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Seamless solutions for implantable medical device components

A leading U.S. manufacturer of precision engineered metal components for implantable medical devices, Hudson Technologies is proud to offer customized solutions for a wide range of applications. Our team works closely with clients throughout every step of the process to turn your concept in reality — from developing the initial design and building a prototype to manufacturing the finished product. With more than 40 years of stamping experience, we’re proud to work with many of the industry’s leading medical device manufacturers.

Products

Hudson specializes in both deep drawn and shallow drawn metal
components and stampings, but deep drawn stamping, in particular, is
especially well-suited to the manufacture of medical device
components; allowing for reduced production time and lower costs,
deep drawn stamping also provides greater product consistency and
produces less material waste. Deep drawn stamping can also
accommodate advanced designs, and a wide range of metals can be
used in the process, allowing for great versatility. At Hudson, we
specialize in deep drawing titanium and stainless steel for medical
devices used in active stimulation and surgical equipment.

When manufacturing deep drawn medical components, we have three
top priorities: keeping medical components clean, working with
cutting-edge precision equipment, and obtaining a high-quality surface
finish.

Tooling and Equipment

High-quality tooling and equipment ensure high-quality end parts for critical medical applications. Our tooling is designed and built in-house by a multi-shift staff of highly trained tool makers, and our machine floor is home to more than 130 forming presses (ranging from 1 to 500 tons), including hydraulic and mechanical presses, as well as a servo press with a CNC lower cushion.

We also offer extensive modification capabilities, allowing for greater component customization, and our equipment features in-house heat treatment options with vacuum and hydrogen annealing capabilities to reduce lead times and provide optimal quality control.

Applications

To ensure we deliver optimally hygienic, safe, and functional medical components, we employ a rigorous quality management system. To keep medical components clean, we only use non-chlorinated lubricants or solvents, employ special cleaning processes to remove any debris after manufacturing, and carefully package products to prevent contamination. To ensure the precision of our equipment, we follow strict industry standards and conduct comprehensive inspections and quality planning. Finally, we make sure all our tools and dies have an outstanding surface finish to ensure the medical components that they produce have high-quality finishes as well — essential for reliable sterilization and reduced risk of infection.

Through these efforts, our team produces industry-leading medical device components, with the assurance of optimal safety, sanitation, and efficiency. Below are some of the most common applications for these devices.

  • Housing and casing components for cardio, neuro,  cochlear, and other implantable medical devices
  • Shields and half-shells
  • Battery cases
  • Capacitor components

Materials

To ensure optimal safety and wellbeing for both patients and practitioners, medical instruments must be manufactured to provide reliable sterility. At Hudson, we make use of top-quality, long-lasting materials that can easily meet the industry’s strict sterility requirements. In particular, we work with stainless steel (surgical steel), which features high corrosion resistance, as well as titanium (Grades 1, 2, 4, 5, 7, 9, 11, and 23), which features high tensile strength and resistance to corrosion and acid.

Titanium Grades
Different grades of titanium provide different benefits; depending on the specific application at hand, any of the following materials may be used.

  • Grade 1 — This unalloyed titanium has the greatest  formability, features excellent resistance to corrosion,  and is highly resilient against impact.
  • Grade 2 — This unalloyed titanium is corrosion  resistant and provides higher strength than Grade 1.  Thanks to its varied usability and wide availability,  Grade 2 titanium is a popular material choice for  stamping; it is easily weldable, formable, and highly  ductile.
  • Grade 4 — Another unalloyed titanium, Grade 4  titanium is very corrosion resistant, formable,  weldable, and strong; this is a medical-grade titanium.
  • Grade 5 — Grade 5 titanium alloy (6% aluminum, 4%  vanadium) is the most commonly used of all titanium  alloys. Applied heat allows for increased strength, and  it is lightweight, highly formable, and corrosion  resistant.
  • Grade 7 — Made of unalloyed titanium plus 0.12 to 0.25% palladium, this is the most corrosion-resistant of all titanium alloys. It is commonly used in chemical processes and production equipment components.
  • Grade 9 — Titanium alloy (3% aluminum, 2.5% vanadium) has high mechanical strength.
  • Grade 11 — Made of unalloyed titanium plus 0.12 to 0.25% palladium, Grade 11 titanium is similar to Grade  1 but features higher corrosion resistance.
  • Grade 23 — This titanium alloy, comprised of 6% aluminum and 4% vanadium with extra low interstitial  (ELI) elements, is considered the ultimate dental- and medical-grade titanium.

    • Stamping features

    Metal stamping is unique in that it allows for a wide range of part modifications, meaning designs can be extremely versatile. Hudson can incorporate the following stamping features into all manufactured parts:

    • Coining — This involves a closed-die squeezing operation that  confines or restrains all work surfaces, creating a well-defined  imprint of the die on the work.
    • Embossing — Embossing creates shallow indentations or raised  designs without significantly affecting the metal’s thickness.
    • Holes — These are formed by cutting a shaped portion of metal  from the drawn part using conventional, extruding, or piercing  punches.

    Designing for Manufacturability and Reliability

    All of Hudson’s products are designed for high manufacturability and reliability, and we understand the importance of close design collaboration between the manufacturer and the client. Our team offers comprehensive design assistance from concept development through final production, and we adhere to stringent guidelines to ensure consistently high-quality medical device components. Below are some of the strategies we implement to guarantee part reliability.

    • FMEA (Failure Modes and Effects Analysis) — This  step-by-step analysis helps us identify all possible failures  that could occur with a product’s design, manufacturing, or  functioning. We can then examine the effects of those  potential failures to determine their priority level and  develop ways to remedy them.
    • FEA (Finite Element Analysis) — FEA helps us predict how  physical forces such as heat, pressure, or vibrations will  affect a product and whether the product can withstand  such elements.
    • Center of Excellence for Manufacturing and Engineering — We stay involved in manufacturing centers of  excellence to help us increase productivity, deliver high  value, lower costs, and improve overall quality while  keeping abreast of best practices.
    • Lean Six Sigma — To ensure we consistently deliver quality  -products and maintain efficient operations, Hudson adheres to  the Lean Six Sigma methodology. This helps us continually  streamline our processes, eliminate waste, and improve  efficiency.
    • REACH and RoHS Compliance — We also comply with both  REACH and RoHS standards to ensure the safety of all staff  and end users. RoHS (Restriction of Hazardous Substances) is  a European Union directive setting forth guidelines for the  manufacture of electronic equipment without the use of six  major hazardous materials. REACH (Registration, Evaluation,  Authorization, and Restriction of Chemicals) is a European  Union regulation requiring manufacturers to provide relevant  information regarding chemical use throughout the supply  chain in order to protect consumer and environmental health.

    Quality

    Hudson Technologies was founded on a commitment to quality throughout all processes and operations. To maintain our high-quality standards, we implement a thorough quality assurance program that includes continual staff training programs and routine assessments. All team members are Six Sigma green- or black-belt certified, and we proudly work under the Kaizen methodology; with roots in Japanese philosophy, Kaizen focuses on methods for continuous process improvement, reduced waste, and streamlined operations.

    The team at Hudson implements advanced quality planning and conducts comprehensive visual inspections to ensure all operations are running smoothly and safely. For instance, our use of the OGP SmartScope dimensional measurement systems — with touch, laser, and optical measuring capabilities — allows us to provide a complete analysis of medical part performance and safety. We also employ statistical process control and software to closely track and monitor our materials and processes.

    Environment

    As a leader in green manufacturing, Hudson has invested a great deal of time and money in developing eco-friendly manufacturing processes that meet high environmental standards. Currently, we are ISO compliant in environmental management systems (ISO 14001:2004), and we aim to help our customers build a greener supply chain themselves; as mentioned earlier, we use only environmentally sound lubricants and work with an aqueous cleaning system.

    No chlorinated lubricants or solvents are used in our TCE-free manufacturing process, meaning no hazardous waste is produced.

    Learn More

    To learn more about Hudson’s precision stamping capabilities for medical device components, check out our comprehensive Medical Solutions Guide , in which we delve further into material selection and prototyping processes, outline relevant stamping applications, and provide more information on our quality certifications and green manufacturing efforts.