Zinnov Medical Devices Engineering Digitalization Globalization · 2019-06-11 · • AI, Cyber Security, Bigdata, IoT and combination products will drive spending on devices Point-Of-Care

TITLE OF PRESENTATION

Digitalization and Globalization of Medical DevicesOctober 2018

2

Consolidated ER&D Spending: ER&D spend is highly consolidated among the top 5 OEMs;Imaging and Non-imaging remain primary spend segments.

R&D

Spen

d (in

Bn)

41%R&D spend contribution by Top 5 R&D spenders

32%Next 10 R&D spend contribution

27%R&D spend contribution by Rest of the Companies

Region-wise R&D Spend

Region % of R&D SpendNorth America 59%

Europe 34%APAC 7%

$24 - 25 BnTotal R&D Spend

Ø Global R&D spend is highly consolidated among top 5 R&D spenders

Medical Devices companies à

Source : DRAUP

Dominant Sub-verticalsNon-imaging diagnostics, Surgical, and Prosthetics

Dominant Sub-verticalsImaging and non-imaging diagnostics

Top 10 R&D Spenders

Philips $2.3 – 2.5 Bn

Abbott $2.1 – 2.3 Bn

Medtronic $2.1 – 2.3 Bn

GE Healthcare $1.4 – 1.6 Bn

Siemens Healthineers

$1.3 – 1.5 Bn

Note: Analysis is based on the DRAUP’s proprietary engineering database, updated in Feb 2018

3

Rest of North America

54%

Rest of Europe

14%

India

6%

76k – 77k R&D Headcount

China

4%

Germany

8%

UK

3%

Bay Area

8%

Consolidated R&D Talent Footprint: ~90% of the global engineering workforce is consolidated in North America and Europe.

Medical Devices R&D Footprint

• Medical Devices R&D is consolidated in the United States and is not very globalised.

• Medical Devices OEMs are not leveraging low-cost talent hotspots like India and China.

• Most of the hubs are located in North America, indicating that the decision making is still governed from the US

Hub Spoke AnalysisNorth America Europe APAC

66%

8%

26%

57%

19%

24%

27%

28%

45%

Outpost

Satellite

Hub

Top Players

(by R&D presence)

• Medical Devices R&D is consolidated in the United States and is not very globalized

• India and China are the emerging tech hotspots for medical device Companies.

• Most of the hubs are located in North America, indicating that the decision-making is still governed from the US

Note: Analysis is based on the DRAUP’s proprietary engineering database, updated in Feb 2018 Source : DRAUP

4

Expanding R&D Talent Footprint: Over the past 3 years, OEMs have started expandingR&D globally, especially setting up centers in India and the Bay Area.

Global Medical R&D Center Distribution and Growth

6.4 – 6.5k

39 – 40k

19 – 20k

4.3 – 4.4k 3.4 – 3.5k

CAGR: 3.4%

CAGR: 3.5%

CAGR:20%CAGR: 3%

• Bangalore and NCR are two major hotspots in India for MD investment.

• Suzhou and Shanghai are two major hotspots in China.

• Fresenius, Medtronic, and Thermo Fischerhave opened multiple R&D centers in China since 2009.

• GICs in India are getting empowered and engaging in strategic partnerships with Service Providers.

• Tech Giants are building software-centric solutions out of Bay Area and have developed a rich Medical Device ecosystem.

• Thermo fischer and GE Healthcare have opened software COEs in Bay Area.

• UK has seen a rise in the Medical Device talent in the last 3 years.

2017

2013

CAGR: 8%

Bay Area Rest of USA Europe India China


5

62% 17% 21%

Medical device Hotspots in US: Increase in the number of digital use cases has led to the emergence of newer digital hotspots in the US

WEST COAST

BAY AREA

PHOENIX

EAST COAST

BOSTON

Hotbeds 2018Emerging Hotbeds

NEW YORK

RALEIGH

ATLANTA

MINNEAPOLIS CHICAGO

11K+ Monitoring, Cloud Analytics,

Genomics, Robotics, Automation

500+Vascular, Pacemakers, Clinical

Diagnostics

GREATER SALT LAKE CITY

1500+Imaging applications, Molecular

Biology, Neurovascular

TEXAS (Austin, Dallas & San Antonio)

1600+Ophthalmology, Surgical,

Neuromodulation, Lenses 800+Surgical Robotics, Oncology,

Ultrasound, Respiratory Devices

700+System Development, Oncology,

Microbiology, Imaging systems

3.4K+Gen-sequencing, Diabetes,

Surgical, Trauma and Extremities

4.5K+Pump Platforms, Mobile CT

scanner, Urology, Endoscopy

2.5K+Ultrasound, Oncology,

Telehealth, Care Delivery4.7K+

Cardiovascular, Navigation,

Patient Monitoring.

44k – 45k US R&D Headcount

46% 39% 15%Traditional

(Mech/Embedded)

Digital ClinicalTraditional

(Mech/Embedded) Digital Clinical

6

~30% of the Medical Devices R&Dtalent in Bay Area is working in Software verticals

300 - 400

200 - 300

500 - 600

100 - 200

Top 5 Medical Devices OEMsbuilding software solutions in Bay Area

Medical Devices OEMs in Bay Area

Note: Analysis is based on the DRAUP’s proprietary engineering database, updated in Feb 2018Source : DRAUP

100 - 200

Future Focus SegmentsCurrent OEM Focus

Punit SuriVP Smart Lab

& Digital ScienceThermoFisher Scientific

Brian StewartSenior Director

Digital EngineeringThermoFisher Scientific

Technology Leaders

Rani PangamSenior DirectorGlobal IT EPMO

Medtronic

Eran RubensChief Technology Officer

Enterprise ImagingThermoFisher Scientific

Non-imaging Diagnostic Non-imaging Diagnostic

Acquisitions

Emerging Focus AreaSoftware-enabled Solutions/WorkloadsCloud Platform for connected health

Automation of Liquid Chromatography

Data Analytics in Non-imaging Diagnostics

Data Interoperability between devices

PCR Cloud Application

Lab Automation

Cloud Bioinformatics solutions

Minimally Invasive devices

Imaging Medical Device

Next generation sequencing

Artificial Pancreas

Genomics

Stem cells

Regenerative medicine

Personalized medicine

West Coast, USA: Medical device giants are setting up software centres in Bay Area in West coast to exploit the strong STEM talent and develop digital use cases

7Note: Analysis is based on the DRAUP’s proprietary engineering database, updated in Feb 2018Source : DRAUP

East Coast, USA: Medical device giants have accelerated capabilities focussed on Product and Systems Development in Boston Area in East Coast

~50% of the Medical Devices R&Dtalent in Boston Area is working in Product and System Development

550 - 600

450 - 500

600 - 650

150 - 200

Top 5 Medical Devices OEMsbuilding software solutions in Bay Area

Medical Devices OEMs in Boston

250 - 300


Jim LaDineVP R&D, Chemical Analysis Division

ThermoFisher Scientific

Technology Leaders

Tom NeufelderSVP, Innovation Leader

- Diagnostic ImagingPhilips Healthcare

Kurt GeitzVice President R&D

Boston Scientific

Acquisitions

Emerging Focus AreaProduct / System Development Workloads• Development of advanced mechatronics products and

systems for Minimally Invasive Surgery

• Development of Mobile CT scanner product for navigated spinal and cranial surgery

• Research and development of Pump Platforms (Mechanical Circulatory Support)

• Development of novel LVAD attachment devices

• Research and development on Rhythmia mapping and navigation system

• Development of ultrasound transducers for diagnostic imaging.

• Research & Development in Mass Spectrometry, Microbiology, Chemical Analysis, Chromatography & Analytical Technologies

• Research and development of Bioprocess Disposable Bioreactor

• Development of custom hardware designs

• Design & Development of Wearable Sensing Solutions

Kevin BourqueVice President R&D

Abbott


Minneapolis, USA: Giants of Minnesota like Medtronic and Boston Scientific are using mechanical capabilities to build cardiovascular devices and surgical tools

~70% of the Medical Devices R&Dtalent in Minneapolis Area is involved inDevelopment of surgical tools and devices for cardiovascular.

1600-1800

600 - 650

1800 - 2000

30-50

Top 5 Medical Devices OEMsin Minnesota

Medical Devices OEMs in Minneapolis

100 - 150


Technology Leaders

Mike HessVP, MCS Business at

Medtronic

Randy SchiestlVice President R&D

Boston Scientific

Acquisitions

Emerging Focus AreaProduct / System Development Workloads

• Development of a product pipeline for a broad portfolio of endovascular products inclusive of PTA, SFA stenting systems

• Development of MRI conditional implantable pacemaker

• Development of new Guide and Diagnostic Catheter products, Cardiology balloon and intravascular filter products.

• Fabricate & test medical device prototypes of implantable ,surgical tools and machinery

• Development of home health telemonitoring software for mobiles

• Data Management, Cloud Computing. Firmware development and Mechanical Design of

Neuromodulation Patient Care Devices

Vicenta HoffmanSr. Director, Global

Sourcing and Supply Chain, St. Jude Medical


Chicago, USA: Robotics, Cloud imaging and Digital pathology solutions are key digital focus areas of medical device giants in Chicago

~50% of the Medical Devices R&Dtalent in Chicago Area is involved indevelopment of Renal therapeutic devices

500 - 600

250 - 300

1300 - 1500

100-150

Top 5 Medical Devices OEMsin Chicago

Medical Devices OEMs in Minneapolis

200 - 250


Technology Leaders

Ying-Cheng LoVP, Global Technology and R&D Innovation,

Baxter

George DaileyDirector, Hardware

EngineeringSiemens Healthineers

Acquisitions

Emerging Focus AreaProduct / System Development Workloads

• Design, development, implementation, and analysis of medical products under Renal Home Therapy and Peritoneal Dialysis (PD) devices

• Development of laparoscopic surgical instrument product line

• Product Development of platelet and red blood cell apheresis collection systems

• Development of Sterile Injectables and cellular therapies

• Development frameworks for controlling a wide variety of laboratory instruments, including liquid handling robots, plate storage robots, fluorescence plate readers, radiometric plate and vial readers.

• Cloud imaging, Advanced Visualization (AW), CVIT, Perinatal, Perioperative and Digital Pathology Solutions

10

R&D Spend Distribution: Diagnostics Devices is the prime spend segment; explosive adoption of EMR, Point of Care Solutions and Connected devices are the key growth drivers.

Therapeutic DevicesDiagnostic Devices

Medical Devices

R&D Spend

expected growth rate

5.7%

Medical Devices Global R&D

Spend

$24-25Bn

4.9

5.9

3.3

1.7

5.9

6

6.7

7.6

4.3

2.3

7.6

7.9

Monitoring Devices

Surgical Devices

Imaging Diagnostic

Non-imaging Diagnostic

Other Therapeutic

Prosthetics

2017 2021E

Medical Devices R&D Spend Distribution across sub-verticalsTherapeutic Devices

• Investments in monitoring devices is majorly driven by the demand of connected home care solutions as a part of value-based care.

6.6%

5.5%

5.6%

5.5%

5.3%

5.5%

Diagnostic Devices

Therapeutic Devices Diagnostic Devices

• 60% growth of global EMR adoption in the last 5 years

• Imaging Diagnostics is experiencing maximum growth in R&D spending because of the huge amount of data being generated

• Point of Care solution in non-imaging diagnostics is the major driving force for growth in this segment


11

Digital Transformation of R&D: Medical Devices R&D spend is expected to reach ~$32BN in the next 5 years, largely driven by investments in digital-centric use cases.

*Analysis of top 32 R&D spenders

G500 Medical Devices R&D Spend (In USD Bn)

$21 -22 $23 -24$24 -25

$31 -32

2015 2016 2017 2022E

Key Digital Transformation Themes

Preventive Care• Enhanced focus on preventive care has warranted

use of predictive analytics• AI, Cyber Security, Bigdata, IoT and combination

products will drive spending on devices

Point-Of-Care (POCT) Testing• Focus on affordable pricing, faster detection, and

reduction in hospital stays are key factors driving consumer device adoption

• Target to reduce the amount of manual labor involved in diagnosing disorders and move from lab to clinic model driving the market for devices

Real-time Monitoring• Increased usage of devices for continuous monitoring

and digital therapeutics have led to higher demand levels of wearables

• Predictive care to manage chronically ill patients and reduce overall visits


Tech Giants• Google, Microsoft and IBM are capitalizing on their native

capability in new technologies and are disrupting conventional business models.

• Google has acquired a start-up called “DeepMind,” focusing on fast analysis and diagnosis of imaging scans.

Cross-Vertical Applications- Telecom and Aerospace

• Remote Medical Center, Teleconsultation and Teleradiology are gaining investments from Telecom players that will help them expand their service portfolio

• Studies on focused sonography have been performed to meet the diagnostic challenges of space medicine and to discover potential applications of point-of-care ultrasound for the aeromedical clinician

Startups• Start-ups are targeting Artificial Intelligence and

Analytics to enhance the patient experience, increase efficiency of devices, and improve clinical workflow.

• Crospon is developing edge minimally invasive medical devices for imaging and aiding surgery in the esophagus and stomach.

12

12KSoftware

Engineering job openingsAcross 32 OEMs during 2017

20Digital CoEs

set up by OEMs in the last3 years

~11%Expected CAGR (2017-2022) growth

in software sub-segment

64% 19% 17%

33% 33% 33%

60% 20% 20%

40% 27% 33%

64% 19% 17%

Digital (Software/Analytics/ML) Clinical (Non-Engineering)Traditional (Mech/Embedded)

R&D Headcount Split by SkillsOEMS Key Digital CoEs

• San Francisco Bay Area• Milwaukee, US• Bangalore, India

• San Francisco Bay Area• Amsterdam, Netherlands• Bangalore, India

• Minneapolis, US• Los Angeles, US• Hyderabad, India

• Minneapolis, US• San Francisco Bay area• Boston, US

• San Francisco Bay area• Indianapolis, US

R&D spend of medical devices companies: Bay Area and Bangalore are emerging as prime hotspots for Digital CoEs of medical device companies

13

GE Healthcare: Organization R&D structure and workforce distribution

Note : DRAUP’s proprietary talent module was used to analyse job roles by Industry and skill type

~7,000R&D Headcount Traditional (Mech/ Emb.) Digital (S/W, Analytics and ML) Clinical (Non-Engineering)

Key Centres & Workloads

Development of imaging for radiology, fluoroscopy, interventional cardiology, angiography, electrophysiology and mammographyDevelopment of patient monitors, Positron Emission Tomography systems

Greater Milwaukee area

~4,500 ~1300 ~1200

Development of GE health cloudSan Francisco Bay Area

Greater Boston Area

R&D talent employed by GE Healthcare across 42 centres globally Life sciences solutions such as Cancer

diagnostic and molecular imaging methods for biopharmaceuticals cancer research

Greater New York City Area

Greater Chicago AreaDevelopment of PACS, Cardiovascular Information System (CVIS), Radiology Information System (RIS), , cloud imaging, Advanced Visualization (AW), Perinatal, Perioperative and digital pathology solutions

Burlington, Vermont AreaDevelopment of next-gen imaging application in emerging web technologies such as HTML5, CSS3, AngularJS, jQuery and associated testing products such as Jasmine

FranceHigh-quality imaging and hybrid workspace operating room

BengaluruDevelopment of CT, MR, molecular imaging, ultrasound, x-ray and patient monitoring products and servicesDevelopment of Perinatal products, High Acuity care products and radiology imaging products Bengaluru

Digital Radiography, Women's Health & Interventional Radiology

Baltimore, Maryland Area Florence, South Carolina Area Phoenix, Arizona Area

Madison, Wisconsin Area Germany

Research and development of Bioprocess business

United KingdomResearch on Genomics and Cellular; Develop the newest generation of medical diagnostic products and contrast media

SwedenDevelopment of chromatography media

NorwayMicrobiological methods for use in production line of injectable drug products

ChinaDevelopment of CT and X-RAY detector,Value Mammography product

Greater Salt Lake City AreaGreater Seattle Area

HungaryIsrael

14

Philips: Organization R&D structure and workforce distribution



Key Centres &

Workloads

~2,500 ~2,500 ~2,500

Development and testing of PACS (Picture Archiving Communication Systems) Development of architecture to build the cloud based Philips HealthSuite Digital Platform

San Francisco Bay Area

R&D talent employed by Philips across 32 centres globally Development of interventional oncology business line with

products such as UroNav (an image-guided stereotactic biopsy system)

San Francisco Bay Area

Development of image-analysis algorithms & system design for ultrasoundDesign of the interface between the ultrasound imaging system and transducerDesign and development of multi-tier objected-oriented components & functionality for a global, large-scale secure critical care clinical information system

Greater Boston Area

Design of clinically viable wearable medical devices for remote patient monitoring (Ex-Telemetry medical devices) Design therapy delivery subsection for Philips ALS (amyotrophic lateral sclerosis) defibrillators

Greater Boston Area

Define, design and build innovative clinical MRI (magnetic resonance imaging) solutions Research on clinical risk algorithms and clinical decision support systems Research in unobtrusive neonatal monitoring & accelerometry for vital sign monitoring Development of the clinical roadmap with respect to fMRI (Functional MRI) and neurosciences

Netherlands

Development of workflow software for Computer Tomography (CT) imaging applicationConcept design, development and industrialization of Microdose, an advanced mammography solutionR&D of image processing and analysis algorithms for radiation therapy treatment

Bengaluru Advanced development of technology solutions to expand CT (computed tomography) spectral imaging capability Long term research in virtual colonoscopy and virtual catheterization applications

Israel

Development of new for home healthcare in field of respiratory care, sleep care & COPD (chronic obstructive pulmonary disease)Project lifecycle management of new mask development and optimization of existing masks

Greater Pittsburgh Area

Design, development and industrialization of Intuis, an entry level interventional X-ray systemNew product development & lifecycle management of cardiovascular cathlab productsDesign & development of mechanical sub-assemblies for surgery C-Arms

Pune

Greater Seattle Area

Greater San Diego Area

Germany

Brazil

Cleveland

United Kingdom

France

China

15

Medtronic: Organization R&D structure and workforce distribution




~4,500 ~1,500 ~1,500R&D talent employed by Medtronic across 41 centres globally Firmware development and mechanical design of

Medtronic Neuromodulation Patient Care DevicesMechanical designs for Cardiac Rhythm and Heart Failure (CRHF) business units, inclusive of Implantable Cardio Defibrillators (ICDs) and Implantable Pulse Generators (IPGs)Analog IC design and development for Medtronic CRHF products

Greater Minneapolis Area

R&D on Aortic and Peripheral devicesR&D on Spine and Oncology procedures, radiofrequency (RF) ablation of metastatic malignant lesions in the vertebral body, spine pain management and interventional oncology, RF bipolar ablation probes, bone biopsy & efficient Pedicle/Cortical Wall access systems

Bay Area

Development of advanced mechatronics products and systems for Minimally Invasive Surgery with a focus is on embedded software for the MIS platform’s robotic subsystem

Greater Boston Area

Greater New York Area

JacksonvilleGreater St. Louis AreaGreater Memphis Area

Software development and design in Respiratory and Monitoring Solutions, Ventilators division

Greater San Diego Area

Design and development of ventilator software with C++ and C# on WinCE and ThreadX, QT on Linux

China

Research and Development of a catheter delivery system for coronary stents

Ireland

Research and Development on hernia repair medical devices and anti-microbial surgical implantResearch and Development in a critical medical equipment sector - Respiratory Unit

France

Concept Design, Analysis, Software development for Early Technologies, Patient Monitoring and RecoveryAdvanced Development, algorithm development, and new technology research for the Medtronic Navigation business

Greater Denver Area

Design and development of mechanical surgical devices in the areas of Thoracic Surgery, Hernia Repair, Minimally Invasive Surgery

India

Greater Memphis Area

Israel

Denmark

Development of Microstream capnography modules, in conjunction with specialized algorithms, as well as CO2 breath sampling lines

16

Abbott: Organization R&D structure and workforce distribution




~1,200 ~8,00 ~1,000R&D talent employed by Abbott across 16 centres globally Development of mechanical circulatory systems,

i.e., blood and implantable heart pumpDevelopment of mechanical circulatory support devices for Left Ventricular Assist DeviceDevelopment of embedded firmware and related applications to support new product development for blood glucose monitoring systems

San Francisco Bay AreaDevelopment of software for implantable ventricular assist devices

Greater Boston Area

Development of leading LIS (Laboratory Information System) product Development of STARLIMS V10.5 using technologies such as JavaScript, .Net in the client side and SSL (STARLIMS Scripting Language) for the server side.

Israel

Development of image guided therapy platforms and technologiesDevelopment and testing for surgical and transcatheter valve testingTechnology development in the area of transcatheter & surgical heart valves and vascular closure

Greater Minneapolis – St. Paul Area

Greater Chicago AreaDevelopment of specifications to release materials (reagents, controls and calibrators)Research, development and technical product support with particular emphasis on infectious disease diagnostics

Texas Area

Product development of class III medical devices for neuromodulation therapy: spinal cord stimulation, deep brain stimulation, and dorsal root ganglion stimulation

United KingdomClinical research associated with Abbott’s Diabetes care productsGermany

Research and manufacturing site for Abbott Vascular Instruments, molecular diagnostics and informatics implementationsProducts developed and produced include balloon dilatation catheters and stent systems

ChinaScientists conduct research and develop products for diagnosing and managing major cardiovascular, endocrine and metabolic diseasesInnovation and acceleration associated with the discovery of new diagnostic tools using a multi-disciplinary, collaborative approach

Testing methods to identify, measure and mitigate MRI induced mechanical hazards including considerations for static force, torque and gradient vibration

Greater Los Angeles Area

17

Roche: Organization R&D structure and workforce distribution




~2,500 ~500 ~1,500R&D talent employed by Roche across 11centres globally

TucsonCore research that encompass chemistry, multiplexing, molecular and advanced systemsResearch and development of key initiatives with a focus on product development including lean workflow solutions, *IHC assay development, *ISH assay development and detection system (reagent) development.

IndianapolisFocus on global information management systems within the Diabetes Care spaceResearch and development of software systems like Accu-Chek 360 and handheld glucose measurement systems such as Accu-Chek Aviva and Accu-Chek for the management of diabetes

MadisonResearching and manufacturing target enrichment probe pools for *DNA sequencingNext generation sequencing combined with sequence capture probe poolsResearching genomic structure to understand the impact of genes on biological processes

SwitzerlandCenter of expertise in modern instrument designDevelopment, production and servicing of instruments and software systems that are used in in vitro diagnostics

Bay AreaDevelop a single-molecule, semiconductor based, *DNA sequencing platform using nanopore technologyDevelop and deliver testing services to perform directed analysis of cell free *DNA in blood

South AfricaDevelops life science reagents for DNA and RNA amplification, sequencing and molecular diagnostics

GermanyResearch and development of in vitro diagnostics productsDevelopment of compounds for Roche lab analyserplatforms

Bay AreaLab automation, workflow, and LIMS software for the NIPT CLIA Lab in San Jose.Develop, deploy and manage software and bioinformatics services on the cloud.Software development, integration and testing for In-Vitro Diagnostics (IVD) medium throughput solution for qualitative & quantitative detection of molecular targets

18

Emerging Medical device companies Dashboard: Ophthalmology, Cardiology, Wearables and Robotics based solutions are key focus areas

Imaging Non-imaging Monitoring Prosthetics Other Therapeutics Surgical

Note: Analysis is based on the DRAUP’s vendor ecosystem module, updated in July, 2018

MRS technology to measure brain metabolites

MRI

ADV

ANCE

MEN

TS

Treat inoperable and hard-to-reach brain lesions using MRI

OPH

THAL

MO

LOGY Provide clinicians a treatment

based decision algorithm

Ophthalmic diagnostic equipment & eye surgical

instruments.

3D M

ODE

L

Analysis of blockages using 3D model of Coronary arteries

DRU

G DE

LIVE

RY Patch pump for subcutaneous delivery of one or more medications

Solving the challenge of self-administering biological medicines

DIAL

YSIS

Tablo-Hemodialysis System, a dialysis machine that can be

used in home or clinic

UltraStream™ Dialysis Catheters

OPH

THAL

MO

LOGY

Ophthalmic biopharmaceutical company treating glaucoma and

other eye diseases

ROBO

TICS Developed highly intuitive

surgical system called Da Vinci.

Identifies potentials in minimally invasive surgery using Robotics

SURG

ICAL

GEL

S

Gels and Bandages for surgical wound treatments that enable

quick blood arrest

CARP

AL S

URG

ERY

Treat carpal tunnel syndrome in a novel fashion, termed Micro-invasive Carpal Tunnel Release

POIN

T-O

F-CA

RE Develop novel sensing technologies for use in

hospital point of care devices

Revolutionizing doctor-patient interaction and

enhancing care coordination

WEA

RABL

ESDeveloped LOOP a wearable that communicates vitals to

clinicians

Wearable that records vitals like heart rate, ECG, Skin

temperature etc.

CARD

IOLO

GY

Developed the world’s largest cardiac data network

WEA

RABL

ES

Wearable sensory prosthesis for patients suffering from balance problems due to peripheral neuropathy

HOLO

GRAP

HY

Developed a proprietary laser-based high-resolution

holographic printing technology.

CARD

IOLO

GYDeveloping a novel

minimally invasive solution for the treatment of mitral

regurgitation (MR)

NAN

OTE

CHN

OLO

GY

Battery powered modular platform to conduct cost-effective diagnostic tests

GEN

OM

ICS

Genome sequencing & machine learning to

modernize infectious disease diagnosis

ROBO

TICS

Introduced Robot-assisted VEM therapy

19

Medical Device OEM Partnerships: Tech Giants, Start-ups, and Service Providers are at the forefront of building digital-first solutions

• Tech giants are partnering with medical device OEMs for off-the-shelf platforms for data collection, processing and Analytics. IBM Watson and Microsoft Azure are notable examples.

• Technology Giants such as Google, IBM and Microsoft are heavily investing in medical devices to enable software-based use cases and disrupting traditional verticals like Monitoring and Imaging Diagnostics.

Technology Giants: Medical equipment companies partner for Software Platforms

Start-ups: Medical OEMs are investing on startups that offer an end to end digital solution.2

• Start-ups are disrupting healthcare value chain to innovate new value segments within deep-domain modalities

• 5 Unicorns have been born in the last 3 years across global locations• Most start-ups are targeting Artificial Intelligence and Analytics to attract investments from OEMs

through end to end digital use case solutions.

Service Providers: Medical OEMs are looking to partner with SPs that encompass high level domain and technical skills to solve Software testing and development challenges3• Service providers need to develop test automation frameworks that can cater the medical OEMs

need to reduce cost, improve efficiency and reduce time to market• Data sanitization and data lake creation is the first level expectation of medical OEMs from their

service partners that can help them generate insights and elevate towards AI solutions.• Service providers have lot of opportunities to develop applications for individual use cases like

monitoring both in patient as well as clinical sides.

Strategic Partnerships with External Support Ecosystem : Tech Giants, Start-ups and SPs

1

Source : DRAUP

Strategic Partnerships of Medical Device OEMs in the Ecosystem

Tech Giants

Startups

20

Tech-Giants: Medical device companies are capitalizing the off-the-shelf analytics platforms developed by Tech Giants like Microsoft and IBM.

Diabetes Care

Chronic Disease Diagnosis

Population Health Management

Connected Health

Point-of-care (POC) Solutions

Key Activities and workloads

To combine the information Medtronic technology gathers with Watson’s ability to examine it, and discover new methods that can advance the treatment of diabetes.

Note: Analysis is based on the DRAUP’s proprietary engineering database

The Medtronic Intellis implant pairs with a Samsung tablet that runs the app that communicates with, and helps control, the device.

Siemens Healthineers will offer PHM solutions and services from IBM Watson Health. This will help in value-based care analytics and reporting and patient engagement.

Building physical products that help patients to thinking about how those products can capture valuable data that provides insight not only into the delivery of care, but into how to improve safety and care delivery.

The companies will jointly design, develop, and market new POC solutions in areas like detection of sepsis and therapeutic drug monitoring as well as the detection of cardiac problems and women’s health conditions.

Use-Cases Partnership

21

Startup investments and acquisitions: Startups that develop end to end use case solutions

in monitoring and Non-imaging devices are prime targets of investments

Imaging Non-imaging Monitoring Prosthetics Other Therapeutics Surgical Key Takeaway

Focussed on the portfolio expansion of imaging devices portfolio

Focused on remote monitoring and data analytics based solutions

Focused on expanding medical device portfolio that enable diagnosis of specific diseases like respiratory and stomach

Highly focused on solutions and devices that help in the diagnosis and treatment of cardiovascular diseases

Focused on remote monitoring and data analytics based solutions

Acquisition Investment

Note: Analysis is based on the DRAUP’s vendor ecosystem module, updated in July, 2018

Focused on the development

of minimally invasive

therapies for the treatment of

mitral regurgitation

Developed a novel 3D

analysis and mapping

system to diagnose variety

of arrhythmias

Focused on the

development of products

for endovascular and

interventional applications.

Treats patients with

debilitating inflammatory

diseases using implantable

bioelectronic devices

Developing edge minimally

invasive medical devices for

imaging and aiding surgery in

the esophagus and stomach.

Provides minimally-invasive

devices for the treatment of

brain aneurysms and

strokes.

Aircraft Medical specializes in

the manufacture of video

laryngoscopes that simplifies

challenging intubations.

AEGEA Medical Inc.

manufactures surgical and

medical instruments.

Fire1 focuses on

developing novel remote

monitoring devices.

Product development of

SMART medication

adherence monitoring and

on a propofol monitor

Nightbalance has created

a device called the Sleep

Position Trainer

Develops MR-guided

Ultrasound technology

devices for image-guided

acoustic surgery.

Viewics provides healthcare

data to surface actionable

intelligence and empower

data-driven. decision-making

Affimed Therapeutics is

focused on developing

recombinant antibody

therapeutics for the treatment

of cancer and other diseases

Insightec

Crospon

Xhale

Medina Fire1 Aircraft Medical AEGEA Medical

Nightbalance

Topera Setpoint Medical IDEV Tendyn

AffimedViewics

22

Technology Service Providers, with their expertise in new age technology and no IP conflicts, are emerging as mature digital partners to OEMs.

Serv

ice P

rovi

der H

eadc

ountà

41%Revenue Contribution by

Top 5 vendors

37%Next 20 R&D spend contribution

22%R&D spend contribution by Rest of the Companies

~$2 Bn – $2.5 Bn

Medical Devices Outsourcing (USD)

Engineering Services companiesà

Source : DRAUP

Dominant sub-verticalsNon-imaging diagnostics, Surgical, and Prosthetics

Dominant sub-verticalsImaging and Non-imaging

Diagnostics

Dominant sub-verticalsImaging and Non-imaging

Diagnostics

Top 5 vendors

Vendor % of Revenue

Capgemini 11.9%

Wipro 8.8%

HCL 8.7%

TCS 8.1%

Quest 3.7%

Recent Significant Deals

Design and implementation of software for low energy device used for continuous blood glucose monitoring.

Development and Testing of the mobile application and other features of Roche’s Diagnostic Products.

Tech Giants Start-ups Service Providers

Note: Data curated by DRAUP Outsourcing module and updated in Feb 2018

23

~40%Total revenue share of Top 5

SPs fromImaging Diagnostics

30%

55%

20%

18%

80%

10%

15%

10%

2%

10%

15%

35%

6%

20%

12%

2%

9%

40%

13%

8%

1%

30%

25%

5%

25%

4%

Imaging Diagnostics Non-Imaging DiagnosticsMonitoring SurgicalProsthetics Other Therapeutics

Revenue split of Top 5 Medical Device SPs(FY 2017)

Key Clients

Top 5 SPs: Imaging diagnostic sub-vertical contributes for more than 40% of the revenue amongst Top 5 SPs

24

Leading Opportunity Areas for SPs

Source : DRAUP*Capability here has been generalized basis standard offerings of some of the Mid-Sized SPs in Medical Devices space

Note: Analysis is based on the DRAUP’s proprietary engineering database, updated in Feb 2018

Bubble size denotes

addressable opportunity

Outsourcing Propensity

• Current Outsourcing Level

• Compete Intensity

• Future Growth Potential

• Ease of Outsourcing

Capabilities (Industry view - Mid Sized SPs)

• Capability (resources/skill set)

• Maturity (Medical Devices relevant experience)

• Solutions / Frameworks / Accelerators

• Adjacency & Scalability

Limited Focus Niche Skills

Investment Focus

Immediate Offerings

*Capability Matrix

Ou

tso

urc

ing

P

rop

en

sit

y

Low

High

High

Data Analytics and Cloud Management

Security

Test Automation

Device Drivers Development

Embedded Engineering

(SW)

Functional Testing

Sustenance Engineering

App development (Web & Mobile)

Embedded Engineering (HW)

E2E Imaging Development

PACS Testing

UI/UX

Opportunities with maximum traction

from OEMs

Non-Functional

Testing

Opportunities to be pursued with a

more services driven approach

Opportunities to be pursued with a

more solution driven approach

25

Opportunity Propensity across sub-verticals

Source : DRAUPNote: Analysis is based on the DRAUP’s proprietary engineering database, updated in Feb 2018

# Opportunity AreasImaging

Diagnostics($M)

Monitoring($M)

Non Imaging Diagnostics

($M)

Other Therapeutic($M)

Surgical($M)

Prosthetics($M)

1 Sustenance Engineering

2 Embedded Engineering (SW)

3 Functional Testing

4 Embedded Engineering (HW)

5 UI / UX

6 E2E Imaging Development

7 Device Drivers Development

8 Security

9 Non-Functional Testing

10 Data Analytics & Cloud Management

11 App Development (Web and Mobile)

12 Test Automation

13 PACS Testing

High Medium Low Not Relevant

26

Majority of these opportunities with Medical Devices OEMS are being addressed by service providers in a pure services driven approach (1/2)

Functional Testing

Testing of ABL90 FLEX analyzer. A Simulator is developed to simulate the functionality of the analyzer.• Execution of Test cases and Test

Scenarios for functional Testing.• Preparation of Test Plan for

functional Testing.• Defect Reporting and tracking using

PVCS.• Preparation of reports for execution.• Bug fixing

• Involved in Test Design, Test Development and Review of test cases.

• Involved in the end to end functional testing.

• Test case creation and execution. Executing the designed scripts using Tanto Script Runner (an In-house tool)

• Capture URS, PRS requirements into ALM

• Create System Design Verification Procedures

• Manage PRS requirements in ALM • Execute test cases in ALM • Generate test reports from ALM and

provide traceability matrix

Non-Functional Testing

• Support and Troubleshoot LATITUDE Remote Monitoring Systems.

• Test, Monitor and troubleshoot the connection between sensors, Pacemaker, communicator and other medical device.

Embedded Software Embedded Hardware UI/UX

• An optional alternative to the Freestyle Libre reader that enables a customer to scan their Freestyle Libre sensor with a compatible smartphone

• Class III App, receives data from the sensor via BLE, displays current glucose, trend arrow and 3, 6, 12 and 24 hours views of the recent glucose history trace.

• Features configurable alerts triggered by different glucose conditions

• Development of Critical Embedded Medical Devices.

• Agile based Sprint methodology. • Tools: Incredibuild, Momentics, SVN

Version tool, Python Editing, Microsoft Visual Studio

• New product design in the field of Patient handling and Electronic packaging of electronic modules for MRI Scanners

• Design assessments, adherence of subsystems to regulatory requirements, guiding global teams towards design change, production parts acceptance assessment and verification strategies

• FDA, GMED & Internal QMS audits

• Develop user interface, workflow, and system requirements for ultrasound imaging applications such as 3D, Contrast Imaging, color Doppler imaging on the Philips Epiq5 and Epiq 7 products

• Analysis, UI Screen Design and Testing of the Ipad Apllication used by Medical Representatives to order certain medical devices and sets for the registered hospitals.

• Unit Testing and System testing for the various modules of Glucose Monitoring System

• Development and testing of code for upgradation & bug fix

• Deploy application in SIT and UAT environments

27

PACS Testing

• Involved in testing of Philips PACS (picture archiving and communication system ).

• Testing PACS four major components: The imaging modalities such as X-ray plain film (PF), computed tomography (CT) and magnetic resonance imaging (MRI), a secured network for the transmission of patient information

• Verification & Validation of Ultrasound Scanner Device

• PACS Application• GE Asset Management Application

E2E Imaging Device Driver Development Sustenance Engineering Security

• Validation of product security of X-ray machine. Product security is attained by applying STIGS (cybersecurity methodology) and security testing is performed on real time machine and software bench using Linux commands

• Modify/Add Siemens custom device drivers to support new WES-7 OS.

• Change all executables of RP500 application to support Raima-12

• Creating Philips' next radiology imaging viewer.

• Altran is responsible for part of the design process, interaction and visual design of the product.

• Developing User console and related software components for GE Healthcare's nextGen Revolution CT-scan machines.

• These machines provide uncompromised image quality and clinical capabilities by converging coverage, spatial resolution, temporal resolution and spectral imaging all in one system.

• Corrective and evolutionary maintenance of the COBAS application Infinity Central Lab Solutions Intersystem using CachObject Script, HTML, CSS, XML, JavaScript, JQuery, Java, Apache, VM, TFS

• Developing an RMS PROServicewhich is a remote service tool, that is used to resolve clinical instrument issues immediately & protect instruments from data security & virus threats.

Majority of these opportunities with Medical Devices OEMS are being addressed by service providers in a pure services driven approach (2/2)

• Enhancement of patient registration algorithms and new hardware support for better performance in computation and heavy volume rendering

• Infosys helps Boston Scientific in Value Engineering of medical devices like Monitoring Systems, Implants and Neuromodulation products

Test Automation: Increase in pressure on Medical Device companies to enhance efficiency & reduce time -to-market is driving them to partner with SPs having strong automation offerings in the medical domain

Medical Device OEMs

Requirement

Reduced cost of operations

Enhanced environment

efficiency

Reduction in Time-to-market

Reusable and Modular

Test environment as a service model

Elimination of errors

OfferingFeatures Support Monitoring & Imaging Devices

Open Source Tools

ThermometerBlood pressure

monitorsGlucometers CT & MRI Sonography

Offering Demand

Mobility TestApplication Test : OS : Android, iOS, Responsiveness Test, Interruption Test, Installation Test,Browser Compatibility Test : Chrome, Safari, Mozilla, Device Compatibility Test

Web ApplicationClient Server Architecture –Cloud based Test (AWS), Web Browser Compatibility, Resolution, Feature Validation, Navigation, Session Timeout, User and Data Security

UI & UsabilityUser Friendliness – GUI standards, Look and Feel, Navigation, Workflow, Keyboard shortcuts, Font, Usability based on User Roles

Offering Workload

1. Test Management• Test setup /

configuration• Test flow creation• Test case creation

2. Test Execution• Execution Engine• Monitoring• Alarms/Events algorithm

3. Analysis & Reporting

• Analysis• Custom reports• Dashboarding

Development of the Automated Test Equipment (ATE) on LabVIEW-2013 to test the software of the new Defibrillator Product. Testing of software on defibrillator hardware board.

Test Automation Case Study

• Creation and execution of automation BPT test cases using Automation tool QTP

• Updating and optimization of automation BPT test cases

• Analyze, report bugs of the failed Test cases • Updating Object Repository as per the

recent changes in application

• Web Service testing of REST API s using automation tool WinECD and SoapUI

• Writing automation scripts (in xml) using WinECD simulator (Philips home-grown).

• Writing and execution of test cases which includes testing of functionality and performance of the services.

Test

Au

tom

ati

on

Op

po

rtu

nit

y

29

Data Analytics as a Service: With an increase in adoption of Digital Health, Medical Device companies are collaborating with SPs having complete analytics workflow expertise to help them in their digital journey (Majority focus on Data Sanitization & Data Lake Creation)

Source: Zinnov Research & Analysis

Data SourcesMedical Devices

Social Media EMR Back-office

Systems Lab Pharmacy Medical Images

Data CollectionDatabase like

NoSQL

Data Processing

Data Streaming

Cloud Storage

Data sanitization and processingData formats (Image, Text, Voice etc.)

Source backgrounds

Open Source Processing Tools

Data lake creation for Use-casesTreatment

Recommendation ML for Illness

Detection Claim Processing EMR/ Patient Analytics

Nursing/ Staffing Scan/ X-ray Analysis

Disease Discovery

Clinical Care Analytics

InsightsData

ExplorationDashboard

Development Analytics AI/ML Applications Alerts

StakeholdersPatients Doctors Hospital Regulators Clinics Payers Researcher

Dat

a an

alyt

ics

Offe

ring

(Com

plet

e W

orkf

low

) Data Analytics Case Study

• Development of application to collect data from source.• Analyse & transform data developing an optimised

dashboard that are used by hospitals in improving the efficiency of operations involved in end to end process w.r.t. ECG & its diagnosis.

• Involved in migration of OBIEE report, dashboards and BIP reports from Integration to Production and Development to Production Analytics.

• Formatting the reports by applying filters and prompts appropriately.

• Modify existing reports and platforms and sanitize the datasets to create insights

• Worked on Data level security by giving permission on catalog objects and Security Tool.

• Unit testing of the reports, validated the data and prepared the documentation for the same with test cases.

30

APP Development: Increase in number of point care devices and adoption of remote monitoring is driving OEMs to partner with SPs to develop mobile/web applications that integrate multiple devices enhancing usability & interoperability of data.

Health Monitoring Devices

ThermometerBlood pressure

monitors Glucometers Weight scale Steps measurement

AnalyseUse Cases

UI/UXDesign

Development

Testing

web

/Mob

ile A

pp

Dev

elop

men

t

Deployment

Glucose Temperature Heartbeat Blood Pressure

Sketch Adobe XD

• UI Wireframing • Prototyping

Cloud & Data Centres

• Functional• Performance

• Installation• Interruption

• Memory• Usability

• Enhancements• Bug fixes

• Quality Assurance

• Project management

• Data Analytics• Data Verification

• Extraction and Classification

• Storage and Bandwidth

Clinical Applications

• Home Health monitoring

• EHR System • PHR application

• Application for hemodialysis machine to collect and display the data received from an electro mechanical subsystem

• Development & testing of application that allows patients track glucose levels and physical activity data using a mobile device

• Development of Mobile Application for real time monitoring of ECG Signal.

• Signal Analysis and Development of framework for testing the application.

• Deploying and supporting DoseWatch, a software solution developed by GE HealthCare.

• Upgrading customers' software installation and providing technical support to customers worldwide.

App Development Case Study

32

Web-based software platformdesigned to make MRStechnology accessible toclinicians and researchersalike. The software combinesa linear combinations modelbased post-processing back-end that represents the mostaccurate method of measuringbrain metabolites with a highlyintuitive and user-friendlyfront-end web-based userinterface

MRI ADVANCEMENTS

Develops technology thatenables neurosurgeons totreat inoperable and hard-to-reach brain lesions using MRI-guided ablation

OPTHALMOLOGY IMAGING

Using OCTA technology,Optovue technologies provideclinicians with information sonew, they demand a differentapproach to treatmentdecision algorithms.

Accutome offers ophthalmicdiagnostic equipment, eyesurgical instruments & clinicalmedications.

OPTICAL IMAGING

Currently addressing ophthalmicmarket needs by providingequipment for early diagnosis,targeted treatment andtreatment monitoring.

3D TECHNOLOGIES

Using data from a standardCT scan, the non-invasiveHeartFlow Analysis creates apersonalized 3D model of thecoronary arteries andanalyzes the impact thatblockages have on blood flow.

Imaging Diagnostics: Emerging Players

33

DIALYSIS

Designed the Tablo-Hemodialysis System, adialysis machine that offerswater purification and createsdialysate, enabling its use inthe home or in the clinic.

Argon Medical develops rangeof medical devices thatOPTION™ Vena Cava Filter,CLEANER™ RotationalThrombectomy System andUltraStream™ DialysisCatheters

DRUG DELIVERY

Evopump developed byCamMed is the first bandage-like patch pump forsubcutaneous delivery of oneor more medications

Clinical stage, privatelyfunded, medical devicecompany focused onadvanced drug delivery andsolving the challenge of self-administering biologicalmedicines

NEUROLOGY

By introducing robot-assistedtherapy to the ICU, REACTIVE-ROBOTICS support therapistsand nurses to provide theoptimal VEM therapy to theirpatients.

OPHTALMOLOGY

Clinical stage, ophthalmicbiopharmaceutical companytransforming the delivery oftherapeutics for the treatment ofprominent eye diseases, suchas glaucoma, dry eyes, allergiceye disease and many others

Therapeutics: Emerging Players

34

Developed the SX-OneMicroKnife® with MeerkatTechnology® to treat carpaltunnel syndrome in a novelfashion, termed Micro-invasiveCarpal Tunnel Release.

CARPAL SURGERY

Using safe, naturally occurringbiomaterials, gel-e designswound treatments for a varietyof applications and patients,spanning from surgical gels tobandages for patients onblood-thinners experiencingroutine nuisance bleeds.

SURGICAL GELS ROBOTICS

The da Vinci systemdeveloped by intuitive surgicalperforms various minimallyinvasive surgeries, with awealth of regulatory approvalscovering a wide spectrum ofsurgical procedures—muchgreater than any of its currentcompetitors on the market.

Together with surgeons thecompany identifies potentialsin minimally invasive surgery,which can be unlocked withthe help of robotics. Thesepotentials may apply toefficiency, safety or trainingaspects as well as to thedevelopment of surgicaltechniques

Surgical: Emerging Players

35

Develop novel sensingtechnologies for use inhospital point of care devices.These devices hold thepotential to identify andmonitor patients at risk ofdeveloping life-threateningconditions at a very earlystage.

POINT-OF-CARE SOLUTIONS

Patientory is empoweringpeople to take charge of theirown health revolutionizing theway doctors and patientsinteract and gain access toinformation, cutting out alllayers and processes thatcurrently are stumbling blocksin care coordination.

REMOTE MONITORING

Offers the VitalConnectPlatform, along with wearablebiosensor that give users andclinicians highly accuratemonitoring and recordingcapabilities for metrics likerespiratory rate, heart rate,heart rate variability, single-lead electrocardiogram, skintemperature, and more.

CARDIOLOGY

Developed the world’s largestcardiac data network, makingcare more accurate,comprehensive and efficient.

Developing transformativedigital health solutions thatenable patients to get the rightcare at the right time. Loopfrom Spry Health Monitorsvitals while you go about yourdaily life & Communicatesrelevant health & fitnessfeedback

Monitoring: Emerging Players

36

Medical device company

developing a novel minimally

invasive solution for the

treatment of mitral

regurgitation (MR)

MITRAL REGURGITATION (MR)

Prellis Biologics, Inc. has

developed a proprietary ultra-

fast laser-based high-

resolution holographic printing

technology.

HOLOGRAPHY

RxFunction develops walkasins –

a wearable sensory prosthesis

with the goal to return patients to

a lifestyle of confidence and

mobility. Walkasins aid in

balance improvement, enabling

doctors to prescribe a wearable

device to patients suffering from

balance problems due to

peripheral neuropathy.

WEARABLES

The Axonics Sacral

Neuromodulation System™ is

the first CE-marked

rechargeable SNM system

designed to improve the

experience of both clinicians

and patients suffering from

Urinary and Fecal dysfunction.

NEUROLOGY

Prosthetics: Emerging Players

37

Using genome sequencing &

machine learning to

modernize infectious disease

diagnosis and treatment

GENOMICSVERY EARLY MOBILIZATION (VEMO)

By introducing robot-assisted

therapy to the ICU,

REACTIVE-ROBOTICS

support therapists and nurses

to provide the optimal VEM

therapy to their patients.

Battery-powered, handheld

diagnostic platform developed

by Two Pore Guys aims to

make time-intensive, costly

diagnostic tests simple and

inexpensive to perform

NANOTECHNOLOGY

Non-Imaging: Emerging Players

Documents

Zinnov Medical Devices Engineering Digitalization Globalization · 2019-06-11 · • AI, Cyber Security, Bigdata, IoT and combination products will drive spending on devices Point-Of-Care