DMC Medical was established in 1998 to develop and distribute a range of cardiovascular accessories for open heart surgery. The company identified substantial opportunities to supply these products to major international kit manufacturers and hospital supply distributors.
In the following years this Irish based company set up a distribution network in the U.S. complete with a Californian based logistics organization, U.S. Customer Service and Regulatory functions.
These same functions also exist in Ireland, where they service the European and Asian markets. The company is registered and audited by the FDA, with products either 510K accredited or listed as appropriate. Substantial investment and infrastructure building, marked this period. The vastly experienced team is drawn from a background of medical device manufacture, quality assurance, product development and customer service.
Interview with Bryan Wixted, CEO of DMC Medical Ltd.
Easy Engineering: What are the main areas of activity of the company?
Bryan Wixted: The Company since its foundation is committed to Research and Development and Innovation. Major resources, personnel, time and commitment were used in developing a strong manufacturing presence in China. Our licensed Chinese partners are all ISO approved and the Company employs direct Chinese representatives to oversee our interests. We have chosen our partners in China based on expertise, capability, reliability and regulatory knowledge and we have a very strong bond with our chosen companies. These companies have been audited by our U.S. based customers and the FDA. Senior management of the Company visit our Chinese partners at least 3 times a year, which now resumes post Covid-19.
E.E: What are the ranges of products?
B.W: DMC’s range of products have greatly increased since 1998 and our portfolio includes custom premium syringes in both polycarbonate & copolyester, a heart positioning device and an innovative wound care range.
All our finished medical devices are manufactured, tested, sterilized and approved to the highest international standards. Manufacturing is certified to ISO13485:2016, while our product range is tested and evaluated in accordance with ISO 10993. Sterilization is by EtO, Gamma Irradiation & performed to current ISO standards. DMC Medical Shannon was audited by the FDA in August 2023 with zero issues noted.
The company has built up an excellent reputation in the U.S. market with the top medical device companies. The majority of our product range is supplied bulk non-sterile, although we have an increasing number of direct hospital sales with a sterile format. Own labelling is also an option on larger quantities.
DMC currently supply a range of custom color syringes suitable for inclusion in surgical kits in addition to the pre-fill drug market. While the bulk of our product goes to the kit packagers and other medical device companies, we also supply our innovative HeartNet™ directly to hospitals throughout the United States for use in open heart surgery.
2023 will see the introduction of the SureSafe™ automatic retractable syringe, which addresses the “Accidental Needlestick Crisis”, where up to 2 million healthcare workers receive accidental needle sticks, which can lead to contacting over 20 life changing pathogens.
DMC Medical has also developed the NuGen™ copolyester syringe that is BPA free (Bisphenol) with advanced chemical & lipid resistance and suitable for both EtO & Gamma sterilization. The NuGen™ is of particular interest to the pre-filled drug market, offering a suitable alternative to Glass syringes.
DMC’s range can be divided into the following categories:
Custom polycarbonate color coded syringes, supplied bulk non-sterile, best suited for the inclusion in cardio vascular surgical kits. Own labelling is an option. EtO sterilizable.
Custom copolyester color coded syringes under the trade name of NuGen™, suitable for the pre-fill drug market. Own labelling is an option and the NuGen™ maybe both EtO & Gamma sterilized.
The HeartNet™ is a heart positioning device used during open heart surgery. The device allows the surgeon an optimum view and access to the heart during the procedure. Supplied both sterile and non-sterile to medical device distributors and hospitals direct.
Our innovative wound care products are both FDA listed & CE marked, where our SupraGel™ (amorphous hydrogel) and our SupraCel™ (flat sheet hydrogel) are suitable for 1st & 2nd degree burns in conjunction with cavity wounds, rashes, grazes and long-term sores. These gels are intelligent gels that will donate moisture to a dry wound, while absorbing excess puss from an exuding wound.
Our wound care products also include the FreezeAid™ cooling bandage. A superb cooling bandage for the treatment of soft tissue injuries. The bandage is available pre-soaked in 3.2m and 1.5m lengths.
E.E: At what stage is the market where you are currently active?
B.W: Our market penetration for the Polycarbonate syringes & HeartNet™ is well established primarily in the United States, although we are making inroads in the European market, which will increase in 2024. We will also introduce the HeartNet™ to the Japanese market in early 2024.
The SureSafe™ automatic retractable syringe will enter a growing market where the demand is increasing year-on-year. There are over 16 billion disposable syringes used annually and we will focus on converting a share of that market from using a standard non- automatic retractable syringe to the cost effective SureSafe™.
The NuGen™ copolyester syringe is gaining in popularity due the increase in awareness and warnings surrounding BPA (Bisphenol) and its effects on health. The removal and conversion of BPA can already be seen from its elimination from baby bottles and sports liquid containers.
Due to our experience in moulding syringes and components DMC is currently researching the medical vial market with a view to manufacturing a vial that’s an alternative to glass. The DMC vial will have advanced chemical, lipid and moisture resistance. This project will commence in early 2024.
E.E: What can you tell us about market trends?
B.W: DMC Medical is currently viewing markets outside our established territories in Europe, Asia, Japan and India through selective specialty distributors and agents.
Market trends and access to the medical device market will be seriously impacted by the transition from the MDD (Medical Device Directive 93/42/EEC) to the new MDR (Medical Devices Regulation 2017/745). Already, due to the complexity of the new regulations many Notified Bodies have exited the market, leaving a backlog for the remaining Notified Bodies in taking up the short fall. This has led to delayed facility audits and the registration in CE marking of products. The answer to the problems encountered in the transition by the EU is to continually push out the dates, for the switch to the MDR.