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© 2017 MANNING ADVISORS LLC
Global  Trends  in  Medical  Device  and  
Diagnostic  OEM  Strategy
and  Implications  for  the  Supply  Chain
March,  2017
Manning  Advisors  LLC
Merger  and  Acquisition,  Advisory,  and  Financial  Services
© 2017 MANNING ADVISORS LLC
Executive Summary
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◼ Medical  Device  OEMs  focusing  on  improved  organic  growth
◼ 2016  saw  major  OEMs  relying  heavily  on  acquisitions  to  improve  revenues
◼ OEMs  see  the  eventual  end  of  needle-­moving  acquisitions  and  are  focusing  on  
how  to  accelerate  organic  growth
◼ Fee-­for-­value  reimbursement  and  growing  use  of  informatics  are  leading  to  
redesign  of  product  suites
◼ The  Supply  Chain  is  consolidating  around  fewer,  larger  players
◼ The  supply  chain  is  also  consolidating  via  acquisitions
◼ OEMs  are  embracing  risk  reduction  by  working  with  larger  supply  chain  partners
◼ The  new  threat  to  existing  supply  chain  companies  is  the  penetration  of  the  
market  by  giant  global  contract  manufacturers  like  Flextronics  and  Celestica
◼ Opportunity  exists  for  smaller,  nimble  players  who  can  assist  OEMs  in  bringing  
product  to  market  more  quickly
◼ Opportunities  also  exist  for  specialized  manufacturers
© 2017 MANNING ADVISORS LLC
About Manning Advisors
◼ Merger  and  acquisition  advisor  to  middle-­market  specialty  
materials  and  precision  engineering  companies
◼ Broad  experience  in  advising  the  medical  device  supply  chain
◼ Strategic  planning  and  value  development  services
◼ Market  analysis  and  market  entry  planning
◼ Offer  both  buy-­ and  sell-­side  services
◼ Please  visit  www.manningadvisors.com for  more  information
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© 2017 MANNING ADVISORS LLC
The Origins of this Presentation
◼ Annual  analysis  of  trends  in  the  the  medical  device  industry  
and  implications  for  its  supply  chain.  Past  years  at  
www.manningadvisors.com/manning-­reports
◼ Grew  out  of  a  presentation  to  mdmX,  an  industry  organization  
of  medical  supply  chain  companies
◼ The  objectives  –
• Identify  themes  driving  medical  OEM  market  and  product  strategies
• Link  OEM  actions  to  impacts  on  contract  manufacturers
◼ Sources  include  public  OEM  presentations  to  the  analyst  
community,  SEC  filings,  news  reports,  and  third-­party  analysis
4
© 2017 MANNING ADVISORS LLC
The Medical Device Industry
◼ Total  market  =  Estimated  US$352  billion   in  2016,  up  $12  billion  over  $340  billion   in  2015  1.
◼ The  Manning   30  
• 30  largest  global  device  and  diagnostic  equipment  companies
• All  companies  on  the  list  have  sales  over  $2  billion
• The  Manning  30  in  aggregate  control  75%  of  the  global  2016  medical  device  and  capital  diagnostic  
equipment  markets
2016  Global  Medical  Device/Diagnostic  Equipment  Market
1. Please see Appendix1 ofthispresentation, The Manning 30,for detail. 5
Manning  30
75%
All  Others
25%
REVENUE %
© 2017 MANNING ADVISORS LLC
Conflicting Trends Have
Constricted Revenue Growth
◼ Drivers of  revenue growth
• Consolidation
• Big deals by  Medtronic,  Danaher,  others,  grew  top  lines
• Reorganization of  business  units  uncovered  additional  medical/diagnostic  
revenue,  for  example  Philips  and  Siemens
• Acquisitions of  smaller  OEMs  also  drove  revenues
• While  small  firms  remain,  few  “needle-­mover”  targets  remain
• Low  interest  rates  fueled  acquisitions
◼ Drags on revenue  growth
• Weak, and  sometimes  negative,  organic growth. Average  organic  growth  
for  Manning  30  under  5%1.
• A strong US dollar suppressed  2016  revenues  in  an  industry  dominated by  
US-­based  companies
◼ Major  OEMs  require  accelerated  organic  growth  as  acquisition  has  its  limits
1. Organic growthestimated by ManningAdvisors from public filings of Manning30companies. Reorganizationof business units withina given company impacts growth
estimates
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© 2017 MANNING ADVISORS LLC
Three Sets of Trends
are Steering OEMs in 2017
1. Long-­term trends of  favorable  demographics  and  
expanding  healthcare  in  developing  countries
2. Medium-­term trend of push  towards  consolidation
3. Newer, evolving trends
• Accelerated  product  commercialization  efforts
• Fee-­for-­value  reimbursement continues  to  grow  in  US
• Move  to  early  detection  and  improved  disease  management  
increases  the  use  of  electronics  in  devices  and  linkage into  “big  
data”  informatics systems
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© 2017 MANNING ADVISORS LLC
Long Term Trends Favor the
Global Medical Device Industry
◼ Continuing  favorable  
demographics  for  device  
consumption
• North  America,  Europe,  Japan  
hitting  peak  device  consumption  as  
post-­WWII  generation  crosses  65
• Middle  classes  of  the  developing  
world  starting  to  consume  product  
in  volume
◼ Expanding  health coverage  in  
developing  countries
◼ The  device  industry  can  expect  
organic  revenue  growth  in  the  
low-­ to  mid-­single  digits  for  
years  to  come
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Significant Opportunity to Improve Patient Care
in Emerging Markets 1., 2.
2015 DEVELOPED
EMERGING
Developed –
(US, Western Europe,
Other Developed)
Emerging –
(China, India,
Other Emerging)
EMERGING
DEVELOPED
GLOBAL
POPULATION
7.3 Billion
MEDTECH
SPENDING
$370 Billion
1. From 2016 Johnson& JohnsonAnalyst Day Presentation, Gary Pruden, Executive Vice President, Hospital Medical Devices.
2. Centers for Medicare& Medicaid Services, Office of the Actuary, NationalHealth Statistics Group.
Source: MedTech market size per EvaluateMedTech; MedTech emerging vs. developed per
BMI; Population per U.S. Census Bureau, International Database
© 2017 MANNING ADVISORS LLC
Medium Term –
Top 30 OEM Consolidation Continues
◼ Major  OEMs  growing  by  acquiring  other  majors  (plus  smaller  firms)
◼ Integration  efforts  well  along.  Promised  savings  are  materializing
• Medtronic  are  well  along  investors  $875  million  annual  savings  by  end  of  2017  and  is  on  track  to  deliver
• Zimmer/Biomet  plans  $270  million  in  annual  savings by  2018
• Abbott/St.  Jude  plans  $500  million  in  savings  by  2020
◼ Threat  to  supply  chains
• Fewer  major  customers  to  approach
• Evolving  expectations of  OEMs  that  supply  chain  partners  should  accept  cost  cuts  and  additional  project  
risk
Acquirer Target Year
Smith &  Nephew Arthrocare 2014
Medtronic Covidien 2015
Zimmer Biomet “
Becton  Dickinson CareFusion “
Pfizer Hospira “
Cardinal Cordis  (J&J) “
Dentsply Sirona 2016
Abbott St.  Jude “
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© 2017 MANNING ADVISORS LLC
Evolving Trends – New Focus on
Getting to Market More Quickly
◼ In  2015,  as  companies  digested  large  acquisitions  and  improved  operations,  
buzzwords  were  “integration”  and  “execution”
◼ In  2016 the  focus  began  to  change.  Leaders  discussed  “increased  
innovation” and  “need  to  innovate  more  rapidly”  
◼ Stated  another  way:  “Given  our  low  organic  growth  rate  we  need  to  get  
new  products  to  market  more  quickly”
◼ Forming  new  partnerships
• Non-­standard   medical  players  like  J&J/Alphabet  (Verb  Surgical),  Medtronic/IBM  Watson,  Boston  
Scientific/Accenture
• Major  OEMs  stress  the  need  to  work  with  their own  supply  chains  (J&J,  Medtronic, Zimmer  Biomet,  
S&N)
◼ Opportunity for  supply  chain if  a  supplier  has  something  to  bring:
• Accelerate  time-­to-­market  via  nimble  manufacturing
• Unique product  development  expertise/capability
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© 2017 MANNING ADVISORS LLC
Evolving Trends – New Focus on
Getting to Market More Quickly
Priority:  accelerate  growth  through  
innovation  and  transform  our  go-­to-­
market  models  
— from  Johnson  &  Johnson  May,  2016  Analyst  
Presentation
Alex  Gorsky
Chairman  and  CEO
“Our  primary  focus  is  growing  our  
market  share  through  what  we  are  
calling  ‘Speed  to  Scale’  product  
launches.  Speed  to  Scale  involves  
coming  to  market  with  a  steady  cadence  
of  new  products  as  a  result  of  faster  
innovation  cycles...”
— Omar  Ishrak
Chairman  and  CEO
Medtronic
Q3  FY16  Earnings  Call
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Focused  On  High-­Value,  High-­Potential  
R&D
• Shifting  an  increasing  proportion  of  
R&D  investment  to  new  product  
development
• Increasing  R&D  operational  
efficiency
• Enhancing  internal  capabilities
• Advancing  strategic  partnerships
• Pursuing  the  most  compelling  
opportunities
— from  January,  2017  JP  Morgan  Healthcare  Conference
José  Almeida
Chairman  and  CEO
Baxter  International
© 2017 MANNING ADVISORS LLC
Evolving Trends – Fee-for-Value
Creates New Device Opportunities
◼ Fee-­for-­service  being  replaced  by  fee  for  value
• Fee-­for-­service  rewards  healthcare  givers  for  activity,  not  results
• Fee-­for-­value  rewards  superior  outcome,  for  example  is  higher  reimbursement  for  fewer  
re-­admittances  or  post-­surgical  infections
1. Data from B.E. Smith “HealthcareTrends 2016”. https://www.besmith.com/thought-leadership/white-papers/healthcare-trends-2016 12
Target percentageof Medicare
fee-for-servicepayments linked
to quality and alternative
payment models1.
All Medicare fee-for-service
Fee-for-service linkedto quality
Alternative payment models
© 2017 MANNING ADVISORS LLC
Evolving Trends – Fee-for-Value
Creates New Device Opportunities
◼ In  2015  Medicare  and  Medicaid  represented  37%  of  US  healthcare  spending1.
◼ In  2016  20%  of  Medicare  reimbursements  were  fee-­for-­value  based2.
◼ US  Centers  for  Medicare  &  Medicaid  services  target  75-­80%  of  Medicare  
reimbursements  by  20201. Private  insurers  also  pressing  ahead  with  fee-­for-­value  
through  their  own  efforts  and  accountable  care  organizations
◼ A  key  motivation  for  OEM  consolidation  is  offering  a  broader,  more  holistic  product  
line  with  better  guarantee  of  results
◼ OEMs  see  requirement/opportunity  to  re-­design  product  lines
• Moving  to  superior  outcomes  from  use  of  new  products
• For  existing  product  lines,  making  them  demonstrably  better  for  patients,  providers,  and  
reimbursement  organizations  
• Devices  for  earlier  detection/treatment  of  diseases,  management  of  chronic  diseases  to  
reduce  costs  which  in  turn  pushes  medicine  out  of  traditional  settings  
• Smartphones  and  tablets  becoming  a  key  link  in  managing  and  operating  devices
◼ Opportunity  for  supply  chain  to  assist  in  the  new  generation  of  devices  called  for  by  
fee-­for-­value  payment  model
1. Centers for Medicare & MedicaidServices, Office of the Actuary, National Health Statistics Group.
2. Data from B.E. Smith “Healthcare Trends 2016”.
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© 2017 MANNING ADVISORS LLC
Evolving Trends –
Fee for Value Devices
◼ New  products  designed  for  superior  medical  and  financial  outcomes
St.  Jude  CardioMEMs Boston  Scientific  WATCHMAN
• Internal  wireless  sensor  detects  rise  in  vascular  
pressure,  an  early  warning  sign  of  heart  failure
• New  standard  of  care
• Warns  healthcare  team  in  advance  of  need  to  
change  medications
• Automated  alerts  to  providers,  pharmacy,  and  
patient
• Saves  an  average  of  $10,640  in  hospitalization  
costs  over  three  years  vs.  traditional  methods
• Medicare  approved  due  to  superior  results
• Left  atrial  appendage  closure  (LAAC)  device  
protects  against  stroke  from  blood  clots
• Addresses  reality  that  40%  of  patients  
prescribed  blood  thinners  do  not  consistently  
take  their  medication
• Direct  and  indirect  costs  of  strokes  over  $65  
billion   annually   in  the  US  1.  
1. Human and Economic Cost of Stroke, AnthonyDi Carlo, Age and Ageing, January, 2009. https://doi.org/10.1093/ageing/afn282 14
© 2017 MANNING ADVISORS LLC
Evolving Trends –
Electronics and Informatics
◼ Major  OEMs  recognize  that  medical  devices  are  often  some  of  the  
most  sophisticated  yet  least  connected  products  in  the  world
◼ Effort  to  improve  outcomes,  lower  costs  by  networking  devices  and  
tracking  data
◼ Every  major  player  is  involved  in  adding  electronics  to  improve  
results
◼ For  OEMs,  electronics  and  informatics  opportunities are  not  just
standalone  products
• Increase  revenue  by  selling  suites  of  products,  not  just  a  standalone   product
• Product  suites  raise  barriers  for  competitors
◼ Opportunity  for supply  chain  to  incorporate electronics  and  software  
in  service  offerings
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© 2017 MANNING ADVISORS LLC
Evolving Trends –
New Electronic Devices
◼ Devices  are  increasingly  incorporating  electronic  or  
electromechanical  components  to  improve  results
Boston  Scientific  ADVANTICS
• Integrated  hardware/software  systems  linking  
patients,  providers,  business  systems
• Offers
• Remote  monitoring  of  devices  and  disease  
states
• Integration  with  medical  records
• Pooled  results  data  to  share  with  all  providers
Stryker  Mako Total  Knee
• Robot  used  to  assist  in  knee  replacement  
surgeries
• Offers
• Consistent,  repeatable  results
• Less  soft  tissue  damage  than  manual  
surgeries
• Reduced  re-­admissions,  lower  costs
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© 2017 MANNING ADVISORS LLC
Summary
◼ OEM  consolidation  continues  but  at  a  slower  pace
◼ Focus  moving  to  accelerate  organic  growth.  Partnership  
opportunities  exist
◼ New  product  lines  influenced  by  reimbursement  trends  
and  expanded  technology  are  coming  to  market
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© 2017 MANNING ADVISORS LLC
The Supply Chain
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© 2017 MANNING ADVISORS LLC
Supplier Consolidation Continues
◼ Sampling   of  deals  above  demonstrates  consolidation   at  all  levels  of  the  supply  chain
◼ $2  billion   plus  in  deal  activity
Target Acquirer Area
Ci  Medical Technimark Design,  molding,  assembly
Creganna  Medical TE  Connectivity Minimally  invasive devices
Phillips-­Medisize Molex Design and  manufacturing  of  complete  devices
Laserage AMETEK Laser  component fabrication
Forum  Plastics Squadron  Capital Precision injection  and  insert  molding  of  surgical  device  components
CEA  Medical  Manufacturing Graphic  Controls Critical  care  and  powered devices
Cartika  Medical Teleflex Cardiovascularcomponents  and  assemblies
NorMedix Surmodics Catheters
Specialty  Silicone  Fabricators Trelleborg Silicone  components
Remmele Medical/Alcoa LISI  Medical Machined  components  and  assemblies
Tegra SFS  Group Precision machining  and  assemblies
Vention  Medical Nordson,  MedPlast MIS  devices, design  services,  and  components/assemblies
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© 2017 MANNING ADVISORS LLC
Rise of the $100 Million
Contract Manufacturer (CM) Continues –
What Drives the Relentless Pace of Acquisitions?
◼ OEM  drive  for  risk reduction
• OEMs  are  now  convinced  they  can  outsource  any  portion  of  design,  manufacturing,  
supply  chain  management,   or  logistics
• Prefer  larger  contract  manufacturers  as  these  partners  allow  them  to  transfer  the  risks  
of  manufacture  more  efficiently  to  supply  chain
• “Risk  reduction”  should  be  understood  in  its  broadest  sense.  Given  a  range  of  
outcomes,  which  approach  offers  the  highest  probability   of  increased  income?  
Includes  many  factors  including   price,  quality,  timely  delivery,  absence  of  defects,  
transference  of  liability
• Looking  for  suppliers  with  broad  capacities,  global  reach,  up-­to-­date  quality  systems,  
and  financial   stability
• “One  neck  to  choke”  strategy
◼ CMs  doing  acquisitions  to  buy customers
• OEM  consolidation   means  fewer  large  customers  for  CMs
• For  CMs,  cracking  into  the  next  major  OEM  may  be  accomplished  more  rapidly  by  
purchasing  a  desired  customer’s  supplier
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© 2017 MANNING ADVISORS LLC
No Lack of Suppliers but Right Suppliers?
◼ Number  of  $100  million  plus  CMs  rising.  Has  the  “risk  
reduction”  theory  played  out?
✔Yes
• Increasingly,  only  the  larger  CMs  are  awarded  contracts  for  manufacturing  new  
products
• Smaller  suppliers  are  overlooked  or  disintermediated  with  associated  margin  
pressures
✖ No
• While  offering  a  broad  portfolio  of  design,  manufacturing,  and  logistical  support  
services,  the  large  CMs  have  struggled  with  consistent  performance  across  
projects
• Often  formed  from  many  acquisitions,  large  CMs  are  still  working  out  their  own  
internal  integration
• Agile  smaller  suppliers  can  assist  OEMs  in  rapidly  getting  product  to  market
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© 2017 MANNING ADVISORS LLC
◼ Global  contract  manufacturers  are  entering  the  medical  supply  
chain  at  the  top  of  the  pyramid  as  prime  contractors
◼ Flextronics International/Flex  Medical
• $1.7  billion  revenues,  65  medical  products  designed,  
~60  medical  transfer  projects
• Opened  530,000  ft2 medical  manufacturing  in  Tijuana,  Mexico  
in  2015  with  2,400  employees
• In  2015  acquired  Farm,  a  medical  device  design  company
• In  2016  hired  John  Carlson  of  J&J  to  run  Flex  Medical  Solutions
◼ Celestica  HealthTech
• Eight  plants  with  ISO13485  certification
• Moving  from  an  electronics  focus  to  include  manufacturing  
of  MIS  devices
◼ Plexus  Corp.
• $780  million  in  sales  in  healthcare/life  sciences  in  in  2016
• Primarily  electronics  but  moving  into  surgical  instruments
The 800-Pound Gorillas are Coming
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© 2017 MANNING ADVISORS LLC
Will the Global CMs Succeed
in Med Device Manufacturing?
◼ Likely  yes
◼ Highly  motivated  to  enter  medical  markets
• Historic  electronics  markets  are  mature  and  low  margin
• Medical  and  diagnostic  devices  are  higher  margin  and  growing  rapidly
• Have  already  made  significant  investments  in  medical  manufacturing  facilities  and  services
◼ Already  have  been  accepted  by  major  OEMs
• Have  significant  medical  revenues
• Increasingly  becoming  prime  contractors
• Match  the  risk  reduction  profile
• One  neck  to  choke
• Financial  strength  and  longevity
• Global  sourcing  mastery
• Expert  at  cost  reduction
• Expert  at  electronics  and  systems  integration  
23
© 2017 MANNING ADVISORS LLC
Will the Global CMs Succeed
in Med Device Manufacturing?
24
◼ Will  they  stumble  in  a  demanding,  regulated  industry?
• They  may  stumble  but  are  likely  to  learn  and  recover
• They  are  rapidly  building  a  track  record
• Global  CMs  are  angling  to  be  prime  contractors  – may  take  three  to  five  years  to  become  “go  
to”  players
◼ Threat  to  specialized  medical  CMs?
• Yes,  the  global  CMs  will  pull  business  and  eventually  press  margins  of  sub-­contractors
• Specialized  medical  device  expertise  and  agility  are  key  to  survival
© 2017 MANNING ADVISORS LLC
The Evolving Supply Chain Structure
◼ New  tier  structure  evolving
25
OEM
Supply  Chain
3-­5  YEARS
Prime  1 Prime  2
OEM
CM  
w/  design
CM
Manufacturing  only
Specialist  1 Specialist  2 Specialist  3
TODAY
© 2017 MANNING ADVISORS LLC
The Evolving Supply Chain Structure
◼ Prime  – Responsible  for  complete  products  and  product  lines
• $100  million   or  greater  in  revenues
• Broad  portfolio   of  manufacturing   capabilities
• Excel  at  program  management
• Excel  at  supply  chain  management
• Often  provide  design  services
• Modern  facilities,  regular  addition   of  new  capabilities
◼ Subcontractor  – Providing  components  and  assemblies  to  primes
• Will  face  radical  pressure  on  costs  and  quality  
• Maintaining   profitability   will  be  tough  over  the  next  five  years
• Requires  continuous  improvement   to  remain  profitable
◼ Specialist  – Unique  component  or  service
• Do  one  thing  well
◼ Identify  your  company’s  place  in  the  supply  chain
26
© 2017 MANNING ADVISORS LLC
Critical Factors for Success
in the New Supply Chain
◼ Risk  reduction
• Financial  stability
• Quality
• Time  to  market/agility
• Cost  reduction
◼ Partnership  capabilities
• Design/development  excellence  in  a  niche/niches
• Supply  chain
• Logistics
• Electronics  and  informatics
27
© 2017 MANNING ADVISORS LLC
For All CMs —
Canaries In the Coalmine
✔ Success
• Growth  in  revenues  with  slight  increases  in  profit  margins  from  year  to  year
• Expanding  offering  of  design,  manufacturing,  or  supply  chain  services
• Gain  in  new  product  launch  projects  from  year  to  year
• Most  challenging:  increasing  number  of  major  OEMs  customers  with  $1  
million  plus  projects  
✖ Stagnation
• No  expansion  of  new  capabilities  to  customers
• Declining  number  of  new  product  projects,  stuck  on  legacy  work
• Disintermediation  from  OEMs
• Weakening  revenue  and  profitability  growth  rates
28
© 2017 MANNING ADVISORS LLC
Appendix 1 – The Manning 30
TOP MEDICAL DEVICE  MANUFACTURERS RANK
2016E  REVENUES  
(US$  Billions)
Medtronic 1 29.0
Johnson  &  Johnson 2 24.9
Philips  Healthcare 3 18.6
GE  Healthcare 4 17.6
Siemens  Healthineers 5 15.2
Danaher 6 12.8
Becton  Dickinson 7 12.5
Cardinal  Health 8 12.4
Stryker 9 10.9
Baxter  International 10 10.0
Abbott  Labs 11 10.0
Boston  Scientific 12 8.3
Zimmer   Biomet 13 7.7
Essilor 14 7.5
B.  Braun 15 7.0
St.  Jude  Medical 16 6.0
Alcon/Novartis 17 5.8
3M  Healthcare 18 5.5
Olympus  Medical 19 5.4
Smith  &  Nephew 20 4.6
Terumo 21 4.5
Dentsply Sirona 22 3.7
CR   Bard 23 3.7
Fresenius 24 3.3
Varian  Medical 25 3.2
Gettinge Group 26 3.2
Edwards  Lifesciences 27 3.0
Hologic 28 2.8
Intuitive  Surgical 29 2.6
Sonova Holding 30 2.3
29
© 2017 MANNING ADVISORS LLC
For More Information
◼ Please  contact:
Tony  Freeman
Managing  Director
Manning  Advisors  LLC
www.manningadvisors.com
(917)  868-­0772
tfreeman@manningadvisors.com
30

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Global Trends in Medical Device and Diagnostic OEM Strategy and Implications for the Supply Chain

  • 1. © 2017 MANNING ADVISORS LLC Global  Trends  in  Medical  Device  and   Diagnostic  OEM  Strategy and  Implications  for  the  Supply  Chain March,  2017 Manning  Advisors  LLC Merger  and  Acquisition,  Advisory,  and  Financial  Services
  • 2. © 2017 MANNING ADVISORS LLC Executive Summary 2 ◼ Medical  Device  OEMs  focusing  on  improved  organic  growth ◼ 2016  saw  major  OEMs  relying  heavily  on  acquisitions  to  improve  revenues ◼ OEMs  see  the  eventual  end  of  needle-­moving  acquisitions  and  are  focusing  on   how  to  accelerate  organic  growth ◼ Fee-­for-­value  reimbursement  and  growing  use  of  informatics  are  leading  to   redesign  of  product  suites ◼ The  Supply  Chain  is  consolidating  around  fewer,  larger  players ◼ The  supply  chain  is  also  consolidating  via  acquisitions ◼ OEMs  are  embracing  risk  reduction  by  working  with  larger  supply  chain  partners ◼ The  new  threat  to  existing  supply  chain  companies  is  the  penetration  of  the   market  by  giant  global  contract  manufacturers  like  Flextronics  and  Celestica ◼ Opportunity  exists  for  smaller,  nimble  players  who  can  assist  OEMs  in  bringing   product  to  market  more  quickly ◼ Opportunities  also  exist  for  specialized  manufacturers
  • 3. © 2017 MANNING ADVISORS LLC About Manning Advisors ◼ Merger  and  acquisition  advisor  to  middle-­market  specialty   materials  and  precision  engineering  companies ◼ Broad  experience  in  advising  the  medical  device  supply  chain ◼ Strategic  planning  and  value  development  services ◼ Market  analysis  and  market  entry  planning ◼ Offer  both  buy-­ and  sell-­side  services ◼ Please  visit  www.manningadvisors.com for  more  information 3
  • 4. © 2017 MANNING ADVISORS LLC The Origins of this Presentation ◼ Annual  analysis  of  trends  in  the  the  medical  device  industry   and  implications  for  its  supply  chain.  Past  years  at   www.manningadvisors.com/manning-­reports ◼ Grew  out  of  a  presentation  to  mdmX,  an  industry  organization   of  medical  supply  chain  companies ◼ The  objectives  – • Identify  themes  driving  medical  OEM  market  and  product  strategies • Link  OEM  actions  to  impacts  on  contract  manufacturers ◼ Sources  include  public  OEM  presentations  to  the  analyst   community,  SEC  filings,  news  reports,  and  third-­party  analysis 4
  • 5. © 2017 MANNING ADVISORS LLC The Medical Device Industry ◼ Total  market  =  Estimated  US$352  billion   in  2016,  up  $12  billion  over  $340  billion   in  2015  1. ◼ The  Manning   30   • 30  largest  global  device  and  diagnostic  equipment  companies • All  companies  on  the  list  have  sales  over  $2  billion • The  Manning  30  in  aggregate  control  75%  of  the  global  2016  medical  device  and  capital  diagnostic   equipment  markets 2016  Global  Medical  Device/Diagnostic  Equipment  Market 1. Please see Appendix1 ofthispresentation, The Manning 30,for detail. 5 Manning  30 75% All  Others 25% REVENUE %
  • 6. © 2017 MANNING ADVISORS LLC Conflicting Trends Have Constricted Revenue Growth ◼ Drivers of  revenue growth • Consolidation • Big deals by  Medtronic,  Danaher,  others,  grew  top  lines • Reorganization of  business  units  uncovered  additional  medical/diagnostic   revenue,  for  example  Philips  and  Siemens • Acquisitions of  smaller  OEMs  also  drove  revenues • While  small  firms  remain,  few  “needle-­mover”  targets  remain • Low  interest  rates  fueled  acquisitions ◼ Drags on revenue  growth • Weak, and  sometimes  negative,  organic growth. Average  organic  growth   for  Manning  30  under  5%1. • A strong US dollar suppressed  2016  revenues  in  an  industry  dominated by   US-­based  companies ◼ Major  OEMs  require  accelerated  organic  growth  as  acquisition  has  its  limits 1. Organic growthestimated by ManningAdvisors from public filings of Manning30companies. Reorganizationof business units withina given company impacts growth estimates 6
  • 7. © 2017 MANNING ADVISORS LLC Three Sets of Trends are Steering OEMs in 2017 1. Long-­term trends of  favorable  demographics  and   expanding  healthcare  in  developing  countries 2. Medium-­term trend of push  towards  consolidation 3. Newer, evolving trends • Accelerated  product  commercialization  efforts • Fee-­for-­value  reimbursement continues  to  grow  in  US • Move  to  early  detection  and  improved  disease  management   increases  the  use  of  electronics  in  devices  and  linkage into  “big   data”  informatics systems 7
  • 8. © 2017 MANNING ADVISORS LLC Long Term Trends Favor the Global Medical Device Industry ◼ Continuing  favorable   demographics  for  device   consumption • North  America,  Europe,  Japan   hitting  peak  device  consumption  as   post-­WWII  generation  crosses  65 • Middle  classes  of  the  developing   world  starting  to  consume  product   in  volume ◼ Expanding  health coverage  in   developing  countries ◼ The  device  industry  can  expect   organic  revenue  growth  in  the   low-­ to  mid-­single  digits  for   years  to  come 8 Significant Opportunity to Improve Patient Care in Emerging Markets 1., 2. 2015 DEVELOPED EMERGING Developed – (US, Western Europe, Other Developed) Emerging – (China, India, Other Emerging) EMERGING DEVELOPED GLOBAL POPULATION 7.3 Billion MEDTECH SPENDING $370 Billion 1. From 2016 Johnson& JohnsonAnalyst Day Presentation, Gary Pruden, Executive Vice President, Hospital Medical Devices. 2. Centers for Medicare& Medicaid Services, Office of the Actuary, NationalHealth Statistics Group. Source: MedTech market size per EvaluateMedTech; MedTech emerging vs. developed per BMI; Population per U.S. Census Bureau, International Database
  • 9. © 2017 MANNING ADVISORS LLC Medium Term – Top 30 OEM Consolidation Continues ◼ Major  OEMs  growing  by  acquiring  other  majors  (plus  smaller  firms) ◼ Integration  efforts  well  along.  Promised  savings  are  materializing • Medtronic  are  well  along  investors  $875  million  annual  savings  by  end  of  2017  and  is  on  track  to  deliver • Zimmer/Biomet  plans  $270  million  in  annual  savings by  2018 • Abbott/St.  Jude  plans  $500  million  in  savings  by  2020 ◼ Threat  to  supply  chains • Fewer  major  customers  to  approach • Evolving  expectations of  OEMs  that  supply  chain  partners  should  accept  cost  cuts  and  additional  project   risk Acquirer Target Year Smith &  Nephew Arthrocare 2014 Medtronic Covidien 2015 Zimmer Biomet “ Becton  Dickinson CareFusion “ Pfizer Hospira “ Cardinal Cordis  (J&J) “ Dentsply Sirona 2016 Abbott St.  Jude “ 9
  • 10. © 2017 MANNING ADVISORS LLC Evolving Trends – New Focus on Getting to Market More Quickly ◼ In  2015,  as  companies  digested  large  acquisitions  and  improved  operations,   buzzwords  were  “integration”  and  “execution” ◼ In  2016 the  focus  began  to  change.  Leaders  discussed  “increased   innovation” and  “need  to  innovate  more  rapidly”   ◼ Stated  another  way:  “Given  our  low  organic  growth  rate  we  need  to  get   new  products  to  market  more  quickly” ◼ Forming  new  partnerships • Non-­standard   medical  players  like  J&J/Alphabet  (Verb  Surgical),  Medtronic/IBM  Watson,  Boston   Scientific/Accenture • Major  OEMs  stress  the  need  to  work  with  their own  supply  chains  (J&J,  Medtronic, Zimmer  Biomet,   S&N) ◼ Opportunity for  supply  chain if  a  supplier  has  something  to  bring: • Accelerate  time-­to-­market  via  nimble  manufacturing • Unique product  development  expertise/capability 10
  • 11. © 2017 MANNING ADVISORS LLC Evolving Trends – New Focus on Getting to Market More Quickly Priority:  accelerate  growth  through   innovation  and  transform  our  go-­to-­ market  models   — from  Johnson  &  Johnson  May,  2016  Analyst   Presentation Alex  Gorsky Chairman  and  CEO “Our  primary  focus  is  growing  our   market  share  through  what  we  are   calling  ‘Speed  to  Scale’  product   launches.  Speed  to  Scale  involves   coming  to  market  with  a  steady  cadence   of  new  products  as  a  result  of  faster   innovation  cycles...” — Omar  Ishrak Chairman  and  CEO Medtronic Q3  FY16  Earnings  Call 11 Focused  On  High-­Value,  High-­Potential   R&D • Shifting  an  increasing  proportion  of   R&D  investment  to  new  product   development • Increasing  R&D  operational   efficiency • Enhancing  internal  capabilities • Advancing  strategic  partnerships • Pursuing  the  most  compelling   opportunities — from  January,  2017  JP  Morgan  Healthcare  Conference José  Almeida Chairman  and  CEO Baxter  International
  • 12. © 2017 MANNING ADVISORS LLC Evolving Trends – Fee-for-Value Creates New Device Opportunities ◼ Fee-­for-­service  being  replaced  by  fee  for  value • Fee-­for-­service  rewards  healthcare  givers  for  activity,  not  results • Fee-­for-­value  rewards  superior  outcome,  for  example  is  higher  reimbursement  for  fewer   re-­admittances  or  post-­surgical  infections 1. Data from B.E. Smith “HealthcareTrends 2016”. https://www.besmith.com/thought-leadership/white-papers/healthcare-trends-2016 12 Target percentageof Medicare fee-for-servicepayments linked to quality and alternative payment models1. All Medicare fee-for-service Fee-for-service linkedto quality Alternative payment models
  • 13. © 2017 MANNING ADVISORS LLC Evolving Trends – Fee-for-Value Creates New Device Opportunities ◼ In  2015  Medicare  and  Medicaid  represented  37%  of  US  healthcare  spending1. ◼ In  2016  20%  of  Medicare  reimbursements  were  fee-­for-­value  based2. ◼ US  Centers  for  Medicare  &  Medicaid  services  target  75-­80%  of  Medicare   reimbursements  by  20201. Private  insurers  also  pressing  ahead  with  fee-­for-­value   through  their  own  efforts  and  accountable  care  organizations ◼ A  key  motivation  for  OEM  consolidation  is  offering  a  broader,  more  holistic  product   line  with  better  guarantee  of  results ◼ OEMs  see  requirement/opportunity  to  re-­design  product  lines • Moving  to  superior  outcomes  from  use  of  new  products • For  existing  product  lines,  making  them  demonstrably  better  for  patients,  providers,  and   reimbursement  organizations   • Devices  for  earlier  detection/treatment  of  diseases,  management  of  chronic  diseases  to   reduce  costs  which  in  turn  pushes  medicine  out  of  traditional  settings   • Smartphones  and  tablets  becoming  a  key  link  in  managing  and  operating  devices ◼ Opportunity  for  supply  chain  to  assist  in  the  new  generation  of  devices  called  for  by   fee-­for-­value  payment  model 1. Centers for Medicare & MedicaidServices, Office of the Actuary, National Health Statistics Group. 2. Data from B.E. Smith “Healthcare Trends 2016”. 13
  • 14. © 2017 MANNING ADVISORS LLC Evolving Trends – Fee for Value Devices ◼ New  products  designed  for  superior  medical  and  financial  outcomes St.  Jude  CardioMEMs Boston  Scientific  WATCHMAN • Internal  wireless  sensor  detects  rise  in  vascular   pressure,  an  early  warning  sign  of  heart  failure • New  standard  of  care • Warns  healthcare  team  in  advance  of  need  to   change  medications • Automated  alerts  to  providers,  pharmacy,  and   patient • Saves  an  average  of  $10,640  in  hospitalization   costs  over  three  years  vs.  traditional  methods • Medicare  approved  due  to  superior  results • Left  atrial  appendage  closure  (LAAC)  device   protects  against  stroke  from  blood  clots • Addresses  reality  that  40%  of  patients   prescribed  blood  thinners  do  not  consistently   take  their  medication • Direct  and  indirect  costs  of  strokes  over  $65   billion   annually   in  the  US  1.   1. Human and Economic Cost of Stroke, AnthonyDi Carlo, Age and Ageing, January, 2009. https://doi.org/10.1093/ageing/afn282 14
  • 15. © 2017 MANNING ADVISORS LLC Evolving Trends – Electronics and Informatics ◼ Major  OEMs  recognize  that  medical  devices  are  often  some  of  the   most  sophisticated  yet  least  connected  products  in  the  world ◼ Effort  to  improve  outcomes,  lower  costs  by  networking  devices  and   tracking  data ◼ Every  major  player  is  involved  in  adding  electronics  to  improve   results ◼ For  OEMs,  electronics  and  informatics  opportunities are  not  just standalone  products • Increase  revenue  by  selling  suites  of  products,  not  just  a  standalone   product • Product  suites  raise  barriers  for  competitors ◼ Opportunity  for supply  chain  to  incorporate electronics  and  software   in  service  offerings 15
  • 16. © 2017 MANNING ADVISORS LLC Evolving Trends – New Electronic Devices ◼ Devices  are  increasingly  incorporating  electronic  or   electromechanical  components  to  improve  results Boston  Scientific  ADVANTICS • Integrated  hardware/software  systems  linking   patients,  providers,  business  systems • Offers • Remote  monitoring  of  devices  and  disease   states • Integration  with  medical  records • Pooled  results  data  to  share  with  all  providers Stryker  Mako Total  Knee • Robot  used  to  assist  in  knee  replacement   surgeries • Offers • Consistent,  repeatable  results • Less  soft  tissue  damage  than  manual   surgeries • Reduced  re-­admissions,  lower  costs 16
  • 17. © 2017 MANNING ADVISORS LLC Summary ◼ OEM  consolidation  continues  but  at  a  slower  pace ◼ Focus  moving  to  accelerate  organic  growth.  Partnership   opportunities  exist ◼ New  product  lines  influenced  by  reimbursement  trends   and  expanded  technology  are  coming  to  market 17
  • 18. © 2017 MANNING ADVISORS LLC The Supply Chain 18
  • 19. © 2017 MANNING ADVISORS LLC Supplier Consolidation Continues ◼ Sampling   of  deals  above  demonstrates  consolidation   at  all  levels  of  the  supply  chain ◼ $2  billion   plus  in  deal  activity Target Acquirer Area Ci  Medical Technimark Design,  molding,  assembly Creganna  Medical TE  Connectivity Minimally  invasive devices Phillips-­Medisize Molex Design and  manufacturing  of  complete  devices Laserage AMETEK Laser  component fabrication Forum  Plastics Squadron  Capital Precision injection  and  insert  molding  of  surgical  device  components CEA  Medical  Manufacturing Graphic  Controls Critical  care  and  powered devices Cartika  Medical Teleflex Cardiovascularcomponents  and  assemblies NorMedix Surmodics Catheters Specialty  Silicone  Fabricators Trelleborg Silicone  components Remmele Medical/Alcoa LISI  Medical Machined  components  and  assemblies Tegra SFS  Group Precision machining  and  assemblies Vention  Medical Nordson,  MedPlast MIS  devices, design  services,  and  components/assemblies 19
  • 20. © 2017 MANNING ADVISORS LLC Rise of the $100 Million Contract Manufacturer (CM) Continues – What Drives the Relentless Pace of Acquisitions? ◼ OEM  drive  for  risk reduction • OEMs  are  now  convinced  they  can  outsource  any  portion  of  design,  manufacturing,   supply  chain  management,   or  logistics • Prefer  larger  contract  manufacturers  as  these  partners  allow  them  to  transfer  the  risks   of  manufacture  more  efficiently  to  supply  chain • “Risk  reduction”  should  be  understood  in  its  broadest  sense.  Given  a  range  of   outcomes,  which  approach  offers  the  highest  probability   of  increased  income?   Includes  many  factors  including   price,  quality,  timely  delivery,  absence  of  defects,   transference  of  liability • Looking  for  suppliers  with  broad  capacities,  global  reach,  up-­to-­date  quality  systems,   and  financial   stability • “One  neck  to  choke”  strategy ◼ CMs  doing  acquisitions  to  buy customers • OEM  consolidation   means  fewer  large  customers  for  CMs • For  CMs,  cracking  into  the  next  major  OEM  may  be  accomplished  more  rapidly  by   purchasing  a  desired  customer’s  supplier 20
  • 21. © 2017 MANNING ADVISORS LLC No Lack of Suppliers but Right Suppliers? ◼ Number  of  $100  million  plus  CMs  rising.  Has  the  “risk   reduction”  theory  played  out? ✔Yes • Increasingly,  only  the  larger  CMs  are  awarded  contracts  for  manufacturing  new   products • Smaller  suppliers  are  overlooked  or  disintermediated  with  associated  margin   pressures ✖ No • While  offering  a  broad  portfolio  of  design,  manufacturing,  and  logistical  support   services,  the  large  CMs  have  struggled  with  consistent  performance  across   projects • Often  formed  from  many  acquisitions,  large  CMs  are  still  working  out  their  own   internal  integration • Agile  smaller  suppliers  can  assist  OEMs  in  rapidly  getting  product  to  market 21
  • 22. © 2017 MANNING ADVISORS LLC ◼ Global  contract  manufacturers  are  entering  the  medical  supply   chain  at  the  top  of  the  pyramid  as  prime  contractors ◼ Flextronics International/Flex  Medical • $1.7  billion  revenues,  65  medical  products  designed,   ~60  medical  transfer  projects • Opened  530,000  ft2 medical  manufacturing  in  Tijuana,  Mexico   in  2015  with  2,400  employees • In  2015  acquired  Farm,  a  medical  device  design  company • In  2016  hired  John  Carlson  of  J&J  to  run  Flex  Medical  Solutions ◼ Celestica  HealthTech • Eight  plants  with  ISO13485  certification • Moving  from  an  electronics  focus  to  include  manufacturing   of  MIS  devices ◼ Plexus  Corp. • $780  million  in  sales  in  healthcare/life  sciences  in  in  2016 • Primarily  electronics  but  moving  into  surgical  instruments The 800-Pound Gorillas are Coming 22
  • 23. © 2017 MANNING ADVISORS LLC Will the Global CMs Succeed in Med Device Manufacturing? ◼ Likely  yes ◼ Highly  motivated  to  enter  medical  markets • Historic  electronics  markets  are  mature  and  low  margin • Medical  and  diagnostic  devices  are  higher  margin  and  growing  rapidly • Have  already  made  significant  investments  in  medical  manufacturing  facilities  and  services ◼ Already  have  been  accepted  by  major  OEMs • Have  significant  medical  revenues • Increasingly  becoming  prime  contractors • Match  the  risk  reduction  profile • One  neck  to  choke • Financial  strength  and  longevity • Global  sourcing  mastery • Expert  at  cost  reduction • Expert  at  electronics  and  systems  integration   23
  • 24. © 2017 MANNING ADVISORS LLC Will the Global CMs Succeed in Med Device Manufacturing? 24 ◼ Will  they  stumble  in  a  demanding,  regulated  industry? • They  may  stumble  but  are  likely  to  learn  and  recover • They  are  rapidly  building  a  track  record • Global  CMs  are  angling  to  be  prime  contractors  – may  take  three  to  five  years  to  become  “go   to”  players ◼ Threat  to  specialized  medical  CMs? • Yes,  the  global  CMs  will  pull  business  and  eventually  press  margins  of  sub-­contractors • Specialized  medical  device  expertise  and  agility  are  key  to  survival
  • 25. © 2017 MANNING ADVISORS LLC The Evolving Supply Chain Structure ◼ New  tier  structure  evolving 25 OEM Supply  Chain 3-­5  YEARS Prime  1 Prime  2 OEM CM   w/  design CM Manufacturing  only Specialist  1 Specialist  2 Specialist  3 TODAY
  • 26. © 2017 MANNING ADVISORS LLC The Evolving Supply Chain Structure ◼ Prime  – Responsible  for  complete  products  and  product  lines • $100  million   or  greater  in  revenues • Broad  portfolio   of  manufacturing   capabilities • Excel  at  program  management • Excel  at  supply  chain  management • Often  provide  design  services • Modern  facilities,  regular  addition   of  new  capabilities ◼ Subcontractor  – Providing  components  and  assemblies  to  primes • Will  face  radical  pressure  on  costs  and  quality   • Maintaining   profitability   will  be  tough  over  the  next  five  years • Requires  continuous  improvement   to  remain  profitable ◼ Specialist  – Unique  component  or  service • Do  one  thing  well ◼ Identify  your  company’s  place  in  the  supply  chain 26
  • 27. © 2017 MANNING ADVISORS LLC Critical Factors for Success in the New Supply Chain ◼ Risk  reduction • Financial  stability • Quality • Time  to  market/agility • Cost  reduction ◼ Partnership  capabilities • Design/development  excellence  in  a  niche/niches • Supply  chain • Logistics • Electronics  and  informatics 27
  • 28. © 2017 MANNING ADVISORS LLC For All CMs — Canaries In the Coalmine ✔ Success • Growth  in  revenues  with  slight  increases  in  profit  margins  from  year  to  year • Expanding  offering  of  design,  manufacturing,  or  supply  chain  services • Gain  in  new  product  launch  projects  from  year  to  year • Most  challenging:  increasing  number  of  major  OEMs  customers  with  $1   million  plus  projects   ✖ Stagnation • No  expansion  of  new  capabilities  to  customers • Declining  number  of  new  product  projects,  stuck  on  legacy  work • Disintermediation  from  OEMs • Weakening  revenue  and  profitability  growth  rates 28
  • 29. © 2017 MANNING ADVISORS LLC Appendix 1 – The Manning 30 TOP MEDICAL DEVICE  MANUFACTURERS RANK 2016E  REVENUES   (US$  Billions) Medtronic 1 29.0 Johnson  &  Johnson 2 24.9 Philips  Healthcare 3 18.6 GE  Healthcare 4 17.6 Siemens  Healthineers 5 15.2 Danaher 6 12.8 Becton  Dickinson 7 12.5 Cardinal  Health 8 12.4 Stryker 9 10.9 Baxter  International 10 10.0 Abbott  Labs 11 10.0 Boston  Scientific 12 8.3 Zimmer   Biomet 13 7.7 Essilor 14 7.5 B.  Braun 15 7.0 St.  Jude  Medical 16 6.0 Alcon/Novartis 17 5.8 3M  Healthcare 18 5.5 Olympus  Medical 19 5.4 Smith  &  Nephew 20 4.6 Terumo 21 4.5 Dentsply Sirona 22 3.7 CR   Bard 23 3.7 Fresenius 24 3.3 Varian  Medical 25 3.2 Gettinge Group 26 3.2 Edwards  Lifesciences 27 3.0 Hologic 28 2.8 Intuitive  Surgical 29 2.6 Sonova Holding 30 2.3 29
  • 30. © 2017 MANNING ADVISORS LLC For More Information ◼ Please  contact: Tony  Freeman Managing  Director Manning  Advisors  LLC www.manningadvisors.com (917)  868-­0772 tfreeman@manningadvisors.com 30