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 The United States medical device manufacturing sector is a highly diversified
industry that produces a range of products designed to diagnose the patients
in healthcare systems worldwide.
 The Key products that comprise the medical device industry, include, surgical
appliances, surgical and medical instruments, electro medical equipment,
Irradiation Apparatus, Dental Equipment manufacturing.
 The following North America Industry Classification System (NAICS) codes
comprise the medical device industry.
NAICS
Code
Sub-Sector Product Classification
334510 Electro Medical Equipment Pacemaker, MRI machines, patient-monitoring
system, Diagnostics equipment
334517 Irradiation Apparatus X-ray devices, other diagnostics imaging, CT
Scanner machines etc.
339112 Surgical & Medical Instrument Anesthesia apparatuses, orthopedic
instruments, catheters, syringes.
339113 Surgical Appliances & Supplies Artificial joints & limbs, orthopedic appliance,
surgical dressing, disposables, wheelchairs,
surgical gloves.
339114 Dental Equipment & Supplies Instruments used by dentists, dental
hygienists, dental chair or any other dental
instruments.
Overview
The US manufacturing market for
medical device and supplies continued its
strong growth in 2015. The United States
remains the world leader by market size,
with total revenue of around $110 billion
– around on-third of the $350 billion
global pie. But the U.S. medical device
industry also faces multifaceted
challenges that are hampering growth.
According to U.S. Govt. by 2020 the U.S
Medical technology excepts only 5%
growth, But during 2013 the growth rate
decreased up to 15%
With more than 16,400 business in the
medical device manufacturing industry,
growth has been driven by a confluence
of new product innovation and continued
growth in physician visits which now
exceed one billion per year.
Cross-border activities should
strengthen too from its current trends as
European and Asian healthcare
companies expand their presence in US
markets by acquiring developing
technologies and collaboration with
medical device companies and
distribution network.
The Merger & Acquisition activity of 2015
focused on medical diagnostic segments.
There were several transactions are $1
billion in value—some of the
transformational—and many smaller
transactions by many of the major United
States and foreign-based medical
technology companies as they sought to
enhance their product portfolios and
technology.
On 2015 merger & acquisition
transactions are $20,621 million and
targeted the large number of
technologies and his research and
development field. In 2014 the M&A
transaction value was $19,630 million.
BD medical device company acquire care
fusion was the biggest deal in 2014. for
accelerate innovative healthcare solution
with leading scale across the medication
management value chain and expand
solution for patient safety.
DENTSPLY International Inc is a global
dental implant manufacturing company
headquarter in St. York, Pennsylvania,
United States. This company was create
the biggest deal in 2015 the deal price
was $5560 million acquisition with
Germany based company Sirona Dental
System. It developed single use dental
supplies with advanced Dental imaging
technology and instruments. Also this
company developed for his dental
technology business, it merge $13
billion with Sirona Dental System
A Surprising Cardio
Acquisition By
Cardinal Health
Dental supply maker
Dentasply to buy
Sirona in $5.56
billion deal
Hill-Rom to buy
privately held Welch
Allyn in $2.1 billion
cash and stock deal
St. Jude Medical,
completed its
biggest transaction
ever with the $3.4
billion acquisition of
Heartmate producer
Thorates Corp.
The 10 largest transaction contributed to around $17,393 million. The standout trade
transaction in 2015 were:-
 DENTSPLY – Sirona
The largest deal by far was Dentsply acquisition of Sirona, a global manufacturer of
Dental implant devices, for $5.56 billion.
 St. Jude – Thoratec
The second deal is St. Jude Acquire Implant Maker Thoratec for $3.4 billion to expand
heart implant medical devices system like MRI, pacemaker.
 Hill-Rom – Welch Allyn
This acquisition between Hill-Rom and Welch Allyn. Hill-Rom to buy privately held
Welch Allyn in $2.1 billion. It develops new technologies, improving patient care
delivery system and reducing healthcare cost for his customers.
 Cardinal Health – Cordic Inc
Cardinal Health acquire Cordic Inc “Cardiology and Endovascular” Division to buy $1994
million.
 Greatbatch, Inc – Lake Region Medical
The 5th largest acquisition is Greatbatch, Inc is a public medical device company acquire
U.S. privately held Lake Region Medical company to buy $1730 million with provide
portfolio of technologies and services to maintain a strong financial profil to drive
shareholders return.
Top 10 U.S. Largest Medical Device M&A
 HeartWare Inc – Valtech Cardio
HeartWare Inc acquire Israel medical device manufacturer Valtech cardio’s mitral and
tricuspid valves. The acquisition deal is $929 million. It develops portfolio of valve repair and
replacement technologies.
 Medtronic – Twelve, Inc
Medtronic acquire Twelve’s mitral valve technology on 2015. The deal price is $458 million. It
provides expertise and proven success in structural heart space to advance the treatment of
mitral regurgitation.
 Edwards Lifesciences – CardiAQ Inc
Edwards Lifesciences is a public held largest medical device manufacturing company acquire
CardiAQ Inc to $400 million. CardiAQ will develops transcatheter mitral valve replacement
devices and development of transformational therapy.
 Integra Life Sciences – TEI Biosciences and TEI Medical
The 9th largest M&A was between Integra Life Sciences and TEI Biosciences and medica. The
deal value is $312 million to expand reconstructive surgery and regenerative wound care
product.
 Conmed – SurgiQuest, Inc
Conmed is surgical and patient monitoring manufacturing company. This company acqueir
SurgiQuest Inc, to buy $265 million. It revitalizing the growth of advance surgical business
for AirSeal System.
Acquirer Target Target Sector Deal(US $ in million)
Dentsply International Inc Sirona Dental Dental Devices 5560
St. Jude Medical Thoratec Corp Medical Devices 3400
Hill-Rom Welch Allyn Medical Devices 2100
Cardinal Health Cordis Medical Devices 1994
Greatbatch, Inc Lake Region Medical Medical Devices 1730
Stryker Corp Physio-Control Inc Medical Devices 1300
Heartware Inc Valtech cardio Medical Devices 929
Xio Group Lumenis Ltd Medical Devices 510
Medtronic Twelve, Inc Medical Devices 458
Edward Lifesciences CardiAQ Valve Tec. Medical Devices 400
Integra Life Sciences TEI Biosciences/Med Medical Devices 312
Conmed SurgiQuest, Inc Medical Devices 265
Abbott Tendyne Holding Inc Medical Devices 250
Medtronic RF Surgical Medical Devices 235
Medtronic Medina Medical Inc Medical Devices 150
The USA medical device M&A has providing the development of Healthcare industry in medical device
sectors. In the year 2014 and 2015 the biggest medical device manufacturing company has been
acquiring the technologies of medical devices. It will bring a great opportunity for USA or Global
healthcare sector. Through this merger and acquisition the medical device are developed and
patient is easily curable. Now it has been developing medical imaging technology like 3 Tesla MRI,
patient monitoring system, CT scanners:, Orthopaedic & Spinal Instruments, Dental Device/
Orthodontics instrument technologies. Some medical device companies like GE healthcare, Stryker,
Abbott, J&J has been developing latest medical technology.
In 2015 USA medical device industry has covered the development and collaboration with
some medical technologies companies and it target 29 companies has been developed his future
advanced technology and FDA will support such companies. It around the deal value of merger &
acquisition is approximately $ 20.621 billion in 2015. DENTSPLY International Inc is the biggest
acquirer company it develops the dental devices. The deal of this company is US $5560 million.
Also Stryker, Medtronic, Edwards Life sciences, Abbott and Integra Life Sciences has been
developing his products by the stage of advancing technologies. Medtronic has acquire 5 medical
device companies to developed advanced Orthopaedics and heart valve technologies. The total deal
value of Medtronic is US $1163 million.
Acquirer Company No of Target Company Total Deal(US $ Million)
Medtronic Plc 6 1163
Stryker Corporation 1 1300
Dentsply Inc 1 5560
St. Jude Medical 1 3400
Hill-Rom 1 2100
Cardinal Health 1 1994
Greatbatch, Inc 1 1730
Heartware Inc 1 929
Wright Medical Inc 1 3300
Edwards Lifesciences 1 400
1163 1300
5560
3400 3300
400
2100 1994 1730
929
0
1000
2000
3000
4000
5000
6000
TOTALDEAL(US$MILLION)
Top 10 Largest Deal of Medical Device Company 2015
The United States medical device
manufacturing sector is a highly
diversified industry that produces a
range of products designed to diagnose
and treat patient in healthcare system
worldwide. There ware approximately
2000 medical device companies in the
U.S. in 2015, mostly small medical device
companies has been acquiring for
developing new technologies on
healthcare industry. The states with the
highest number of medical device
companies include California, Florida,
New York, Pennsylvania, Michigan,
Massachusetts, Illinois, Minnesota and
Georgia.
12% 5%
45%
23%
9%
6%
Sub-Sector breakdown of U.S.
Medical Device
Electro-medical
equipment
Irradiation
apparatuses
Surgical and
medical
instruments
Surgical appliances
and supplies
Dental equipment
and supplies
Others
California, 20 %
Florida, 5.58 %
New York, 5.28 %
Pennsylvania, 5.2 %
Michigan, 2.68 %
Massachusetts, 7.14 %
Illinois, 4.09 %Minnesota, 4.01 %Georgia, 2.16 %
New Jersey, 4.24 %
Ohio, 3.27 %
North Carolina, 2.3 %
Other Area, 34.05 %
U.S. Area Geographical Breakdown
California Florida New York Pennsylvania Michigan
Massachusetts Illinois Minnesota Georgia New Jersey
Ohio North Carolina Other Area
U.S medical device companies are classified under Tier-1 and Tier-2, Such companies who that
design, make and sell medical devices to end user from those provide parts for medical devices
and control the manufacturing of the devices are tier 1 companies. In the assessment of the
medical device industry 70% of companies are Tier -1 and other 30% companies are Tier-2 and
other.
Look at this Graphs:-
% Tier 1 % Tier 2
Series1 70.07 32.22
0.00
20.00
40.00
60.00
80.00
%ofManufacturer
Tier1 & Tier2 Breakdown of Medical Device
Companies
Total Manufacturer 2000
% Tier-1 70.07
% Tier-2 32.22
Medical Device R&D teams are facing a number
of business and regulatory challenges,
resulting in longer product development cycles
and escalating product cos. Meanwhile, the
demand for medical devices from emerging has
led to the need for accelerated product
adaption for these markets, putting further
pressure on limited resources.
 J&J at ‘bold steps’ in device deals in 2016,
details 5 device collaboration
In this collaboration J&J disclosed 22 new partnerships,
including with HistoSonics to use its noninvasive soft
tissue ablation technology to treat solid tumors that
aren't good candidates for surgical resection such as
liver and pancreatic cancer.
Carbon 3D to develop custom surgical devices using its
technology to pool resin instead of printing
technology.
This company collaborate with Google Life sciences to
developed in the area of Atrial fibrillation in the United
States. This is accelerating growth to the strategic
investment in innovation.
 Medtronic Collaboration on Novel Infusion Set
“on Track”
It develop a new insulin infusion set including a couple
of new call analyzers with faster simultaneous
measurement capabilites. BD will intordused
FACSSymphony offer high speed analysis that is 20
time faster than other non-flow platforms.
 Medtronic adds Resolute Onyx™ Drug-Eluting
Stent Sizes and Expand Indications
 J&J marks Rs 650 Core more for Telengana for Manufacturing facilities
 J&J lay off 3000 as it restructures medical device business to new growth technologies and new products
development in orthopedic, Surgery, and Cardiovascular business.
 J&J innovation – JJDC, Inc makes $15 million investments in Vivo Capital found and developing healthcare
companies in the U.S. and China
 J&J led investment in Israeli Bone Regeneration CartHeal. The Funds will be used to promote ongoing
manufacturing scale-up, plans for initial European commercialization in 2017 and expansion of clinical
studies to new therapeutics areas.
 DePuy Synthes €53million investment in new manufacturing facilities will lead to creation of 80 jobs in
Cork.
 Stryker submits plans for new €22 million R&D hub:- This will provide for product design and technology
development, product testing facilities and manufacturing process development with product tanning
facilities.
 Orthopedic Giants Stryker development on state-of-the-art 3D printing facilities in late 2016.
 Medtronic Partners with Local Chinese Government to Manufacture Insulin Pumps.
 Medtronic to manufacture IN.PACT Admiral drug-coated balloon at new high-tech facility

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USA Medical Device & Equipment Report 2015

  • 1.
  • 2.  The United States medical device manufacturing sector is a highly diversified industry that produces a range of products designed to diagnose the patients in healthcare systems worldwide.  The Key products that comprise the medical device industry, include, surgical appliances, surgical and medical instruments, electro medical equipment, Irradiation Apparatus, Dental Equipment manufacturing.  The following North America Industry Classification System (NAICS) codes comprise the medical device industry.
  • 3. NAICS Code Sub-Sector Product Classification 334510 Electro Medical Equipment Pacemaker, MRI machines, patient-monitoring system, Diagnostics equipment 334517 Irradiation Apparatus X-ray devices, other diagnostics imaging, CT Scanner machines etc. 339112 Surgical & Medical Instrument Anesthesia apparatuses, orthopedic instruments, catheters, syringes. 339113 Surgical Appliances & Supplies Artificial joints & limbs, orthopedic appliance, surgical dressing, disposables, wheelchairs, surgical gloves. 339114 Dental Equipment & Supplies Instruments used by dentists, dental hygienists, dental chair or any other dental instruments.
  • 4. Overview The US manufacturing market for medical device and supplies continued its strong growth in 2015. The United States remains the world leader by market size, with total revenue of around $110 billion – around on-third of the $350 billion global pie. But the U.S. medical device industry also faces multifaceted challenges that are hampering growth. According to U.S. Govt. by 2020 the U.S Medical technology excepts only 5% growth, But during 2013 the growth rate decreased up to 15% With more than 16,400 business in the medical device manufacturing industry, growth has been driven by a confluence of new product innovation and continued growth in physician visits which now exceed one billion per year. Cross-border activities should strengthen too from its current trends as European and Asian healthcare companies expand their presence in US markets by acquiring developing technologies and collaboration with medical device companies and distribution network.
  • 5. The Merger & Acquisition activity of 2015 focused on medical diagnostic segments. There were several transactions are $1 billion in value—some of the transformational—and many smaller transactions by many of the major United States and foreign-based medical technology companies as they sought to enhance their product portfolios and technology. On 2015 merger & acquisition transactions are $20,621 million and targeted the large number of technologies and his research and development field. In 2014 the M&A transaction value was $19,630 million. BD medical device company acquire care fusion was the biggest deal in 2014. for accelerate innovative healthcare solution with leading scale across the medication management value chain and expand solution for patient safety. DENTSPLY International Inc is a global dental implant manufacturing company headquarter in St. York, Pennsylvania, United States. This company was create the biggest deal in 2015 the deal price was $5560 million acquisition with Germany based company Sirona Dental System. It developed single use dental supplies with advanced Dental imaging technology and instruments. Also this company developed for his dental technology business, it merge $13 billion with Sirona Dental System
  • 6. A Surprising Cardio Acquisition By Cardinal Health Dental supply maker Dentasply to buy Sirona in $5.56 billion deal Hill-Rom to buy privately held Welch Allyn in $2.1 billion cash and stock deal St. Jude Medical, completed its biggest transaction ever with the $3.4 billion acquisition of Heartmate producer Thorates Corp.
  • 7. The 10 largest transaction contributed to around $17,393 million. The standout trade transaction in 2015 were:-  DENTSPLY – Sirona The largest deal by far was Dentsply acquisition of Sirona, a global manufacturer of Dental implant devices, for $5.56 billion.  St. Jude – Thoratec The second deal is St. Jude Acquire Implant Maker Thoratec for $3.4 billion to expand heart implant medical devices system like MRI, pacemaker.  Hill-Rom – Welch Allyn This acquisition between Hill-Rom and Welch Allyn. Hill-Rom to buy privately held Welch Allyn in $2.1 billion. It develops new technologies, improving patient care delivery system and reducing healthcare cost for his customers.  Cardinal Health – Cordic Inc Cardinal Health acquire Cordic Inc “Cardiology and Endovascular” Division to buy $1994 million.  Greatbatch, Inc – Lake Region Medical The 5th largest acquisition is Greatbatch, Inc is a public medical device company acquire U.S. privately held Lake Region Medical company to buy $1730 million with provide portfolio of technologies and services to maintain a strong financial profil to drive shareholders return.
  • 8. Top 10 U.S. Largest Medical Device M&A  HeartWare Inc – Valtech Cardio HeartWare Inc acquire Israel medical device manufacturer Valtech cardio’s mitral and tricuspid valves. The acquisition deal is $929 million. It develops portfolio of valve repair and replacement technologies.  Medtronic – Twelve, Inc Medtronic acquire Twelve’s mitral valve technology on 2015. The deal price is $458 million. It provides expertise and proven success in structural heart space to advance the treatment of mitral regurgitation.  Edwards Lifesciences – CardiAQ Inc Edwards Lifesciences is a public held largest medical device manufacturing company acquire CardiAQ Inc to $400 million. CardiAQ will develops transcatheter mitral valve replacement devices and development of transformational therapy.  Integra Life Sciences – TEI Biosciences and TEI Medical The 9th largest M&A was between Integra Life Sciences and TEI Biosciences and medica. The deal value is $312 million to expand reconstructive surgery and regenerative wound care product.  Conmed – SurgiQuest, Inc Conmed is surgical and patient monitoring manufacturing company. This company acqueir SurgiQuest Inc, to buy $265 million. It revitalizing the growth of advance surgical business for AirSeal System.
  • 9. Acquirer Target Target Sector Deal(US $ in million) Dentsply International Inc Sirona Dental Dental Devices 5560 St. Jude Medical Thoratec Corp Medical Devices 3400 Hill-Rom Welch Allyn Medical Devices 2100 Cardinal Health Cordis Medical Devices 1994 Greatbatch, Inc Lake Region Medical Medical Devices 1730 Stryker Corp Physio-Control Inc Medical Devices 1300 Heartware Inc Valtech cardio Medical Devices 929 Xio Group Lumenis Ltd Medical Devices 510 Medtronic Twelve, Inc Medical Devices 458 Edward Lifesciences CardiAQ Valve Tec. Medical Devices 400 Integra Life Sciences TEI Biosciences/Med Medical Devices 312 Conmed SurgiQuest, Inc Medical Devices 265 Abbott Tendyne Holding Inc Medical Devices 250 Medtronic RF Surgical Medical Devices 235 Medtronic Medina Medical Inc Medical Devices 150
  • 10. The USA medical device M&A has providing the development of Healthcare industry in medical device sectors. In the year 2014 and 2015 the biggest medical device manufacturing company has been acquiring the technologies of medical devices. It will bring a great opportunity for USA or Global healthcare sector. Through this merger and acquisition the medical device are developed and patient is easily curable. Now it has been developing medical imaging technology like 3 Tesla MRI, patient monitoring system, CT scanners:, Orthopaedic & Spinal Instruments, Dental Device/ Orthodontics instrument technologies. Some medical device companies like GE healthcare, Stryker, Abbott, J&J has been developing latest medical technology. In 2015 USA medical device industry has covered the development and collaboration with some medical technologies companies and it target 29 companies has been developed his future advanced technology and FDA will support such companies. It around the deal value of merger & acquisition is approximately $ 20.621 billion in 2015. DENTSPLY International Inc is the biggest acquirer company it develops the dental devices. The deal of this company is US $5560 million. Also Stryker, Medtronic, Edwards Life sciences, Abbott and Integra Life Sciences has been developing his products by the stage of advancing technologies. Medtronic has acquire 5 medical device companies to developed advanced Orthopaedics and heart valve technologies. The total deal value of Medtronic is US $1163 million.
  • 11. Acquirer Company No of Target Company Total Deal(US $ Million) Medtronic Plc 6 1163 Stryker Corporation 1 1300 Dentsply Inc 1 5560 St. Jude Medical 1 3400 Hill-Rom 1 2100 Cardinal Health 1 1994 Greatbatch, Inc 1 1730 Heartware Inc 1 929 Wright Medical Inc 1 3300 Edwards Lifesciences 1 400 1163 1300 5560 3400 3300 400 2100 1994 1730 929 0 1000 2000 3000 4000 5000 6000 TOTALDEAL(US$MILLION) Top 10 Largest Deal of Medical Device Company 2015
  • 12. The United States medical device manufacturing sector is a highly diversified industry that produces a range of products designed to diagnose and treat patient in healthcare system worldwide. There ware approximately 2000 medical device companies in the U.S. in 2015, mostly small medical device companies has been acquiring for developing new technologies on healthcare industry. The states with the highest number of medical device companies include California, Florida, New York, Pennsylvania, Michigan, Massachusetts, Illinois, Minnesota and Georgia. 12% 5% 45% 23% 9% 6% Sub-Sector breakdown of U.S. Medical Device Electro-medical equipment Irradiation apparatuses Surgical and medical instruments Surgical appliances and supplies Dental equipment and supplies Others
  • 13. California, 20 % Florida, 5.58 % New York, 5.28 % Pennsylvania, 5.2 % Michigan, 2.68 % Massachusetts, 7.14 % Illinois, 4.09 %Minnesota, 4.01 %Georgia, 2.16 % New Jersey, 4.24 % Ohio, 3.27 % North Carolina, 2.3 % Other Area, 34.05 % U.S. Area Geographical Breakdown California Florida New York Pennsylvania Michigan Massachusetts Illinois Minnesota Georgia New Jersey Ohio North Carolina Other Area
  • 14. U.S medical device companies are classified under Tier-1 and Tier-2, Such companies who that design, make and sell medical devices to end user from those provide parts for medical devices and control the manufacturing of the devices are tier 1 companies. In the assessment of the medical device industry 70% of companies are Tier -1 and other 30% companies are Tier-2 and other. Look at this Graphs:- % Tier 1 % Tier 2 Series1 70.07 32.22 0.00 20.00 40.00 60.00 80.00 %ofManufacturer Tier1 & Tier2 Breakdown of Medical Device Companies Total Manufacturer 2000 % Tier-1 70.07 % Tier-2 32.22
  • 15. Medical Device R&D teams are facing a number of business and regulatory challenges, resulting in longer product development cycles and escalating product cos. Meanwhile, the demand for medical devices from emerging has led to the need for accelerated product adaption for these markets, putting further pressure on limited resources.  J&J at ‘bold steps’ in device deals in 2016, details 5 device collaboration In this collaboration J&J disclosed 22 new partnerships, including with HistoSonics to use its noninvasive soft tissue ablation technology to treat solid tumors that aren't good candidates for surgical resection such as liver and pancreatic cancer. Carbon 3D to develop custom surgical devices using its technology to pool resin instead of printing technology. This company collaborate with Google Life sciences to developed in the area of Atrial fibrillation in the United States. This is accelerating growth to the strategic investment in innovation.  Medtronic Collaboration on Novel Infusion Set “on Track” It develop a new insulin infusion set including a couple of new call analyzers with faster simultaneous measurement capabilites. BD will intordused FACSSymphony offer high speed analysis that is 20 time faster than other non-flow platforms.  Medtronic adds Resolute Onyx™ Drug-Eluting Stent Sizes and Expand Indications
  • 16.  J&J marks Rs 650 Core more for Telengana for Manufacturing facilities  J&J lay off 3000 as it restructures medical device business to new growth technologies and new products development in orthopedic, Surgery, and Cardiovascular business.  J&J innovation – JJDC, Inc makes $15 million investments in Vivo Capital found and developing healthcare companies in the U.S. and China  J&J led investment in Israeli Bone Regeneration CartHeal. The Funds will be used to promote ongoing manufacturing scale-up, plans for initial European commercialization in 2017 and expansion of clinical studies to new therapeutics areas.  DePuy Synthes €53million investment in new manufacturing facilities will lead to creation of 80 jobs in Cork.  Stryker submits plans for new €22 million R&D hub:- This will provide for product design and technology development, product testing facilities and manufacturing process development with product tanning facilities.  Orthopedic Giants Stryker development on state-of-the-art 3D printing facilities in late 2016.  Medtronic Partners with Local Chinese Government to Manufacture Insulin Pumps.  Medtronic to manufacture IN.PACT Admiral drug-coated balloon at new high-tech facility