Sandvik Materials Technology Business Unit Medical Corp. Palm Coast

For Sandvik, the key to streamlined development lies in the early stages. Optimised communication between teams, small scale prototyping and leveraging experience speeds up the development process and minimises waste.

Developing partnerships with customers has been at the core of Sandvik’s company ethos since its founding. By aligning our team with that of the customer, effective communication optimises the development process.

While many component manufacturers will assess the need from an initial drawing or print from a customer and make a large sample based on the perceived requirements, Sandvik first makes a prototype for customers to test.

“One way we help speed up the process relative to other suppliers is that we’re willing to make these very small custom prototype batches for customers so that they can truly tease out all the issues that they may have with the design,” explains Gary Davies, Production Manager at Sandvik. “This is a very iterative process where we make a prototype and they test it out. They can then provide some feedback and this may happen two or three times until we’ve settled on the most effective design.”

 “Sometimes the customer doesn’t know exactly what they need, and if they request a large sample of a product that’s not useful to them, it could be a waste of time, effort and money. Small scale prototyping means that they can find a suitable product having only used two or three prototypes to get there.”

Here, Sandvik can leverage its experience to provide customers with suggestions and not need to start over again during the prototype stages. In many cases, this may involve offering solutions that the customer was not aware of.

Once an agreement is made about what the product needs in terms of physical dimensions, chemical properties and other configurations, Sandvik takes the customer through the full qualification and validation process that’s required by the regulatory bodies. From initial design and prototyping to refining and validating the final product, Sandvik works to ensure that development is optimised to get medical devices to market fast.

Selecting optimal coating(s) for wire-based components incorporated into medical devices can be a challenging task for even the most experienced design team due to the numerous and everchanging options promoted in the marketplace. 

Sandvik offers more than forty (40) different polymer based stand-alone dip coating options as well as extruded coating capabilities under the trademark EXERA®, which in many cases are combined to formulate a customer focused solution. With our very good concentricity and dimensional control in extruded coating  we can offer an extrusion process that's not a common capability globally. Coating is one of our core competencies.

Information available from brochures or digital media platforms offers some insight into options available to the product designer. However, product performance, manufacturability and cost considerations are usually not as well defined. 

Let us share our experience ;

• How to select the optimal coating(s) for wire-based components incorporated into medical devices.
• About the key interactive parameters that can help drive a better product design decision.
• About polymer coating material types with respect to general properties and other primary reasons for selection based on the application or process considerations.
• About the method that has been useful to define the final polymer coating options.

Making Sandvik ’s entrance into the medical devices sector in which ultra-fine wire is used in the applications, the company introduced the EXERA® trademark in 2016 to wire-based components that are custom made to transmit, sense or stimulate within the human body. Since entering the medical devices field, Sandvik’s history and expertise in stainless steel has been invaluable.

The ultra-fine wire is also used in other microtechnology devices. Besides ultra-fine wire Sandvik also produces micro-tubes and strip steel for various microtechnology and medical applications.

Working with more than 200 alloys, and specializing in choosing the best materials and configurations, EXERA® wire-based components are used for a variety of medical applications including vascular therapy, biosensing and neurostimulation. So far, they have been used for devices such as;

• Vascular therapy:
  Catheters and guidewires: Medical wire requires good corrosion and moderate tensile strength, fatigue and relaxation resistance.
  
  Pacing leads: Medical wire will generally need ultra-high strength, ductility, toughness and very good corrosion resistance. Sandvik 12R10 HV medical wire and Sandvik 316LVM medical wire are used for these sensors, catheters and heart mapping/monitoring devices.

• Cochlear remediation:
  Cochlear implants: Sandvik offers high-quality medical wires produced from platinum- iridium alloys to be encased in the silicone of the implant’s electrode array.
  
  Middle ear implants: These devices require a tightly coiled metal wire for sound transmission. Sandvik offers coiled wires with a polymer or PTFE coating.
  
  Bone conducting systems: Medical wire is used in these devices helps transmit energy to the transducer that is directly in contact with the skull.

• Sensing solutions:
  Thermocouple: Two or more wires made from different metals are coupled to provide a variable EMF response at different temperatures.
  
  Glucose sensor: This device requires a fine wire for a sensor thinner than a needle.
  
  Electrical sensors: Sandvik categorizes these devices into multi-electrode arrays and tetrodes.

• Stimulation therapy:
  Deep brain stimulations: Sandvik offers high-quality conductive wires with high durability properties. These form an essential part of modern neurostimulation devices.

Single strand or multi-filar cables can be manipulated into different cable configurations. Coatings, such as PTFE or polymer, can be applied to any cable arrangement. 

Single strand wire configurations can also be formed into multi-filar or microcable arrangements. 

Sandvik offers an extensive range of wire for making guidewires which act as an integral part of medical devices used to treat cardiovascular, endovascular and peripheral vascular disorders.

Guidewires access a patient’s coronary and peripheral vascular system for a variety of diagnostic and therapeutic medical procedures. Guidewires are generally used as a guide for the purpose of placing and guiding large devices such as balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA). When the tip of the devices reaches the intended endpoint, the wires act as a guide which is followed by the large catheters for easier transfer to the treatment site. Guidewires are characterized by properties such as moderate tensile strength, good corrosion resistance, and moderate fatigue and relaxation resistance.

Sandvik offer an extensive portfolio of added value operations regarding cable manufacturing. We invite you to collaborate directly with our engineers to manipulate and modify our capabilities to exceed your needs. 

Some cable value addeded operations:

• Cut to lenght
• Coiling
• Mechanical assembly
• Lead finishing (stripping and forming)
• Twisting and stranding to custom cable solutions
• Straightening (mechanical or thermal treatment)

Microsensors becomes smaller and smaller and more advanced and is today an indispensable tool in many medicial applications. They are used in various continous measurement devices to measure blood sugar, temperature, pressure, Ph value, flow volume or respiratory values like oxygen or carbon dioxide. 

The developement of integrated sensors also becomes more and more desireble so that you can measure many different values at the samt time avoiding to have several catheters inserted into the body increasing the risk of infections.

What we find with a lot of our customers is that they’re looking at more advancements in their designs – they don’t just want a precision wire, they need precise, multifunction wires. Sandvik has been assisting for the past couple of years in the design of a composite wire that has different elements incorporated into that one wire system. One part of the wire is used to locate the sensing device inside the body, almost like a smart guidewire. Another senses heat, another senses something else. So we’re really at the top of our game with that creation.

Looking toward the future
In addition to the new composite wire there is another bit of research that’s really set to change the preventative medicine scene: There’s a new device Sandvik is getting involved with bringing to the marketplace that will prevent and manage heart failure before it gets to an acute stage. The wire is inserted in your cardiovascular system and there’s an antenna that’s attached to this sensor –so the whole system provides a continuous output of blood flow and pressure, that would give the physician an indication that you’re starting on the early stages of heart failure and exactly where the problem areas are. They then start you on a remedial path long before you can ever be considered acute.

Besides offering high quality precision wire to medical applications the fine wire is also used in various other microtechnology devices.

Sandvik offers fine wire in a wide range of stainless steels and nickel alloys including resistance and resistance heating alloys. The wire is available in sizes ranging down to 10 microns.

The fine wire is supplied in round or shaped form and is delivered with or without insulation and coating. Sandvik's fine wire is typically used in applications, such as:

• Bonding wire
• Computer disc drives
• Electronic components
• Heating applications like small heaters
• Loudspeaker applications

Fine wire insulation and coating
Sandvik offers several types of coatings including PTFE coating and adhesive bondcoats for its fine wire, all available in multiple colors.

For insulation and bondable coatings of fine wire Sandvik uses mainly a continuous 'flood coating' process but can also offer an extruded coating process if required.  The Fflood coating' process gives the wire quality and performance benefits over other techniques applied for fine wire, as 'flood coating' guarantees a complete coating over the wire surface, which is both consistent and extremely tenacious.

As one of the world’s leading metal producers and metallurgy pioneers we have strict control over our supply chain. This also means that advances and adaptations occur fast here. In other words, at Sandvik, innovation literally begins from the ground up.

For over 150 years, Sandvik has maintained a world-leading position in materials engineering and manipulation. Our operations are based on unique expertise in molecular technology and extensive insight into industrial processes. We invest substantially in research and development and maintain close cooperation with our customers and suppliers. From our beginning as a pioneer in malleable steel with the perfecting of the Bessemer method, to our commitment to high value-added products in advanced steels and special alloys, we continue to set the industry standard.

Today we offer more than 200 alloys as standard but custom made alloys are made upon request. Together we can design a product that cannot be found anywhere else in the world.