PTS Pulse Q3 2023

pts
pulse Q3

PTS Pulse October 2023

Employee Connection:
One Sinocare: Pioneering the Future of Diabetes Management

In a pivotal town hall meeting held on July 19, 2023, at the PTS Diagnostics headquarters, Chairman Li, President of Sinocare, and Jonathan Chapman, CEO of PTS Diagnostics and Trividia, outlined the transformative journey ahead for the healthcare industry. The meeting served as a platform to discuss the challenges and innovations in diabetes management, unveiling a vision that encompasses One Sinocare, the partnership between Sinocare, PTS Diagnostics, and Trividia.

Chairman Li, a medical doctor with a profound understanding of healthcare dynamics, began by framing the identity of Sinocare as a “Digital Diabetes Leader.” He recognized the global shift towards chronic diseases as the paramount health concern. The rising prevalence of diabetes, once rare in China, now holds a prominent place in worldwide health concerns. A striking revelation was that 40% of diabetes complications are related to cardiovascular issues, emphasizing the need for comprehensive care.
Chairman Li outlined the future as “PreVantage,” a revolutionary concept bridging the gap between doctors and devices. The vision is to offer products that encompass the full range of diabetes-related chronic disease indicators, from cholesterol to creatinine.

Jonathan Chapman, the CEO of PTS Diagnostics and Trividia, resonated with Chairman Li’s vision. He shared a noteworthy analogy, recounting the 1992 Dream Team Olympic basketball’s early struggles, illustrating the significance of teamwork over individual prowess.

Chapman’s emphasis was on integration and standardization across One Sinocare. He highlighted the inherent benefits of size in risk mitigation and investments. However, he assured that each company would retain flexibility for localized agility.

PTS Diagnostics, under Chapman’s leadership, reported a robust start to the year, surpassing expectations across all brands. The European CardioChek business, in particular, stood out. Chapman acknowledged that this success also brought the challenge of meeting customer demands for “just in time” order fulfillment, which necessitated close customer engagement and proactive sales forecasts.

The introduction of the cobranded TRUE+ A1CNow Self Check project presented an exciting opportunity with pharmacy connections, prompting careful resource allocation considerations.

Chapman also provided context for
PTS Diagnostics in alignment with Sinocare’s vision. Their aim is to transform complex health data into clear, actionable, and practical advice for patients. This shift is crucial in response to the pandemic’s disruptive products, changing demographics, and evolving patient expectations.

Chairman Li emphasized the vital role PTS Diagnostics plays in delivering high-quality products to patients. The collaboration within One Sinocare, he believes, will significantly enhance product quality.

A recurring theme throughout the meeting was the need for mutual understanding and trust among the companies. Chairman Li recognized that as the companies evolve, they must embrace diverse personalities and approaches while working towards the same global goal. This adaptability and tolerance for differences will render us more competitive on the global stage.

The town hall meeting on July 19, 2023, marked a significant milestone in the journey of One Sinocare. The unified vision of combining resources, expertise, and cultures is set to drive innovation in diabetes management and ultimately improve the quality of life for patients worldwide. With trust and understanding as their foundation, Sinocare, PTS Diagnostics, and Trividia are poised to lead the way in revolutionizing the healthcare landscape and achieving their shared commitment to making a positive impact on the lives of those living with diabetes. 

PTS Quality Team group photo


The PTS Quality Team Embraces and Embodies Excellence

In the ever-evolving world of medical device manufacturing, ensuring the highest standards of quality is not just a goal; it’s a commitment. Our Quality Assurance (QA) and Quality Control (QC) teams play a pivotal role in upholding this commitment. During a recent interview with our Quality team, we gained valuable insights into their proactive approach and dedication to maintaining excellence.

While quality is ultimately the responsibility of every employee within our organization, the quality team helps us maintain the high standards we’ve set for ourselves by developing and maintaining a series of checks and balances.

Quality Assurance and Quality Control

The Quality Team can be described as having two primary areas of focus: Quality Assurance (QA) and Quality Control (QC).

QA is a proactive force within our organization. They have implemented robust systems to ensure that quality procedures are met, emphasizing the prevention of defects before they occur. Compliance is a fundamental aspect of their role, ensuring that we adhere to the rules and regulations that govern our industry. They understand that staying ahead of the curve is key, constantly reviewing and adapting our processes to align with new standards.

QC, on the other hand, serves as the final gatekeeper, diligently inspecting products for defects and making corrections before they leave our facility. Their focus is on product quality and reacting swiftly to maintain the highest standards. They are the people who keep the product moving out the door to keep pace with customer demand.

A Legacy to Be Proud Of

The Quality team is made up of some of the most tenured professionals in the company. Many of the team members have science or engineering backgrounds and have gained valuable on-the-job experiences during the many years they have spent at PTS.

A few highlights for the team, include:

Their role in the handling of the FDA Warning Letter, which required quite a bit of determination and resilience. Thousands of pages of documentation passed between our staff and the FDA during the warning letter period. The quality team remained diligent for years opening Corrective and Preventive Actions for each observation and providing monthly updates throughout the process and ensuring that every concern was addressed meticulously.

Their repeatedly positive audit results, year after year which require a comprehensive review of our current processes to help us ensure that we are always in compliance with the latest industry standards.

And the certification and re-certification of our products by industry standards, like CRMLN and NGSP. Achieving and maintaining product certifications is no small feat. It requires months of dedicated effort, collaboration with healthcare professionals and labs, and rigorous testing.

On top of all of that, the team has also been instrumental in implementing product improvements, ensuring that our offerings continue to meet and exceed the expectations of our customers and regulatory bodies.

One Unified Team

Although the Quality teams face stress and pressures each day, they truly enjoy their work while enjoying each other’s company. They credit their boss, Heidi Strunk, with creating an environment where they feel they are working as a unified team toward a common goal: upholding quality excellence in all aspects of their work.

One thing that quality team wants you to know as PTS employee, is that they see you as an extended part of their team, too. Since Quality is everyone’s job, the team issues CAPAs and NCRs to help us all better understand the roles we play in helping produce the best possible product. CAPAs and NCRs aren’t punishments; they are invitations to join them in PTS’s continued journey toward excellence.

All in all, we believe that our Quality team is one of the best in the industry. Their dedication, expertise, and proactive approach ensure that we continue to thrive during dynamic and challenging times. We salute their unwavering commitment and look forward to the continued success they will bring to our organization.

Accuracy Vs. Precision
You may have seen the words “accurate and precise” used to describe our devices. But do you know how those two terms differ? Take a look at the infographic below for a quick explanation.
Accuracy definition vs Precision definition

PTS Employee Spotlights

Wahnetta Beverly
Automation Supervisor

We’re dedicating a special Employee Spotlight to Wahnetta Beverly this quarter. She’s retiring after 25 years of outstanding service to PTS. We asked her a few additional questions about her time here and what she’ll miss (and not miss!) about her job.

Wahnetta Beverly - We'll miss you!

When did you join PTS?
September 21, 1998

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

Favorite place to “get away”.
Home doing crafts, and walking my dog.

Best part about your job at PTS?
Working with and meeting an amazing group of people.

What do you like best about working at PTS?
Producing the test strips. Running the automated machines.

When you first started working at PTS, did you think you’d stay for a long time? Why or why not?
When I first started I had no idea I’d be here this long. I had previously worked for Indiana Bell or Ameritech, now AT&T, for 26 years. Had my own Daycare for 4 years and was tired of the mothers not appreciating my help. My niece sent me here. I started out in Manual Strip Production. There were only three of us. This was a new company I had no idea we’d grow and still be operating. Sometimes we didn’t get paid. I just needed to work and put my daughter through school. Sorry long story, but no I didn’t even think about how long I’d be here.

What’s one thing you’ll miss about coming to work every day?
Well, I’ve known almost everyone since I’ve been here. It’s like leaving a family. I’ll really miss my team in Automation.

What’s one thing you WILL NOT miss about coming to work every day?
I won’t have to get up and take the drive to be on time in bad weather or worry about the roads. It’s been a pleasure working here. All in all it’s been a good adventure in my life.

Do you have a secret talent? What is it?
I love to do crafts. sewing, embroidery.

One thing you can’t resist?
Sweets, chocolate.

Best advice you have ever been given?
Do unto others.

Michelle Deal
Sr. Quality Compliance Principal

Michelle Deal on Vacation

When did you join PTS?
September 2006

Name three hashtags that describe you.

#LoveMyFamily #LoveMyFriends #Caring

Favorite place to “get away”.
My very favorite place is home!

What do you like best about working at PTS?
The best part of working at PTS is working alongside all of the great people. I have made so many wonderful friends throughout the years.

Best part about your job at PTS?
I have done many jobs in the 17 years I have been at PTS, and the common theme among all of them has been being fortunate to be in a position to make quality products alongside quality people.

Do you have a secret talent? What is it?
I can plank for 8 minutes. Silly!

One thing you can’t resist?
Listening to 70’s music (and maybe blaring out the lyrics).

Best advice you have ever been given?
Treat people the way you would like to be treated. I really try to live that daily.

Alexandre Lages
Regional Sales Manager Europe

Alexandre Lages headshot

When did you join PTS?
February 2023

Name three hashtags that describe you.
#Active #Independent #Adventurer

Favorite place to “get away”.
Driving in a speed track.

Best part about your job at PTS?
Meeting with customers and helping them find solutions.

Favorite part about working at PTS?
Having a fantastic and competent team supporting my work!

Do you have a secret talent? What is it?
Crafting

One thing you can’t resist?
Enjoying Life 🙂

Best advice you have ever been given?
Don’t be afraid to fail, follow your instinct!

HR Corner:

Cog Wheels

Company Events Survey

Thank you to all who completed the Company Events Survey! Your responses will be used to help HR plan for future events. We will do our best to incorporate the input as feasible within a reasonable limit based on schedules, budgets, etc. We truly appreciate your time and valuable input!

Sunnyvale Statistic table
Whitestown stats table

Upcoming Company Events

Watch your email inboxes! More details about each event will be sent when the time draws near.

  • Pumpkin Hunt: Starting October 3rd, twice a week, there will be a pumpkin hunt! We will hide the pumpkin around the building and whoever finds it wins a gift card!
  • Halloween Costume Contest: Dress in your best costume! The winners will receive gift cards!
  • Chili Cookoff: For those who want to compete for the BEST chili, you will have your chance! We will have a chili cookoff and employees will have small samples to see which they would vote #1! The winner will receive a gift card!
  • World Diabetes Day: Selfie booth, giveaways, and more. Details to come!
  • Thanksgiving Luncheon: Details to come!
  • Elf on the Shelf – Month of December: Starting the first week of December, up until Christmas, we will hide elves twice a week! If you find an elf, you will win a gift card!
  • 2023 Holiday Party: Details to come!

Quarterly Question

Each quarter we ask PTS employees to participate in a fun question ranging in a variety of topics.

“Would you rather live without air conditioning (heat and AC)
or without internet access? Why? ”

“Would you rather live without air conditioning (heat and AC)
or without internet access? Why? ”

Internet! Being too hot is miserable.
68°.
— Brittany Dobson, Document Control

I would go without internet access. I enjoy the climate controlled comfort of my house. 68°, year round.
— Carolyn Schmitt, Regulatory

I’d rather live without internet access. I still have my cellular network. There is no way I’d survive without AC. 69°.
— Jade Campbell, Operations
Internet.

I hate being hot! . During summer 70°, during winter 65°.
— Amy Howell, TSS

Without internet because I could go to a Starbucks for internet.  I could not function as a human without AC. 75°.
— Wanda Franklin, Technical Support

I would rather live without air conditioning than not have internet access because the work I do requires internet connection.  I have lived without air conditioning half of my life; I can live without it again. I cannot feed my family without work though, so my logical conclusion is to have internet rather than air conditioning. 72° Farenheit.
— Almi Joseph, Finance
Internet access.

You’d be miserable without either one of these, but you can’t DIE from lack of internet access. 70°.
— Issa Emeish, Legal

I should say the internet because books exist and homeostasis is more important than YouTube, but I choose heating/cooling because i’m a stupid human man in 2023. 73°.
— Harley Howell, Customer Service

Temperature control. The internet is how we interact with the world today. 73°.
— Alex Bridges, Ops Engineering
Internet Access.

I’m old enough to have without the internet and I don’t live in a mild climate. We could probably survive without A/C, but probably not heat in our winters. 73°-74° in the summer.
— Cameron Dobson, Marketing

I find it essential to have access to both air conditioning and the internet, as they contribute to my physical comfort and mental well-being, respectively.
78° Farenheit.
— Jianwen Cai, Alignment 
Internet.

I would rather enjoy the cool house with my family. Everyone needs to unplug and get back to what is important in this short life, their family. I get upset when I see everyone seating around the living room, lounging on the couch with their eyes glued to their phones. Let’s get back to conversations instead of TikTok, Facebook and bad news. 68°.
— Amy Kersey, Finance

Without Internet. Lived the past 3 years without it and only recently got it for my wife’s WFH job, not hard to do if you don’t do any streaming. 78°.
— George Spoerl, Ops Engineering

Without internet access. I’ll just read a book with my AC going! I can’t sleep while hot. 69°.
— Abbey Braasch, Human Resources

I live in Florida. AC is an essential item, more so than internet access. 74° during the day and 68° at night .
— Kim Zeltwanger, Human Resources

I can’t live without either 🙂 71°.
— Amanda Wethington , Accounting

Internet is an employment necessity, so it’d be nearly impossible to work without it. That said, I’m old enough to remember what living without internet access was like, we all managed. Depending on the climate going without can be life threatening. Ex three-fourths of Alaska is in the North Temperate Zone & one-fourth is north of the Arctic Circle the lack of heat is life threatening. Florida ranks overall as the warmest state year-round, central heat & air will always be my choice. 70° Farenheit.
— Jeanny Garcia, Customer Service

No AC. I’ve been camping in 90°+ degree weather and -5° weather and have been fine. But considering my job is in IT, Internet access is kind of important. 72°.
— Mark Sweet, IT

I live in Arizona so it would need to be air conditioning in the summer for my survival. I’ll give up Heat in the winter for Internet Access! 76°.
— Don Bellissimo, Sales

I would choose to live without air conditioning. I am not a fan of being cold and I rely on the internet for both work and entertainment purposes. It allows me to stay connected, research information, and unwind after a long day. 78°.
— Sonja Little, Customer Service

Not even close…take that internet NOW. 70°.
— Cliffe Allen, Sales

Without air conditioning. I would just move to a place with a more stable climate… and less humidity. 70°.
— Shelby Smiley, Quality

Celebrating Together

Thank you to everybody that participated in some of our recent events and celebrations!

Do you have an idea for a future PTS Pulse newsletter story?

If so, submit to: media@PTSDiagnostics.com

PTS Pulse Q2 2023

pts
pulse Q2

PTS June 2023 Blog header

Employee Connection:
Engineers are the Oil in the PTS Machine

At PTS Diagnostics, we rely on a group of multi-faceted engineers to keep our operations running smoothly and to ensure that we deliver the highest quality products. This talented team— comprised of operations engineers, software engineers, mechanical engineers, validation specialists, scientists, and interns—is a driving force behind our company’s success.

When it comes to problem-solving, the engineering teams at PTS leave no stone unturned. During brainstorming sessions, they encourage a free flow of ideas, welcoming even the most unconventional suggestions. From exploring potential failures to considering out-of-the-box solutions, these collaborative discussions fuel their innovation engine. By fostering an environment that promotes creativity, our engineers thrive and continually push the boundaries of what’s possible.

Our group of operations engineers and machinists is led by David Gloudemans. From managing manufacturing and process operations, to ensuring equipment maintenance, David’s team keeps our production lines running smoothly and diligently crafts precision parts for our operations in both Whitestown and Sunnyvale branches.

Our sustaining engineering team, led by Steve Zucker, focuses on optimizing product performance, particularly the intricate interaction between our PTS Panels test strips and CardioChek Plus analyzers. This cross-functional dream team brings together a diverse range of engineering disciplines, such as chemistry, software development, mechanical design, validation, along with the fresh perspectives of our enthusiastic interns.

A remarkable amount of overlap and synergy exists between David’s and Steve’s teams. The seamless integration of these engineering specialties ensures that we deliver nothing short of excellence. Together, they tackle complex questions and challenges that demand the collective knowledge and experience of both groups. It is through this collaboration that solutions are found, and our products continue to exceed expectations.

In the past couple of years, the engineering teams have helped us to successfully overcome a wide range of complex challenges. To name a few:

  • They spearheaded the transformation and successful launch of CardioChek Plus v1.12— an impressive user interface upgrade driven by customer feedback.
  • They led the efforts to modify the battery door on our CardioChek analyzers, which required extensive input from multiple team members and meticulous analysis of field events. With the FDA’s approval being a prerequisite for any changes we make, the project required a seamless collaboration between our engineers and regulatory experts. In the end, the teams devised a novel mold design and introduced a practical ribbon feature, facilitating easier battery removal. Accomplishments like these exemplify our unwavering commitment to continuous improvement.
  • Our engineering teams also have faced the critical challenge of IVDR certification. Meeting the new requirements demands rigorous documentation, comprehensive understanding, and exhaustive testing.
  • Over the past year, they have made significant progress in improving yields in the automation process. This ensures that our products are made in a high-quality manner and delivered on time.
  • Currently, they are successfully executing the duplication of the A1C processes at PTS Whitestown. This includes mixing chemicals and applying them to substrates, cutting and slitting materials, making samplers, making cartridges, programming monitors, qualifying printer equipment, and more. The engineers also modelled the capacity needs for 2023/2024 and the future.
  • The maintenance and machinist group produces components that are obsolete and can’t be purchased off the shelf. Their quick response has saved both facilities from begin down for long periods of time. They also are partners in the tooling development.
  • They are the process technical resources and are the first line of defense in troubleshooting and making improvements to existing equipment. And, they do all of this while supporting the production floor.

In 2023 and beyond, our engineers continue to tackle thorny problems and set ambitious goals. Two key objectives they are currently working on are the duplication of A1CNow manufacturing at The Whitestown facility and the smooth launch of a new lipid panel test strip formulation.

Thanks, PTS engineers, for lending your considerable talents to PTS Diagnostics!

FARMacy West Virginia Prescription for Produce Program:

Transforming Health through Nutrition

In a state plagued by poor health statistics, Carol Antonelli- Greco, a dedicated family physician in Wheeling, West Virginia, recognized the need to address the underlying issues contributing to prevalent health conditions like diabetes, hypertension, and obesity. Through partnerships with the West Virginia University Extension Office, urban farming group Grow Ohio Valley, and local health clinics, she founded the FARMacy West Virginia Prescription for Produce Program in 2016.

FARMacy photo

By prescribing produce to patients, the program bridges the gap between farmers and individuals with chronic disease who are in need, ensuring a direct exchange of fresh, locally grown food. This innovative approach aims to promote better health outcomes by addressing the root causes of chronic diseases through nutrition and culinary knowledge.

The program directors have also worked closely with the WVU School of Public Health’s Office of Health Services Research to standardize the collection of program participants’ health data so that they could report on the impacts of the program on a statewide level. Some of the data collected came from our very own A1CNow+ test system!

The transformative power of the FARMacy program is evident both through the data, and through the stories of individuals who have experienced positive changes in their health and lifestyle. Participants reported weight loss, improved blood pressure, better kidney function, and normalized blood work results. Preliminary data shows that participants experienced a 0.9% decrease in A1C, on average.

Understanding the significance of personal connections in patient care, the FARMacy program goes beyond providing healthy food. Local WVU extension staff members played a pivotal role in educating patients during produce pickups. By offering written materials, sharing recipes, and engaging in one-on-one conversations, she ensured that patients received the necessary support and guidance to make informed decisions about their health. This personalized approach fostered trust, empowerment, and a sense of accountability, encouraging patients to take control of their well-being.

By replacing unhealthy food choices with fresh produce, individuals realized that making small, sustainable changes in their diet and exercise routines can have significant and lasting impacts on their overall well-being.

It is programs like FARMacy that give our work meaning. As a PTS employee you played a small, but important role in providing greater access to care for people with diabetes and heart disease risk factors in West Virginia!

To learn more about the FARMacy Program you can watch a short documentary here: https://youtu.be/Sf8AVddVZkg

Product Highlight:
PTS Scientists Co-Author Published Research By Latasha Little, Product Labeling Manager

3D Model render
(a) 3D model structure of the oxygen insensitive enzyme that was developed in this project.

As a PTS employee, you may already know that triglycerides are an important biomarker of various diseases, including hyperlipidemia. But you may not have known (until now) that two PTS Diagnostics scientists, Gary Hughes and Adrianna Scheller, have recently published a journal article about the development of an enzyme that may be used in future electrochemical measurement methods for analytes like triglycerides. We asked Gary and Adrianna a few questions to help us better understand their work and its implications.

How did you both get involved in this research project?

  • Adrianna: When I joined PTS, the research project was already ongoing. Gary asked if I could get involved and perform some experiments to help finalize the project.
  • Gary: Dr. Aniruddha Patwardhan first met Dr. Sode at the Diabetes Technology Meeting when presenting our poster on the recently released CardioChek Plus (2014). We started having a discussion on his research, and I kept running into him at this and other conferences and eventually collaborated on this project starting in 2019.

What question or challenge was the research setting out to address?

  • The research project addressed the lack of oxygen insensitive enzymes utilized to detect triglycerides electrochemically.

Please explain the goals/findings for the research.

  • The aims of the research project were to develop an oxygen insensitive enzyme capable for use in the development of an electrochemical triglyceride sensor.

What are the possible real-world applications?

  • The real-world applications of this research project include the development of potential triglyceride / lipid panel assays that only require a fingerstick volume worth of blood.

Why is it important?

  • Current triglyceride / lipid panel assays typically require a larger volume of blood and could benefit from improved sensitivity, accuracy, and precision.
Au IDE graphic
(b )Example of a gold (Au)-interdigitated electrode (IDE) electrochemical test strip that was used throughout this project.

What were your roles in the project? Briefly explain.

  • Adrianna: I helped finalize the project by developing calibration curves for triglyceride detection in serum.
  • Gary: Initially, I coordinated getting sensors and materials to the team. After the enzyme was developed, I was able to conduct experiments and helped with editing the manuscript.
Current Chart Graphic
(c) Calibration curve of electrochemical glycerol 3-phosphate (Glp) measurement using the enzyme (a) within the formulary on the IDE electrodes (b). Measuring Glp is a preliminary step in measuring triglycerides.

What was your favorite aspect of the project?

  • Adrianna: My favorite aspect of this project was getting to see the collaboration between an industry company such as PTS and an academic professor such as Dr. Sode. Last year I graduated from graduate school where I performed academic research every day and now, I have worked at PTS doing industrial research, so I enjoyed how this project connected to two together.
  • Gary: Much of the initial research was done during the middle of the pandemic, so just reaching the finish line was thrilling. Also, doing that first experiment with the new enzyme and realizing the immense potential this could have was super exciting.

Does this research have any connection to PTS products?

  • R&D undertakes these types of collaborative initiatives in an effort to identify new materials and/or technologies for future potential development projects. This research in particular could be beneficial for potential triglyceride lipid panel projects in the future.

Read the full research paper here:

https://ptsdiagnostics.showpad.com/share/1McpBSzy8uRvPDRT45gmK

PTS Employee Spotlights

Cliffe Allen
Vice President, US Sales

Cliffe Allen group photo

When did you join PTS?
2015

Name three hashtags that describe you.
#ProudDad #FigureItOut #PositiveOutlook

Favorite place to “get away”.
Any golf course, especially new ones, and most importantly, with good friends. I’m lucky to have a group of close friends that like to golf also. That is like therapy to me.

Best part about your job at PTS?
The people I work with every day. From the internal PTS
departments to the people on our sales team. We all are rowing in the same direction, with the same purpose. It is inevitable that the rowing gets out of sync from time to time, but we always figure out how to get back into a rhythm.

Do you have a secret talent? What is it?
I’m a pretty decent basketball player, and still play twice a week.

One thing you can’t resist?
DQ Blizzards, especially the Chocolate Extreme.

Best advice you have ever been given?
Everything happens for a reason—it’s always true, sometimes it just takes a while to figure out the reason.

Abbey Braasch
HR Generalist

Abbey Braasch and child
When did you join PTS?
March 2023

Name three hashtags that describe you.
#Empathetic #Achiever #Developer

Favorite place to “get away”.
Hocking Hills! I love all trails though – please give me some recommendations 🙂

What do you like best about working at PTS?
Having a father who had diabetes and passed at a young age, I love knowing that PTS is making a HUGE difference in the lives of so many!

Best part about your job at PTS?
The awesome people I get to meet and interact with daily! PTS is filled with so many great individuals and I’m happy I get to work alongside each one.

Do you have a secret talent? What is it?
I survived growing up with 7 siblings (6 of them being older than I am), and still tolerate them to this day.

One thing you can’t resist?
Early morning cuddles with my 6-year-old. Great start to my day!

Best advice you have ever been given?
Be fearless in the pursuit of what sets your soul on fire.

Kyle Nelson
Inside Sales Specialist

Kyle Nelson Headshot

When did you join PTS?
March 2022

Name three hashtags that describe you.
#Funny #Social #Caring #Honest

Favorite place to “get away”.
Nature. The woods and rivers are my happy place.

Best part about your job at PTS?
I enjoy traveling to trade shows and learning more about how our devices make a difference in the medical environment. I enjoy meeting and speaking with people from various backgrounds who are all committed to improving the lives of those around them.

Favorite part about working at PTS?
What I like best about working at PTS is the close-knit community here. Everyone has been very welcoming and made me feel like a part of the team.

Do you have a secret talent? What is it?
Massage Therapy.

One thing you can’t resist?
BBQ especially ribs.

Best advice you have ever been given?
Treat others as you would like to be treated.

Alex Bridges
Senior Controls and Systems Engineer

Alex Bridges and Dog

When did you join PTS?
July 25, 2022

Name three hashtags that describe you.
#BoardGameEnthusiast #NewDad #Pleasant

Favorite place to “get away”.
I love the Rocky Mountains. Skiing, Hiking, Camping, Snowshoeing, or just lounging in a cabin are the best ways to put me at ease.

Best part about your job at PTS?
I’m the kind of person who enjoys variety and puzzle solving in my daily responsibilities. The best part of my job is all the different kinds of problems I get asked to help out with. It feels great to finally arrive at a complete answer to a tough question with a grateful coworker.

Favorite part about working at PTS?
The people I get to work with here are truly remarkable! It is so rare to have such a capable, compassionate, and creative group of coworkers. The excellent team here makes coming to work so much easier.

Do you have a secret talent? What is it?
I’ve been working on coin flipping tricks. I’m not very good, but it’s a nice way to keep my hands occupied.

One thing you can’t resist?
Fresh Mango. I’m almost glad they don’t grow well here, because I would probably eat only mangoes for the rest of my life if I had access to a tree.

Best advice you have ever been given?
Take everything one step at a time. If something feels too hard, you are trying to take too big of a step.

HR Corner:

Cog Wheels

It’s BASEBALL SEASON!
Indianapolis Indians Tickets Available (Whitestown)!

PTS has season tickets for Indianapolis Indians tickets for home games hosted at Victory Field downtown Indianapolis. We have four tickets for each game, which are available for any interested employee. The Indians schedule can be found here: https://www.milb.com/indianapolis/schedule/2023-04

Tickets are distributed first come, first serve. Please visit the HR office to see available dates, sign up, and receive your tickets! PLAY BALL!!!

Also, Join us Friday, July 28 for for PTS Family Day at the Indianapolis Indians Game. Stay tuned for more details.

Safety Team News

2023 Noise Survey: Personal noise exposure testing was conducted at our Whitestown Facility to establish a noise exposure baseline for the manufacturing areas:

  • Manual Strip Production
  • Chemical Production
  • Automated Strip Production

We are pleased to inform you that we remain compliant with Federal and Local Hearing Conservations Regulations. We are delighted to confirm that we have a safe and healthy work environment for our PTS family. Specific results can be obtained from Sarah Chavez, Environmental Health and Safety Manager at schavez@trividiahealth.com.

As always, please let any of the Safety Team members know of any safety/health concerns or recommendations.

 

Cog WheelsA Message from Jonathan Chapman, President & CEO

Dear All,

I wanted to let you know that PTS Diagnostics has received the official letter from Gina Brackett, Director, Compliance Branch at the US Food and Drug Administration confirming that the FDA has completed its verification of PTS’ corrective actions in response to the 2019 Warning Letter. The FDA has concluded that PTS has adequately addressed the violations that were identified.

As you know, it has been a long road for PTS that has involved a very thorough overhaul of the Company’s QMS and a great deal of time and effort to undertake numerous remediation activities. Although it has been a painful chapter in the Company’s history, it is nevertheless coming out of it a stronger, more robust company, better positioned to meet the opportunities presented by the market.

The response to remediate the issues identified in the Warning Letter, has been an exercise that many people have contributed towards across the whole organization. That process and the development of a strategic workplan would not have been possible without Heidi Strunk’s and Will Benedict’s leadership, nor the dedication and work ethic of the QA, RA, and Operations teams and the many other people that stepped up to help. I do want to acknowledge and thank each of you for your tremendous and tireless contributions in navigating PTS through the response to the Warning Letter.

Congratulations and thank you.

Jonathan Chapman | President & CEO

2023 Company Holidays

  • Monday, January 2: New Year’s Day
  • Monday, May 29: Memorial Day
  • Tuesday, July 4: Independence Day
  • Monday, September 4: Labor Day
  • Thursday, November 23: Thanksgiving Day
  • Friday, November 24: Day After Thanksgiving
  • Monday, December 25: Christmas (1st Observed Day)
  • Tuesday, December 26: Day After Christmas (2nd Observed Day)

Please Welcome Our Summer 2023 Interns!

We are thrilled to have four interns with us this summer:

Claire Lu Headshot

Claire Liu:
Sustaining Scientist

Jennifer Quercioli Headshot

Jennifer Quercioli:
Sustaining Engineering

Jesse Crist headshot

Jesse Crist:
Manufacturing Engineering

Phillip Zirkle Headshot

Phillip Zirkle:
Manufacturing Engineering

Quarterly Question

Each quarter we ask PTS employees to participate in a fun question ranging in a variety of topics. This quarter we asked about things that we tend to be a little snobby about!

“What is something you are a little bit snobby about?”

 I’m a little bit snobby about my chosen sports teams; the Chicago White Sox and Notre Dame football.
Carolyn Schmitt, Regulatory Affairs

A good cup of coffee.
Kyle Nelson, Inside Sales

All-inclusive resorts. Just. No. I want to actually be able to go out and explore locally if I am flying out somewhere for my vacation.
Anushree Deshinge, Quality

Water. To me, different sources (bottled and tap) taste vastly different. If I have a choice, there are certain brands I prefer or at least filtered. If there are no other options around, I squeeze extra lemon in it to mask the flavor of dirt/metal/insert gross aftertaste here. 💧
Latasha Little, Marketing

Die Hard is a Christmas movie. I get into this argument with my wife all the time. What makes a Christmas Movie? Here’s the checklist:

  • Takes place during Christmas
  • Has Christmas music
  • Has a Christmas tree in it
  • Has Christmas presents
  • Has a Christmas party (work party @ Nakatomi Plaza)
  • Has a happy ending where the good guy ends up with his wife and kids for the holiday
  • And it snows

I mean, c’mon – Bad Santa gets a pass?
Jason Morrison, Finance

Butter not margarine or other spreads.
Gary Hughes, R&D

”The whole World calls “Football/Fútbol” while Americans call “Soccer.” When Americans call “football,” the sport only uses foot to kick the ball as kickoff, a field goal for 3-pts or an extra point. Are you “Fútbol or Soccer?” LOL
Annie VuMendoza, Quality

I’m a little bit snobby about apples. Don’t even try to hand me a Red Delicious. I will take it as a personal insult.
Andrea Sauceda, Marketing

McDonald’s Diet Coke is the BEST! Hotel Snob—No Super 8, Hotel 6 or Hotel with an External Room Entry Door for me!
Bridget Melland, Sales

Condiments/Sauces! I absolutely hate ALL condiments/sauces, except buffalo sauce.
Abbey Braasch, Human Resources

I am snobby about pop… I won’t touch a Pepsi product… I like coke. But I take it a bit farther and won’t touch diet pop either. Your brain doesn’t register the difference between diet pop and regular pop… they are both loaded with bad stuff, even though diet pop has less calories. So why bother with diet pop? Have the real thing and satisfy your craving for SUGAR!!!! You’ll drink less of the stuff.
Beth Russell, Sales

When the mailman or mailwoman “stuffs” my mail in the mail box… =(
Sarah Chavez, EHS

Things like sheets, pillows, toilet paper, paper towels, cell phones, etc. For things that you have to use on a daily basis, the quality of life benefits usually outweigh the extra expense.
Issa Emeish, Legal

Pie crust—it must be homemade, and made with lard.
Heidi Strunk, Quality and Regulatory

I am snobby about who has a cat as pet because I think cat is not loyal to the owners.
Jianwen Cai, Alignment Department

I don’t wear the same shirt in a month nor the same shoes twice in a row. (I get it from my mother)
Ashley Moses, Operations

A few imposter food items will NEVER live up to the original:

  • ”Breakfast” maple (corn) syrup < Pure Maple Syrup
  • Margarine < Butter
  • Miracle Whip < Mayonnaise
  • Skim Milk < Whole Milk
    George Spoerl, Ops Engineering

One thing I am snobby about is food made by others including friends, family and yes, colleagues. I have borderline germaphobia when it comes to food. Growing up, I observed questionable cooking etiquette courtesy of my grandmothers (and mother for that matter). Such etiquette traumatized me, leaving irreparable emotional scar tissue. Catered food or food ordered from a restaurant is fine, but when it comes to food from family, friends (or colleagues) my issues get the best of me. My wife will bring home homemade cookies from work or homemade leftovers when she visits her family, and when offered I decline. Next time there’s a pitch-in or chili cookoff, don’t take offense if I opt not to participate. I mean no harm. It’s just me being me, dealing with my emotional scar tissue.
— Jason Boesche, Operations

I am definitely Diet Coke-biased. If a restaurant only offers Pepsi products, I will typically ask for Diet Mountain Dew, or go with unsweet tea.
— Cameron Dobson, Marketing

I swear I can taste soap and the plastic in Tupperware after they’ve gone through any dishwasher (I’ve tried more than one). They’re ok for storing vegetables, but definitely not bread or any absorbing carb. I’ll eat a sandwich and can tell if the bread was stored in plastic. I also refuse to eat the Parmesan cheese that comes in the tall container! 😖
— Shelby Smiley, Quality

I am irritated when I listen to the morning traffic report (to decide what route to take to work) and the reporter references a crash at the intersection of two streets that don’t intersect (for example the intersection of Georgetown and Zionsville Roads!!). Also I hate it when they mispronounce and/or misspell road names. Thanks for letting me vent!
— Margo Enright, Regulatory Affairs

There are very things I am snobby about… but private label Q-Tips and Cheese Slices… ABSOLUTELY NO Kraft “fake” cheese… only real cheese.
— Gary Johnson, Sales

I’m a bit of a snob about brown eggs vs. white eggs, I have sworn since I was a little kid that brown eggs are saltier and yolkier and have better flavor. Whether that is true or not is irrelevant. But I’m a MAJOR snob about Cheez-Its vs. Cheese Nips, Goldfish or any other cheesy cracker. Cheez-Its or go home tbqh.
— Harley Howell, Customer Service

Finally was able to take a vacation in Italy with my wife!
Don Bellissimo, U.S. Sales

Class of 2023 Photos

Thank you for helping us celebrate!

Collage of graduates

Who's That Grad?

Think you know which of your coworkers were in the following graduation photos? Email Latasha with
your guesses and we’ll draw a winner with the most correct guesses to receive a gift card!

Collage of previous graduates

Do you have an idea for a future PTS Pulse newsletter story?

If so, submit to: media@PTSDiagnostics.com

PTS Pulse Q4 2022

pts
pulse Q4

Lab tech running test

The Future of PTS:
2022 and Beyond By Jonathan Chapman, President and Chief Executive Officer

2022 has been a terrific year for the organization despite its share of challenges. The pandemic brought
about some big changes in healthcare and specifically in PTS’ traditional
core markets.

Some customers who we expected to make a near full recovery in 2022 —like our traditional global screening customers— did see growth compared to 2021, but have continued to struggle. When we look at 2023, though, there are positive signs that the beginnings of the recovery we saw in 2022 will continue into 2023. Sales to Direct Screening customers and to Distributors who supply healthcare providers’ offices led a rally toward the end of the year.

Pharmacies, another core segment for PTS, have not re-embraced point-of-care testing at the rates we had hoped, as they continue to be distracted by the demands of providing vaccinations instead. The Home Health market, however, delivered strong results for A1CNow sales. Overall though, the net result is that the hard fought for successes combined with the Global Sales Teams’ concerted efforts to grow our U.S. distribution business and recapture lost tender business in Mexico have us poised to hit our overall profitability targets for 2022.

This puts us on much more solid ground for a building momentum in 2023 and beyond.

Facing New Challenges

There is no question that we will be facing increased competition in the marketplace as we head into 2023. Other medical device manufacturers are looking to grab some of our market share by positioning their products as better solutions in the pharmacy and healthcare provider markets. Dry blood spot cards and other devices continue to be a competitor in the home testing market.


However, we will continue to differentiate ourselves, along with our partners at Sinocare and Trividia, with our high-quality products, and our many years of experience as leaders in the management of diabetes and its comorbidities. We will also continue to lean on our culture of resourcefulness and creativity to think beyond our limits.

We must continue to diversify and expand our customer base in the US as well as our Distributor network around the world. Our products have far-reaching utility and in absence of new products we must add new vertical markets to achieve revenue targets. Areas like home health, physician office laboratories, pediatrics and community health represent significant growth opportunities in 2023 and beyond.

One of the ways we hope to prove our continued leadership in this space, is by launching a new point-of-care analyzer late in 2023 that measures a patient’s blood creatinine levels. That data is used to help healthcare providers identify patients who at risk of developing kidney disease.

At-home testing continues to be in demand in our post-pandemic world, as a way for people to complete their biometric screenings without the hassle of attending multiple appointments. To help meet the needs of these consumers, we plan to extend our home testing portfolio in 2023 to include CardioChek Plus Home with Lipid Panel + eGLU test strips. This will help us expand into a new market and mitigate some of the losses we have sustained due to changes in the Health & Wellness Screening industry.

The at-home testing market will also drive a greater need for our devices to offer seamless connectivity to healthcare provider’s patient record systems. Not only will this increase the ease and convenience of our test systems, it will also allow providers to have greater trust in receiving results from a patient’s self-test. If the results are being beamed directly from the device into the records system, there’s less likelihood of error in the reporting of the results.

Advancing Business Processes

In order to support new initiatives and our expansion into new markets, we will need to be creative with our resources and innovative in our approach. We will continue to look for ways to streamline our business processes and improve our reporting and analysis.

We anticipate that supply chain challenges are likely to continue to follow us into 2023. Our Finance and Sales teams will be working on providing real-time data analysis to allow for more precise forecasting that will give our Operations team information they need to continue to manage inventories and customer expectations.

We will also continue looking for ways to further align PTS Diagnostics and Trividia to expand our resources, strengthen our processes, reach new markets, and meet the growing needs of our customers.

We Are Counting on You

Our people are and will always be our biggest asset. We have a great culture made up of talented people and strong teams. In 2023, we will look for ways to invest in each of you by creating professional growth opportunities. Continuing our revenue growth trends and introducing new products and initiatives will better enable us to do that. I genuinely appreciate the important and significant role that each person at PTS plays in moving our business forward and in making this a rewarding place to work.

We have a unique product line, and in a post-pandemic world, management of high-risk persons with diabetes and other chronic disease states is seen as paramount to improving future outcomes. Our best days are clearly ahead of us. Thank you for being a part of the PTS Team.

 

Employee Connection:2022 Year in Review

“Everything changes and nothing remains still; and you cannot step twice into the same stream.” — Heraclitus
 

If there is one thing that has not changed much since 2020, it is the tendency for articles in this newsletter to start by marveling at how much change there’s been. Even when everything else in the world feels uncertain, you can at least count on this one small thing to remain the same. (You’re welcome?)

Anyway, we recently surveyed a group of PTS employees to get their take on the highs and lows of 2022. Here’s what they had to say:

When you look back at 2022, what are some things that you and your team are most proud of?

“Maintaining the supply of raw materials in one of the most chaotic supply- chain-challenged eras!”
— Ann Fausset, Operations

“We achieved IVDR certification of our quality system AND achieved our first IVDR product certification.”
— Heidi Strunk, Quality & Regulatory

“2022 was challenging trying to find the right lane on the freeway to hit cruising speed. We had to compete with not only our biggest competitor, but other product lines for time and space as the PPE craze is wrapping up. We did exactly what I expected from our team—we hit cruising speed early and didn’t let up.”
Gary Johnson, U.S. Sales

What are some new things you and your team members learned this year? How might your newly acquired skills and knowledge shape what you do in 2023?

“We learned, and are continuing to learn, how to best integrate with the broader PTS/THI/Sinocare teams, while developing new partnerships and new relationships externally and within the business. This should lead to a more motivated, driven team, supporting growth and development.”
— Andrew Greaves, International Sales

What is something that helped you and your team stay motivated in 2022?

“The continued support from the executive team, finance, marketing, manufacturing, shipping, and customer service is what makes the sales side of PTS successful. We need the full company to be in sync and we will continue to grow.”
— Gary Johnson, U.S. Sales

“Knowing that, as hard as it might seem initially, once you are up and ready to go, the whole team helps each other out.”
— Amy Howell, Customer Service and TSS

“The customer/patient. We’re not supplying widgets, but health care maintenance for our customers.”
— Ann Fausset, Operations

What words of wisdom do you have for new PTS employees as we head into 2023?

“Realize you are now a learner. Be open to new experiences and accept help. Coming from a position where you knew it all to one where you know nothing is overwhelming for everyone.”
— Amy Howell, Customer Service and TSS

“Make sure to ask for help when needed. We are all so busy and juggling different projects, we forget to check in with the new people. PTS has great people and would do anything for each other, we’re just pulled in multiple directions right now.”
— Ann Fausset, Operations

“Get to know and understand the business, the team and wider global family, be proud of what we do every day, improving health all over the world.”
— Andrew Greaves, International Sales

“If you have a good team, you can do just about anything. Never be daunted by the challenge you’re facing.”
— Carolyn Schmitt, Quality & Regulatory

“We will face adversity in 2023 with getting the time share with our distribution partners. We have to be creative with our resources and think past the typical avenues from the past.”
— Gary Johnson, U.S. Sales

“Keep the focus moving forward. Maintain that drive or urge to find new business and to challenge yourself every day. “
— Jeremy Farmer, U.S. Sales

Employee Connection

Customer Corner:
What’s Next?
2023 Market Forecast

The shift from centralized to decentralized healthcare delivery is creating new opportunities for PTS Diagnostics all over the world. We can expect our growth and recovery to continue into 2023 and beyond, according to two of our market experts, Vice President of U.S. Sales Cliffe Allen and Vice President of International Sales David Brandt.

“Healthcare providers have recognized that you can’t look at just COVID. Many countries are developing programs now to reach out to those who are at the greatest risk not only for COVID-19 complications, but other life-threatening diseases and comorbidities like diabetes and heart disease. We’re seeing increasing demand for our products in multiple countries,” David said in a recent interview.

As the demand for our products increases, so does our reach into various emerging markets for point-of-care-testing. Cliffe said that the days of centralized healthcare delivery—where most patients would expect all their healthcare needs to be fulfilled through one doctor’s office or hospital system—are behind us.

“It seems that the historic model of a patient’s healthcare experience being transacted in a physician office is fading away. Many alternative channels like pharmacies and home health agencies are being heavily utilized by employers and insurance companies for population health. PTS has to stay ahead of these trends by continuing to partner with new healthcare service providers, so that our products are placed before the patients arrive.”

Ironically, physician offices will continue to be our biggest growth target in 2023 despite a decrease in demand for their services. Physicians who want to stay in business will need to compete with pharmacies and home health agencies for patients by offering faster, better lab tests and patient-friendly services. Our Field Sales and Inside Sales teams and our partners at MedPro will be instrumental in allowing us to open more doors in that sector.

Other groups who are helping us open doors right now are our partners at Trividia and Sinocare, and our very own Quality and Regulatory team, especially in international markets.

David said that the incredible leadership of the Quality and Regulatory team combined with the efforts of many people in several departments across the organization on IVDR and UKCA registrations have put us in a great position for expanding our sales in the EU (European Union), the UK, and other regions around the world.

Also, because Trividia has introduced us to some of their customer contacts, and because both of our international sales teams can now cross-promote products from both companies, we have been able to drum up more overall interest across the entire combined portfolio. David expects that those opportunities will only continue to grow in 2023.

There is also a lot in store for PTS and Trividia synergies on the U.S. sales front. Several of the objectives of the Transformation Team—on which Cliffe serves as a leader—are focused on additional efforts to bring the two companies together.

“We have already jointly attended conferences, and I continue to work closely with my counterpart, Gregg Johnson, at Trividia on business building opportunities. Certainly, more to come on that.” Cliffe said.

While there are a lot of exciting possibilities on the horizon, 2023 will not pass by without its challenges. Supply chain issues may continue to make our transition to “just-in-time” inventory practices a bit bumpy. And the turbulence may increase as demand increases and customers’ expectations of acceptable lead times continue to shorten. Cliffe said that this “puts a tremendous amount of pressure on our manufacturing and shipping teams and our Quality team who has to test all of our lots as they are prepared for shipment.”

We are also beginning to see more competition, as other medical devices companies try to find their niches in the rapidly changing healthcare market. We will need to remain vigilant on developing new products and enhancing our current offerings with better connectivity features.

While some of these projects may seem daunting, both David and Cliffe are confident that we will continue to find ways to overcome any limitations and our products will continue to play an even greater role in increasing access to diabetes and cardiovascular disease care around the world.

“It’s a great time to be at PTS and I’m excited to take part in what’s coming next.” David said.

 

Product Highlight:
2022’s Top Products

PTS Employee Spotlights

George Spoerl
Senior Manufacturing Engineer

George Spoerl

When did you join PTS?

May 2022

Name three hashtags that describe you.
#NotOnSocialMedia #iLiveUnderARock #ItsPronouncedOctothorpe

Favorite place to “get away.”

I love to go camping with my wife to get away from it all and disconnect from the internet. My runner up would be a ski lodge vacation to hit the slopes all day and hot tub in the evening.

Best part about your job at PTS?

I love being involved in critical decisions that steer the direction of our operation.

Favorite part about working at PTS?

The teamwork here is impressive to say the least. The way everyone can come together to drive creative solutions often on strict timelines. I am so honored to say that everyone I have met here at PTS is actively looking out for each other and for the best interest of our company.

Secret Talent?

Not necessarily a secret, but many people here may not know that I used to be the varsity tennis head coach for a high school back in Wisconsin before we moved to the great state of Indiana.


One thing you can’t resist?
A ‘Good Deal.’

Best advice you’ve ever been given?

The world offers you comfort. But you were not made for comfort. You were made for greatness.

Wahnetta Beverly
Automation Supervisor

Wahnetta Beverly

When did you join PTS?
September 21,1998

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

Favorite place to “get away”.

Home doing crafts, and walking my dog.

Best part about your job at PTS?

Working with and meeting an amazing group of people.

Favorite part about working at PTS?

Producing the test strips. Running the automated machines.

Secret Talent?

I love to do crafts. sewing, embroidery.

One thing you can’t resist?

Sweets, chocolate.
 

Best advice you have ever been given?
Do unto others.

Grant Barry
Territory Sales Manager - North Central

Grant Barry

When did you join PTS?

January 2022

Name three hashtags that describe you.
#Lively #Neighborly #Loyal

Favorite place to “get away.”

A day on the golf course with my good buds is the perfect place for me to get away.

Best part about your job at PTS?

Being on the sales side of the business means that no two days are ever the same. I like the challenge that this sort of working environment presents.

Favorite part about working at PTS?

I like the fact that I have been tasked with a job to do, and that I’m given the resources and amount of space required to get the job done. Also, I like that we bring a quality product to market that I can stand behind. As a salesperson, having confidence in what you sell is pretty important.

One thing you can’t resist?
Taking over the kitchen during the holidays.

Best advice you have ever been given?
“Eat at a local restaurant tonight. Get the cream sauce. Have a cold pint at 4 o’clock in a mostly empty bar. Go somewhere you’ve never been. Listen to someone you think may have nothing in common with you. Order the steak rare. Eat an oyster. Have a negroni. Have two. Be open to a world where you may not understand or agree with the person next to you, but have a drink with them anyway. Eat slowly. Tip your server. Check in on your friends. Check in on yourself. Enjoy the ride!” — Anthony Bourdain

Derek Page
Customer Service Specialist

Derek Page and family

When did you join PTS?

June 2022

Name three hashtags that describe you.
#Motivated #Confident #Family

Favorite place to “get away.”

The Gym!

Best part about your job at PTS?

The ability to learn something new/different everyday, with growth potential.

Favorite part about working at PTS?

The teamwork, every role and position is key to the success of everyone.

Secret Talent?

Yes! I can sing!

One thing you can’t resist?

I can not resist seeing my kids excel in all they do.

Best advice you have ever been given?

Why stress/worry about things that are out of my control or can’t change.

HR Corner Reminders:

Cog Wheels

Find Great Deals at LifeMart

Thinking about signing up for a virtual gym membership or meal delivery service to help you meet your 2023 wellness goals? Planning a vacation for 2023? Thinking it might be time to get a new phone? Don’t forget about LifeMart! You can find great deals there on all of these items and more.

ADP: Myself > Benefits > Employee Discounts – LifeMart

Use Your Floating Holidays
Before Dec. 31

Please be certain to utilize all floating holiday before the end of the year! These cannot be carried over into 2023. Employees may carry over up to 80 hours of PTO hours into 2023. Anything over 80 hours will be forfeited at the end of the year.

***CA employees are exempt from this PTO carryover policy as a separate policy is in place in conjunction with state laws***

Help is Here!

The Fourth Quarter and End of Year holidays can be stressful and overwhelming. We encourage all employees to utilize our Employee Assistance Program:

EAP Website: www.GuidanceResources.com (WEB ID is ONEAMERICA3)

2022 Service Awards

Congratulations to the following Service Award Recipients!

Chalice

Twenty Five-Year Anniversary

  • Brian Yates

Fifteen-Year Anniversaries

  • Ben Benedict
  • Nele Taevere

Ten-Year Anniversary

  • Randall Cundiff

Five-Year Anniversaries

  • Andrew Greaves
  • Gary Johnson
  • Scott Lee
  • David Miller
  • Andrea Sauceda
  • Margarita Velazco
  • Lucia Lam
  • Precioso Pe Benito

Quarterly Question

“What’s the Best Gift You’ve Been Given?”

Outside of jewelry, the best present I ever received was an early Xmas gift…my son was born December 13th and he has been a joy his whole life! I’m not going to share how old he is!!!

— Beth Russell, Sales – U.S.

Easy answer. My wife and children!

— Tony Colman, R&D and Engineering

A jacket that my mother made for me.  She spent hours quilting and sewing it, in my favorite colors.

— Heidi Strunk, Quality & Regulatory

The time that I receive from family and friends when we get together.

— Carolyn Schmitt, Quality & Regulatory

My Boys – I know. Mushy answer.

— Ann Faussett, Operations

Best Gift Given/Given to someone else is a combo – In 2020 my family chipped in and purchased 4 plots of land in Scotland for each other and we all became “Lords” and “Ladies”. It was one of those covid purchases around the holidays and the money goes to a good cause. It was a fun gift; each plot is one square foot so technically we own that land for the remainder of our lives and we all became Lords & Ladies.

— Jason Morrison, Finance & IT
 

As a kid, I remember the best gift I received was a Barbie Dream house (complete with elevator, which you essentially had to pull with a string).
Me and my sister played with it until it literally fell apart many, many years later. One of the highlights of my childhood! As an adult, the best gift for me is any time spent with my family; it is the best gift of all.

— Latasha Little, Marketing

The best gift I’ve received AND given is: the gift of TIME. Instead of gifts, my three sisters and I plan a brunch in January after the Christmas dust settles. We go out to a fun brunch place and catch up and visit with each other (this tradition has now been extended to include husbands, significant others, THEIR siblings/spouses, and of course…all of our kiddos!)

— Jessica Gahimer, Human Resources

My two wild, wonderful children.

— Andrea Sauceda, Marketing

“What’s the Worst Gift You’ve Been Given?”
Not sure there’s really been one.
 
— Carolyn Schmitt, Quality & Regulatory
 
Nothing sticks out, so must not have been that bad to make a list.
 
— Ann Faussett, Operations
 
Worst gift was a tie between a knife set and an electric razor, both perfectly good gifts, just not a lot of thought going into that decision.
 
— Cliffe Allen, Domestic Sales
 
I’ve always been grateful for whatever comes my way.
 
— Jason Morrison, Finance & IT
 
My mother-in-law had a habit of going to flea markets. One Christmas, all of the six son-in-law’s received knives, with handles that served as brass knuckles with spikes on them. Tis’ the season. It remains legendary.
 
— Scott Lee, Marketing
 
Growing up my parents allowed me and my brother to pick out one present to open on Christmas Eve. I was probably in 6th grade, and selected ankle weights, and didn’t even know what they were at that age. To say the least I was not thrilled.
 
— Cameron Dobson, Marketing
 
A guy I dated in high school gave me a bottle of men’s cologne for Christmas. (It was Liz Claiborne for Men to be precise.) The worst part is that because my dear mother had trained me to never, ever, ever express anything but excitement and gratitude for any gift I was given—no matter what—I pretended that I loved it and even went so far as to generously spray it all over me to prove it (So committed to this lie, was I). I broke up with him a couple of weeks later. Not because of the gift exactly, but it certainly did not help his case.
 

— Andrea Sauceda, Marketing

“What’s the Best Gift You’ve Given Someone Else?
A river cruise on the Delta Queen steamboat.  My parents had always wanted to go, but never felt they could spend the money.  I used my first bonus to send them.
 
— Heidi Strunk, Quality & Regulatory
 

When I was able to get my husband
to take his first trip to Europe to visit me in Germany.

— Carolyn Schmitt, Quality & Regulatory
 
A successful surprise party for a person that never could be surprised!
 
— Ann Faussett, Operations
 

Best gift ever given was the Walt Disney World annual pass for my daughter

after graduating from Purdue, for so many reasons.
 
— Cliffe Allen, Domestic Sales
 
My nephew in Tennessee got married about 5 years ago. The week before their wedding the photographer backed out on them. I agreed to play photographer for him and his now wife that I had never met, stressing that I am not a professional and did not want his wife to be disappointed. Everything turned out great and they were very happy.
 
— Cameron Dobson, Marketing
 
I gave the first scarf I ever knitted to my grandmother, because she passed her passion for making things with strings and fabrics on to me. And in return she gave me the gift of pretending to love it. (I didn’t realize at that time that you should generally not knit any item of clothing using 100% wool yarn, because it will end up being unbearably hot and itchy. LOL)
 

— Andrea Sauceda, Marketing

Holiday Season with PTS Diagnostics

Thank you for celebrating the holidays with us!

Collage of holiday celebrations

PTS Pulse Q3 2022

pts
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?

PASTA

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

Yazmin

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 https://ptsdiagnostics.sharepoint.com/sites/HR

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

Nature.
— 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

Questions.
— 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