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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. 

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!

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.

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.”