Lessons Learned Working at Neodyne Bioscience in 2015 and 2016

This is a summary and reflection of my work at Neodyne Bioscience in 2015 and 2016.  Not only did I become a project manager on R&D project, but I also worked on several Operations and Quality Assurance projects that involved transforming a CAD file on the computer screen into a feasible product in the customer’s hands. I came away with a better understanding of system thinking and producing medical devices.

About Neodyne Bioscience

Neodyne Bioscience Inc. is a Class I medical device company located in Northern California that specializes in scar management technology.  Their non-sterile Embrace product is a disposable applicator that transfers a predetermined level of strain to a single-use adhesive silicone sheet. The product is placed over a closed scar resulting in a uniform compressive strain, or stress-shield around the closed scar, which can minimize the visibility and profile of a scar.  This mechanical shielding is better than creams, oily gels, and static silicone gel sheeting.

(Here is a pdf of the powerpoint slides I created:neodyne-internship-presentation-v2)

embrace-products

Neodyne markets 4cm, 6cm, and 16cm sizes of the Embrace product to physicians is developing a retail channel for 4cm and 12cm sizes of the Embrace product and 12cm Minimize product.  The Minimize product does not transfer a level of strain. Instead, it incorporates silicone’s restorative properties to help minimize the profile and size of a closed scar.

I worked at Neodyne as an intern in 2015 and 2016

The great benefit of working at a small company is that I often got to work with different people on different tasks.  Not only did I work on R&D tasks, but I also worked on several Operations and Quality Assurance projects.  Interning at Neodyne for the second time, I was able to increase the versatility of skills and projects in comparison to my first summer there, and I was very surprised in how much I learned and experienced despite only being there three months.  I came away with a better understanding of what it takes to design and produce medical devices. Below is an image comparing what I did between my two summers.

first-and-second-summer

A few months before I arrived, the company was about to go to market with the 16cm size Minimize product, but the Marketing team determined the 12cm size would be better for the retail customer. When I arrived, the 12cm initial design was complete and needed to be sent out for quotes on materials and labor. The 12cm design also needed FDA documentation just like we had for the 16cm size, but most of the documentation stayed the same between the two projects.  The project plan and schedule needed to be heavily modified.  I had demonstrated domain expertise that earned the trust of the department heads to become one of project leads for the Minimize product and giving me firsthand experience at being a product manager.

1612-minimize-product

Within R&D, I recorded detailed notes about several in-house experiments including the effects of adhesives from Tyvek material to paper, wear studies, and tensile tests in various applications.  The testing often focused on cost reduction and while maintained the production specs such as effectiveness and duration of the product.  This was needed to justify the use of alternative materials.  Phil Wadlow, another engineer, and I collaborated to create new fixture designs to address in-house and contract assemblers’ complaints and experimentation needed for new devices. I created parts and assemblies, correctly mated parts together, created exploded views, and used configurations within assemblies all on Solidworks 2015.  Go/No-Go gauges and assembly instructions were also needed for the new company product to ensure each process step was in the specification.  If results continue to prove to be successful, I may have my name included on a patent for work I did on the company’s future pipeline project.

rd-iceberg

I soon realize working with the R&D team (and the other departments) that an R&D project doesn’t just consist of CAD work.  It takes a whole lot of work to transform the CAD on the computer screen into a feasible product in the customer’s hands.

Tracking the Scrap

My first project with the Operations team was to create Pareto charts and Excel spreadsheets to track the various aspects of the scrap rate of the assemblies and the individual parts. We wanted to see what step of the building process had the most scrap and what was affecting the yield. Below the picture shows the high-level process of creating the product.

scrap-analysis-slide-1

Since the complaints process was a beast of its own, I was told not to include those in the scrap analysis.

scrap-analysis-slide-2

The contract manufacturing would get the raw materials from the suppliers, and they would build it per the work instructions that we gave them.  We would then receive the product and check a random sample.  If the product passed our screening, we would ship three products and instruction to the customer. This process might seem simple, but tracing the errors and scrap material is very complicated.

scrap-analysis-slide-3

Ultimately, I sorted the different places where the product might fail, and I categorized the errors at the contact manufacturer as either part, operator, or fixture errors:

  • Part errors meant the raw material were out of spec and the raw material had traceability by comparing the parts to the drawing. At this step, if many parts were failing, we would talk with the supplier to understand the issue.
  • Operator-related failures were classified when scrap was caused by cross training or backup assemblers replacing the sick or vacationing primary assemblers at the production line.  There wasn’t much we could do to fix these operator-related failures so we would phone over to see how long the situation was supposed to last.
  • Fixture problems were evident when multiple independent assemblers had similar failures. These type of failures required the R&D team to work with the assembler to better address the fixture issues. The fixtures problems were the area I mostly addressed.

scrap-analysis-slide-4

Based on an initial data analysis, I thought that the errors with the first part we related to the raw materials, but I realized was the buildup of scrap was due to the later building steps.  The errors at the first step accounted for the first item; however, the second step errors accounts for both the second item and the first item that was, unfortunately, scrapped along with the second item.  All but one of the items are permanently attached to each other after each step, so the last step created five times more scrap than the first step.  During my short time at Neodyne, I focused my time on improving the passing rate of the last step of the fixture design.

steps-of-scrap

The numbered boxes are the items apart of the build process, for example, step 5 has 5 different items each from the previous steps.

Around this time, Juliet Heye had joined Neodyne for a summer internship. One of the projects Juliet and I collaborated on was addressing the product’s lot information smearing off after handling. As the project progressed, we discovered that this problem had multiple solutions.  We reached out to our main supplier and other suppliers to evaluate our options based on cost.  We tested different inks on established plastic labels versus the same inks on paper labels.  We found that some of the inks either scratched off or smeared off the labels.

“Compromise means both sides give more than 50%”

After talking to the Marketing department, we discovered that the plastic labels had been chosen for their transparent aesthetic look instead of generic paper labels. Since the products were moving to retail stores, the final label had to pass the cost and aesthetic criteria. This collaboration of Marketing and Engineering departments taught us a lot about dealing with multiple voices and opinions. We realize we couldn’t optimize any one attribute of ink and label to make everyone agree.  We found a good combination of ink and transparent labels that made everyone satisfied.

ink-label-problem

The Three P’s.  Products, Packaging, Pallets.

I also learned about pallet configuration, testing for transit shipping, and some of the underlying principles of packaging science.  I took a pdf catalog of the top sellers of boxes and to determine what size shipper box gave us the lowest price per product derived from dividing the length, width, and height of the shipper box by length width, and height of the product.

Within the initial testing, it was found that stacking more than seven boxes on its smallest side caused the product to fail the drop tests, so this eliminated some orientations of the product in the shipper box. There was a tradeoff between the integrity structure of the products versus the number and cost of shipper boxes on the pallet. The number of boxes is also a part of another tradeoff of choosing between the easy-to-design custom size boxes and the cheap standard size boxes.

We ultimately found that we would be using enough custom size shipper boxes at a reasonable price to fit eighty products per shipper box.

I put in a lot of work into the pallet configuration even doing some research to see if there was any free software to help with the process. We also visited a packaging engineer who greatly helped us better understand the packaging science and common practices for medical device field.  We learned about the testing that our pallet would need to undergo. We were given a tour of the testing faculty which was very interesting and eye opening. The following images show brief some of the things we learned.

talking-to-experts

best-and-worst-case

Finally, Juliet and I were tasked with preparing the correct NAFTA documentation for contract manufacturer in Mexico to receive and send parts into the United States.  Along with the paperwork and record keeping, we were able to help out Quality Assurance. Any new document or modification to anything in the company had to go through the DCO (Document Change Order) process, and we were often tasked with the first few steps of the process. Listing what new or modified document this DCO was about, the justification or follow up action that needed to be done to approve the new or changed item and handing off the physical copies of the files to be signed off by the required personal are the steps we learned.  We gained enough trust to close or perform the last step of the DCO process which is to go through and make sure the digital document or drawing matched the hard copies that were signed off by the required people.  Then the correct version had to be filed away, and the earlier hard copy versions had to be archived.  This side of the medical company was a very important function of the organization while its value is hidden to most employees outside of engineering and other support departments.

qa

After Action Reports

Given the different dynamics of projects in school and industry, after actions reports aren’t done in school, but are very valuable in the workplace.  At the end of every project or major task I did, I would take some time to write up a brief summary of what I developed, instructions, and three things I would have done if I had more time, resources, etc.

While analyzing the cost of the ink and label, we explored different areas of the product that could be changed to save money.  The Tyvek Chevron pouches could be changed to smaller corner peel paper pouches.  The products used the Tyvek pouch to give the product a more medical aesthetic look than other; the paper pouches cost significantly less than the Tyvek pouches.  Corner peel couldn’t be done on the Tyvek pouch, but the corner peel style doesn’t take up as much material as the Chevron style which allows the pouches to be shorter.  Corner peel style would mean smaller pouches as well as smaller cartons and cardboard shipper boxes.  I did the next best thing I could do, I wrote all this down and passed it on to other people by the time I left.

proposed-plan-after-leaving

What I Learned

All those things mentioned above summarizes the work I was a part of during my summer internship. I want to use this last part of the post to explain some other things I learn.

The best way to get another company to either send you information or send you a sample of material is to say that you are the head or VP of a department in the company. However, it’s best that your choice doesn’t exist in the company while still sounding like a legit, real position. At one of my companies, I said I was the Head of Materials or the VP of New Initiatives. Frankly, no one has time to help an intern.

A three-minute phone number will save you a three hour Google search. The trade-off between calling someone or emailing someone is that phone calls are great for getting information quickly, but email conversions are for great for traceability and forwarding that information quickly to a group of individuals.

I have found that when I send a brief summary of the topics or questions, I would like to go over, people are better prepared for the meeting and in effect reduces the meeting time. This is especially more valuable for introverts who typically don’t like thinking on their feet and rather prefer the extra time to prepared.

Whenever there is a process involving multiple people, it is very important to see what their personal checklist or the things they look for at their step of the process. For example one person considered he or she is done when X & Y is done; however, the next person will consider starting when X, Y, and Z are done.  There might be a company policy or a way of doing things, but there can be a preferred, hearsay procedure that people might have.

For an intern, the how you do something can be more important than obtaining the right answer. If you can show that you walked around and explored different approaches to solving a problem because some problem’s solutions are recommendations or options, not facts.

learn

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