Increasing Electronic Content in Medical Devices Spurs Growth

The medical electronics manufacturing services (EMS) market is benefitting from an increase in original equipment manufacturer (OEM) outsourcing. Increases in electronic content, costs, wireless connectivity, and convergence have encouraged OEMs to view EMS providers as strategic partners. This research service discusses the trends for growth, challenges, services, and products. Analyses are included for forecasts, geography, the competitive environment, and vertical markets. Product segments include: cardiovascular; imaging; patient monitoring; endoscopes; audiology and hearing; and respiratory and anesthetics. North America, Europe, Asia-Pacific, and Rest of World are the regions. The base year is 2012, and forecasts are provided to 2019.

Executive Summary

• The increase in electronic content within the medical industry has been a crucial driver for the growth in electronics manufacturing services (EMS).
• The EMS medical market generated revenue of $ million in 2012. The market is expected to have an percent compound annual growth rate (CAGR) and $Xmillion in revenue in 2019.
• The primary drivers for original equipment manufacturer (OEM) outsourcing include increasing cost pressures and the need to generate profits in a low- to medium-volume manufacturing environment.
• The US Affordable Care Act and the 2013 excise tax are expected to further exacerbate cost pressures for OEMs in North America and encourage more OEM outsourcing in the region.
• In addition, EMS providers have the advantage of being able to leverage electronics expertise from different verticals. They are in a position to transfer best practices and elevate OEM competitive positioning in the medical industry.
• EMS providers will also benefit from burgeoning opportunities to get involved in the early design stage of devices.
• OEMs will also continue to seek EMS support to streamline supply chain costs and leverage their global footprint.
• The EMS medical market will benefit from rapidly growing demand in remote diagnostics, patient monitoring, cardiovascular, and neurological medical product segments, including consumer medical products and single-use products.
• The bulk of EMS revenue still derives from manufacturing services. Highly regulated conditions and liability concerns continue to encourage OEMs’ hesitancy to outsource strategic services.
• On the direct fulfillment end, OEMs prefer to retain control over the final distribution to end customers (hospitals and physicians), and this is not expected to change much during the forecast period.
• Opportunities for complete, high-level assembly in the medical industry will evolve gradually in the forecast period.

CEO’s Perspective

1. OEMs will increase outsourcing to counter cost pressures, such as the new excise tax.
2. New medical product companies will be virtual, meaning most or all manufacturing will be outsourced in the next years.
3. EMS providers’ role in improving efficiency, time to market, cost, quality, production technology, and access to emerging regions will increase.
4. The top medical product companies will continue to outsource their older products that require cost reductions to remain viable.

Definitions

• The scope of the study is medical device outsourcing to EMS providers.
• The study includes revenue forecasts based on product and geographic segmentation.
• Geographic regions include:
- North America
- Europe
- Asia-Pacific
- Rest of World
• Vertical market segmentation includes:
- Cardiovascular
- Patient monitoring
- Imaging
- Endoscopy
- Audiology and hearing
- Respiratory and anesthesia
- Others (includes urology, infusion systems, orthopedics, therapeutic, ophthalmology, general surgery, minimally invasive surgery, and hemodialysis)
• The study covers revenue and trends from a manufacturing perspective.
• All revenue and prices in the study are in US dollars, unless otherwise specified.
• Cardiovascular Market—includes products in three main sectors: cardiac rhythm management and congestive heart failure, interventional cardiology, and cardiac surgery; products include pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy, stents, and cardiac catheters
• Patient monitoring Market—includes multiparameter monitoring equipment, fetal and neonatal monitoring systems, cardiovascular monitoring products, sleep apnea monitoring equipment, diabetes/glucose self-monitoring products, blood pressure monitoring products, temperature monitoring products, and anesthesia equipment
• Imaging Market—includes MRI systems, ultrasound, computer tomography, X-ray machines, and nuclear medical imaging products
• Endoscopy Market—includes gastrointestinal endoscopes, enteroscopes, choledochoscopes, urology endoscopes, arthroscopes, sigmoidoscopes, and capsule endoscopes
• Audiology and Hearing Market—includes auditory brainstem response (ABR) and otoacoustic emission (OAE) analyzers, analog and digital hearing instruments, and ENT endoscopes such as sinoscopes and octoscopes
• Respiratory and Anesthesia Market—includes oxygen therapy products, concentrators, liquid oxygen products, compressed gas cylinders, nebulizers, and anesthesia delivery systems
• Others—includes urology, infusion systems, orthopedics, therapeutic, ophthalmology, general surgery, minimally invasive surgery, and hemodialysis
The US Food and Drug Administration (FDA) categorizes a medical devices into one of three classes based on its application, associated risks, and required levels of approvals.
Class I Devices
These represent minimal potential harm; therefore, they are subjected to less regulatory control. Class I devices are not associated with high risks or used for sustaining life. Examples of Class I devices include bedpans, hand-held surgical instruments, bandages, and gloves.
Class II Devices
Class II devices are governed by general and special (tests and validation processes) controls. Due to the greater risk and some life-sustaining qualities of Class II devices, general controls alone are insufficient to judge and assure safety and effectiveness. The devices are held to more stringent regulations than Class I devices to ensure they do not cause issues for a patient. Examples of Class II devices include X-ray machines, infusion pumps, surgical and acupuncture needles, and patient monitors.
Class III Devices
Class III devices face the most stringent regulatory control because they aid in ensuring a patient’s well being and sustaining life. In addition to general and special controls, all Class III devices require pre-market approval to ensure safety and effectiveness. Examples of Class III devices include heart valves, surgical implants, pacemakers, and external defibrillators.

Key Questions This Study Will Answer

• Is the EMS medical market growing, how long will it continue to grow, and at what rate?
• Which are the high-growth segments? How do demand and growth opportunities vary by geographic regions?
• How will the role of EMS evolve over time? What is the percentage of revenue from services?
• Are the services currently offered meeting customer needs, or is additional development needed?
• Are EMS providers ready to tackle the challenges of operating in the medical industry? What do they need to cultivate in terms of best practices to take their businesses to the next level? How will this affect order fulfillment and distribution strategy?

Table Of Contents

Table Of Contents

1. Executive Summary
2. Market Overview
3. Total EMS Medical Market
• External Challenges: Drivers and Restraints
• Forecasts and Trends
• Market Share and Competitive Analysis
• Mega Trends and Industry Convergence Implications
4. Cardiovascular Segment Breakdown
5. Imaging Segment Breakdown
6. Patient Monitoring Segment Breakdown
7. Endoscopes Segment Breakdown
8. Respiratory and Anesthetics Segment Breakdown
9. Audiology and Hearing Segment Breakdown
10. Others Segment Breakdown
11. North America Breakdown
12. Europe Breakdown
13. Asia-Pacific Breakdown
14. Rest of World Breakdown
15. The Last Word (Conclusions and Implications)
16. Appendix

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