Global Trends in Medical Device and Diagnostic OEM Strategy and Implications for the Supply Chain
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The document analyzes trends in the medical device industry, focusing on OEM strategies, supply chain dynamics, and the impact of reimbursement models on product development. It highlights the shift towards organic growth and innovation, the consolidation among major players, and the emergence of large global contract manufacturers posing new challenges to existing supply chain companies. Key opportunities are identified for smaller manufacturers and specialized suppliers to assist OEMs in speedier product commercialization and enhanced technology integration.
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 [email protected] 30