Packaging Validation Best Practices | Podcast

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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.

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.