QualiMed is a full service provider of a range of implantable interventional and surgical devices, catheters, orthopedic fixation, drug device combination products and biodegradable implants at its facility based outside of Hamburg Germany. The company will only engage in development project where it has the majority of manufacturing volumes for global market once the devices pass through the regulatory stage of development.

Development

QualiMed is known world wide as a leading designer and developer of implantable devices from the Ideation phase through to production. QualiMed will only engage in the development of devices where it will have a contractual obligation to manufacture a majority of the products once they are commercialized. 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 QualiMed has developed a number of drug device combination products that are currently being sold world wide through its partner customers. The company has expertise with a variety of Bioabsorable and Biodegradable materials for use in medical device implants.

Mechanical

Manufacturing & Development
QualiMed developed, established and manufactures different technologies in the mechanical area of medical products. The major processes are as follow:

• Crimping
• The crimping process is one of the most critical processes in manufacturing a stent delivery system. QualiMed has developed its own unique crimping technology which is also patented worldwide. For this invention QualiMed received the “Innovations Award” in 2006 for the creation of this technology. Our crimping technology is a semi automated process and suitable for non coated as well as coated Stents. It measures a number of critical to quality parameters necessary to achieve a consistent result for high production throughput as well as the sensitivity for varying materials to insure the system can adjust to the material characteristics and specifications.
  
  

• Electro Spinning
• Electro Spinning uses an electrical charge to draw very fine (typically on the micro or nano scale) fibers from a liquid. Electro Spinning shares characteristics of both Electro Spraying and conventional solution dry spinning of fibers. The process is non-invasive and does not require the use of coagulation chemistry or high temperatures to produce solid threads from solution. This makes the process particularly suited to the production of fibers using large and complex molecules. Electro Spinning gives QualiMed the option for new products in new working fields as well as to improve its existing product line. Based on this polymeric nanofibre mats and based on their special structure, they are able to emulate the natural environment of cells.
  
  Within QualiMed’s biodegradable devices programs we are also working on biodegradable electrospun coverings for different applications were covering protection functionality is only required for a certain period of time.
  
  QualiMed has capabilities to work with fibers with a range variation of fibre diameters between 10 and 1000 nanometres. The fibres can be also combined with nanoparticles or pharmaceutical substances to meet specific user demands.
  
  

• Electropolishing
• Through the use of its proprietary electro polishing process that have been developed to polish, passivate, and deburr the various metals or alloys the company works with it has been able to improve the performance standards of the implantable devices for its customer partners. Our proprietary process of applying a specific electrochemical condition, most often involving a mass transport limited dissolution reaction combined with a second regulated condition of establishing heterogeneities due to crystal orientation in a polycrystalline material being suppressed and so that no pitting occurs through our process controls established over the last 10 years that allow us to modify the current density at the key areas where polishing is most difficult. We have a strong level of experience in polishing; stainless steal, Cobalt Chromium, Nitinol, Iron, Magnesium, tantalum markers, and other associated alloys.

• Injection Molding
• QualiMed has also experience in designing, developing, and manufacturing injected moulded parts for the various devices utilized by its customer partners utilized in the Interventional and Surgical Areas including orthopaedic devices. Possibility to work with technical plastics as well as high filled materials to get highest solidity especially for orthopaedic fixtures
  
  

• Laser Cutting
• QualiMed has over ten years in the design development and manufacturing of products using various laser cutting technologies including, ND:YAG, Piko- and Femto laser system and is experienced in laser cutting of various materials including Cobalt Chromium, Titanium, Iron, Magnesium and other alloys as well as bio absorbable materials. We have expert knowledge in laser cutting small diameter tubes as well as high dimensional tubes for a wide variety of implantable devices. We are able to design products for laser cutting involving mini as well as high dimensional tubing and flat material depending on the customers needs. 
  
  

• Materials
• Over many years QualiMed along with its partners has continuously optimized each process step for a high quality production which also takes into account raw material selection to insure that products reaching the market meet the demand specifications based on key user requirements. QualiMed evaluates each supplier and establishes quality standard to meet the customer partner demand and insure that its raw material supplier is selected based on the high precision requirements of the users. This selection process includes such items as wall thickness, concentricity, surface quality for the inner and outer areas, as well as various metallurgical properties based on our user needs. QualiMed has experience in Laser cutting Stainless Steel, Cobalt Chromium, Titanium, Iron, Magnesium and other alloys as well as bio absorbable materials.

• Mechanical Shaping & Forming
• Creating and object from a piece of metal is truly an amazing process. When looking at sculptures and metal structures one may take for granted the time, effort, and ingenuity that were required to form and create the object being admired. QualiMed has over 10 years of experience forming, shaping, and polishing various metallic materials including titanium, cobalt chromium, stainless steel, nickel titanium, magnesium, iron, and various biodegradable alloys and polymers. Through the science of studying the physical and chemical behavior of metallic and polymer elements QualiMed has the capabilities to select, form, and shape the material to meet the desired user needs specifications.

• Rapid Prototyping
• QualiMed uses rapid prototyping for the automatic construction of physical objects using adaptive manufacturing technology. The word rapid is of course relative as the construction of a model can take a few hours or days depending on the complexity and the size of the design. QualiMeds belief is the utilization of additive manufacturing technology for rapid prototyping takes virtual designs from computer aided design (CAD) or animation modelling software and turns it into a physical product that can enhance design validation through direct user interface. For our customer partners we offer the rapid prototyping service which enables them to do a first concept design feasibility while reducing the risk of cost, time, and design validation issues associated with early stage device development or late stage design or production improvements. The use of Rapid Prototyping gives the customer a physical tool to assess if the design outputs have a high likely hood of meeting the user needs before making additional more time consuming and expensive changes to the products.

Cathete
Manufacturing & Development

QualiMed has the unique 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 multilayer tubings.
The company has the capabilities to produce a variety of devices including the following:

• Small to large sized non- semi- and compliant balloon catheter for PTCA and PTA indications with varying balloon wall thicknesses and levels of rated burst
• A variety of stent delivery systems, with and without braided tubings and different release technologies
• Aspiration catheter with good kinking resistance, high aspirating volume with small entry profile (6F)
• Perfusion catheter;

Balloon

Manufacturing & Development

QualiMed has developed Balloon blowing expertise to get high quality balloons with different customized behavior like non-compliant, semi-compliant and compliant balloons. With capabilities to use different materials and one or more multi layer tubings to build the balloons, coupled with modern, complete process controlled manufacturing, allows for the production of virtually any design with a controlled constant balloon behavior.

Drug Device Combination

Manufacturing & Development
Regulatory requirements for Drug Combination Devices are much more complicated because medical device regulations as well as medicinal substance regulations are involved. QualiMed has capabilities to coat materials with bio stable and biodegradable polymers from stainless steel, cobalt chromium, Nitinol, and an assortment of other polymers.

Additionally, QualiMed can assist in helping its customer partners establish their regulatory strategies involving drug device combination devices:

For example for Drug Eluting Stents (DES) different possibilities can be distinguished depending on the knowledge of the ancillary medicinal substance:

1. the medicinal substance of the combination is already used in a CE marked DES with the same indication and the Manufacturer claims:
   
   
   • a. comparable medicinal substance release characteristics
     
     
     1. same stent material with the same surface coating and drug carrier system
     2. same stent material with a different surface coating and drug carrier system
     3. different stent material with same surface coating and drug carrier system
     4. different stent material with different surface coating and drug carrier system
   • 
     b. different medicinal substance release characteristics
   
   
2. the medicinal substance of the combination is known to the competent authority as an active pharmaceutical ingredient or formulated medicinal product in an authorised medicinal product but not as a component of a (previously) CE marked DES
3. 3. the medicinal substance of the combination is a new active substance and therefore not known to a Competent Authority neither as an active pharmaceutical ingredient or formulated medicinal product in an authorised medicinal product nor as a component of a CE marked DES (D).

Biodegradable
Manufacturing & Development

• During the last few years biodegradable materials have had a high interest for medical applications for implantable devices due to the elimination of the need for product removal post implant and the reduction of complications associated with long term implantations. QualiMed focuses on individually solutions for its partner customers that address the special requirements of the application in the human body. QualiMed has current expertise and offers three different materials, magnesium, iron and biodegradable polymers 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. This broad band of materials provides a range of individual solutions for our customer partners requirements QualiMed is currently working on additional combination materials to enhance future applications and use and has a steadfast belief that Biodegradable implants will offer a new way of healing for future generations world wide including the use of electro spinning of biodegradable nano fibres to provide a covering for various medical devices.
  
  

• Hydrogels
• QualiMed uses Hydrogels, which are a network of polymer chains that are water-insoluble and are highly absorbent and posses a degree of flexibility very similar to natural tissue while being virtually biologically inert, hemocompatible, and environmentally sensitive to conditions such as ph levels and the like. QualiMeds use ofhydrogels includes coating on implantable devices and there catheter based delivery devices. Coating thickness can be adjusted based upon customer’s request.

• *Carbon Coatings
  • Ion-implantations are used to render a metal that is implanted virtually inert by eliminating the negative effects of Nickel diffusion from the surface when the metallic material comes into contact with the body to insure they are rendered harmless. QualiMed’s approach of using a proprietary process that bombards the metallic surface with carbon ions that change the surface at a nano level and creates a new interface that is resistant to any surface damage inherent with traditional carbon coating. QualiMed provides different ion-implantation possibilities including C+, O+,CO+ and N+.
    
    

• *Drug Coatings
  • In 1999 QualiMed started to develop drug coatings to improve the clinical outcome of implantable devices and especially coronary stents. Since the beginning the coating developments were diversified in bio-stable and biodegradable polymer coatings as well as in different drugs and drug concentrations. Since January 2006 QualiMed realized three CE approvals for Drug Eluting Stents (DES) based on bio-stable polymer drug coatings.
    
    

    Current developments are looking for drug combinations in coatings for further improvement of clinical outcome by addressing different phases of development. Internal developments are available for customer licensing.

• Hydrophilic & Hydrophobic Coatings
  • QualiMed med has the ability to use a variety of coating technologies to insure that the various technologies it manufactures and develops meet the lubricious requirements of the customers to insure optimal performance.
  • Inspired by the “lotus-leaf effect” a lot of techniques have been developed to create super-hydrophobic surfaces. The aim of the scientists is to create a coating with a surface morphology that mimics the morphology of the lotus-leaf.When in the presence of water or body fluids, the hydrophilic polymer adsorbs water molecules to create a watery interface at the surface of the device. The water cushion reduces wet friction, protein adsorption and cell adhesion allowing the device to mover more freely in various conditions.
    
    

• *Urethanes & Silicones
  • QualiMed has the possibility to cover Stents and other devices with thin films to prevent the stent structure against. This medical-grade elastomers are manufactured under strict GMP conditions specifically synthesized to overcome the in vivo formation of stress-induced micro fissures. This makes our material an excellent material choice for medical device applications requiring long term durability. This high biocompatible material can include a hydrophilic or hydrophobic behavior on the surface as needed by our customer partners.

Regulatory

Regulatory strategies and assessments are already 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 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.

The Regulatory Affairs department continues to be involved in the further development process steps including:

• Design Input
• Regulatory Assessment
• Risk Analysis
• Design Output (Design Verification and Validation)

This is done to insure that during the development process key items around risk mitigation are initiated to insure that the technology meets the rigors associated with key test metrics required to insure the product achieves regulatory approval. Regulatory is involved in the assessment of risk from the point of material selection to the testing of design inputs and outputs based on key user needs specification that will require regulatory support.

Our Regulatory Team has deep involvement and assessment of the testing required to establish regulatory approval and to mitigate any risk associated with the various requirements for approval such as:

• Bench Testing
• Animal Testing & Trials
• Human Clinical Trials

We believe it is essential to have the regulatory team involved in the design of each phase of the testing be it bench, animal, or clinical to insure the appropriate data is being captured and tested to insure that regulatory approval can be achieved.

Our regulatory team has a deep experience in the approval of products in Europe, Asia, and North America either directly or via our customer partners. The regulatory team plays and active role or supportive role for our customer partners depending on their needs and sophistication. QualiMed, through its regulatory department provides a variety of services to support customer needs for approval of all Classification of devices including:

• CE Approval
• CE Transfer
• FDA Approval
• World Wide Registration

Even if the focus of approval strategies is concentrated on Europe (CE approval) and US, QualiMed also gives regulatory support for all national approval processes worldwide depending on various customer requirements

Over the past ten years QualiMed and its partners have acquired a significant amount of experience and contacts in the Interventional and Surgical fields. Weather QualiMeds partners seek additional input on product design and development or have a desire to establish a clinical advisory board to conduct clinical experiments or trials QualiMed can utilize its network of clinical advisors to insure that the right groups are established to execute the clinical testing of your technology.

During our history QualiMed was involved in a huge number of pre-clinical and clinical studies from the simple to the more complex drug device combination technologies and thus established an extended expertise in planning, organization, supporting, conducting and assessment in these areas.

The basis regulations for planning and conduction of Clinical Studies for Medical Products are described in different directives and standards. QualiMed supports the following standards for its clinical trials capabilities:

• Medical Device Directive 93/42/EEC and its latest changes based on
• Directive 2007/47/EC
• Medizinproduktegesetz (MPG) national medical product laws, e.g. Germany
• ISO 14155-1:2009
• ISO 14155-2:2009

Clinical Investigation Plan (CIP), for details please contact us (hyperlink)
Albeit a complicated process QualiMed has successfully engaged in a number of key clinical trails to achieve regulatory success globally including complicated drug device combination trials and can leverage its historical experience to help you manage the regulatory requirements in the areas where you are focused and wish to achieve regulatory approval to market your technology.

Clinical Areas of Expertise
QualiMed 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 your technology into the market. These areas of expertise include:

Interventional Area in:
**Interventional Cardiology
**Interventional Gastroenterology
**Interventional Pulmonology
**Interventional Radiology

Surgical Areas in:
**Bariatric Surgery
**Cardiac Surgery
**General Surgery
**Orthopedic Surgery
**Peripheral Vascular Surgery
**Thoracic Surgery

Quality

QualiMed is running a modern Quality Management system focussing on controlling processes and building in quality from the early product stages. QualiMed is certified to ISO 13485:2003 and ISO 9001:2008 standards and Medical Device Directive 93/42 Annex II and V.

Risk management throughout the development process is QualiMed´s key tool to achieve safe product design, selection of best components and to implement the right controls in production. The products are manufactured under clean room conditions and are controlled for perfect surface and mechanical properties to ensure outstanding biocompatibility.

Quality Assurance is completely implemented into the production processes: The quality controls are organized as In Process Controls run by operator teams. Regular and ad hoc trainings assure high standard education for each employee and his needs.

Combined with QualiMeds electronic data infrastructure – a comprehensive customized ERP system - Qualimed has a powerful tool to control and analyze quality in order to continually improve processes for the benefit of patients and customers. This approach to Quality animates the positive attitude towards quality across the QualiMed team every day.