The Digital Era In The Medtech Industry - Deloitte

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The digital era in the MedTech industryDigital supply networks and MedTech

Opportunities and keyconsiderations for MedTechOpportunities for digital transformation are available throughout life sciences organizations’ business, from business operations suchas production and enabling functions to engagement with patients, physicians, health systems, and payers to developing new productsand services. Realizing each opportunity requires the capabilities of a digitally maturing organization, including an overall strategy,culture of collaboration and experimentation, and supportive leadership.Digital transformation offers MedTech companies opportunities to execute efficiently, engage effectively, and innovate new productsand services.Execute: Digital can help companies execute better by improving performance and reducing costs through collaboration, centralizationof digital technologies to streamline delivery, and enhanced capabilities across the organization or division.Engage effectively: Digital can help companies deliver a differentiated, engaging, digitally enabled impactful experience to keycustomers, the workforce, and ecosystem partners. Key elements include using digital platforms to engage patients and otherstakeholders remotely, leveraging social and other community networks, and personalizing experiences with user data to delivergreater value.Innovate products and services: Digital transformation offers opportunities to envision and deploy products and services with new orenhanced value. Opportunities also exist to improve the return on research and development.This paper focuses on digital transformation execution within the MedTech industry by identifying key areas to leverage digitaltechnologies and guidelines for building a strategy that will enable growth.Key considerationsIn recent years, increased pricing pressure and stringent regulations along with the slow paceof product development and chronic operational inefficiencies have given many MedTechcompanies pause about their existing operating model. By leveraging digital supply networks,MedTech players now have the opportunity to spur growth and differentiate their entireorganization by digitizing their supply chain functions.Our analysis has identified five supply chain areas (inventory management, logistics anddistribution, device maintenance, product development, and warehouse operations) whereMedTech companies can reap the most benefits when adopting digital technologies. By doingso, they can enable increased supply chain visibility, reduced maintenance and R&D costs,greater customer satisfaction, and improved patient experience.To embark on a digital journey, MedTech players are advised to build a digital strategyroad map around the following four steps: getting started now with small and immediateincremental changes, developing a more tech-savvy workforce, addressing cyber risks, andadopting agile methodologies.2

The digital era in the MedTech industry Introduction IntroductionMoore’s law dictates that the density oftransistors in an integrated circuit doublesroughly every two years. This rule of thumbhas since extended into advancements inother technology systems, across storage,computing power, and even the numberof pixels on a digital camera. As a result ofthe exponential growth, dramatic boostsin the performance of digital systems andthe affordability of individual componentshave ushered in a new era of disruptionand paved the way for data-driven decisionmaking. From a supply chain perspective,such advances have initiated a fundamentalshift from linear, sequential supply chainoperations to interconnected and dynamicnetworks, termed digital supply networks or“DSNs” (see figure 1).By integrating a company’s entire supplychain to inform and achieve businessobjectives rather than narrowly manageand optimize discrete functions, theapplications of DSNs promise to enrich dayto-day operations and serve as a source ofstrategic differentiation for businesses in thevery near future (see figures 2 and 3).1Companies in sectors as diverse asinformation and communicationstechnology (ICT), financial services, andconsumer and industrial products (CIP)have already begun to reap the operationaland strategic benefits of digital adoption.Faced with rising price pressures imposedby health care providers and challengedwith ever increasing operational costsalong with lower returns from maturingproducts, companies in the medical devicesand products industry (referred to in thispaper as “MedTech”) must now also lookat new ways to improve their bottom line.Embracing digitization in operations isbecoming less of a choice and more of animperative to remain cost competitive in thecoming years.In the following, we will explain why the timeis now for MedTech companies to digitizetheir operations and how, by doing so, theycan build the necessary momentum forenduring profitability growth.Figure 1: Traditional supply chain versus Digital Supply NetworksTraditional supply chainDigital supply networksSynchronizedplanningConnectedcustomer telligentsupply3

The digital era in the MedTech industry Drivers for digitization Drivers for digitizationIn recent years, forces ranging fromincreased pricing pressure, to morestringent regulations and operationalinefficiencies arising from a general trend ofconsolidations have reshaped the MedTechlandscape. These trends show no signsof reversing.Increasing pricing pressureStiff price competition and downstreampressure in the MedTech sector continue tobe growing concerns for business leaders,as demonstrated by recent surveys ofmanagers in medium and large MedTechcompanies.2 Forced to reduce health carespending in an uncertain economy, payers,providers, and governments constantlydemand lower-cost devices, value- andoutcome-based payment models, and morestringent regulatory processes.3 Moreover,patients themselves have become valueconscious consumers in an era of risingout-of-pocket (OOP) expenditures. Althoughwilling to pay out of pocket for qualitypremium services, patients are increasinglysensitive to prices and susceptible tobypassing treatments when faced with highdeductibles, especially in the United States.4As a result, prices for MedTech productshave continued to decrease. For instance,market analysis has shown that the averagesale prices for 71 common cardiac andorthopedic devices have fallen by about 4percent from 2010 to 2016, and the price forbasic pacemakers in hospitals decreasedby about 5 percent from 2013 to 2016.5To combat these falling prices, MedTechplayers must not only provide superiortechnologies or features, but also deliveroutstanding value to patients and providerswhile keeping costs to a minimum.Figure 2: Year-over-year growth of global MedTech revenue 600 500 400 309 300 3184% 3304%3% 200 341 356 369 384 400 4174%4%4%4%4%20112012201320142015 438 460 484 510 5385%5%5%5%5%201620172018201920203% 100 2007200820092010Global MedTech revenue, billionY/Y revenue growth, %Source: GlobalData Medical, as of November 2017Although it has historically experienced a constant and steady growth worldwide, averaging a 4 percent year-overyear revenue growth in the last 10 years, and is projected to hit 540B in revenue in 2020, the MedTech industry hasnot seen its profit margins follow the same upward revenue trend. In the United States, profit margins have declinedslightly from 6.7 percent in 2012 to 6.6 percent in 2017, and are projected to further fall to 6.3 percent in 2022.224

The digital era in the MedTech industry Drivers for digitization More stringent regulationsIn addition to a downward pressure onpricing, MedTech companies face additionalchallenges in recent legislations that look toelevate operating costs, especially in maturemarkets. For example, the recent EuropeanUnion Medical Devices Regulation (MDR)will enforce a more thorough assessment ofproduct safety and performance by placingtighter requirements on clinical evaluationand traceability of devices throughoutthe supply chain. By 2020, manufacturerswill have to fully comply with the newregulation, and as a result, face increasedoperational complexity and considerablyhigher compliance costs, potentially in themillions. Ultimately, organizations may haveto consider whether specific products havesufficient returns to remain on the market.6Operational impacts of M&AOn top of the additional costs of newregulations, operational issues frommerger and acquisition (M&A) activitywill continue to be a major hurdle forMedTech companies in the near future.The consolidation trend within the industryshows no sign of slowing down in the comingyears, mainly driven by a desire to achieveshorter product life cycles and combathigh costs of developing new technologies.7Although M&A activities help to achievescale and help position companies forsuccess by delivering a wide portfolio ofproducts to hospital buyer groups, they alsopresent a source of operational inefficiencyand quality-related risks.8 In the processof making acquisitions to maintain acompetitive edge, large MedTech companiestend to absorb older legacy designs andsystems, giving rise to multiple designplatforms for similar devices within thesame company as well as disparate qualityenterprise resource planning (ERP) andplanning systems overall.9Figure 3: 2017 Medtech revenue by region and projected revenue for 2020North America 189Asia-Pacific 123Europe 127Other regions 22 219 140 154 2620172020MedTech revenue by region, billionSource: GlobalData Medical, as of November 20175

The digital era in the MedTech industry Drivers for digitization Potential benefits ofdigitizationWhile the challenges may seem daunting,MedTech companies can focus on newtechnologies and frameworks as a way ofcountering these threats and positivelyimpacting their bottom line. Increasingoperational efficiency and providingincreased value to their customers throughDSNs would certainly be a start. But whichMedTech functions would benefit the mostfrom digital supply networks, and whatspecific technologies would best justify theirimplementation costs?Internet of things (IoT)Inventory managementDigital supply networks can leveragedata from digital sensors and connectedpackaging to provide real-time visibility ofinventory at all locations, connect smartcabinets that automatically track inventorytransactions, and trigger replenishmentrequests. Surgical kits represent an aptexample of an area ripe for improvement.Typically, the kits contain several devicesand are sold on consignment. Today,hospitals generally send back the kits forreprovisioning after certain items haverun out, at which point the manufacturerdiscovers and replenishes the necessaryitems, often giving rise to a 30-day lagin the process.10 To avoid this, mostmanufacturers keep a high level ofconsigned inventory, at the expense ofexcessive and obsolete inventory. Takingadvantage of IoT—a network of devices,machines, and other items embeddedwith sensors to enable interconnectivityand exchange of data—can help connectmanufacturers with suppliers. For example,having the kits tagged with RFIDs, whichare in turn tracked by a hospital’s smartcabinets, allows for immediate inventory6replenishment and customer billing assoon as parts of the kit are removed. Ourestimations indicate that, in addition to thetime that sales representatives gain by nothaving to manually monitor the status ofthe kits, companies are potentially able tolower consigned inventory by 25 percentand reduce their excessive and obsoleteinventory by more than 50 percent.11Logistics and distributionAchieving a higher degree of visibility overthe end-to-end supply chain constitutesanother long-lasting challenge for MedTechcompanies. Having historically struggledto effectively manage the tracking, tracing,and monitoring across all steps of thevalue chain, MedTech players have bornethe costs of physical product damages,encountered deterioration duringdistribution, and faced the consequencesof widespread counterfeiting in themarket. Taking advantage of the IoT couldlet MedTech companies reap the desiredbenefits of supply chain visibility. Althoughpieces of the supply chain today are alreadyconnected to track and monitor packages,tinier embedded sensors can enable moreaccurate tagging and an unprecedenteddegree of real-time tracking and tracingof medical devices. This results in greatervisibility and control over manufacturing,storage, and transportation conditions suchas temperature, light exposure, humidity,pressure, and location. IoT can also ensurea greater level of integrity and securityin an industry where fraud and securityare widespread concerns (according tothe World Health Organization, 8 percentof medical products are estimated tobe counterfeited worldwide and theftis becoming more widespread andsophisticated.12 Ultimately, the patient canbenefit from this supply chain performancethrough having access to consistent, wellfunctioning products

The digital era in the MedTech industry Potential benefits of digitization Device maintenanceService contracts have long been one of themost profitable lines of business for medicaldevices manufacturers, and in many cases,generated much more lucrativeprofit margins than the sale of originalequipment. Nonetheless, service managersare experiencing increased pressureto maintain a high level of customersatisfaction at lower costs, and medicaldevices organizations need to look for newways to minimize the occurrence of externalfailures and schedule product maintenancebefore a major event occurs.In this context, medical devicesmanufacturers can make use of IoT toenable remote connectivity and record dataranging from environmental conditions tooperational settings and rates of failure. Bydoing so, MedTech companies can improvethe efficiency of supporting operations,increase their customer satisfaction byreducing potential equipment downtime,and ultimately maximize their servicecontract profit margins.13 However, realizingthis ideal state is only possible if equippedwith the right capabilities to extractmeaningful data. Analyzing an outpourof information coming from embeddedsensors calls for machine learning. Thisconcept constitutes a subset of artificialintelligence (AI) and refers to the abilityIn the time of online and social media, news of recalls of medicaldevices and lawsuits against their manufacturers spreads acrossthe globe faster than ever. The impact of a company’s share pricecan be as high as 10 percent after a major quality event,24 not tomention the long-term implications for a company’s brand.of computer systems to improve theirperformance through exposure to largequantities of data without the need tofollow programmed instructions. At itscore, machine learning is the processof unsupervised learning in data. Oncediscovered, such patterns help to makeeducated predictions.14 In the context ofmedical device maintenance, machinelearning can optimize the maintenanceschedule by best balancing variablessuch as cost, customer satisfaction,and resource management. In addition,machine learning has the potential todevelop deeper strategic insights andcreate a data-driven business model byaggregating and summarizing the data oncustomer habits and utilization patterns.Through a combination of IoT and machinelearning, medical devices manufacturershave the potential to minimize downtimeand interruption in health care practiceswhile realizing benefits in terms of reducedmaintenance costs and increased providerand patient satisfaction.Additive manufacturing andaugmented realityProduct developmentA major challenge faced by MedTechcompanies is to move beyond the traditionalR&D model involving one-at-a-time designiterations (see figure 4). Due to its inherentslow pace and long duration, the classicalmodel constitutes a major source of cost(see figure 5) and does not always guaranteethe desired product specifications in termsof manufacturability, reliability, and quality.This is particularly true given the increase inpatient demand for personalized options,thus making it more difficult for companiesto accelerate product development whileminimizing R&D and manufacturing costs.DSNs can have a deep impact on companies’R&D and manufacturing functions byopening up a whole new frontier of digitaland manufacturing development. Whereastraditional product development impliedone-at-a-time design iterations that couldlast for months, digital manufacturing hasthe potential to drastically reduce R&Dspend by shortening development cyclesand letting companies increase the numberof design iterations to deliver higher-qualityproducts at a dramatically reduced cost.15Recent technological advances inaugmented reality (AR) and additivemanufacturing (AM) illustrate the magnitudeof this paradigm shift. AR enhanceshuman decision making by bridging thegap between the physical world and adigital space dominated by data andinformation that is traditionally displayedon two-dimensional screens and pages.With the help of AR, 3D models come tolife, eradicating the gap between physicaland digital and enabling R&D departments7

The digital era in the MedTech industry Potential benefits of digitization to fully conceptualize and optimize theirdesigns for manufacturability and reliability.AM (“3D printing”), the process of creatingobjects by joining or solidifying materialsunder computer control, constitutes a rapidmethodology to move from digital design toprototyping to even mass production. Theconjunction of AR and AM has paved theway for MedTech companies to streamlineproduct life cycle, accelerating the launchesof new and personalized products atminimum costs, and enabling a moreefficient maintenance and provision ofservicing elements.Warehouse operationsIn addition to the value delivered tophysicians (e.g., in trainings and in OR16),R&D, and manufacturing departments,augmented reality can prove valuable forother critical functions in the MedTechindustry, such as warehouse operations.Said operations account for roughly 20percent of all logistic costs;17 their relianceupon paper-based checklists introduceshuman operators to a swath of logisticalnightmares, including delays and manmade errors. AR could greatly enhancethe accuracy of inventory selection, byinstructing workers to the exact location ofproducts and empowering them with themost optimal route to get there.Figure 4: Medical device prototype evaluation processPrPasstotyFailInternal to externalprocess that goes on untilthe prototype meets theuser needs. It evaluateswhether the productdelivers benefits accordingto the needs of thetargeted users.opeVerification1OutputValidation2User needsInputPasssesocPrFailMedical deviceExternal to externalprocess that links userneeds with the finalmedical device ready formass manufacturing.Is the design outputaligned with the designinput?1Does the prototype meetthe user needs?2Figure 5: R&D spending as aR&Dpercentageofa revenue2009-2022spending aspercentagefromof .1%20092010Source: 02020212022Research and development is oneof the highest sources of cost forMedTech companies, estimated tobe between 6 and 7 percent of acompany’s revenues.23 This is a resultof a long and cost-intensive process,which requires the completion ofsteps such as identification of worthyideas, patent development, creationof strategic alliances, FDA registration,clinical trials, sales, marketing, anddesign for manufacturability.

The digital era in the MedTech industry How to start on the digitization path How to start on thedigitization pathThe question for MedTech companiesis not whether they should embark on adigital journey for their supply chain andglobal operations functions. Rather, it isabout where and how to start. Our analysissuggests that MedTech players shouldbuild a digitization strategy around fourmain steps.Think big, start small, act fastWhile these changes can have widespreadimplications, Deloitte recommends a “thinkbig, start small, act fast” methodology whenadopting digital technologies. Developinga future state vision in which the supplychain is optimized from suppliers—toproviders and patients—is the first step inthe process, followed by starting with smallincremental changes to mitigate the risk ofchange and to demonstrate early successto the organization.18 MedTech companiesshould keep growth in mind and prioritizeareas that can unlock several stages ofpotential value while acting fast to achievequick wins. By focusing on low-hanging fruit,companies can build on early successes andcontinue to establish DSNs where they makestrategic and financial sense.Develop new workforce skills andcapabilitiesTo fully take advantage of the possibilitiesoffered by DSNs, MedTech companiesshould recognize that they need to traintheir workforce innovatively and plan timeand resources accordingly. For example,R&D technicians and engineers should becapable of not only running an injectionmolding machine or a 3D printer, but alsosending a digital model of a product underdevelopment to a third-party manufacturer,or analyzing production data to improvethe design for reliability. In general, theworkforce should become more tech-savvyand adapt to multifaceted tasks, rather thanfocusing on department-specific activities.The imperative for the workforce to be wellversed in digital solutions is threefold. First,as consumers of the underlying technology,users must be able to extract value fromdigital solutions. Second, as buyers of thesesolutions, users need to be educated onthe solutions and recommended a suiteand sequence of technologies that drivethe most substantial impact. Third, asimplementers of digital solutions, teamsneed to be prepared for a different workingrelationship with IT. Since many of thetechnologies require minimal integration,individual teams may supplant IT as theprimary owners of the technology.19Address cybersecurity risksIn enabling holistic decision making throughan increased transparency of informationacross all areas of the value chain,20 theconnected nature of digital supply networksmakes cybersecurity more importantthan ever. Whether it is a risk related tothe possibility of someone changing amachine setting on an automated processthat makes life-saving devices or switchinga pacemaker off in a patient’s body, thetime is now for MedTech companiesto address cybersecurity in the supplychain. Based on our experience in otherindustries also involved in the digitizationprocess, we believe there are three mainareas where MedTech players shouldfocus. First, companies should choosethe right technology along the digitizationpath and address cybersecurity as a toppriority to avoid potential issues downthe road. Second, MedTech companiesshould continuously train employees on thelatest security threats and correspondingcountermeasures. Third, companies shouldappropriately develop backup solutions andbuild safeguards to potential threats.Adopt agile systems for DSNdevelopment and deploymentIn order to secure approval and adoptmeaningful change throughout theorganization, MedTech companies can takean agile approach to DSN development anddeployment. This approach enables thedevelopment of requirements iterativelyrather than at the onset of the project.The opportunity to refine and adjustgives adopters the required flexibility tocontinually tweak development based onever-changing goals and provides themwith increased confidence toward the finalsuccess of the initiative, cycle after cycle.9

The digital era in the MedTech industry Conclusion ConclusionThe bottom lineWhile other sectors have embraced thefourth Industrial Revolution by leveragingDSN capabilities, the MedTech sector hasbeen a more conservative follower, relyingon established products, technologies,processes, and systems to conductbusiness. However, due to the current shiftin the MedTech competitive landscape,companies are now faced with an array ofchallenges that will continue to impact thebottom line. Downstream pricing pressures,non-traditional challengers, stringentregulations, and operational inefficienciesdue to industry consolidation are forcingmany MedTech companies to reactand implement effective cost reductionstrategies to remain competitive. No longercan MedTech companies rely on theirprevious business models to drive growth;they should adapt to the environmentand take advantage of current solutions inthe marketplace.Fortunately, in a time characterizedby sharply declining costs of digitaltechnologies and an exponential growthof computing power,21 there are manysolutions to these problems. MedTechcompanies now have the potential toeffectively tackle their most pressingchallenges and counterbalance bottom lineimpacts by applying solutions such as IoT,machine learning, additive manufacturing,and augmented reality. By doing so,MedTech players can complement andexpand the classical functionalities providedby IT (e.g., ERP systems) while enabling afull integration between IT and operationstechnology (OT). These technologiescan positively drive change throughouteach stage of the MedTech supply chain,ultimately leading to increased valuedelivered to the end customer or patient.The time to act is now. Acting proactivelyand leveraging the recent advancementsin digital technologies are critical for thefuture success of MedTech companies.And although the MedTech sector hasnot yet fully embraced DSNs, the currentenvironment and availability of such digitaltechnologies will likely cause DSNs to soonbecome a prerequisite for competitiveMedTech corporations rather than adifferentiator. While establishing DSNsmay appear intimidating, there are tacticalsteps organizations can take to get startedimmediately. By starting small, developingnew skills in the workforce, addressingcybersecurity risks, and taking an agileapproach, companies can makea sustainable and tangible impact totheir operations.Contact usStephen LaaperPrincipalDeloitte Consulting LLPslaaper@deloitte.com 1 617 437 2377Allan KrulPrincipalDeloitte Consulting LLPakrul@deloitte.com 1 404 631 3299Alex BredemusManagerDeloitte Consulting LLPabredemus@deloitte.com 1 612 659 2504Tommaso NardiConsultantDeloitte Consulting LLPtonardi@deloitte.com 1 312 486 0439AcknowledgementsThe authors would like to thank Glenn Snyder, Jesse Singh, Peggy Fasano, and Matthew Giannuzzi of Deloitte Consulting LLP for their valuableinput, insights, and efforts in the preparation of this perspective.10

The digital era in the MedTech industry End notes End notes1234567891011121314151617181920212223Adam Mussomeli, Doug Gish, and Stephen Laaper, The rise of the digital supply network, Deloitte University Press, s/us/articles/3465 Digital-supply-network/DUP Digital-supply-network.pdf.Medical device manufacturing in the US, IBISWorld, 2017.2017 Global medical device industry outlook, Emergo, /outlook-medical-device-industry.2017 Global life sciences outlook, Deloitte, 2017, -sector-outlook.html.Julie Meehan, Marc Abels, Anand Sairam, and Omer Saka, Capturing the value of Medtech ingenuity, Deloitte, ion.pdf.Joe Carlson, “Medical device makers face challenge of falling prices,” Star Tribune, February 6, �Medical Devices Regulatory Framework,” European Commission, evices/regulatory-framework en.Fink Desford, “Why the medtech contract manufacturing M&A trend isn’t slowing down,” Medical Design & Outsourcing, August8, 2017, h-contract-manufacturing-ma/.Understanding barriers to medical device quality, Food and Drug Administration, sOffices/CDRH/CDRHReports/UCM277323.pdf.The digital edge in life sciences: The business case for digital supply networks, Deloitte, 2017, d.Toby Hay, “Comment: Internet of Things will revolutionise how healthcare is delivered,” Digital Supply Chain, August 2, healthcare-delivered; BarryMcDonogh, “Combatting counterfeiting in Medtech,” Medical Product Outsourcing, 2016,https://www.mpo-mag.com/contents/view ting-in-medtech.“MTS Blog: The big, bad, and ugly costs of medical device recalls,” Medical Tracking Solutions (website), lls.Charles Florin and Abhinav Srivastava, MedTech Prognostic IoT: Predictive maintenance for medical devices, Karvy Analytics, Patrick Laurent, Thibault Chollet, and Elsa Herzberg, “Intelligent automation entering the business world,” Inside, issue 8, April2015, orld.html.“Worldwide medtech research and development spending as percent of medtech revenue from 2009 to 2022,” Statista, 2017.Rob Bodor, “Gaining a competitive edge with digital manufacturing,” Medical De

Global MedTech revenue, billion Y/Y revenue growth, % Figure 2: Year-over-year growth of global MedTech revenue Although it has historically experienced a constant and steady growth worldwide, averaging a 4 percent year-over-year revenue growth in the last 10 years, and is projected to hit 540B in revenue in 2020, the MedTech industry has

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