Stron Medical, Part of Q3 Medical Group
Stron Medical was launched in 2010 as a product line of QualiMed. With an impressive range of innovative products and a committed team of sales professionals, Stron Medical provides end-to-end solutions within Germany. QualiMed was found in 1997 as an OEM manufacturer for implantable medical devices with a focus on the development and regulatory approval of coronary stents and their respective delivery devices. Later the business was expanded to peripheral vascular and non vascular implants. In the last years QualiMed started with the development of various biodegradable technologies, drug device combination products, and micro-intervention implants as part of its diversification and competitiveness strategy. The company has production capabilities for stents, catheters, drug device combination products, and biodegradable technologies for a variety of interventional and surgical applications and holds more than 70 patents and utility models World Wide.
Company details
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- Business Type:
- Manufacturer
- Industry Type:
- Medical Equipment
- Market Focus:
- Globally (various continents)
Welcome
QualiMed was founded in 1997 as an OEM and private label manufacturer for implantable medical devices and is based in Winsen, Germany. Our primary focus is to create an alliance of global distribution partners and their associated physicians, to develop new technology with existing products for the patients they treat. By aligning ourselves with world key opinion leading medical practitioners in Interventional Cardiology, Peripheral Vascular and Non Vascular Specialties, we aspire to create medical devices “Created by Physicians for Physicians.”
Development Methodology
The company has created a 12 Step process to take products from Ideation through to manufacturing and commercialization. The approach lets the companies team assess new ideas, market conditions, competitive landscapes, and current technology including IP in an effort to determine the viability of various technologies and partners it would choose to bring products through the commercialization and sustaining engineering life cycle.
Company Profile
Up to date QualiMed has obtained CE approvals for more than 70 different products. QualiMed has developed over 4 Drug Eluting Stents of which it has two (2) CE approvals utilizing bio stable polymers and one more based on a proprietary fast absorbing biodegradable polymer coatings entering the commercialization phase.
Manufacturing is organized outside of Hamburg Germany in the town of Winsen where QualiMed runs two Class 10,000 Clean rooms according to EEC GMP standards.
In 2008 Eric K. Mangiardi joined the Board of Directors at QualiMed as an active investor with a primary focus to assist the company in the development and implementation of its strategic plan, operational growth, and product diversification strategy.
Business Model
We provide business management and consulting services for our clients and customers such as regulatory, product design, development, supply chain, warehousing, sales, and distribution channel management including sales acceleration using our Modified Generic Strategy™ that embraces a network based computing approach to commercialization.
The Modified Generic Strategy Model allows the company to leverage these relationships through a variety of offerings via its OEM, Private Label, Own Brand, and Development channels. This expanded channel or “Network” approach allows Qualimed to leverage its core expertise and skills in design, development, and manufacturing while taking advantage of market consolidation conditions that have left many channel participants with a reduced portfolio of interventional products to sell and seeking alternatives to these large cap companies that have consolidated them out of the channel. Because these channel partners are well trained, have strong historical relationships with the key user base, and are working with physicians that are skilled in the clinical use of the technology, there is a significant opportunity to accelerate the company’s growth through this multi-channel approach.
Relationship selling plays a significant role in what the doctors choose in the care for their patients and Qualimed plans to leverage the elasticity in the sales channel with its growing technology platform of innovative technologies.
- Own Brand: The company's Own Brand lines offer a full range of products through a growing number of exclusive and non-exclusive distributors in Europe, Asia, South America and Africa. Currently the company is selling products or registering its technology in over 40 countries globally.
- Private Label: The company provides a turnkey medical device offering to Private Label customers on a fee-for-service basis, which includes an upfront licensing fee for approved products in the coronary, peripheral vascular, and non-vascular areas. As part of the fee the company provides additional support services to accelerate the product transfers such as the establishment of a quality system for new entrants moving from pure distribution into having their own brand, CE transfers, inventory management, authorized representations, and other services as needed from time to time as requested by the customers. This private or ‘white’ label approach allows Qualimed to provide its products to multiple customers, further expanding its footprint in this highly fragmented market.
- OEM: The company's OEM division produces products for its customers on an exclusive basis. These customers either bring existing products for production or desire new products to be designed, developed and manufactured at Qualimed. Qualimed only engages in paid or funded development projects where it will have control of the manufacturing rights in the future and can leverage the developments into some future application it will develop on its own.
- Development: The company's Development is focused on novel development projects in the areas of Mechanical Implants, Catheters, Drug Device Combination, and Biodegradable technologies both internally sponsored by the company and its physician advisory network as well as externally funded projects from various corporate partners and government funded entities. Qualimed only engages in paid or funded development projects where it will have control of the manufacturing rights for completed developments and where developments will enhance the company’s internal capabilities.
Manufacturing & Development
The company is a full service provider of implantable interventional and surgical devices, catheters, drug device combination products and biodegradable implants all produced at its manufacturing facility based outside of Hamburg Germany.
The company is known worldwide as a leading designer, developer, producer, and seller of implantable devices The company has extensive expertise with mechanical devices used in all interventional and surgical areas as well as various catheter technologies including ballooning with various materials, sizes, and diameters. Additionally, the company has developed a number of drug device combination products that are currently being sold worldwide through its sales channel.
Biodegradable
The company focuses on individual solutions for its partner customers that address the special requirements of the application in the human body. The company has current biodegradable expertise and offers different material solutions like magnesium, iron, biodegradable polymers, and hydrogel for the construction of medical device implants. The degradation time can be varied from weeks to years in the human body depending on the anatomical requirements where the devices are implanted. The company is currently working on additional combination materials to enhance future applications and use.
The company has a steadfast belief that Biodegradable implants will offer a new way of healing for future generations’ worldwide.
Mechanical
The company develops and manufactures a variety of different technologies for medical device implants ranging from small coronary or neuro implants to large bore stent for pulmonary, esophageal, and other gastro intestinal indications. The company has the ability to perform all steps of the production process for the early design and prototyping through to scale up and production.
Catheter
The company has the capabilities to deliver various single and multi lumen catheters made from a large selection of materials specifically selected based on our customers design input specifications including but not limited to strong platform materials like polyamides and polyamide blends, PEEK, Polyimide, braided tubes and various multilayer tubing’s.
Balloon
The company has balloon blowing expertise to get high quality balloons with different customized behavior like non-compliant, semi-compliant and compliant balloons. The company has capabilities to use different materials and one or more multi-layer tubing’s to build the balloons, this coupled with a modern, complete process controlled manufacturing process, allows for the production of virtually any design with a controlled constant balloon behavior.
Drug Device Combination
The company has capabilities to coat materials with bio stable and biodegradable polymers such as stainless steel, cobalt chromium, nitinol, other alloys, nylons, urethanes, and an assortment of other materials with a variety of drugs including paclitaxel and sirolimus based pharmacologics.
Regulatory requirements for Drug Combination Devices are much more complicated because medical device regulations as well as medicinal substance regulations are involved. The company can assist in helping its customer partners establish their regulatory strategies involving drug device combination technologies.
Coatings & Coverings
The company developed and established different technologies for coatings and coverings of medical products in the broadest sense. This includes ion implantation technology to improve surface biocompatibility, covered stents to prevent in growth, and coated surfaces as a material to create a base to launch drugs elution properties from. The company has coating capabilities for dip coating, spray coating, an electro spinning.
Regulatory
Regulatory strategies and assessments are involved in an early stage of the QualiMed development methodology. After the product or concept Idea Phase is initiated a corresponding literature review and feasibility assessment will be performed and supported by the Regulatory Affairs department to make sure that ideas will have a certain level of approval success at the end of the development and the commencement of commercialization.
Clinical Expertise
Over the past ten years the company has established clinical trial channel to test products and technologies in the areas of interventional cardiology, peripheral vascular, and non-vascular areas. The company is utilizing its network of clinical advisors to insure that the right groups are established to execute on the clinical testing needs for its technology and to produce clinical papers to support its developments and subsequent launch of its technology.
Once products are approved this network can be used to help with the clinical introduction of the technology as well as aftermarket training as needed.
Clinical Areas of Expertise
The company has an extensive network and expertise in various clinical specialties and is focused on leveraging these relationships to insure that products meet the clinical needs in the market. Once products are approved this network can be used to help with the clinical introduction of the technology into the market.
Quality
The company is running a modern Quality Management System focusing on controlling processes and building in quality from the early product stages. The company is certified to ISO 13485:2012 and ISO 9001:2008 standards and Medical Device Directive 93/42/EEC Annex II.
Risk management throughout the development process is the company’s key tool to achieve safe product design, selection of best components, and to implement the right controls in production.