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Medical Devices: Burgeoning industry has plenty of opportunities in wearables, old age care and neurology

Table of Contents
Executive Summary
Medical devices: Very diverse market and new business models are emerging
Wearable Medical Devices: Segment is seeing significant technological innovation
Neurological Implants: Segment is seeing significant new growth for medical devices
Aging Demographics: A highly important segment for medical devices
Medical Devices: new business models are emerging to suit the changing regulatory environment
Medical devices are extremely diverse and compete in different segments
Class I includes low risk devices such as bandages and stethoscopes
Class II includes moderate risk devices such as wheelchairs
Class III devices include the highest risk devices, such as pacemakers or implants
US and EU regulatory pathways are only similar on the surface
Concerning cases of defective and dangerous medical devices have surfaced, leading to questions over regulation
FDA device regulations have been inadequate for a number of years
Competitors starting to move in on Medtronic over next decade
Constricted healthcare budgets mean players have to plan carefully
Blockbuster treatment areas are now becoming quite crowded
The medical device industry is changing, and players need to adapt
New business to consumer models are popular at present
Future business models might involve a "mega play" across the value chain
Amazon might soon become a significant competitor in healthcare
Growth of the Chinese medical device market is significant but western players are less welcome
Wearable Medical Devices: Segment is seeing significant technological innovation
Apple Watch and Apple Health App are strong market offerings acting as potential substitutes
Other companies can piggy-back on good wearable devices
Global levels of diabetes are expected to rise, providing a huge opportunity for medical device manufacturers
Guardian Connect from Medtronic is part of a new wave of wearable diabetes devices
Insulin pumps offer an advanced level of diabetes treatment
Remote monitoring becoming the new industry goal
Kardia Band from AliveCor is another device using wearables, but with a subscription business model
Remote monitoring can lead to patient disengagement
Simplicity could be a route to faster regulatory approval
Regulation for wearables has been obsolete for a number of years
The FDA itself is aware of this problem and is taking steps to improve the process
Neurological Implants: Segment is seeing significant new growth for medical devices
Assisting brains that need repair is a key aim of neural implants and BCIs
Cochlear implants are very common place, non-invasive and can restore senses
Deep brain stimulation can alleviate the symptoms of Parkinson's disease
Retinal implant technology is allowing the blind to see again through a bionic eye
Treatment of spinal injuries to allow patients with paraplegia to move again
Microfibers are becoming more advanced and this is opening up new possibilities
The next step for BCIs is human enhancement
DARPA has been working on this field for a number of years for defense purposes
Kernel is looking to find ways to improve human intelligence and cure disease
Neuralink is planning to create an AI interface between the brain and computers
Even successful programs have shown that side effects can be severe
Aging Demographics: A highly important segment for medical devices
New alert technology allows elderly people to stay at home, keeping many out of care systems
Internet of things is changing how care is delivered to an aging population
New medical devices coming to the market include bespoke artificial limbs
New generation of smart pacemakers could be susceptible to hacking
Nascent technology can radically improve the mobility of an aging population, creating new business
Toyota's Mobility Challenge means better solutions to lower limb paralysis are coming
Mobility presents growing business opportunities for innovation
Remotely taking doctors into homes: technology streamlines treatment of elderly patients
Communication technology designed for over 65 year olds is a growth industry
Many of the latest devices are perfect for seniors, but not marketed as such
Key Findings
Sources
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List of Figures
Figure 1: Medical Device Industry Theme Report Topics
Figure 2: Current Route to Device Regulatory Approval in the US and EU 2019
Figure 3: Percentage of Medical Devices in Each Class in the US
Figure 4: Difference in Approval Pathway - US and EU
Figure 5: Characteristics of EU Approval Pathways
Figure 6: Johnson & Johnson Total Sales 2017, Breakdown by Segment, $bn
Figure 7: Top R&D Medical Device Spenders by % of Annual Sales
Figure 8: Leading Medical Device Players and their Number of Pipeline Products
Figure 9: Timeline of Amazon Moves in the Healthcare Market 2018
Figure 10: Chinese Median Age and Average Annual Wage Growth (US$), 2010-2017
Figure 11: Health and Lifestyle Monitoring from Apple Watches and Health Apps
Figure 12: Apple Watch Emergency SOS and Fall Detection
Figure 13: Medtronic Guardian Connect App
Figure 14: People with Diabetes Worldwide by Region (Millions), 2017-2045
Figure 15: Medtronic Guardian Connect Low Profile Sensor
Figure 16: Tactio Healthcare App Services Options
Figure 17: Kardia Band ECG Monitor
Figure 18: Brain Implant Representation
Figure 19: Top Six Fastest Growing Medical Equipment Segments by Expected Growth CAGR (%), 2013-2020
Figure 20: Cochlear Implant from Advanced Bionics
Figure 21: Deep Brain Stimulation Approved Uses and Potential Future Uses
Figure 22: Top Five Funded Global Start-ups in Eye Disease and Blindness Therapy Areas ($m), 2018
Figure 23: Second Sight Argus II Retinal Implant Device
Figure 24: New Flexible Microfibers may Provide Breakthrough in Spinal Injuries
Figure 25: Public Opinion in the US on Biological Tech, Pew Research, 2016
Figure 26: Over 65s as a % of the Global Population, 1960-2017
Figure 27: CareClip
Figure 28: Conformis iTotal Custom Made Knee Replacement
Figure 29: HAL-5 Robotic Exoskeleton
Figure 30: Evowalk Muscle Leg Stimulation Technology
Figure 31: RollerScoot
Figure 32: Percentage of UK Residents over 65-74 who own a Smartphone
Figure 33: Percentage of UK over 65-year-olds who go online
Figure 34: Doro 580 Mobile Phone
Figure 35: Apple i-watch SOS Function
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