Spartan Insights: from Featured Spartan, Packaging Engineer, Donald Krebs.

This week’s Featured Spartan was Donald Krebs, Staff Packaging Engineer at Edwards Life Sciences, (See his LI profile.) Donald had agreed to answer questions about his industry, career background, and anything else he can help you learn to further your career. This discussion was be open from 04/15/15 until 04/28/2015.

Spartan Insights is a regularly scheduled Linkedin discussion thread inside of the MSUALUMNI Linkedin group. Each discussion is meant to give you the opportunity to ask questions regarding one Spartan’s experience within a specific company, industry, or occupation. Answers will be given at the convenience and discretion of the featured Spartan and will be answered from the Spartan’s own personal experiences and opinions which are not meant to be representative of his/her company’s official position. Questions regarding a person’s applicant status at the featured Spartan’s place of business will not be answered in this forum. Interested in being a helpful Spartan? Contact me at isbelld@msu.edu.

Donald Krebs

Hello Fellow Spartans, I’m happy to answer any questions I can in hopes of being helpful.

May 20th will be my eight year anniversary with Edwards Lifesciences. Since I have joined the company it has nearly tripled in size. During that time I have gained experience in packaging and manufacturing engineering. I currently support our $820 million Heart Vale Therapy Business. I recently just finished my MBA at the University California, Irvine. Additionally, I have recently achieved Six Sigma Black Belt Certification. I’m currently managing the projects of a group of eleven engineers with a pathway to move into a leadership function.

Let’s see how much interest, if any, a Packaging Professional receives on this forum! 😉

All the best,

Don

Dave Isbell

Hi Donald, Thanks for being here and ready to help Spartans to learn! I’m hoping we can get some of the other people in packaging to chime in here, but to start, can you describe to us who are not packaging professionals what a typical day/week might look like in that occupation? Why might that be relevant for someone in a different section of the company, say marketing or accounting, to know what those of you in packaging do for the business?

Eric – Donald, As a small disposable medical device company, we often struggle with the costs of quality testing/certification. Does the university offer any means to perform packaging, sterility, and aging testing? Next, what is the future of biodegradable packaging in the healthcare industry.
Thanks for making yourself available!

Donald Krebs

Hi Dave, Absolutely! First of all, in most large Medical Device companies there are two types of packaging engineers: Packaging Development Engineers and Sustaining Packaging Engineers. Packaging Development Engineers work with cross functional R&D teams to develop new packages for new products, while those new products are in the development process. Sustaining Packaging Engineers, which I am one of, address packages of products that have been commercialized. A sustaining packaging engineer is responsible for cost savings projects, packaging design changes (post launch) that may derive from complaints or changes in the market/supply chain, validation of alternate material, manufacturing equipment troubleshooting, root cause investigations, and representing the company during regulatory body inspections such as the FDA or TUV for example. A packaging development engineer is responsible for understanding the customer needs and translating them into measurable design requirements which the final package that is developed can be objectively measured against to prove adequacy and of court validation and verification activities. The staple to any engineering function (packaging and beyond) in the medical device industry is validation and verification. The medical device industry is a highly regulated environment and all engineering activities must be proceduralized and documented. One must “Say what you do, Do what you say, and Document it”. To answer your question from a sustaining packaging engineer perspective, it is hard to have a routine week or day because I look at myself more as a fire fighter. I do have long term projects however issues arise in manufacturing and in the supply chain on a weekly basis that must be dealt with therefore it is hard to have a “routine”. I really enjoy the sense of urgency my job requires because it makes the days go by fast and helps me know I make a difference in the business. I hope I answered your question Dave!

Donald Krebs

Hi Eric, thanks for the question. To my knowledge MSU School of Packaging does not have a laboratory certified for packaging tests on medical devices however I would wager there are local private testing labs that are in South-Eastern Michigan. Private message me if you have trouble finding one, I would be happy to assist you.

In regards to your question regarding biodegradable packaging materials for medical device packaging, I would say the one material that I have seen with true potential is PLA. Granted PLA won’t withstand most sterilization methods, it could be a good material for non-steriles. In my opinion, the unfortunate truth is there will never be a place for biodegradable packaging material for the primary packaging of sterile medical devices because the barrier requirements are extremely high and the sterilization environments too harsh. I do believe there is a great deal of opportunity in secondary and tertiary layers however. In these instances the PLA packaging layer would have to be added after the sterilization process to avoid degradation. PLease let me know if you have more questions! Thanks

Eric – Donald I appreciate the insights. Let me digest your reply and I’ll get to you.

Colleen – Hi Donald, A good friend of mine is currently studying packaging at MSU while I am studying Marketing. She had an internship with a food and beverage company and often griped about the marketers not considering how their ideas impacted others (in this case, the packaging engineers). Can you explain how you work with marketers when developing new product packages and any common issues that arise?

Curtis – Do you do seal strength testing at ELS? How do you establish your minimum seal peel strengths for your sterile barrier systems. Are they the same for different material combos and sterilization modalities? Is it an arbitrary number lost in the fog of time?

KaraHi Donald! I see you answered Eric’s question regarding biodegradable packaging materials for medical device packaging, but I was curious about your insights regarding biodegradable packaging in general. I don’t know much about the packaging industry, but I am passionate about environmentalism and wondered how the packaging industry is developing more eco-friendly materials?

Donald Krebs

Hi Colleen,

That is a great question! Edwards is a R&D driven company in an extremely regulated environment where as many food companies are marketing driven in a less regulated environment. This makes my experience with the Marketing department extremely different than your friend’s. Our marketing department has nowhere near the freedom as they do in food and beverage companies because priority number one of all medical device companies is to ensure patient safety. Many times the marketing department approaches our packaging department collaboratively exploring options of what we could or couldn’t do with a package design. The marketing department depends on the packaging group to ensure that the packages are able to deliver our devices in a sterile state as our products are implantable devices. If the devices are contaminated that could cause serious complications to our patients, even death.

The parallel to your friend’s problem in the medical device industry is that packaging has historically been somewhat of an after thought. Historically, the device development teams often brought packaging into the project at the end after the device has been developed and basically say “package it, and do it fast”. This approach eliminated the packaging engineer to fully understand the device, which could allow him/her to create competitive advantages through features of the packaging. This trend is changing due to the focus the notified bodies like the FDA have been placing on packaging validations. As of late, at least at Edwards, packaging engineers are brought on early in the development of devices allow for really cool packaging innovations, which make the interaction of the clinician with our devices easier and more positive.

I hope this gives you some insight on the differences between the food and medical device industry in regards to packaging challenges.

Donald Krebs

Hi Curt!

I hope you are well! HealthPack isn’t the same without you, sincerely. Is this a track question? As you know, Edwards commissioned the brilliance of the Spartan Design Group to cover this very issue! You’ve probably forgotten more on this topic than I will ever know 😉

Without compromising any IP of Edwards, yes we conduct seal testing to characterize our packages during validation so that we can subsequently use seal strength testing for in-process monitoring and lot release testing. We have two types of seal strength specifications Process Specifications and Design Specifications. Our design seal strength specifications define the minimum seal strength needed to maintain a sterile barrier for a given package after distribution and conditioning until the point of use. Process specifications allow us to keep an eye on our sealing processes and rapidly detect if there is a problem with equipment (such as drift) or material (lot anomaly). Of course this is all governed by ISO 11607.

Donald Krebs

Hi Kara, Sustainability and carbon footprint of a given company is a very important topic in packaging and it is because of rightfully conscientious consumers like yourself. Consumers are simply more likely to choose a more environmentally friendly product over another substitute that isn’t as environmentally friendly. This impacts sales, which gets all companies’ attention. A major element that directly impacts the measure of a company’s sustainability is its packaging. After all, the packaging is what ends up in the landfill in all cases. The truth is, sustainable packaging such as reusable packaging or biodegradable packaging is more costly than “environmentally unfriendly” packaging. Therefore for more companies to adopt such packaging there must be a demand from the market. Consumers must be willing to pay more for the environmental options which will “pull” more and more of these packages into the market.

Curtis –   Thanks for your kind words Don, I appreciate them very much. No, this inquiry was not a set up, in fact the setting of baseline minimum specified values has been a much misunderstood process. The reason I asked was this forum made it easy….and we hear this so often from our clients. There are conflicting interpretations by FDA, CDRH field personal, file reviewers a notified bodies…and they all swear that they are right. The MDM doesn’t know what to do. I’ve found that the specific number you assign to a seal strength is not nearly as important as “do you check for it” at appropriate times during the R&D, manufacturing and sourcing of the SBS components.

Dave Isbell

Donald, what advice would you give for aspiring packaging professionals as they graduate in the next month or so? What might you tell a current student who has not yet chosen a major about why packaging is a profession s/he might want to consider?

Donald Krebs

Hi Curtis, Thanks for sharing the reality of the situation. It is amazing how something like specification derivation can be so ambiguous! I am extremely biased but I think Edwards is pretty advanced on how we develop our specifications.

Donald Krebs

Hi Dave, I would encourage an aspiring packaging professional that is graduating next year to take a second internship if they don’t already have a job lined up at this point. Employers these days are looking for experienced new hires. The more experience you can gain through MSU’s School of Packaging the better off you will be. Additionally, taking an internship in a new industry gives you a chance to test out an industry to see if you like it more or less than another industry. I would also recommend a student that is about to graduate to really work hard to make lasting ties with your classmates and supporters of the MSU School of Packaging. Get involved in as many extracurricular activities as possible and have fun!

To the students out there that are undecided in their majors I say this; there are less than ten Universities in the US that offer majors in Packaging. Michigan State University’s School of Packaging is ranked number one and the biggest, graduating about 300 students each year. If each school was graduating as many students as MSU (and they’re not) that would equate to 3,000 new packaging professionals entering the market each year. Compare that to any other major at Michigan State and you will see that the job market supply is relatively low to other majors such at Mechanical, Chemical, Civil Engineering. There is a high demand for Packaging Professionals because they are hard to find. If the supply is low and the demand is high then it really puts you in a good position of negotiation.

In short, if you’re a hard worker and a packaging major from Michigan State you will always have a job with recruiters contacting regularly about positions across the country. Excellent job security!

Dave Isbell

Thank you Donald for sharing your insights and for your willingness to help Spartans in this way! This Spartan Insights discussion was originally hosted in the MSU Alumni Association Linkedin group. Look for new discussions starting every week!

 

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