it was fun listening to other teams and their presentations as well. After the presentations and a reception, the GMI team had the opportunity to tour a breast implant manufacturing line. The tour was highly detailed and very interesting, and I felt like I was experiencing the TV show “How It’s Made” in real life. Because of strict sanitary codes, we had to dress up in white gowns called Bunny Suits. Men with beards had to wear special face covers, and women couldn’t wear heels and had to have their entire foot covered. Since the group had just finished presentations just one hour prior, several women were wearing heels or flats. Luckily, the company had several pairs of giant socks and disposable shoes handy so we could properly cover our feet. I can’t give much info about the tour since I signed a non disclosure agreement, but here is some general information about my experience:

  • It’s rather difficult to get into a bunny suit without contaminating anything
  • This company makes 1,800 different sizes of implants
  • It usually takes 7-9 days for an implant to be made start to finish
  • You’re not allowed to touch anything
  • The rooms are strategically pressurized to keep dirt particles from flowing in and contaminating the implants
  • Our tour guide was a processing engineer, and it took him 8 months to learn the entire process of breast implant manufacture in chemical and mechanical detail to give a tour. Great job Marlin!
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Week 5: Implementation

This week, we made our way back to San Jose, the nation’s capital, for a Medical Device Implementation short course. The class was taught by our own Dr Richardson to the 8 GMI students and 25 professionals from medical device companies in San Jose. “Implementation” is the work that needs to be done after a device has been designed in order to get it to market. We talked about 8 different elements of implementation: product development processes, intellectual property, quality, manufacturing, clinical testing, regulatory, sales and marketing, and reimbursement. The class was structured such that we were to pick a publicly marketed device as a case study. We would receive lectures in the morning, then apply what we learned to our group’s device through activities in the afternoon. For example, when learning about intellectual property, we conducted patent searches for similar products to identify our IP risk.

After finishing the course, I feel that I have a much better holistic, bird’s-eye-view understanding of what goes on in a medical device company. One thing academia doesn’t do very well is give you a good understanding of how companies work. With internship experience, I knew a little about manufacturing, quality, and their role in the corporate landscape, but everything else was a black box in my mind. Moreover, my experience was not in the medical device industry, so aspects like clinical testing and reimbursement were especially alien to me. We didn’t have time to dive deep into any one subject in this class, but broad coverage of the whole process was helpful to start filling in gaps in my understanding.

At the end of the week, Establishment Labs, the company that hosted us for the week, was gracious enough to give us a tour of their facilities. That was an exciting way to end the week!

Looking ahead, next week we begin our internships at Boston Scientific! So far, all I know is that I will be working in manufacturing (with Josh), but I’m really looking forward to getting work at one of the largest medical device company in the world. I have two major goals going in: to start evaluating what role in a medical device company I would enjoy as a career, and to get as much experience in manufacturing as I can.

A preliminary tour of the Boston Scientific campus we will be working at

As I will be seeking full-time employment soon, I want to determine as soon as possible what roles within a company my skills and personality fit best with. I know I’ll get a good look at what a manufacturing engineer does, but I’m hoping I will also have access to professionals working in other parts of the company. Through my own work experience and getting to ask people about their work routines, I hope to learn as much as I can about the many roles an engineer can play in a medical device company.

Whichever direction I decide to pursue, though, I will benefit from having good manufacturing experience. Manufacturing is where the money is made, so in a sense everyone’s job is to make manufacturing better, just in different ways. Therefore, I hope to dive as deep into this role as I can this summer to support my future career.

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Implementation: Eviva La Vida

 

The medical device product development process consists of three main steps: identification, innovation, and implementation. We spent our first several weeks in Costa Rica focused on identifying unmet needs throughout various hospitals in the country, including Clinica Biblica, Hospital Mexico, and Hospital Liberia, and innovating solutions for those needs during the innovation short course with Dr. Richardson and Dr. Wettergreen. For the last week, we have been focused on the implementation aspect of medical device design through our implementation short course with Dr. Richardson and Luis Diego (one of the GMI students from last year’s cohort).

The members of this course consisted of the GMI students, as well as industry professionals from a variety of medtech companies and departments. On Monday, we chose our groups and a medical device that we wanted to use for our case study for the remainder of the week. I joined Natalia, Juan, and Andres from Hologic, and we became team Eviva La Vida. Our team name was based off of the medical device that we chose to analyze for this course, the Eviva breast biopsy system from Hologic, and the phrase “viva la vida,” which means “long live life.” Surprisingly, the team name was something that I came up with (I say surprisingly, because I have never been good at coming up with team names), and I think that it fits well with the device that we chose, as biopsies are crucial in the detection of cancer and helping patients live a long and healthy life.

Throughout the week, we learned several components of the medical device implementation process, including:

  • Intellectual property
  • Manufacturing
  • Quality systems
  • Regulatory strategies
  • Clinical strategies
  • Reimbursement
  • Sales and marketing

The course was structured so that we had lectures in the mornings that included various small activities and project-based learning in the afternoons, in which we did workshops to apply the principles we had discussed in the lectures. I really enjoyed this structure, as I tend to learn best by doing, and I appreciated getting to apply the lecture information to the medical device we chose to analyze as a team. Some of the work that we did included a patent and prior art search, a labor, burden, and materials (LBM) analysis, a design for manufacturing (DFM) analysis to reduce cost, a design failure modes and effects analysis (DFMEA) and risk mitigation plan, a regulatory pathway analysis for FDA approval, a clinical trial plan, a marketing plan and sales model, and a reimbursement evaluation.

I know what you’re thinking, how on Earth did we manage to accomplish all of that in four days? The answer is Dr. Richardson is a wizard. I’m totally kidding, although he may be superhuman, as he managed to finish this week strong despite having a horrible cold (major props to him for sticking it out). In all seriousness, one of the greatest aspects of these short courses is the limited amount of time that you have to complete your project. That may seem counterintuitive (I would’ve thought the same prior to this program), but in reality, having such a short amount of time to reach a goal makes your team work more efficiently to get the job done and limits you from overanalyzing everything. I will admit that accepting these short deadlines was a bit of a challenge for my inner perfectionist, but these experiences have forced me to work outside of my comfort zone and have inspired a lot of personal and professional growth, which I am grateful for. Self-improvement is something that I try to strive for every day, and working with these industry professionals over the last week was a perfect example of how to do just that. I find it inspiring that these people took an entire week “off” of work (I say “off” because many of them still had to work before and after our class every day) in order to continue learning about the field that they work in and develop additional skills outside of their job titles.

On Friday, we presented our work to the other groups, as well as representatives from various companies. Everyone did an excellent job, and again I am amazed at the Costa Ricans’ ability to present so well in English. After our presentations, we got to tour Establishment Labs, which is the first medtech company that originated in Costa Rica. We got to walk through the entire manufacturing and assembly process for their breast implants, which was quite a unique and valuable experience. I really enjoyed getting to see the process in action and walking through all of the steps. Prior to Friday, I didn’t realize how extensive the manufacturing process can be and how much of an impact it has on product development.

On a less serious note, one of the highlights of my week was finally finding creamy peanut butter! Creamy peanut butter is not very common here in Costa Rica, so I was really excited when I found some at the grocery store. Also, 6 of us decided to attend a yoga class on Thursday evening, which turned out to be a lot of fun and surprisingly relaxing (shout out to Tasha for the idea!). I was slightly skeptical prior to the class, as my previous attempts at yoga turned out to be very stressful and not relaxing at all. Despite not being able to understand the majority of what the instructor was saying (I’m still working on my Spanish skills—ha!), I had a really great time.

We have settled in our homes for the next 6 weeks in Santa Ana, which are incredibly nice (thanks Dr. Richardson and Sheretta!) and will be relaxing this weekend in preparation for our internships beginning on Monday. Pura Vida!

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Design for Manufacture

This week, Dr. Richardson led us in another short course. He employed the model of learn-by-doing as we created a presentation every afternoon regarding our product and incorporating what we had learned in the morning. We were in groups with professionals in the medtech industry and I learned a lot from their expertise and experience. My favorite lesson was about design for manufacture; we learned how to reduce manufacturing costs by simple design changes like substituting snap connections for bolts. It was enlightening to me when the manufacturing engineers in the room presented us with a top-ten list of what annoys them most about the designs they are given. It was an honor to work with these professionals and to benefit from their wisdom. I also received some great advice about interviewing, weighing job offers, and taking advantage of every opportunity.

Roy and Solange: my amazing presentation group for the short course.

A big thank you to Motiva for hosting us for the short course and for the great food!

As usual, the short course ended with a showcase on Friday where we were able to present our product through the lens of the week’s lessons. I am very grateful for these opportunities to practice my soft skills that I believe are vital to any professional. This week I focused on making eye contact with specific members of the audience and not looking at my slides while presenting. After watching the other presentations, next time I will focus on adding emphasis with my voice and hand gestures while grabbing the audience’s attention with an interesting fact or story.

On Monday, I’ll start my internship at Boston Scientific. I’ll be in the cardiology department of R & D in the Heredia location. I’m very excited to gain actual experience in bioengineering. I’m looking forward to learning all that I can by asking questions, designing, presenting, working, and being immersed in the industry. Since this will be my first real look at what bioengineers do, I’m itching to confirm my career choice and also gain insights into which parts of the industry interest me most. Likewise, I’m excited to benefit from the wisdom of my coworkers who I hope will not tire of my endless questions. I want to take full advantage of their experience and also learn by observation what it means to be an excellent employee and what it takes to be a great manager. I believe that I will also learn many vital soft skills like presenting clearly, communicating effectively, holding meetings, and working smart and hard. While my main goals for this summer are professional and personal growth, I know that everything I will experience at Boston Scientific will both motivate me in my studies when I return to Rice and also help me to find a job.

Just for fun, here’s an example of how my engineering brain works: I pondered the hotel’s shampoo supply (yes, I’m such a nerd). When I used the hotel’s free shampoo the first night, it was not at all what I expected (see picture). It was a relatively large packet filled with a tiny amount of shampoo. I was a bit annoyed; I assumed some sort of manufacturing defect had not sufficiently filled the packet. However, when I used what I could squeeze out the package, it was actually too much shampoo for my hair. I was confused why the producer had elected to concentrate the shampoo to an abnormal level. The next day, after discussing designing for manufacture in class, it hit me: why pay to ship water to someone in the shower? By concentrating the soap and reducing the amount of water in the solution, the manufacturer cut the shipping weight in half because no one needs more water in the shower. This is a perfect example of how I want to train myself to think in unconventional ways so that I too can devise clever ways to design products.

The confounding soap packet.

My rough CAD model of the soap packet. (I told you I’m a nerd)

The approximate dimensions of the soap packet (in inches).

As always, fun facts about Costa Rica:

  • Costa Ricans always follow high fives by fist bumps
  • No one uses addresses, just landmarks for directions
  • There is no carpet in the buildings, only tile or occasionally concrete, probably for cleaning purposes

The street by our hotel. Notice the fog/rain rolling in and covering the mountains behind. We have a breathtaking view on clear days.

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Dialoasis, Design, and Determination

Heading into our big implementation week, I spent a lot of time thinking about dialysis, and what exactly we were setting out to accomplish. My motivation for joining the GMI program was driven by the desire to work to improve the lives of patients around the world. After spending a few weeks in Costa Rica observing in hospital settings and speaking with patients and doctors, I felt like I had a better understanding of why the current systems left many patients with Chronic Kidney Failure (CKD) feeling unsatisfied. For starters, Chronic Ambulatory Peritoneal Dialysis (CAPD) is a rigorous process – many patients require treatment up to 4 times a day, and the process takes a long time. Though this process could be done in the home, patients are mostly unable to do so due to inadequate infrastructure. For example, the environment for the procedure must be sterile, and many homes lack a suitable space for safe therapy. The process also requires a strict hand washing procedure, and the sinks in patient homes are inappropriate. This means that patients must be transported to the hospital daily, which is strenuous to the patient and drains hospital resources. Moreover, the patient’s quality of life declines significantly – they spend a huge portion of their lives in the hospital, and this impacts their ability to work and live autonomously. For me, the opportunity to see firsthand how dialysis treatment is affecting these patients’ lives made the project much more meaningful, and really got me excited to do my best work.

With our patient needs in mind, GMI has set out to devise a way to allow patients with CKD to perform their dialysis treatments in the comfort of their own homes. The team last year set the foundation by designing a small room, or cuartito, that could be set up in the patient’s home to allow them to do their dialysis treatments. Our goal for the past two weeks has been to refine this design, source materials locally, build a prototype, and get feedback from dialysis patients, doctors, and nurses.

In order to achieve this goal, we decided to divide up into three teams. Callie, Anna and Karlee focused on finding the materials we needed to form the cuartito, Chandler and Josh focused on devising a testing plan and interview guide, and Ryan, Tasha and I worked on designing and building the prototype. We had five days to put together all of these pieces so that we could get feedback at Hospital Liberia on Friday morning.

The design and building process was really exciting. We were collaborating with Invenio and using their machine shop, so they ordered the frame and panels that would make up the walls of the device. This allowed us to focus our design questions on the interior, specifically the sink. We felt the sink was one of the most important aspects of our design, so we devoted a lot of time and consideration into how we should construct it. We discussed design criteria for what we wanted the sink to accomplish. First and foremost, we wanted our sink to be effective at giving the user enough space to wash their hands up to their elbows. We also wanted it to be affordable, durable, easy to clean and not take up too much space in our cuartito.

We considered multiple options, including buying a readymade sink. In the end, we chose to design our own. This would allow us to test out our unique design ideas and get feedback, which would be valuable moving forward with the project. It also gave us greater flexibility in making the sink cohesive with the rest of the unit. We settled on a trough-style sink design, as can be seen in the image below. This design allows the user to have a lot of space inside of the sink, which is critical due to the nature of the hand washing process. It also allowed us to anchor the sink to the panels, eliminating the need for legs which take up valuable real estate in the cuartito and make it more difficult to navigate. Though it would be difficult to put this sink together in the short time frame we had, we believed it would be worthwhile in the long run.

Building the sink was very challenging, particularly because we were unfamiliar with the machines that Invenio had, and because of all of the moving parts to our project that had to be settled before we could commence building. By Wednesday afternoon, with the help of Dr. Richardson, we were able to devise a simple way to put together our sink, deciding to just cut and bend the sheet metal into place, and then seal off the edges to make it watertight. This plan seemed simple enough, but we definitely had our work cut out for us (pun intended). The cutting process took a very long time, and the bending process even longer. The bending machine we were using was pretty finicky, and Dr. Richardson, Tasha, Ryan and I exhausted quite a bit of energy trying to get it to cooperate. But after some blood (Dr. Richardson’s), sweat (all of ours) and tears (just kidding), we built a sink!

Other design questions that we considered were layout and the door. We wanted to maximize foot space in the cuartito so that the user could extend their legs during the procedure, or a caretaker could fit inside to help the patient. We also wanted to make the device modular, so that it could be rearranged to suit the patient’s preferences and the layout of their home. When selecting a door, we wanted something lightweight and closable so the patient would be able to keep out children and pets, and also sheer to allow a family member to check in on the patient during the procedure if need be.

After a few long nights this week, we finally were able to get the device assembled. We were pretty proud of how it looked! The prototype was functional and aesthetically pleasing, and we were excited to hear the hospital’s feedback. Our final hurdle on Thursday night was getting the device disassembled and loaded into the truck to transport to Liberia. A few hours of tetris later, we were ready to go!

On Friday morning, we arrived at Hospital Liberia and assembled our device as quickly as possible. It was a little stressful and we faced some unexpected difficulties in getting it up, but finally we had it all installed, got water running through the sink, and began bringing in patients and doctors. The feedback we got was very useful, and it was awesome to see that people were really excited about the project. This device has the potential to revolutionize the way dialysis is delivered in Costa Rica, and I am really excited to see where this project goes over the course of the next year!

The development of our prototype was really exciting, but this week was trying in a number of ways. Logistically, it was difficult for us to accomplish things at times because we all needed to be in different places at once, but we only have one car and only one Dr. Richardson to shuttle us from place to place. This meant that we had to be very flexible with our plans. For example, the design team spent a good portion of Tuesday morning working at a local McDonald’s taking advantage of the free wifi (though honestly I enjoyed this, mainly due to the McFlurries). Moreover, because our work was so intertwined, oftentimes some of our sub teams were left waiting for another part of the project to be completed before they could do their own work. This was a little frustrating at times, and definitely something that could be improved in the future by considering a different structure for dividing tasks.

This week was also our last in Guanacaste! On Friday, our last night at Earth, we met some students from the other Earth campus and hung out with them. It was really cool to hear firsthand about the Earth structure and how they apply the things they learn in the classroom to their work. On Saturday we drove back down to Santa Ana where we will be spending the remainder of the summer. On our way back, we took a detour at Monteverde where we did some zip lining, rappelling, and Tarzan swing-ing! It was an awesome way to decompress after a pretty stressful and taxing week, and the scenery was beautiful.

This week, we are back in the city and will be taking an industry course! Stay tuned for more adventures.

Posted in Sanjana | Leave a comment

Week 4: Cuartito Completo

In approximately 35 hours of a work week, our team had completed a (mostly) fully functioning prototype for our DialOasis implementation project! An unbelievable feat that we were all certainly proud of. A feat like this requires concentrated time blocks of work, efficient planning, quick decision making, and of course a skilled team.

As a little recap of our project- DialOasis was a design conceived in last year’s GMI team and it was our goal this year to execute this design in Costa Rica, working with the materials and tools accessible to us. This is easier said than done. In the United States, we are spoiled with a wide variety of machines, innumerable materials organized neatly online, and even the familiarity with stores and store types available. When working in a country that is foreign to you and even more so not very developed in the digital world, much of what you find is by word of mouth- hence conversing with the locals is absolutely vital. Additionally, having a key local collaborator as we did with Invenio University to provide a work space and their assistance in making this project aided our team immensely.

When approaching our project we had pre-established teams working on the various aspects; material acquisition, prototype design and manufacturing, and prototype testing. I was on the design and manufacturing team. Throughout the week, each team had to present their findings and designs to the rest of the teams as mini check-ins for the progression of the project. I found these progress updates to be very important as they laid the foundation for the iterative process of design. Each team’s presentation introduced more information that either confirmed or altered another team’s plans. For example, when the materials team presented to the build team their findings in the local hardware store, it caused the build team to reconsider how we constructed the layout of the dialysis room. Another key turning point for the build team was when the testing team presented several good considerations we needed to take per the recommendations of a maintenance engineer and doctors at Liberia Hospital. I noticed at times each team’s decisions were contingent on another team(s) so it made it difficult to proceed. In the future, it would be more helpful if the teams collaborated more during their decision making processes, prior to the check-ins. Again, I highlight the fact that the design process is by no means linear. In fact, it goes forwards then backwards then forwards again and maybe even through a loop! But that is all the fun (or not so fun) parts of it and most importantly what makes a good project.

Now to focus more the build’s team process. My team was made up of me, Ryan, and Sanjana. It was imperative for our build team to design and properly execute the ideas we came up with through CAD, but with limited time we mostly needed to physically test our ideas on the go.  During the idea brainstorming process, I found myself mentally shutting down my own ideas that didn’t make sense. This is mainly coming from a lack of experience for building large scale objects using power tools and not knowing what was at our disposal. However, I learned that I needed to think a little bit further than outside the box- call the ideas “wild”, if you may. It is these “wild” ideas that can spark breakthrough solutions. As a team, we had to plan the key features of the dialysis room: how the panels connected, the sink (which I will delve deeper into), the layout of the room, accessory units, and the door. The engineers at Invenio were incredibly supportive in helping us build the frame of the dialysis room, which allowed us to focus on the sink design.

The sink was the star of the show for our prototype because it was the biggest aesthetic concern for the dialysis patients. Prior to beginning a dialysis session, patients must wash their hands for 5 minutes of rigorous scrubbing and keep their hand sterile during the process. Therefore when designing the sink we had ensure that the sink provided sufficient space for the patient to wash their hands (without floor spillage). It also had to be feasibly built or bought, a reasonable cost, and easy to maintain by the patient. We ended up coming up with a trough-like shape for the sink that would be wide enough for the patient’s hand-washing process. Because the material’s team had a limited resource cache, our sink idea could not be found in the hardware stores, so we decided to build and manually bend this sink out of stainless steel with an origami approach. To explain what I mean by origami, we had to cut and bend the stainless steel (and I will emphasize manually, thanks to Dr. Richardson for helping us a ton!) to enclose on the sides and attach to the back piece of stainless steel… all in one piece! It turned out pleasantly very successful. The back panel included a shelf for soap and towels and we also installed a rain- gutter system underneath to catch the used water into a bucket. All the remaining fine details of the layout were ironed out after we finished the sink with the help of the other teams. We were so relieved that our sink idea worked out even better than we thought.

Step 1: Design sink and trace out shape onto stainless steel sheet.

Step 2: Cut the stainless steel sheet.

Step 3: Bend the stainless steel sheet with a very outdated manual sheer press device. In this moment, we had freed the sheet from the press during one of its many ‘stuck in locked position’ situations.

Step 4: Completed sink ready to be mounted to a panel inside the dialysis room!

 

The cuartito successfully mounted to the truck!

Now although our job was technically done, making the prototype is only part of the implementation process. Next we had to get patient and hospital staff feedback! Well actually first we had to disassemble and transport this dialysis room over an hour drive to the hospital, in which some of the drive consisted of very bumpy roads. Additionally, the truck that we had to use to transport the room was too small and on Thursday at 8pm, we had no other options… Working with what we had, we managed to situate the panels in teepee structure that really stabilized the pieces well, with the help of straps and cardboard!

 

Friday was the day that all our hard work and dedication would shine! We had the opportunity to set up our dialysis room in the dialysis department in the Liberia Hospital. Four dialysis patients and many nurses, doctors, and even the hospital director crowded in the tiny room to offer their perspectives and share their enthusiasm. We received a lot of very valuable viewpoints and feedback that would benefit the room and ultimately the patient using the room. Some of the patients were simply too happy to point out any flaws, but the more feedback we heard- the more we can improve for the second iteration of the prototype. It was exciting to see DialOasis become a viable product that will soon be in patients’ homes in Costa Rica and even more exciting to see patient’s reactions and hear their expectations.

Completed cuartito inside Liberia Hospital!

Inside look at the sink.

Sitting area for patient during dialysis.

 

Here we are with all the nurses, doctors, and hospital director at Liberia Hospital.

Looking back on this ‘sprint’ to complete a DialOasis prototype, I enjoyed completing this big project in such a short time period. We concentrated what really could have been a month’s work into one week. Yes it was hard, but having less time created more pressure to allow creative productiveness to flow. It was especially crucial to have the stakeholders’ thoughts on the project sooner rather than when the final product was fully complete to ultimately save time and money

 

 

 

Here at GMI, we tend to live by mantra of work hard, play hard. We ended our full week with an adrenaline rushing zip-lining tour in Monteverde! It was unbelievably amazing and exhilarating. The zip line course took us through the densely packed forests and high above the cloud forests, making us feel like birds in the sky.

 

We are now back in the central valley of Costa Rica in the city of Santa Ana. Although, I will miss the wildness and jungle setting of Guanacaste, it also made me appreciate what the central valley provided- less bugs and less humidity! This week we will get ready for our internships through a one week industry course. It is also my birthday on Tuesday so I’m looking forward to celebrating with my GMI team 🙂

Until next week! Pura Vida.

Posted in Tasha | Leave a comment

DialOasis Coming to Life

This week we’ve been “sprinting” to the finish line with our DialOasis project. A “sprint” is a five-day push to design and create a prototype of a solution. The goal of a sprint is customer feedback on the last day. This provides maximum value with minimal investment; usually, it is apparent during customer interviews if the product will be a failure once it gets to market. If a product is not economically viable, it is critical to discover it as soon as possible to minimize losses and move on quickly. In traditional settings, the product is only tested in its final state which is after the vast majority of the total time and money is invested. However, sprint flips this and tests the product as soon as possible in order to improve it based on customer feedback or scrap the project altogether. This approach complements the needs-finding approach to innovation that we learned earlier this month. The needs-finding approach is to design a solution that meets a need, not to design a product that the creator thinks would be useful. This increases the probability that the solution will actually be successful instead of just gathering dust in an abandoned warehouse. A sprint further increases the probability of success by incorporating customer feedback. (The definition of success depends on the company but may include: marketability, profitability, utility, improvement to quality of life, or total impact.)

Our CAD model of the cuartito prototype. Colors are exaggerated for effect and two panels are removed for viewing.

For our sprint this week, we focused on the DialOasis project, and we named the prototype “cuartito” which means “little room.” DialOasis is a device that was designed by the previous year’s GMI students to allow dialysis patients to receive treatment at home. This saves them about 50 hours per week in the hospital for treatment. We conducted our sprint in five days with the help of Invenio (a Costa Rican university) who aided in construction and provided indispensable supplies and expertise. We spent Day 1 finalizing our design, delegating tasks, and scouting the resources available. On Day 2 we bought materials and began construction. We continued construction on Days 3 & 4. Finally, at 9:00pm on Day 4, the prototype was built and loaded on a truck, we were ready for customer feedback on Day 5. We spent Day 5 at the hospital where we set up our cuartito for the current dialysis patients and physicians to critique. Overall, their impressions were very positive. In fact, because of the polite culture of Costa Rica, we had difficulties discovering what aspects of the prototype they would like to change. But after five patients, ten nurses, two engineers, and one hospital director, we had gathered some concrete improvements and precious feedback that will help us improve our design. The next steps will be redesigning, taking into account the suggestions we received, and then small-scale clinical trials in the fall.

The hospital staff that reviewed our prototype and the Invenio magicians that made it possible.

As with any team project, I learned some valuable lessons during the week:

  • Prototypes are vital to designs, the more the better
  • Team dynamics should be frequently reassessed

First, I learned that prototypes are vital to designs and should be made frequently in the design process. Prototypes are useful because they translate abstract ideas into reality. They help us communicate ideas while pointing out design flaws that are almost impossible to foresee on paper but often obvious while building or using the product. Prototypes offer a reliable measure of the feasibility of the product because they force generalizations and overlooked details onto center stage. I also learned that prototypes can be functional or aesthetic depending on the purpose of the prototype. For example,

Sitting in the cuartito. It was a very comfortable chair!

in our cuartito, the sink worked beautifully (functional), but the room was not draft-resistant (aesthetic). This was because the goal of our prototype was patient insights; patients needed to use the sink to tell us what they thought, but the cuartito could have drafts because we weren’t yet looking for regulatory approval or performing clinical trials. Another important concept I was exposed to was the balance between improving details of the prototype and focusing on the overall appearance and functionality. Since sprints typically last for only five days, it is vital to prioritize prototype features. Personally, I have a hard time completing tasks in a manner I feel is only half-way. This presents challenges for me then for prototypes because part of the definition of a prototype is unfinished. Thankfully, my teammates reminded me of this throughout the week and kept me on track. Another aspect of this was knowing when to backtrack and try a different approach before getting too deep or too attached that change is near impossible. This was a lesson hard-learned this week as we strove to optimize one part of the design and as a consequence neglected less important parts of the design like door handles and hose attachments.

It took quite a few hands to construct our cuartito.

Other important lessons that I learned concerned team dynamics. First, delegation is very helpful. However, it must be done carefully and reassessed frequently to ensure an equal distribution of work so that progress is made as quickly and efficiently as possible. This requires constant communication between each task-group. As an engineering student, I am not yet proficient at continual communication so our briefings at the start and end of the day helped me to understand what each task-group was working on and how all the pieces fit together. For my next sprint though, I would like to experiment with briefings at lunch as well to help reassess the workload distribution. Another lesson I learned about team dynamics concerned decision-making. Often, team decisions cannot be made unanimously because of time constraints and diverse perspectives, so compromising is important. This is reliant on an atmosphere that encourages critiquing design ideas at certain points. If ideas are never critiqued, then superior ideas cannot be synthesized. On the other hand, if ideas are never “frozen” to be beyond critique and change, then the work is hindered by second-guessing. So here we have another delicate balance. As a personal opinion, I think that aspects of the project that are moving more slowly than expected or are encountering difficulties should be “unfrozen” in order to reevaluate them and, as a team, decide the best way to move forward. I think this helps projects from getting bogged down. Also, it can be helpful to bring in another team member that has not worked as much on that aspect of the project as an unbiased opinion. This fights the attachment to one’s own work that is simply human nature. One of my personal goals is to learn to do this and to appreciate feedback that I do not want to hear. I have a tendency to get attached to my work, but one of the keys in a sprint is to be flexible and unattached to ideas in order to improve or quickly change tactics.

Overall, I believe our sprint was a great success. I know that I have been discussing mainly shortcomings of the week because those are what I learned the most from so let me say it again: I believe our sprint was a great success. We were able to construct and get feedback on a largely functional prototype of a very complex project in only five days. We worked hard and long to get it done, and it paid off. The feedback we received on Day 5 will propel us forward in our cuartito design. I greatly enjoyed the hands-on aspects of this project. Since I was little, I have loved to build things, whether with legos or power tools; I derive a deep sense of satisfaction in getting my hands dirty and seeing my designs come to life. I also enjoyed heading the effort of creating a CAD model of our design; it was just like seeing it come to life in the workshop, only virtually. I am very proud of the team’s performance in the entire sprint and our accomplishments, and I am very thankful to our partners at Invenio who made it all possible.

On a less serious note, more fun facts about Costa Rica:

  • It is so humid in some parts that the air dissolves candy mints that are left out
  • There are only two seasons: wet and dry and no summer or winter
  • Speed limits are in kilometers/hour and are rarely followed
  • Food is about the same price as in the USA while wages are well less than half which is why rice and beans are staple foods

 

Surf’s up!

At the risk of running a week behind my companions in narrating our trip to the beach last weekend, I’ll be brief: We went to two beaches, one each day. The first day, we surfed (which was an absolute blast!), we swam, and I galloped atop a horse on the beach (I’m not going to check it off my bucket list because it was so fun that I want to do it again). The second day was fun as well and more relaxing: we swam, got sand fleas laying on the sand, played Frisbee, and I made a sand castle.

Riding a horse on the beach: dream come true!

My sand castle reminded me of this verse and how God keeps me going.

 

 

 

 

 

 

 

 

 

 

This weekend, we toured Monte Verde via zipline. Monte Verde is a “cloud forest” which means that it is a rainforest that is high enough in altitude to be covered in clouds most of the time. It was amazing! We went on 9 normal ziplines (sitting position), 2 superman ziplines (laying position), and a giant Tarzan swing. The superman ziplines were my favorite because it felt like I was flying. The first one was actually the longest zipline in Latin America at just under 1 mile long and I went so fast that the rain actually stung my face. The Tarzan swing was certainly an adrenaline rush (so naturally I loved it). It was a 120-foot tall swing. I started at the top, and after being secured, I stepped off the platform. Since it was a giant pendulum, I free-fell the first 20 feet or so before being pulled into more of swinging motion. The trip was a welcome break to the 4-hour drive back to San Jose where we will be spending the rest of our time in Costa Rica.

Ziplining through the rainforest in Monte Verde.

The superman zipline was my favorite.

Pura Vida! And hasta la proxima semana!

Posted in Callie | Leave a comment