Point-of-care diagnostics start-up partners with J-Pac to speed product development

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The point-of-care diagnostic market exploded in 2020 and isn’t looking back. But becoming a market leader requires building a great product and commercializing as quickly as possible.

In a suddenly crowded vertical, established medical device companies have an edge when it comes to supply chain stability and distribution capacity. One of J-Pac’s customers, a British startup pioneering a device with lab-level diagnostic power in a portable box, has its own competitive advantage: agility.

“With a bigger company, you will take years to do the things we can do in months,” said their lead engineer.

If competition beats the British diagnostic startup to market, they’ll face a steep hill to profitability. That’s why speed is key. But while their speed is impressive, it poses significant challenges to suppliers. And for a company built to move fast, suppliers that can’t match their pace only hold them back.

J-Pac met their challenge despite early struggles working through builds of ever-changing designs. J-Pac’s logistical flexibility allows their customer to maintain speed, and their robust process control measures provide confidence headed into Verification and Validation prior to FDA submission and production at scale.

Many suppliers, few right-fit partners

The British startup’s point of care diagnostic device delivers results in less than 20 minutes. It’s built for applicability across a range of markets, but they’re targeting the cardiac market first.

Their lead engineer’s mission? To find a blister manufacturing partner for her microfluidic cartridges, which hold a series of uniquely shaped blisters containing diagnostic reagents. Without the capabilities in-house, the startup needed an outside partner.

In the early stages of product development, the startup worked with a contract manufacturer that specialized in small runs and prototype manufacturing. Built to work to in ever-changing designs and fluid processes, that partner couldn’t contract-manufacture a device at the scale required for commercialization. They weren’t meant to be a manufacturing partner all the way to market and beyond.


“This involves sensitive reagents,” she said. “It’s not that easy to say, ‘I’ll invest a lot of time here working with this supplier and then I’ll move and go and work with that supplier.’ They didn’t have the capacity, so we moved on.”


The lead engineer knew the primary challenge for a manufacturing partner would be adapting to the startup’s speed. “I have feedback from different suppliers that they sometimes struggle to cope with us.”

This would be especially true during preparation for process qualification: She needed a partner built for at-scale production, not product development. She didn’t want to go through qualification twice, so she needed a long-term partner capable of producing millions of blisters.

“This involves sensitive reagents,” she said. “It’s not that easy to say, ‘I’ll invest a lot of time here working with this supplier, and then I’ll move and go and work with that supplier.’ They didn’t have the capacity, so we moved on.”

The blister market for pill packaging boasts an abundance of suppliers of all kinds — finding the right fit is simple. But microfluidic blister manufacturing is highly technical and lacks a mature supply chain. There’s little standardization when it comes to tooling, and many suppliers lack trust-building track records.

The lead engineer considered more than ten potential partners. She wanted:

  • Robust process control and quality control systems in place
  • Production capacity for 15,000 test run blisters, eventually scaling up to millions
  • Strong, responsive communication
  • A sense of urgency — they should be doing everything they can to be fast.

And then she found J-Pac Medical.

A logistical fit builds trust with flexibility

The lead engineer chose J-Pac because they met her key qualifications and moved quickly. She ordered sample blisters from J-Pac’s simple online store, and the relationship kicked off from there.

“With J-Pac, they were fast, also. It was the first company I was able to order samples from. That was really something. It was very easy to get the first samples just filled with water or dyed liquids, which was not very easy in other companies.”

Six small round blisters

J-Pac also proved more resourceful than competitors. Instead of requiring the startup to send reagents for the blisters across the Atlantic, they source identical formulations domestically. This cuts customs delays — allowing them to maintain pace while adjusting and improving their in-house formula.

Logistical flexibility fights off slowdowns in more ways than one. For the startup diagnostic company to maintain a breakneck pace, they need to continue prototyping with their original manufacturing partner. Information exchange causes logistical delays in many vendor relationships.

Some companies solve this problem by plodding forward more methodically and pushing back a target commercialization date. The diagnostic startup won’t be giving up their competitive advantage so easily.

Because J-Pac proved logistically flexible, the lead engineer isn’t caught waiting on vendors struggling to get on the same page. She’s able to keep using their speed to her advantage.

And the teams enjoy working together. She appreciates inside sales manager Kim Fall’s attitude and kindness. Engineering programs coordinator Kayla Smith and packaging engineer Brianna Atwood work through builds with her frequently, and senior vice president of operations and engineering Phil Littlefield gets involved when timelines start to look particularly tight.

“I know it’s not been easy,” she said. “But I think it has been fun, honestly.”

Meeting logistical chain demands is one thing. Keeping up with the startup’s internal speed poses an entirely different obstacle for a manufacturing partner.

Yin and yang meeting the challenge

The lead engineer knew J-Pac Medical was the perfect partner for the future. But she didn’t know whether they were perfect for the present.

At this point-of-care diagnostic startup, designs change quickly, documentation is produced only when necessary and teams are more focused on development of a product than a quality control system.

By contrast, J-Pac prefers producing robust documentation and manufacturing developed products at scale, putting it at odds with the chaos of constant change and slim process control favored by this British diagnostic startup.


“Everything needs to be signed off. Everything needs to be controlled. And that is very good — though not at the early stage — because it’ll help us, and it gives us the confidence that when we are in production, we won’t expect to receive a lot of failed batches because things were off that control. We’ve seen they really have things under control, so it’s very good.”


“They struggled a bit while we were changing the design because it changes very, very fast,” the lead engineer said of J-Pac. “So you talk with us one week, and you talk with us two weeks later and things have changed a lot.”

She didn’t expect their partner to have it easy. J-Pac proved themselves by meeting an unavoidable obstacle with dedication and urgency. The initial challenge ran two ways when J-Pac’s process control systems tested the startup’s ability to produce important documentation.

And the lead engineer sees that struggle as a built-in side effect of J-Pac’s strengths. “I’m absolutely sure J-Pac is the best supplier when you have everything stable and you freeze your design,” she said.

“We really made an effort and tried to get everything as organized as we could with the pace we have, to transfer to them the information,” she said. “We were not always very successful.”

She knows J-Pac’s meticulous system works to their advantage — it’s a huge reason why she trusts them as a partner moving forward. J-Pac’s trustworthy manufacturing process strengthens their product today and will reinforce their FDA verification application.

“Everything needs to be signed off. Everything needs to be controlled,” she said. “And that is very good — though not at the early stage — because it’ll help us, and it gives us the confidence that when we are in production, we won’t expect to receive a lot of failed batches because things were off that control. We’ve seen they really have things under control, so it’s very good.”

That two-way challenge elevated both companies, and their weaknesses aren’t holding the diagnostic device back. Their strengths power it forward.

Keeping and building momentum

The diagnostic startup knows it is a challenging partner. But the lead engineer appreciates the collaboration between her team and J-Pac’s in pushing toward a shared goal. Dedicated customer service, engineering, and project management teams allow the partnership to push through any obstacle.

“Kim is very nice. Kyla and Brianna are always very helpful,” she said of the J-Pac team. “Phil joins some of the meetings — in particular, if we have some stresses with the timelines…”

With production qualification well underway, she hopes to see the point-of-care diagnostic device beginning the verification process in just a few months.      

“In the end, we always find a way. And Phil is very good at that. He always finds a way and comes back and reviews the schedule or adjusts it or finds a way around how we’d do something.”

The end result: a point-of-care diagnostic start-up confidently speeding to market thanks to a partnership between agile innovation and trustworthy manufacturing.

Need a blister manufacturing partner to help you get to market and beyond?

The path to commercialization challenges every point-of-care diagnostics company in one way or another. Find a partner that can help you leverage your strengths by bolstering your weaknesses, and you’ll approach commercialization quickly and reliably.

Due to our flexibility and broad set of capabilities, a lot of diagnostic companies see us as a right-fit blister manufacturing partner. Book a call to learn whether we can help your company get to market and scale profitably.

Family-owned surgical device company advances ophthalmic community

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In the early 90s, Ronald Dykes managed a sales territory for an implantable lens company. He was successful, having developed strong friendships with ophthalmologists that competitors saw as customers.

But the ophthalmic surgery market was changing. Ophthalmologists needed a trustworthy diamond blade. So he designed one, opening Diamatrix in 1993. The ophthalmic supply company now serves surgeons worldwide.

When Matthew Dykes and his sister, Michelle Underhill, purchased Diamatrix from their father in 2020, they didn’t overhaul the ophthalmic surgical supply company’s culture or reform its identity. They set out to continue what their father, Ronald Dykes, started almost 30 years before.

The trapezoidal diamond knife designed by Ronald would become Diamatrix’s flagship and a catalyst for years of success. According to Matthew, “A lot of our blade designs and early instruments are evident of us being a small company trying to be as responsive as possible to the surgeons.”

Matthew sees close relationships with ophthalmic surgeons as the foundation of Diamatrix’s value in the industry. Diamatrix acts as an outlet to bring products surgeons need to market quickly. 

But what if a family-owned company wants to grow while preserving its strong identity? How can medical device companies build on the success of flagship products as their market constantly adapts to deliver more effective care for patients?

Diamatrix looked toward a strategic partner that would amplify their values.

When COVID-19 shook the supply chain and labor force, Diamatrix started considering a new packaging and labeling partner. Simultaneously, customer feedback helped them identify a potential improvement to their XPANDNT product.

Ronald, still an active advisor to the company, met their would-be partner out and about during MD&M in Anaheim. J-Pac Medical was a larger vendor than any Diamatrix was working with at the time, but they hit it off from the start.

J-Pac showed more interest in the new XPANDNT project than Diamatrix’s then-supplier, who was struggling with logistical chain issues. 

Meetings grew easily into a productive partnership between Diamatrix and J-Pac, who’ve helped Diamatrix:

  • Quickly launch the second generation of an ophthalmic surgery tool in the U.S.
  • Build a more robust supply chain without damaging their local relationships
  • Speed to European commercialization with MDR expertise and robust documentation

Their collective success pushes Diamatrix forward by amplifying their strengths.  

Creative responsiveness gets new devices into production quickly

“My dad’s got a real artistic background,” Matthew said. Diamatrix designs have always been notably innovative and forward-thinking. “He actually was a fine arts major, and a lot of who Diamatrix is, is his creative ideas really imbued into the company.”

Their founder’s creativity didn’t lack focus either. Ideas were drawn directly from doctors themselves. 

And Diamatrix continues to see this responsiveness as one of their key strengths. Take their XPANDNT product as an example. It’s used to stretch the iris and allow for simpler, safer eye surgery.

The tool has two main parts. One is the wire ring used to stretch the iris during surgery. The other is the cannula it extends from. The ring deploys from the cannula into the eye and stretches the iris by expanding. 

Diamatrix received feedback from surgeons about the way the ring deployed. The cannula was a silver tube 2.5mm wide. Diamatrix determined they could improve the product’s performance by making the tube even smaller.


“It feels like J-Pac is an extension of our business,” Matthew said. “I know they are huge and do a lot for really big companies, but for us as a small company, being able to leverage some of their resources, which have been exceptional, and really feel like part of the team with them has been good.”


When Diamatrix had a solid grasp on their new design, J-Pac picked up the new work without any holdups, even though the improved design demanded process changes. 

By fabricating the tip of the cannula out of Teflon-coated polyamide instead of silver, they made the device’s tip over .5mm smaller. This led to smoother deployment of the tool’s operating ring. But the material change meant gamma sterilization wouldn’t cut it anymore. The XPANDNT now required ethylene oxide sterilization.

No worries. To a company with J-Pac’s resources, such a shift was simple. 

“It feels like J-Pac is an extension of our business,” Matthew said. “I know they are huge and do a lot for really big companies, but for us as a small company, being able to leverage some of their resources, which have been exceptional, and really feel like part of the team with them has been good.”

The initial payoff of this relationship was a quick first shipment of the second generation XPANDNT product in the U.S. “I think we moved pretty quick on this project. I don’t know if we could have moved any faster,” said Matthew. Diamatrix’s speed to market maintains their position as a responsive partner to ophthalmic surgeons.

But overcoming regulatory obstacles to enter the European market would be a tougher, slower task.

Clean, thorough documentation makes for faster, easier regulatory approval

The XPANDNT upgrades make the product safer. But taking those upgrades to market involves more complexity than pointing out an improvement.

Beginning on May 26, 2021, the EU’s Medical Device Directive (MDD) gave way to their new Medical Device Regulation (MDR). What was once a set of guidelines became a strict regulatory document, four times as long with more stringent requirements.


“The quality of the paperwork coming out of J-Pac, it’s very logical. I mean, it’s an inside baseball thing, but I think what they give us is perfect for us to just review and slap our name on.”


While unchanged devices have until 2024 to comply with MDR, devices that undergo significant design changes must align with the new rules. Diamatrix needs to certify their new sterilization process to sell the second generation XPANDNT into Europe.

J-Pac and Diamatrix developed continuity quickly and managed to overcome the common pitfalls he associates with manufacturer and contract manufacturer relations. Documents on Matthew’s end match documents on J-Pac’s end, which creates easy traceability, a key consideration of Europe’s MDR.

“The quality of the paperwork coming out of J-Pac, it’s very logical,” said Matthew. “I mean, it’s an inside baseball thing, but I think what they give us is perfect for us to just review and slap our name on.”

J-Pac also assists with producing MDR-friendly documentation for all Diamatrix’s products. 

A strong partnership with J-Pac allows Matthew to focus on advancing ophthalmic surgery and Diamtrix’s relationships within the industry. 

But Diamatrix is built on more than a strong relationship with the ophthalmic community. They have built long-lasting partnerships with Woodlands-area suppliers and local vendors to make up their supply chain. 

Preserving these relationships helps fulfill Ronald’s vision for the company when he grew it in the 90s.

Building a more robust and convenient supply chain for the long haul

Going through a supplier change during a logistical crisis wasn’t ideal in terms of timing, but J-Pac needed to prove successful regardless. The strength (or weakness) of Diamatrix’s supply chain would either be a driving force for growth or a headwind slowing their progress.


“As a production manager, it would be so much easier if you could just order the component as a whole, as opposed to buying each one of the little pieces and trying to coordinate that”


J-Pac now handles all the supply chain management for Diamatrix, a responsibility Matthew was worried about outsourcing. 

“As a production manager, it would be so much easier if you could just order the component as a whole, as opposed to buying each one of the little pieces and trying to coordinate that,” he said. “But it was kind of scary letting someone else take over the ordering of the components.”

He also worried about maintaining vendor relationships his dad started years ago. They have a built-in understanding of how Diamatrix works. It allows for strong two-way communication and quick problem resolution. 

For example, they have a strong relationship with a nearby printer who helps companies across the greater Houston area. Matthew worried that he couldn’t expect enough flexibility from another partner to keep working with Diamatrix’s long-time vendors. “My fear was that they would break those relationships that we’ve had for forever.”

But J-Pac simply said, “Sure thing.” 

Now, Matthew entrusts his supply chain to J-Pac, a team with the experience to navigate complex situations and the resources to help Diamatrix scale and grow in response to their industry. 

“They do that at a price point that I think made sense for us, and based on the quality of what we get from them and the attention and the care that we get, I think they do a really good job.”

Partnership with J-Pac makes a strong impression

Shortly after starting to sell the updated XPANDNT into the U.S., Matthew was in talks with a major international distributor who wanted to come visit Diamatrix. 

Matthew didn’t feel great about showing off Diamatrix’s headquarters. It’s more of a 4,000-square-foot transportation warehouse than an impressive manufacturing facility.

“So, I was like, ‘Well, let’s meet at J-Pac.’” Matthew said. “I didn’t even ask Jeff (J-Pac’s president). I was just like, ‘We should meet at J-Pac,’ because I knew that if I brought them there, they’d be impressed.”

J-Pac facility
front facade of J-Pac headquarters

He recalls another facility they toured when they discussed switching packaging partners, which he describes as “sad and run down.” But “J-Pac doesn’t feel that way. J-Pac is a place I might want to work, and the people that run it genuinely care.”

So Matthew met the international distributor in Boston and toured J-Pac’s facility with them before taking a plane south to Texas to meet back at Diamatrix’s headquarters.

“They loved the guys at J-Pac,” Matthew said. Their trip to the States was meant to evaluate whether Diamatrix was in a strong position to be a market leader in Europe. “They were very interested in J-Pac’s capabilities, and I think having J-Pac as a partner proved to them that we’re doing as much as we can and we’re moving as quickly as we can.”

J-Pac’s value to Diamatrix isn’t covered by either their advanced manufacturing capabilities or by their supply chain management skills. J-Pac’s ability to do both is unique, and their flexibility in aligning with Diamatrix’s values means they can share in J-Pac’s strength.

Think your company could benefit from a stronger packaging and/or sterilization partner?

Medical device companies of all sizes can benefit from the right partnerships at all stages of their growth. 

Whether you’re looking to shift from your current vendor or in need of a product development partner, talk to J-Pac. We can handle rapid commercialization, broad scopes of work and even supply chain management — making your job easier and your company stronger.

If you’re looking for a partner or just have questions, please reach out. We’d love to talk shop and specs.

Development of an investigational cancer detection system, one milestone at a time

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Bringing life-saving medical devices to market takes innovation, courage, and technical expertise.

Biotech startup Lumicell knows commercialization also takes an immense amount of work carried out in a rigorously controlled quality system that meets strict FDA regulatory requirements. Based in Massachusetts, Lumicell has been working for over ten years to solve a potentially life-threatening problem for breast cancer patients: residual cancer left behind during lumpectomy procedures.

Med-tech startups focus their early efforts and investment on designing technologies and conducting the research necessary to demonstrate that their novel products can be safe and clinically effective for humans.

Winning FDA approval and the right to sell the new product, however, requires much more. Approval takes appropriate manufacturing and packaging facilities, robust quality systems and demonstration of rigorous manufacturing and testing processes in accordance with international and domestic standards.

“Not only are these manufacturing skills and resources often unavailable to med-tech startups, they are difficult to justify investing in prior to the product being approved for sale,” says Sean Madden, senior vice president of R&D at Lumicell.

Lumicell’s innovative combination medical device and imaging agent system remain in development and have not yet been approved by the U.S. Food and Drug Administration. Thankfully, some ideas are too powerful to be deterred by the challenge.

A landscape-altering breakthrough in cancer surgery

Women in the U.S. have a 1 in 8 lifetime risk of being diagnosed with breast cancer. Every two minutes, one new case is diagnosed. Breast cancer is the most common cancer in women around the world, with an estimated US incidence of 342,000 new cases in 2022 [1].

A lumpectomy, also known as breast conserving surgery (BCS), is the standard of care in treating non-invasive and early-stage breast cancer. During a lumpectomy procedure, the tumor and some surrounding tissue are removed. Pathologists process the excised tissue after the surgery and examine the tissue’s outer edge to infer whether cancer may remain in a patient’s body.

A “negative margin” (no cancer cells at the outer edge) infers all the cancer has been removed. A “positive margin” (cancerous cells at the edge) infers that cancer cells may have been left behind and the patient should undergo a second surgery.

Studies have shown that between 20-40% of procedures result in positive margins, indicating residual cancer that requires a second surgery to remove [2, 3, 4].

Cancer treatment evolves constantly but slowly, and rates of lumpectomies with positive margins have been trending downward over the last 5-10 years [5]. But that reduction has been gradual, and it seems that a reliable process for achieving negative margins requires a game-changing innovation.

Also, studies have shown that ~14% of patients with negative margins still have residual cancer left behind that is currently not addressed by any available surgical procedure [6]. In this more challenging scenario the unmet need can have serious consequences down the road.

But these are not numbers we need to live with.

To address these clinical needs, Lumicell is developing a novel imaging system consisting of a proprietary optical imaging agent, a hand-held imaging device, and patient-calibrated tumor detection software Together, they comprise the Lumicell Direct Visualization System (DVS), designed to illuminate cancer cells in real time and enable surgeons to see and remove residual cancer during the initial lumpectomy surgery. The proprietary optical imaging agent is also being tested in multiple solid tumor cancer types. The Lumicell DVS combines cutting edge drug design, advanced optics, and sophisticated algorithms to help solve one of surgical oncology’s most pressing issues.

A feasibility study in 230 breast cancer patients showed the potential of the Lumicell DVS to not only reduce positive margins during the initial procedure, but also guide the removal of residual cancer in negative margin patients, for whom there would otherwise be no surgical treatment [7]. Revolutionary breakthroughs in development like the Lumicell DVS require expensive and time-consuming clinical trials to prove safety and effectiveness, so they are rare and slow in arriving to market.

The manufacturing hurdle

Medical device development occurs in a number of stages. What someone might call “early-stage” could extend from R&D all the way to feasibility trials. From there, the device still needs to be tested in large human clinical trials and pass design validation and process qualification to produce a reviewable submission for FDA approval.

The full skillset a team needs to develop a medical device is rarely found under one roof. Lumicell has crucial core-competencies in-house:

  • Top development talent to turn ideas and concepts into manufacturable products
  • An in-house Clinical Operations team for designing and carrying out clinical trials and analyzing the results
  • A management team with a solid understanding of the short- and long-term milestones they need to achieve and what practical steps need to be taken to get there

But they recognize when it is time to look outside of their organization when more specialized expertise is needed. Like many medical device startups, the Lumicell team excels at innovation. But they sought a strong partner for manufacturing a significant volume of the device and validating a scalable process.

Manufacturing proof-of-concept with a streamlined process

Matthew Salame, senior product development engineer, leads product development of the single use sterile cover that drapes over the reusable handheld probe. The sterile cover is designed to establish the focal plane of the imaging probe when scanning the surgical cavity and minimize cavity exposure to the device.

“We need this subsystem in place,” Matt says. “And we sought for someone to both commercially manufacture and package our subsystem as well as help us with the product development stages — creating engineering builds, prototypes, samples — so that we can do design verification and validation testing as part of our submission package to the FDA.”

Shortly after he arrived at Lumicell, Matt visited J-Pac Medical’s contract manufacturing facility to talk through engineering builds and a product realization plan. While there, he saw commercialized devices in production at scale. He remembers feeling that the Lumicell system could reach that point and make a difference.

But it would require a strong partnership.

“There are a lot of nuances associated with the engineering builds and the sterilization, manufacturing, and packaging of this product. We’re able to lean on J-Pac for their experience,” Matt says.

Lumicell works with multiple vendors across the production of its full system. Relationship management is key but pulls on its experts’ time. Not having the right partner could put stress on the entire operation. J-Pac connected Lumicell with a sterilization team in its network that could assist while working towards taking sterilization of the subsystem in-house to simplify Lumicell’s process.

Matt says, “They have many of the capabilities that we need that, in summation, help to create a more streamlined workflow for us,” including manufacturing, sterilization, packaging, and supply chain management.

There are many device manufacturers and many packaging suppliers, but fewer partners who can do both. And even fewer that can handle sterilization, manage the project’s supply chain, and assist with product development on top of it all.


“We’re meeting our milestones and we believe we are on track to succeed,” Sean says. “And I don’t think we could have gotten to this point without J-Pac.”


“It absolutely limits the amount of work we need to do to create traceability between additional suppliers or qualifying different suppliers or ensuring that they are in tight communication when the product goes from one facility to the other. The parts come in at J-Pac and finished product leaves J-Pac in a simplified process flow,” Matt says.

Lumicell’s team has been built to ensure the development of the best product possible, and its internal structure has proven robust enough to manage late-stage development of a complex device. The company is now laser focused on FDA submission for marketing approval and building out its commercial infrastructure.

“Success will be measured by FDA approval and widespread adoption in order to improve the current standard of care. We’re meeting our milestones and we believe we are on track to succeed,” Sean says. “And I don’t think we could have gotten to this point without J-Pac.”

Get your device over the manufacturing hurdle and into the market

Lumicell can see the opportunity ahead for patients, once its DVS is approved. Getting to market is complicated, and the hurdles along the way can’t distract you from your goal: to develop a safe and effective device that helps people.

Sometimes the best way to do that is to align with a strong, strategic partner. Contact J-Pac to assist your company with product development, preparation for FDA approval, and production at scale.


References

  1. American Cancer Society. Cancer Facts and Figures 2022. Atlanta, Ga: American Cancer Society; 2022.
  2. Hotsinpiller, WJ, Everett, AS, Richman, JS, Parker, C, Boggs, DH. Rates of margin positive resection with breast conservation for invasive breast cancer using the NCDB. Breast. 2021;60:86-89.
  3. Brouwer de Koning SG, Vrancken Peeters M-JTFD, Jóźwiak K, Bhairosing PA, Ruers TJM. Tumor Resection Margin Definitions in Breast-Conserving Surgery: Systematic Review and Meta-analysis of the Current Literature. Clin Breast Cancer. 2018;18(4):e595-e600.
  4. Smith BL, Lanahan CR, Specht MC, et al. Feasibility Study of a Novel Protease-Activated Fluorescent Imaging System for Real-Time, Intraoperative Detection of Residual Breast Cancer in Breast Conserving Surgery. Ann Surg Oncol. 2020;27(6):1854-1861.
  5. Piper, M.L., Wong, J., Fahrner-Scott, K. et al. Success rates of re-excision after positive margins for invasive lobular carcinoma of the breast. NPJ Breast Cancer. 2019;5:29.
  6. Dupont E, Tsangaris T, Garcia-Cantu C, et al. Resection of Cavity Shave Margins in Stage 0-III Breast Cancer Patients Undergoing Breast Conserving Surgery: A Prospective Multicenter Randomized Controlled Trial. Ann Surg. 2021 May 1;273(5):876-881.
  7. Hwang ES, Beitsch P, Blumencranz P, et al. Clinical Impact of Intraoperative Margin Assessment in Breast-Conserving Surgery With a Novel Pegulicianine Fluorescence–Guided System: A Nonrandomized Controlled Trial. JAMA Surg. Published online May 11, 2022. doi:10.1001/jamasurg.2022.1075

Point-of-Care Diagnostic Blisters

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The Challenge

A Diagnostic Device Company approached J-Pac Medical to develop reagent blisters that would accommodate single test quantities of reagent to be mounted onboard Point-of-Care Test Cards.

The company needed support to identify appropriate materials, methods and procedures to provide reagent filled foil blisters that could be shipped safely in bulk, yet dispense the reagent in a controlled way when coupled to the test card and ultimately activated during the performed diagnostic test.

Our Solutions

J-Pac Medical identified and procured all equipment needed, fabricated all tooling, and developed & validated all processes associated with the filling, forming and sealing of these reagent blisters.

The Results

The company became first to market for a point-of-care diagnostic product utilizing reagents on a disposable test cartridge.

Implant Textiles

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The Challenge

A Medical Device company with a broad presence in the soft tissue repair surgical segment came to J-Pac with a challenge to manufacture a 3-Dimensional shaped, multi-component textile implant.

The company had prototyped the product, but had failed to find a suitable manufacturer after a global search.

Our Solutions

J-Pac Medical provided the tooling, equipment and validated processes to pressure form and assemble the textile implant, as well as provide it with a custom edge treatment designed to enhance tissue passage and reduce particulate.

The implant was provided to the customer in a tray/lid primary package put-up, also manufactured by J-Pac Medical.

The Results

The company achieved first to market status with an innovative design that became the leading mesh technology in the market.