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New Report on Role of Dimensional Metrology in Medical Device Industry

Reportlinker.com announces that a new market research report is available in its catalogue: Analysis of the Global Dimensional Metrology Market in the Medical Device Industry

Standardizing Regulations Globally Will Lead to Sustained Growth

The role of dimensional metrology in the medical device industry is in a nascent stage. Several market participants are exploring opportunities that are currently emerging in this space. This market engineering research service primarily focuses on dimensional metrology in orthopedic and dental implants, stents, and catheters. The service provides revenue forecasts, outlines geographic trends, highlights market drivers and restraints, and offers a market share analysis. Region breakdowns are provided for North America, Europe, Asia-Pacific, and Rest of World. The study period is from 2009 to 2017, with a base year of 2012.

Executive Summary

  • The total dimensional metrology market in the medical device industry generated a revenue of $X million in 2012 at a growth rate of Xpercent over 2011.
  • The multi-sensor system segment held the largest market share with X percent for the medical device industry. It is expected to grow at a CAGR of Xpercent from 2012 to 2018.
  • The North American and European markets are the two biggest markets for the dimensional metrology industry and are expected to remain so until the end of the forecast period. In the future, the demand and supply is expected to shift to Asian countries, such as India and China, as medical manufacturers slowly try to increase production capabilities in low-cost countries.
  • Quality Vision International (QVI), Mitutoyo Corporation, Micro-Vu Corporation, and Nikon Metrology are Tier I market participants. Research indicates that these Tier I companies captured X percent of the total market in 2012.
  • The dimensional metrology market for the medical device industry has not experienced any serious developments in terms of technology and market revenue. However, there is a higher demand for superior technology, greater accuracy, faster measurement capabilities, and ease of use—all of which invite more opportunities for advances multi-sensor system technology and for average prices to increase over time.
  • Stringent regulations in the medical devices industry are the main factors driving the demand for dimensional metrology. In Europe, the quality of systems is assessed under the parameters of International Organization for Standardization (ISO) 9001 and ISO 13485, and Medical Device and Diagnostic Industry (MDDI) requirements must be met. In the United States (U.S)., the quality of systems is assessed with reference to Quality System Regulation (QSR),Code of Federal Regulation (CFR) Part 820. The products are assessed based on the technical profile of the product submitted for pre-market approval.
  • Medical device manufacturers seek flexibility in dimensional metrology machines, as accuracy and reliability are imperative attributes of existing dimensional metrology technology in bridge-type coordinate measuring machines (bridge-type CMMs), vision measuring machines (VMMs), and optical digitizer and scanners (ODS). A machine that is able to measure objects of different sizes and structures is expected to turn heads in the medical device industry.
  • The total dimensional metrology market for the medical device industry is expected to reach $X million at the end of 2017.
  • Errors in implant manufacturing results in significant financial loss, damages brand perception, and threatens customer loyalty to medical devices manufacturers. In the long run, implant manufacturers are expected to invest in high-precision dimensional metrology equipment to reduce manufacturing errors.
  • Several small-sized metrology companies have established their presence by selling scanners to hospitals and doctors.
    • Although products sold to doctors and hospitals are lower in cost, they sell in greater volumes.
    • In the future, larger companies in the dimensional metrology industry are expected to enter this segment as well.
  • Approximately X percent of medical device manufacturers are characterized as small and medium-sized companies. Several small and medium-sized firms are struggling to attain a breakeven-point due to low scalability and the dominance of leading medical device manufacturers in the market.
  • In the future, cost-effective and highly accurate dimensional metrology equipment will serve as an ideal alternative for companies with a limited budget. Such equipment is likely to showcase significant market penetration.

CEO's Perspective

  1. For dimensional metrology companies to begin targeting medical devices industry, strategic acquisition of existing metrology vendors focusing on medical devices industry will reduce the go-to-market period.
  2. Low-cost dimensional metrology equipment for mid- and small-sized medical device companies will broaden the target market and market scope.
  3. High-precision attribute of profile projectors and multi-sensor system are likely to dominate the market over the forecast period.
  4. Medical devices companies are focusing on local sourcing to keep the production costs low. Increased regional presence of dimensional metrology vendors is likely to attract more opportunities.
  5. Companies utilize direct sales channels due to an increase in demand for custom solutions.

Definitions

The segments covered in this study are broadly divided into the following:

Vision Measuring Machines (VMMs)

  • Measuring Microscopes — These are the oldest optical measurement systems in the world. They are constructed using two compound microscopes in order to perform both two- and three-dimensional measurements. Initially an analog instrument, today's technological advancement has led to an interfacing with computers for better analysis.
  • Profile Projectors — The most common piece of vision equipment, these systems are very simple in their design. The image of the object being examined is projected onto a screen together with a two-dimensional axis for measurements and for reference. They can be classified as horizontal or vertical, depending whether their line of vision is parallel or perpendicular to the ground.
  • Multi-sensor Systems — The working principle behind such systems involves measuring the test piece by means of different probes, both contact and non-contact. With instant capture and analysis using the most advanced video systems, multi-sensor systems can be categorized into manual and automated systems. The automated systems use computer numeric control (CNC) to make automatic measurements.

Coordinate Measuring Machines

  • Bridge-type Coordinate Measuring Machines (Bridge-type CMM) bridge machine has a horizontal frame that is supported by two vertical columns, whereas the machine arm is vertically suspended to measure the work piece.
  • The gantry-type CMM, horizontal arm machines and articulated arm machines are not widely provided as solutions by dimensional metrology vendors to the medical devices industry. Hence those technologies are not being covered in this study.

Optical Digitizer and Scanner (ODS ) Market

  • 3-D Laser Scanners — 3D scanning is the process of measuring digitized data of a object with equipment that uses laser light to measure the distance between the object and the scanner.
  • White Light Scanners — White Light Scanner machines are used to measure physical geometry. White Scanners are the most preferred for the measurement of entire physical geometrical characteristics.
  • Laser Tracker — The laser tracker technology is appropriate for measuring of larger objects in automotive and aerospace industry. The research study focuses on orthopedic and dental implants in the medical devices industry. Medical implants are generally small in size and has complex structures. Measurement of implant objects using laser tracker will not be an appropriate solution for the medical device industry. Dimensional metrology vendors do not provide laser tracker technology solutions to the medical devices industry. Hence laser tracker technology is not covered in this study.

Regional Segmentation

The study also breaks down each of these markets into segments based on the following four broad geographic regions and provides an analysis of the market in each of these regions.

Geographic Regions Covered

  • North America: Includes the United States and Canada
  • Europe: vIncludes countries in western and eastern Europe, including Russia
  • Asia-Pacific: Includes countries on the western border of the Pacific Ocean, including those on the Indo-Chinese peninsula and the Pacific islands, and central Asia
  • Rest of World: Latin America (Brazil, Mexico, Argentina, and Central and South America) and regions not mentioned above, particularly the Caribbean Islands, the Middle East, and Africa

Study Timeframe:

  • Study period: 2009–2017
  • Base year: 2012
  • Forecast period: 2013–2017 End-user segments include key medical devices such as orthopedic and dental implants.

Key Questions This Study Will Answer

  • Is the global medical devices growing; how will it continue to grow and at what rate ?
  • Are existing competitors structured to meet customer needs?
  • What metrology technologies are preferred the most?
  • Which of the regional markets holds most of the growth opportunities for VMMs, bridge-type CMMs, and ODS market?
  • What economic factors are expected to affect the dimensional metrology market for the medical device industry ?

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