First Accomplishment of a Merger

A behind the scenes look at what makes it work

The initial achievement of the Minnesota Rubber and QMR Plastics merger with S&W Plastics has been a new partnership with Antares Pharma for the manufacture, assembly and packaging of an innovative insulin injector.

When Antares Pharma made the strategic decision to outsource the entire manufacture and assembly of its Midi-Jector VISION needle free injection device, it came at an opportune time for Minnesota Rubber and QMR Plastics.

In concert with its S&W Plastics supplier, Minnesota Rubber QMR Plastics was looking for ways to expand their medical businesses. Both wanted to move to the next level and manufacture complete medical products. Both were successful manufacturers of medical components and sub-assemblies and had strengths the other lacked. When the opportunity arose for S&W to be acquired by Minnesota Rubber QMR Plastics, a winwin situation presented itself for the two and for Antares Pharma.

Antares Expands its Products, Looks for Manufacturing

"Antares Pharma is developing a number of important new medical products to augment our Medi-Jector VISION," reports Peter Sadowski, Ph.D., Vice President Devices Group. "Because we want to focus on developing and marketing these products, we've looked at manufacturing alternatives starting with our Medi-Jector VISION. We saw a good partnership opportunity when Minnesota Rubber QMR Plastics bought S&W Plastics and expanded its medical capabilities."

Outsourcing the manufacture of the Medi-Jector VISION was a logical step for Antares Pharma. With between 15 and 20 vendors supplying 39 different components for the product, Sadowski said the coordination process was difficult and inefficient. The product evolved through seven major redesigns over a 20-year period so managing vendor relations was an ongoing challenge. With a stream of new Antares Pharma products on the horizon, Sadowski said the ideal solution for manufacturing its Medi-Jector VISION was to partner with a single manufacturer capable of most aspects of manufacturing, including mold design and build, molding, machining, component sourcing and assembly and packaging in certified facilities with a clean room environment.

"There were many manufacturing options offered to us for the Medi-Jector VISION, " said Sadowski, "but we needed to partner with someone close by who we trusted. This was our first foray into a partnership of this magnitude and it had to be right. S&W had excellent molding, assembly and packaging capabilities just minutes from our offices. They had a satisfactory 10-year history as a component supplier to us. Minnesota Rubber QMR Plastics also had a track record in the medical industry with a longstanding reputation as a leading manufacturer of sealing devices, Eastover formulations and medical silicone."

The companies worked together to combine their experience in medical manufacturing to transition QMR Plastics into the integrated medical device manufacture that Antares needed for the successful manufacture of the Medi-Jector VISION. This included process transfer and development and the necessary registrations. The transition process was smooth, taking just six months and saving jobs.

The Device in a Market-Proven Design

The Medi-Jector VISION is an engineering marvel, albeit with some manufacturing complexities. From a user's point of view disliking needles, it's a godsend. It makes taking insulin fast, easy and needle free. The Medi-Jector VISION utilizes a spring to push insulin through a micro-fine opening in the tip of a needle-free syringe. A fine liquid stream of insulin penetrates the skin. The correctly metered insulin dose is dispersed into the layer of fatty tissue under the skin. The task is complete instantly without the use of a needle.

The Medi-Jector VISION accurately dispenses all types of U100 insulin. The correct dosage is easily set by viewing the dosage window that shows how many units of insulin have been drawn into the injector. The disposable syringe portion of the device is sterile and reusable for 21 injections or 14 days, whichever comes first. The device is durably manufactured and tested to last for at least two years.

User comfort, convenience and ease of use were the design drivers through seven different versions of the needle free injection device. The earliest version of the Medi-Jector was made of machined metal components and was twice the size of the present design. It was heavy, difficult to lubricate and keep clean through repeated use. Also, individual skin texture differences had to be taken into account so user operated pressure adjustments was needed. It wasn't easy and it was confusing.

For the Medi-Jector VISION, a choice of three injector nozzles was designed. Users determine what works when they begin using the device, and then use that nozzle going forward. To eliminate the lubrication problem and to reduce size, weight and enhance product function, medical grade plastic materials replaced many of the machined metal components.

The present design, sold widely in both U.S. and European markets, requires highly trained technicians through all stages of manufacture and assembly.

Seamless Transition of Manufacturing

"The biggest challenge in the manufacturing move," according to Harlow Thielke, quality engineer for Minnesota Rubber QMR Plastics, "was learning everything about each of the 30 plus components - the specifications and quality requirements - that make up a completed Medi-Jector VISION. The second biggest challenge was moving the Antares Pharma class 10,000 Clean room facility.

"During discussions," continued Thielke, "we proposed bringing the Antares production people in as our employees to help operate the newly configured clean rooms and the newly acquired facilities. Antares Pharma officials liked that idea because it provided continuity using experienced personnel, and more important, it saved several jobs."

In addition to the personnel transfer, process training that enabled Minnesota Rubber QMR Plastics to achieves its ISO 13488 certification was facilitated. The company reports that it received EN ISO 13485:2003 certification in November 2005, giving its Medical Company Group certification to manufacture a broad range of medical devices in addition to the Medi-Jector VISION.

"Our quality training for the higher level of medical product manufacturing was really facilitated with our partnership with Antares Pharma," said Thielke. "In my own case, my counterpart there, Sharlene Johnson, the responsible quality engineer, helped me get up to speed quickly. In addition to quality issues, we confer daily on order progress and when needed, I drop by her office or she stops at our facility. Being just a few minutes away makes it easy for everyone to stay on top of every detail."

A key area Thielke points out that Johnson has helped is in managing the quality issues which differ with European and Japanese customers and their American counterparts. "We had to learn and manage those differences quickly," said Thielke "and our proximity and confidence in each other helped facilitate the process."

According to Antares Pharma, the production transition was made without any interruption of product supply to its international customer base with high volume requirements.

Assembly and Calibration Stages

Thielke explains that there are multiple stages of assembly, in process calibration and final inspection for the Medi-Jector VISION.

All disposable components pass through an inspection and a pre-sterilization inspection and a post-sterilization final inspection. The disposables are assembled in a Class 10,000 clean room with thousands assembled and packaged every month. The disposables manufacturing process undergoes periodic scheduled bioburden monitoring by an independent vendor contracted by Minnesota Rubber QMR Plastics to verify compliance with the sterilization validation.

Antares Pharma also provides Medi-Jector VISION kits, assembled by Minnesota Rubber QMR Plastics containing the device, disposables, manuals and videotapes in appropriate languages applicable to the geographic area of distribution.

Thielke said that, "by partnering with Antares Pharma in a co-managed manufacturing effort, we were able to maintain the highest quality levels while greatly expanding our facilities and medical certifications to offer complete medical product manufacturing partnerships to additional companies." TMD

To learn more about the Medi-Jector VISION, call 763-475-7700, e-mail info@anterspharma.com, or visit the web site at www.mediject.com. Write Antares Pharma Inc. 13755 1st Avenue North, Suites 100, Minneapolis MN 55441. Medi-Jector VISION is a registered trademark of Antares Parma Inc.

For more information on Minnesota Rubber QMR Plastics, call 952-927-1400, e-mail info@mnrubbber.com, or visit the web site at www.mnrubber.com. Write 1100 Xenium Lane North, Minneapolis MN 55441.