Author: snichols
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Category: Media, Packaging & assembly
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Listen to CEO, Jeff Barrett, with Greenlight Guru’s Etienne Nichols, as they discuss best practices surrounding medical device packaging validation.
Author: jboeckmann
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Category: Case study, Packaging & assembly
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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:
Their collective success pushes Diamatrix forward by amplifying their strengths.
“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.
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.
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.”
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.”
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.
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.
Author: jboeckmann
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Category: Case study
Tags: Tags: Medical device assembly and packaging
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.
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.
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:
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.
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.”
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.
Author: snichols
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Category: Media, News and Info
Tags: Tags: Diagnostics, Medical device assembly and packaging, Regulatory, Sterilization
With state-of-the-art facilities in Somersworth, New Hampshire and Costa Rica, J-Pac Medical supports 70,000 total square feet of dedicated medical device manufacturing, assembly and packaging space.
We help innovative medical and molecular diagnostics companies speed time-to-market and scale up manufacturing for the long term.
Author: snichols
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Category: Media
Tags: Tags: Medical device assembly and packaging, Sterilization
J-Pac Medical CEO, Jeff Barrett, discusses medical device design, packaging and sterilization validation on SPOT Radio with host Charlie Webb. Understanding ISO 11607 allows contract packagers to avoid failures due to packaging system design, feasibility testing and packaging system as a whole.
