DDL

Source: Healthcare Digital

Date :18/03/2008 04:14:23

Pat Nolan, President of DDL explains how helping others meet the most stringent medical device standards has brought 50 percent growth in the past year

Written by Emmet Cole and produced by Jon Ellingwood

When a landmark international standard altered the direction of the medical device industry in the mid-1990s, packaging and testing innovator DDL made sure it was there to greet them with open arms. That approach to service has never stopped, and it’s changed the pace of how quickly business in the industry gets done.

“You hear time is money, but money in this industry isn’t usually a factor in terms of how much companies are willing pay,” says DDL president Pat Nolan. “What they want is time. They want to reduce time to market, and we can help with that.”

Innovation pushed DDL to the front when industry needed it - customer service kept it there. With an unwavering commitment to quality work and its customers, DDL is forging the future of the medical device packaging industry.

ISO Service Success

The key to DDL’s success can be traced back to 1997, when the company led the way in developing protocols that helped medical device manufacturers comply with the new 11607 ISO Standard - an outline of principal requirements for packaging and process development for terminally sterilized medical devices, and validation requirements for packaging steps. The international standard helped clarify guidelines for both single-use and reusable materials, and improved effectiveness for both forming and sealing; two critical steps in medical device packaging.

“We were the first ones in with marketplace with an all-encompassing protocol for testing to meet the standards,” Nolan says. “Being first in the market gave us a competitive advantage, and we backed that up with lot of very good packaging expertise.”

Currently, this expertise means services like random vibration, seal peel, compression, repetitive shock, leak by dye penetration, bubble leak and drop testing. DDL offers packaging engineering consulting, complete package design, rapid package prototyping, and project management.

The company also offers medical device product test, and a suite of consulting services and product certification called PackServices.

Working with DDL helps customers to lower costs, reduce time to market, create innovative designs and comply with regulations. “We spend hours with customers just to inform them what they need to do,” Nolan says. “That’s just our cost of sale to build relationships with our customers.”

Up Close Customer Service

DDL’s innovative, customer-awareness approach carries on today, and now the company appears poised to take customer-satisfaction several steps further — all the way into its customer’s facilities. “We would like to take our range of expertise in operations and testing labs, and go into Fortune 500 companies that have existing testing labs, and basically provide expertise and skill to their lab to manage their facilities,” Nolan says. “It’s kind of a unique development for us in terms of lab management experience.”

The company already has employees working at Colgate Palmolive’s technical center in New Jersey, and hopes to expand that initiative to include several other companies in the near future. It’s all part of an intense focus on customer service. “We’re very customer oriented. We really believe that,” Nolan says. We make sure everyone in the company has good communication skills and stays in close contact with customers, pretty much on-demand so we get back to customers within 24 hours.”

As result, the company, based out of Eden Prarie, Minn. has grown by at least 25 percent in each of the past four years, including an enormous $48.5 million in revenues in 2007 -- a 47 percent increase from 2006. DDL has also more than doubled its employee count since 2004, growing from 22 to 55.

In 2002, DDL opened a lab in Fountain Valley, Calif. to accommodate its growing Southern Californian customer base. With new labs opening in Houston, Texas and Eddison, NJ, the company expects to hit another 50 percent growth this year.

Two Plus Two Equals Eight

DDL’s success also attracted TCP Reliable, a New Jersey-based temperature controlled packaging company attempting to reach a broader range of customers. TCP Reliable offers products like a dry ice substitute to refrigeration and insulated and pre-qualified shipping containers. But sensing the need to expand, the company noticed DDL’s success in packaging and thermal performance testing for medical device companies, and soon looked to join forces.

“The merger essentially was a strategic maneuver acquisition on the buyer’s part,” Nolan says. “TCP Reliable is essentially in the manufacturing business, making temperature control packaging and gell packs and things like that. They do a little testing on their own products and for customers who need testing, but they saw big value in starting up more services.”

So the company purchased DDL in October 2007, and DDL is being run as a wholly owned subsidiary with little deviation from the company’s current day-to-day operations. The two companies run their testing and manufacturing operations separately. The companies believe their collaboration will become the leading packaging engineering group in the medical device and biopharmaceutical industries. “They didn’t want to offset the apple cart, if you will. They didn’t want to rock the boat too much and mess with a successful business,” Nolan says. “They wanted to integrate what we do into what they do, and determine what synergies there are and list opportunities to sell each other’s products into each other’s list, and make two plus two equal eight.”

Big Future

The company believes that in the fast-growing medical device industry, its effective, innovative brand of packaging will be critical to the success of increasingly complex products. Furthermore, Nolan says that the industry has been slow to adapt to the ISO standards, and the supply of companies needing DDL’s help is not expected to dry up.

“It’s just more awareness from the medical manufacturers that they actually need to comply with the international standard,” Nolan says. “It’s taken a good 10 years from time first it was published to only couple years ago. The FDA has spent more time auditing MDM facilities and looking at packaging for compliance.”

But the company faces challenges in maintaining quality service amidst the rapid growth. And as DDL leaves behind a longer and longer trail of success, the company has noticed more and more of its competition begin to take a flattering copycat approach to business. “Our competition is looking at us as ‘We want to be them’ in terms of the success we’ve had, and they’re trying to do it themselves,” Nolan says. “The competition is taking note, and there’s more and more competition in business because it’s a good market to be in. Being the leader, people are always taking potshots at you, trying to emulate you and take away your business.”

It’s the price of innovation, and it’s pushing DDL further onto the forefront of the medical device packaging industry.

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