News - Early Collaborative Key To Designing For Medical Applications

FOR IMMEDIATE RELEASE:

Early Collaboration is Key to Designing for Medical Applications

Cleveland, OH - June 6, 2013

Helix yields higher value through early-stage disciplined realization design processes for medical devices.

Advanced medical device designs are evolving rapidly and demand higher standards for medical liability. Applying linear motion components to these medical applications yield the best results when collaboration begins at the early stages of the design. Modification to current parts or a custom design may offer the optimum solution; therefore, an emphasis must be placed on collaboration during the early stages of design with medical device manufacturers.

Helix Linear Technologies offers a wide variety precision linear actuator and lead screw options for medical applications. As a leading linear systems and components manufacturer, Helix Linear Technologies (Cleveland, OH) recognizes that medical application specifications often exceed the capabilities of standard, cataloged products. Helix leveragesdecades of expertise when modifying standard parts or creating custom designs for medical applications. Helix utilizes vigorous quality systems, a vertically integrated manufacturing model and implements a disciplined product realization process that reflects the Food and Drug Administration's Quality System Regulation 21 CFR-Part 280.

According to Helix Linear Technologies' CEO, Christopher Nook, "We often start with the customer's performance specifications focused on the product's expected life, environmental conditions, material selection and physical size. We then incorporate enhancements to the product's design that address the rigors of most medical applications. This process has allowed us to sell modified standard products to the Medical industry very successfully."

The following disciplined realization process is executed for Helix medical device applications.

Priorities for Design:

Beginning with specification requirements provided by the medical device manufacturer, definition of design priorities must be incorporated for finished devices intended for human use including:

  • Performance: load capacity and length/range of travel requirements
  • Efficiency: high-precision/low-precision
  • Accuracy: lead accuracy measured in microns; 10ths of 1,000s of inches
  • Envelope: compact
  • Material Constraints: stainless steel, magnetism/non-magnetism, radioactive elements, etc.
  • Operating Environment: non-direct exposure with patients or attached to the human body, etc.

Design Reviews:

Design reviews are conducted at various stages involving comprehensive, systematic, and documented examinations of a design that will evaluate the adequacy of the design requirements and evaluate the capability of the design to meet these requirements.

Designing a lead screw is not practical if it can't be consistently and efficiently produced. Helix leverages SolidWorks® COSMOS software at this stage to provide a full range of integrated modeling and simulation that medical product manufacturers need to design better products, faster - and at lower cost.

Medical Device Trends/ Products:

PRECISION LEAD SCREWS DESIGNED FOR COMPACT / PRECISION APPLICATIONS:

With the growing worldwide shift toward smaller packaged applications - typical requirements include lower load capacity and higher precision. Helix has recently introduced its Precision Miniature Lead Screw line designed for smaller footprint applications to meet the needs of these medical applications. In addition to medical equipment, these screws can be used in robots, guided missiles, unmanned vehicles, aerospace applications and many others.

The Precision Miniature Lead Screws were developed as an extension to its Power-AC™ offering to provide design engineers a globally accepted product for compact, portable, and lightweight applications requiring high accuracy, repeatability, and durability.

The small diameter (below 10mm) ball screws are designed with a load capacity of 40-100lbs., and a high precision (lead accuracy measured in microns; 10ths of 1,000s of inches).

  • Lead accuracy of: ± 100μm/300mm - Standard Rolled (Carry, MRT)/ ± 25μm/300mm - Precision Rolled (PMT)
  • Standard diameters from 6mm to 12mm
  • Standard leads from 1mm to 6mm

According to Helix Linear Technologies CEO, Christopher Nook, "The Precision Miniature Lead Screw's small size and customizable design offer precise, efficient movement in a compact package for medical device applications."

Designed in both metric and imperial dimensions to meet universal industry performance standards, Helix catalogs Precision Miniature Lead Screw sizes from 4mm to 24mm and 1/8" to 1" diameters respectively, available in both alloy and stainless steel.

Market Trends / Conclusion:

The footprint for medical device applications is reflecting a trend toward diminutive devices worldwide. Until recent developments in medical device miniaturization, a heavy, permanently fitted installation was necessary for a doctor to measure a diabetic's blood sugar level. Today this is achieved using a portable device no larger than that of a matchbox. Ever smaller dimensions are also the aim in machine elements. In the past, "micro dimensions" (diameter 6 mm and less) in lead screws were reserved for the production technique of "grinding".

Inverse to this trend; precision and performance requirements are growing higher, as are liability and compliance standards. The end result, however, remains steady - custom solutions that are ready for production, meet stringent performance and compliance standards, and ultimately provide a better product. Since higher liability factors and higher performance standards are the norm, involving medical device manufacturers at the inception of design is paramount to meeting all industry protocols and compliance requirements when linear motion components are involved.

The standard, rolled sizes available from most suppliers extended as far as a diameter of around 6 mm. If a smaller diameter was required for design reasons, recourse was taken to the ground lead screw - but at a very steep price.

This has radically changed today. Because of their own pressure for miniaturization, the medical technology industry (as well as optics, etc.) are increasingly demanding smaller screws. This has motivated most manufacturers to tackle and solve production problems associated with rolling micro diameters.


Corporate Profile:

Helix Linear Technologies, a wholly owned subsidiary of Nook Industries, is the most high-tech lead screw manufacturing facility in the world. Since the release of the Helix Precision Miniature Lead Screw, Helix produces the broadest product line of any lead screw manufacturer globally. With over 40 years experience, Helix Linear Technologies, Inc. has been a leading manufacturer of linear motion components and systems. The progressive growth of Helix has been achieved through its commitment to quality, continuous improvement, defect prevention, and the use of statistical methods and consistent training to ensure the quality of its products.

Headquartered in Beachwood, Ohio, Helix Linear Technologies is a wholly owned subsidiary of Nook Industries, an ISO 9001-2008 registered company, and provides controlled motion solutions in a wide range of industries including; transportation, medical/diagnostics, paper, chemical, food/beverage, solar/aerospace, entertainment and communications markets. Clients in these markets rely on the company's products for tooling, product design and engineering flexibility to provide modified standard products to meet their respective application requirements.

Whether the application requires an off-the-shelf linear motion component or an engineered solution tailored to fit your application - Helix provides comprehensive engineering, design and analysis in providing the highest quality linear motion manufacturing solutions on the market today.

For more detailed information, visit the Helix web site at: www.helixlinear.com or call: 1-855-435-4958.

©2013 Helix Linear Technologies, Inc.


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Editorial Contact:

John McLoughlin / Helix Linear Technologies, Inc.
Main: (855) 435-4958
jmcloughlin@helixlinear.com