PTS Pulse Q3 2022

pulse Q3

Perseverance Pays: IVDR Certification and the 2022 Mexico Tender

On a typical day as a PTS employee, you might be a bit dismayed to see your email inbox filling up with dozens of rapid-fire messages from your bosses.
But it was no cause for email-induced anxiety on at least two days last month, as congratulatory messages poured in:

“Great job, team. This is a big deal.”

“Great job and your perseverance paid off!”

“Great news for all of us.”

“It sure is an exciting time to be part of PTS!!”

The causes for all this celebration were that, one, our IVDR team completed the process of self-certifying the CardioChek Plus analyzer allowing us to resume sales in the European Union, and two, we were awarded Mexico’s 2022 tender for lipid panel tests. Both are major accomplishments for us as an organization and are a testament to the grit and determination of PTS employees.

What It Takes to Get IVDR-Certified

In May of 2017, The European Union (EU) announced changes to its Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). The new regulations were designed, in part, to require more transparency from manufacturers and to unite EU member countries under a consistent regulatory framework.

In May of 2022, the EU began enforcement of the new regulations which requires manufacturers to have their products certified under IVDR before they can be sold in EU countries.

So, what has this meant for us and our products? Well, for starters, it has meant that our products were placed into new classes which require more rigorous documentation, and in some cases, additional certification by a “notified body” to become certified. (A notified body is a company that has been certified by the EU as a company that can legally certify manufacturers under IVDR.) It has also meant that before we could even begin the process of certifying a product, we had to certify our entire Quality Management System (QMS.)

Does all this sound a bit overwhelming? That’s because it is. Especially when you consider that no member of the IVDR team is solely focused on it as their only project. Each person on the team, which is led by Heidi Strunk, Carolyn Schmitt, Janice Keeney, and Steve Zucker, has been juggling multiple projects while wading through thousands—literally thousands!—of pages of new IVDR requests and clarifications.

Another important component of the project has been navigating the necessary changes to product labeling that are required with each IVDR submission. Latasha Little has led the IVDR labelling efforts for the better part of the last year, working in close collaboration with the Regulatory group to research labeling needs, create labeling drafts, and develop updated standards for creating artwork for vial labels, boxes, and package inserts.

This makes the fact that we were able to hit our deadlines for products in our space and achieve IVDR certification even more remarkable.

Being allowed to sell the CardioChek Plus analyzer in the EU has obvious benefits. But the current IVDR efforts may help us get additional products approved in the EU more quickly. Carolyn Schmitt, Regulatory Affairs Manager, explained:

“We took what learned from the QMS certification and applied it to the CardioChek Plus analyzer certification. Right now, we are working on getting Cholesterol and Lipid Panel through the certification process, and we are applying what we learned from the analyzer certification to those. Each one gets a little bit easier as we learn what EU commission and our notified body needs from us. There really wasn’t a roadmap, since all of this is new. We had to make our own.”

In the future, our IVDR efforts may also give us a future advantage in other markets. Other countries are beginning to request information in formats similar to the IVDR data submissions. The level of detail we have had to provide in our documentation of every aspect of our business—from production to post-market surveillance—and all the things we’ve learned along the way are preparing us to smoothly jump over any regulatory hurdle placed in front of us.

But what it takes to get certified under IVDR is more than an eye for detail and an abundance of patience. It takes people who care, and who work hard to support each other through big challenges like these!

¡Viva PTS! The 2022 Mexico Tender

Each year, our International Sales team submits a proposal for each of Mexico’s government tenders for A1C and Lipid Panel testing. Last year, we lost the A1C tender to a competitor. And, the Lipid Panel tender was abandoned, meaning that it was not awarded to anyone. It was a big disappointment, but it didn’t mean that David Brandt and his team were going to give up on it!

And, as we learned on September 7, that perseverance paid off. We were selected to supply Mexico’s government with Lipid Panel tests for 2022. According to David, this would not have been possible if we had not been in the right position to supply the tests.

“Before we can even bid, we have to complete all of our regulatory processes and make sure our Mexico registrations are current. We have the Quality & Regulatory team to thank for that. Also, the Mexican government had to feel confident enough in our operations to trust that we could deliver the products they needed on time. So, thank you to our production teams for running a world class operation. And, thanks in advance to our Customer Service and Technical Support teams who will be helping our customers in Mexico have the best possible experience with our products.”

Sinocare, Trividia, and PTS Diagnostics Kick-Off Cross-Selling Enablement Strategy

A salesperson’s efforts can only stretch as far as their product l know-how and insights. That’s why a team of representatives from PTS Diagnostics, Trividia, and Sinocare are working together to develop a comprehensive sales enablement strategy.

The team is led by VP of Global Marketing Laurie Gutzwiller and includes Sophia Sun and Echo Gao from Sinocare, and Annemarie Ramos and Olga Gutierrez from Trividia and David Brandt from PTS Diagnostics. Their goal is to create a process that will help our newly integrated international salesforce to fully understand each organizations’ unique products and their market potential.

Imagine that you are an experienced sales professional who is suddenly asked to start selling from two additional product portfolios, each with 30 or more individual offerings. What would you need to be successful?

First, you’d need information on which products can be sold in which countries. You’d also need information on pricing, target customer profiles, and talking points. You’d also need to know how to obtain the physical products yourself and learn how to use them for demonstration purposes. You would need to know who you can call for tech support and customer support. You’d also need access to marketing materials for the products and would need to know about current promotions—All of this and so much more!

As a result, during the summer of 2022, an array of customized sales enablement materials were made available to internationally focused marketing and sales staff from Sinocare, Trivia, and PTS. Included in these programs is information about A1CNow+, CardioChek Plus, the Safe BGM series, PCH50, the True Metrix portfolio and others. Together, the products form a robust catalog of diabetes, cardiovascular disease, and glucose management solutions.

“We want to give everyone the tools needed to be successful as we integrate the international sales efforts,” explains VP of International Sales, David Brandt. “The marketing team has prepared a lot of content for our newly development sales teams the resources they need to be successful.”

Sinocare Blocks

Product Highlight:
Sinocare Products

PTS Employee Spotlights

Annmarie Ramos
Director, Global Product Management

When did you join PTS?

June 2022

Name three hashtags that describe you.
#ItoldYouSo #Focus#Mermaid

Favorite place to “get away.”
The Florida Keys – anywhere on the water.

Best part about your job at PTS?
Learning new things! Every company is different but seeing the synergies and opportunities to grow allows for me to see the amazing things to look forward to!

Favorite part about working at PTS?
The people! It has been wonderful meeting and learning from everyone and having a great support group at PTS to help as I get familiar with the new products and new processes.

One thing you can’t resist?


Best advice you have ever been given?
Always lead with the positive before you state the negative!

Brad Combs
Executive Director, R&D

Brad Combs

When did you join PTS?
Trividia – May 2014, PTS – January 2022

Name three hashtags that describe you.
#LoveTheEverglades #Dedicated #Considerate

Favorite place to “get away”.
Florida Everglades (kayak fishing or hunting).

Best part about your job at PTS?
Working with really good people on creative solutions to technical challenges.

Favorite part about working at PTS?
Being part of a team that works well together.

One thing you can’t resist?
Outdoor adventures in the Florida Everglades
(or Chicago Style Pizza!)

Best advice you have ever been given?
“If you aim at nothing, you will hit it every time”
– (years ago from friend Zig Ziglar)

Kim Zeltwanger
Executive Director, Human Resources

When did you join PTS?

May 2022

Name three hashtags that describe you.
#PelotonObsessed #ProudSFUMom#DoingMyOwnThing

Favorite place to “get away.”
Anywhere with sun and salt water

Best part about your job at PTS?
Meeting and working with all the great employees of PTS

Favorite part about working at PTS?
All the fun employee events that PTS does (haven’t actually participated yet, but looking forward to doing so).

One thing you can’t resist?
Warm chocolate chip cookies.

Best advice you have ever been given?
Professional growth is not supposed to feel comfortable. Being uncomfortable means you’re learning and growing.

Sarah Chavez
Environmental Health and Safety Manager

Sarah Chavez

When did you join PTS?
December 1, 2015

Name three hashtags that describe you.
#LoveAllCreatures #LoveFamilyAndGod #LoveMyWork

Favorite place to “get away.”
My home.

Best part about your job at PTS?
Lifetime friendships.

Favorite part about working at PTS?
Knowing that we are making a difference in people’s lives.

One thing you can’t resist?
Helping a creature in need.

Best advice you have ever been given?
Always do your BEST!

Yazmín Liranzo
Payroll Manager


When did you join PTS?
Joined THI in March 2006 and took over the payroll for PTS in March of 2022.

Name three hashtags that describe you.
#Queen#CrazyGirl #Funny

Favorite place to “get away.”
Anywhere that has an All-Inclusive hotel stay – Mexico is my favorite.

Best part about your job at PTS?
Being The Money Lady and The Queen of Payroll.

Favorite part about working at PTS?
Great company! Employees are great – such a great environment to work in.

One thing you can’t resist?
Sweets – Cookies, Cakes – anything that has Gluten

Best advice you have ever been given?
Change your thinking, change your life. “Choose a job you love, and you will never have to work a day in your life.” – Confucius

HR Corner Reminders:

Cog Wheels

  • Please note the following PTS closures for the Fall/Winter holidays: 11/24 & 11/25, 12/23 & 12/26
  • Thank you, Josie Soliven, for organizing the Annual Indianapolis Indians Family event at Victory Field!
  • Please welcome our PTS University students joining our Whitestown Engineering Team: Bin (Tom) Yun & Shi Yin

Don’t Miss Out on These Rewards!

PTS offers the following reward programs:

Covid Vaccine: $100 gift card for providing a copy of your vaccination card

Health Rewards: $100 gift card for annual check-up

Gym Membership Reimbursement: $20 per month (paid quarterly)
Referral Bonuses: $500 after the referred employee has worked for three months

Additional details are available at

Quarterly Question

“What inspires you?”

The Saints!
— George Spoerl, Manufacturing, Sustaining Engineering, and Supply Chain

Walking in nature; being able to see the sky, feel the sun, and hear the birds and insects.
— Amy Howell, Customer Service and TSS

— Carolyn Schmitt, Quality & Regulatory

Jesus, authenticity, caring and Fridays.
— Will Benedict, Executive Team

What inspires me ? I have to be honest and I am not blowing smoke its Gary Johnson, no one works harder or smarter than he does. Great support you call him he responds right away and has an answer, keeps us all motivated with words of encouragement and support, brings positive vibes about the company. There is nothing more inspiring than a leader that leads.
— Mike Kraus, Domestic Sales

My inspiration comes from my daily devotional & then I try to be work in some endorphin releasing cardio!!!!
— Beth Russell, Domestic Sales

My family and friends inspire me to be the best mom, nana, friend I can be. My co-workers inspire me to continue to learn and make a difference for our company. My team inspires me to be the best leader I can be and help create a culture where people can grow and have fun while elevating our presence in our industry.
— Laurie Gutzwiller, Marketing

Going for a walk with my wife and dogs!
— Jonathan Deal, Marketing

Simple. Time with family and away from any mobile device recharges my batteries.
— Cliffe Allen, Domestic Sales

Good ole soul searching. Remembering how good I really have it!
— Amy Kersey, Finance

Two things that inspire me are: kindness and integrity.
— Margo Enright, Quality & Regulatory

“It doesn’t matter if you win or lose, as long as you win.”
— Gary Johnson, Domestic Sales

Exploring God’s creation with family.
Never cease to be awed and inspired by the Lord’s handy work.
— Cameron Dobson, Marketing

“Respect and kindness without agenda.
And also a crisp, fall day inspires happiness for me every time. 😊
— Latasha Little, Marketing

What inspires me is my family and my relationship with God. My husband and daughter are major factors in my decisions and my reactions. When I’m having a bad day, I say a little prayer to The Father.
— Wanda Franklin, Customer Service and TSS

— Andrea Sauceda, Marketing

My new husband, Hank!
— Gretchen Robertson, Domestic Sales

What inspires me, is when we go to events like the Indians game and I see the families of PTS employees as, in addition to what our products do to help the world, to me that is our “why.”
— Steve Riendeau, Executive Team

Work: I do take inspiration in knowing what we do at PTS around the world helps to save lives and improve health.
Personal: I am inspired by the way people deal with major health issues in ways that I can’t comprehend, my wife being one of those inspirational people.
Personal: music is uplifting and can take the sting out of a very bad day.
And as my inspirational leader, Forest Gump says: “And that’s all I gotta say about that!”
— Andrew Greaves, International Sales

Depends on the context but uplifting music and kindness gets me out of a funk.
— David Brandt, International Sales

Kindness, empathy and anything health and wellness related inspires me.
— Kim Zeltwanger, Human Resources

When I think of inspiration I think of my mother. She had diabetes and a lot of complications from that. No matter how sick she got or the how many things popped up she kept her head up, told everyone she was fine and kept moving forward. So when things get tough I think of her and just keep moving forward. That’s where my inspiration comes from.
— Janice Keeney, Quality & Regulatory

What inspires me is knowing that I am part of a team with a common set of goals. That gives me strength and confidence knowing that there are people I can rely on and forces me to pick myself up if I’m down as others are also relying on me.
— Jonathan Chapman, Executive Team

The Pets of PTS

PTS Pets 1