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MEDTECH IN 2020:

The Key Themes Shaping


An Industry In Transition

POWERED BY MEDTECH INSIGHT IN COLLABORATION WITH


MEDTECH IN 2020:
The Key Themes Shaping An Industry In Transition

The medtech industry enters the new decade in a state of increasing flux. Major, time-
sensitive changes are redefining the European and global regulatory environment with a
ripple-effect of profound impact on well-established processes and even future product
availability in certain markets. These regulatory changes are happening alongside
massive innovation, continued impacts from mergers and acquisitions, advances in
digital health and data analytics, and a fundamental shift in the focus of health care
and payer-provider reimbursement models, creating a perfect storm that is reshaping
operations and revealing new opportunities to improve the lives of patients.

More than ever, patient care and quality of life are the driving force behind innovation
to the medtech industry. The European regulatory changes can be traced back to a focus
on patient safety, while the industry’s use of digital health devices, real-world evidence, PATIENT CENTRICITY: THE DRIVING FORCE Patient-centricity has been a focal point of
data, and advanced analytics also revolves around these most important of stakeholders. BEHIND THE NEW MEDTECH conversations about the future of medtech in
Medtech companies have always been patient- the past, only for the promise of the concept to
Patients and the medtech industry as a whole, have the opportunity to benefit from the
centric organizations. Yet today, with the point of fail to fully materialize. That old gap between
renewed focus on the needs of the ultimate users of health products and services.
care moving from hospitals to homes and physicians the promise and reality reflected unrealistic
evolving from authorities to guides, what it means expectations, assumptions about decommissioning
Understanding the external forces is only one part of the challenge for medtech
to make patients the focal point of operations is and restructuring that could not happen quickly,
companies in 2020. To emerge from this period of change as industry leaders, companies changing. These changes interweaved with market the vested interests of providers and difficulties
will need to find ways to steer clear of abundant headwinds while taking full advantage access, value-based pricing and reimbursement, reallocating budgets.
of available tailwinds of technology and outside resources with focused domain digital health, virtual trials, new regulations, and the
expertise. Required will be new ways of working that bring down barriers and enable pursuit of innovation are forcing transformation for This time around, there are reasons to believe
collaboration and true orchestration truly cross-functional across the organization. companies looking for global excellence. the industry will clear any barriers, in part
because the changing nature of health care
In this eBook, we look at the five trends reshaping medtech, from the move to patient- Medtech companies have always been patient- delivery has thrust patient-centric themes to the
centric organizations. Yet today, with the point of top of agendas. A focus on the specific needs and
centricity that is touching every part of the industry through to the business process
care moving from hospitals to homes and physicians characteristics of individuals is central to many
orchestration that is enabling companies to retool their operations and processes to thrive
evolving from authorities to guides, what it means technologies that are reshaping health care,
in the new normal. This eBook tells the story of an industry that is responding to significant to make patients the focal point of operations is including companion diagnostics, imaging and
external pressures and opportunities with equally significant internal developments, changing. These changes interweaved with market robotic-assisted surgery.
thereby positioning itself to better meet the needs of patients in the new decade ahead. access, value-based pricing and reimbursement,
digital health, new regulations and the pursuit of The position of patients at the center of the new
Nick Taylor Bhavik Patel, innovation are forcing transformation for companies medtech is perhaps best exemplified by the rise
Medtech Insight Senior Vice President, IQVIA MedTech
looking for global excellence. Addressing these of digital health, which, through the continuous
changes, companies need to orchestrate across their collection and analysis of data from individuals, is
business processes to thrive.1 unavoidably patient-centric.

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HOW DIGITAL HEALTH IS REDEFINING facilitating virtual trials by enabling sponsors to the post-market context, the value of its insights
HOW MEDTECH HELPS PATIENTS remotely identify participants and collect data extends across the value chain.
Connected devices that can be modulated from them, streamlining the process of generating
to facilitate personalized care are a direct evidence to support claims about a device.1 Importantly, patients are increasingly in charge
manifestation of patient-centricity. Virtual trials can of the data behind these insights. Ownership of
be conducted and treatments can be monitored Johnson & Johnson delivered the view that sensors data is shifting from institutions to consumers,
and tailored to the specific needs of the patient. and wearables are clearly a huge opportunity for putting patients in control of how their information
Additionally, robotics and the continued growth of the medical device industry, but the question is is aggregated for population-level analyses that
3D printed devices is also tied to personalization of how to develop technologies that take advantage improve care. Analysis of digital health data is part
care and technology and ways in which companies of the data that devices such as FitBits and Apple of a broader effort involving real-world evidence.
are leveraging innovation to meeting both speed- Watches deliver. J&J collaborates with Apple in That effort is based on four main sources of
to-delivery and patient-specific care. research on the use of wearable technology on longitudinal data: medical records, prescription
early detection of atrial fibrillation. data, hospital encounters, and claims from payers,
The role of patient-centricity is further evident with hospitals and drug plans. While RWE is typically
the rise of digital health. Breaking digital health AI can be used in all areas of work, from the thought of in the postmarket context, the value of
into its component parts, which include connected disruptively innovative to the more prosaic, such as its insights extends across the value chain. RWE
devices, software as a device, patient data and real- ensuring health-care staff clean their hands before informs everything from device concepts and trial
world evidence, and personalized devices shows and after touching patients. This particular project designs to health care professional training and
the central role patients play and the importance of is owned by Radius Innovation, which used an AI the generation of evidence to support premium Those benefits stem from the fact that companies
human data science in a digital health world.1 application to synchronize the number of hand pricing in a value-based health care environment. as well as regulators will have more and better
sanitizing events across a hospital, resulting in Thus, it is a concept to consumer and back again data on their products. Regulators glean insights
Connected devices that can be modulated to proactive uptake and more hand-washing. environment that requires business process from the data that enable them to take a more
facilitate personalized care and remote monitoring orchestration to fully leverage the benefits. informed, risk-based approach to oversight,
are a direct manifestation of patient-centricity. Regulatory pathways for AI-based devices have Business process orchestration permits such reducing au-diting of some companies on the
Treatment can be monitored and tailored to the been the focus of US FDA attention, which sees the company-wide use of RWE by breaking down silos grounds that the data provide confidence in
specific needs of the patient and the continued compliance landscape as continually evolving as while overlaying quality, regulatory, safety and their compliance. That too will benefit patients
growth of 3D-printed devices exemplifies ways technology advances. That, and reimbursement, other functions from clinical to commercial that by increasing scrutiny of high-risk products and
in which companies are leveraging innovation to are huge outstanding issues for an industry that span the entire product life cycle. That means companies. Medtech companies, in turn, can use
meet both speed-to-delivery and patient-specific once again is seemingly ahead of government and people working at each step in the value chain from data captured in orchestrating their business
care. Patient-centricity is also evident in connected central decision-makers on pivotal medtech market concept to market have access to information both processes from research and development and
devices that can constantly gather data on patients. access themes. AI comes under the headings of upstream and downstream of them.1 clinical trials through commercial operations and
When combined with data captured by software as “value generation” and “reduced overall health service providers for not only compliance but
a device products, such as medical apps, which can system burden.” The hope is that driving for better Innovation In The Big Data additional evidence and analytic capabilities to
include geo-centric and other physical and personal outcomes and cost-effectiveness at an early stage Digital Health Era further innovation and operational excellence.1
data, the output of connected devices in our IoT early will deliver a clear-cut value proposition.2 The proliferation of data is happening in unison with
(Internet of Things) world we operate in today yields a related expansion in advanced analytic capabilities. Leveraging Data To Optimize
unprecedented insights into the day-to-day health of UNLOCKING THE POWER OF REAL WORLD Faced with the need to analyze data from sources Clinical Operations
individual patients and can be used to identify clinical EVIDENCE, DATA AND ANALYTICS such as connected devices and other external data Human data science is an emerging discipline that
trial populations and even support virtual trials.1 Analysis of digital health data is part of a broader sources, medtech companies are leveraging the relies on precision data rather than the law of
effort involving real-world evidence (RWE). That power of cloud computing along with machine averages to drive patient solutions. Data analytics
Each component of digital health is powerful effort is based on four main sources of longitudinal learning (ML) and artificial intelligence (AI). These can help predict which sites can deliver the right
in isolation. However, their full potential only data: medical records, prescription data, hospital advanced technologies are enabling companies to patients, increasing enrollment speed up to 30%.
becomes apparent and fully realized when they encounters and claims from payers, hospitals and get insights from big data and perform predictive Meanwhile, using data to take a holistic view of
are combined. Together, the components are drug plans. While RWE is typically thought of in analytics and better risk management. trial sites and identify patients at higher risk means

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actions can be triggered across the study team to Real-World Evidence Findings for analytics and deep insights that justify pricing strategy for dealing with all the ramifications as
avoid issues before they occur. policies. For example, they are able to consolidate well as opportunities. The MDR builds upon the
In today’s emerging era of value-based and analyze their data on reimbursement options medical device and active implantable directives,
Companies that are able to leverage data solutions health care, safety, efficacy and quality data and budgets, surgical outcomes, procedure costs, tightens pre-approval requirements and adds
to glean these types of insights are more successful that used to be sufficient to get products to hospital infrastructure and patient goals, as well as unique product tracking and additional post-market
at managing change, Dr. Christopher Fang, vice patients in even the most demanding of mar- regulatory requirements and product demand in requirements. Some already-marketed medical
president clinical solutions, IQVIA MedTech noted. ket access environments are falling short. each target market. products have been or will have to be reclassified,
Using advanced analytics, human data science can Payers want to see stronger evidence of requiring new regulatory approval, new CE-marks,
also reveal more about complex treatments as need and the positive effect that is delivered. Meanwhile, real-time, real-world data generated and consequent investment of time and effort.
more data is captured from patients. It integrates from the use of products can provide unique
the study of human science with breakthroughs in Apparent is the importance companies are insights into patient and provider perception of Preparing For MDR
data science and technology, building an ecosystem placing on real-world evidence. Such evi- value, leading to product improvements, new In their work with medical device and diagnostics
of knowledge based on a better understanding of dence can persuade payers and providers to products and better pricing strategies. Such data- companies around the globe, IQVIA MedTech
human experience. cover and use products by showing how they driven pricing strategies position device makers to consultants have seen the degree to which
positively affect outcomes in the real world. compete in a value-based world. companies are trying to prepare for the MDR and
“Because of connective devices and the internet, the significant burden on the industry.
we have the ability to capture more data from a lot Likewise, almost two-thirds of respondents Data insights also promote safer products. For
more people, including geo-tagging it. Capturing think RWE in clinical trials is very or critical- example, harnessing artificial intelligence and Under the MDR, there are several changes
opt-in information from people’s Apple Watch or ly important. However, people are far less machine learning allows firms to capture adverse affecting the quality management system.
Fitbit allows us to know exactly how active someone certain about how to act on this knowledge. event data and create cases automatically, before These include new process requirements that
is and more, by measuring the steps one takes from More than two-thirds of respondents are un- a complaint or event is reported. Machine learning manufacturers will have to adopt, and new device
where and when and what one’s heart rate and sure how RWE can help them, are just starting and artificial intelligence can be applied to social technical file requirements that companies will
blood pressure are,” Fang said. “This data, when to learn how to use the real-world evidence, and other data to anticipate and automate cases need to meet. Device manufacturers need to make
triangulated with other health and medical history, or are finding their activities constrained by for investigation ahead of time-sensitive problems. adjustments to their risk and quality management
can be helpful when looking for certain trial patient limited access to high-quality data. This can also provide useful information to design processes and systems to have the required data
populations. Now, at a touch of a button, one can product updates and adjust product capabilities. and reports available for audit.
Less than 20% of all respondents said RWE in
have the information and demographics to identify
trials has been the cornerstone of their activ-
certain trial populations and candidates. It used to To be useful, rich data must be aggregated from In the case of regulatory changes involving product
ities for some time, although that figure shot
take weeks or months to identify such trial groups.” numerous sources such as de-identified patient reclassification, preparation may require additional
up to 33% among executives, once again
records, global sales figures, internet of things data clinical data, and maybe even new clinical trials
suggesting siloed workers may have led to
As the world becomes more digitally connected, feeds and more. Integrating multiple disparate to support Clinical Evaluation Reports (CERs) and
an artificially low overall survey result, and
data can be the silver bullet if MedTech firms sets of data can be challenging. In health care, provide the information needed by Notified Bodies
the need for companies to better orchestrate
leverage it to optimize clinical operations and to this becomes more daunting given the need to and regulators for approval.
across business processes.
orchestrate across other business operations. protect patient privacy and account for geographic
In this way, silos can be broken down so that (Source: How Medtech Is Responding To Changes Set To differences and partial data sets.5 At the same time, companies must manage
clinical data and regulatory interoperate, as Reshape The Industry report, 2019) increased post-market vigilance and safety efforts
do commercial units and manufacturing, from CRUNCH TIME: HOW REGULATORY CHANGES to address the new and expanded reporting
concept to market across the entire business to ARE RESHAPING COMPLIANCE requirements, as well as the accelerated timeline
better guide and align strategy and execution.3 the organization. This is especially true against The European Union’s Medical Device Regulation for vigilance reporting, which has been reduced
the backdrop of consolidation and intense pricing (2017/745/EU) comes into full effect in May 2020. from 30 days to 15 days under the MDR and IVDR.
Data Insights Support Market Success pressures in the health care sector. The changes it will introduce are a major concern
Companies that want to achieve commercial for medtech firms worldwide. Many device makers In light of these changes and challenges, some
success should ensure data from all business areas Harmonizing data and operations allows companies don’t have the resources and deep understanding companies may have to choose between investing
is harmonized and integrated into every unit in to apply artificial intelligence and machine learning of the MDR requirements or lack a complete heavily to maintain or expand product placement in

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key markets and pulling or delaying market launch How Patients Are Reshaping Regulation These consequences are a growing concern,
of certain products. This has the potential for broad Changing regulations are also driving companies particularly as many medical device firms are
supply chain and even patient care ramifications.6 to relook at how they orchestrate compliance still underprepared for the MDR, set to take full
across their operation. Patient-centricity underlies effect in May 2020, says Larry Ferrere, senior
Fortunately, complying with these regulatory changing regulations and product innovation director, strategy & marketing, MedTech Center
changes and keeping track of new requirements and improved safety is a by-product. The focus of Excellence, IQVIA MedTech. For example, many
worldwide can be made easier by: on further enhancing patient safety, manifested haven’t updated their quality management systems
in new and constantly evolving regulations, will to report the additional clinical data and safety
• Working with consultants that have deep require medtech companies to capture and events required under the new regulations. They
MedTech regulatory expertise report additional data on their prod-ucts. These also face the risk that reclassified products that
regulatory changes may create challenges related require a new CE certification and notified body
• In-sourcing additional resources to assist to product reclassification and approvals through involvement will not be approved in time to meet
with the new demand notified bodies in the near term, but medtech the looming regulatory deadlines and will have to
companies that adapt effectively to the new be withdrawn from key markets.
• Applying better automation and technology regulatory environment will be best positioned to
to increase efficiencies and management reap the benefits long term.1 While the MDR is a significant concern in the EU,
in particular, there is also a ripple effect where the
• Leveraging tech-enabled managed services Those benefits stem from the fact that companies CE mark has been used as a basis for certification concept-to-market quality compliance needs, along
providers to manage some of the clinical as well as regulators will have more and better data in other markets. If a new EU CE mark is required with improved data and safety features.
and data needs on their products. Regulators glean insights from under the MDR, companies will need recertification
the data that enable them to take a more informed, in their other markets, as well. A more effective compliance program includes
Key Findings risk-based approach to oversight, reducing au- integrated solutions that automatically track
diting of some companies on the grounds that And at the same time these changes are taking new requirements and regulatory changes,
the data provide confidence in their compliance. place, MedTech firms must continue to track orchestrating alerts and updates across the
• Almost 40% of executives with operations
That too will benefit patients by increasing scrutiny evolving regulatory requirements in more extended enterprise. Solutions that are powered
in the EU said the impending Medical
of high-risk products and companies. Medtech than 100 key markets, with updates coming as by artificial intelligence techniques, including
Device Regulations will have a significant
companies, in turn, can use data captured in frequently as every 20 minutes. natural language processing and machine
or critical impact on their businesses.
orchestrating their business processes from learning, and that leverage big data from
• Faced with the need to recertify products research and development and clinical trials These needs and changes create opportunity, and connected devices, market insights and social
in compliance with the new, tougher rules, through commercial operations and service leading companies are embracing the changes media signals, can improve decision-making and
almost 20% of respondents expect to with- providers for not only compliance but additional as a driver to take steps forward. By applying overall business and product effectiveness.
draw devices from the market rather than evidence and analytic capabilities to further advanced technology versus assigning more staff
go through the revised regulatory process. innovation and operational excellence. to existing processes, and by examining which Managing regulatory changes and maintaining
processes can be outsourced to managed services compliance is easier with up-to-date, integrated
• Across the whole data set, 83% of re-
Compliance providers with the right people-power and domain regulatory intelligence, regulatory information
spondents said they are yet to reclassify
While the clinical department is dealing with expertise, companies can focus resources on core management, and quality management systems
any products.
trial timeline and enrollment pressures, the processes that differentiate them in their market that track global regulations and orchestrate across
• A significant minority of respondents compliance department is grappling with risk while remaining compliant. myriad business processes, says Donal Cumiskey,
think they currently capture less than management, quality maturity, postmarket senior director of compliance solutions strategy
20% of the data required by the new vigilance, product safety, commercial compliance, For example, the MDR can be a driver for companies for IQVIA MedTech. This is particularly important
regulations. and the need to track and react to shifting global to abandon obsolete and disparate quality processes amid the heavy regulatory change and merger and
regulations and audits. MedTech firms that fail to for an orchestrated, enterprisewide quality acquisition activity that has marked the MedTech
(Source: How Medtech Is Responding To Changes Set To
properly manage these challenges, face regulatory management solution. Such a solution should space, so companies can harmonize and optimize
Reshape The Industry report, 2019)
actions and loss of market share. include support for MDR and risk management for across divisions, sites and markets globally.

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Better compliance solutions also allow companies technology-enabled managed services necessary
BUSINESS PROCESS Why is business process orchestration
to track patient safety events more effectively to combine each link in the value chain. In practice, ORCHESTRATION necessary for medical device and in vitro
and sooner. These events and other real-world these changes will require medtech companies to
diagnostics companies?
evidence in turn give firms more supporting use the collective resources and industry expertise
evidence if they are subject to an audit, and they they possess and that of their trusted partners. In today’s competitive and changing market, MedTech companies
must abandon traditional siloed business approaches and adopt
also allow a postmarket feedback loop that can
business process orchestration — linking data, processes and people
inform decisions in other departments. Business process orchestration is a new way of all the way from R&D through commercial operations — from
working for many medtech companies but it is concept to market.
All of these improvements drive quality maturity, a necessary change. Companies that make this
which lowers the cost of both maintaining high transformation with be best positioned to emerge
quality, as well as the frequency and cost of from these times of change as industry leaders.
addressing events related to quality problems.8 As patient-centricity, digital health and regulatory

BUSINESS PROCESS ORCHESTRATION:


THE GLUE THAT BINDS THE NEW MEDTECH
changes are behind many of the forces reshaping
the medtech industry, companies that put the
patient and data at the center of their innovation
Orchestration means

BETTER
02 Orchestration means

COMPLIANT
Companies will, and are, moving past a focus on will be the long-term winners. INNOVATION • R&D uses market data and real- • Regulatory Intelligence informs OPERATIONS
simply integrating disparate systems and siloed
groups to one that fosters and operates in a Successful companies will leverage deep and
world evidence to design better
clinical trials and cut time to market
all units of regulatory changes FROM END
true cross-functional and extended enterprise unmatched domain expertise, transformative • Regulatory ensures
• Integrated RID, RIM
and QMS can more
TO END
collaborative fashion. Operating across business technology, unparalleled data and advanced analytics compliance considerations efficiently get products
processes, including the systems and technology to while adopting business process orchestration, in target markets around into new markets
the globe are met
support the needed business process orchestration equipping them to improve their operations while •P
 roduct lifecycle quality
• Analytics can identify the compliance including
illustrates how leading companies will further adapt keeping patients at the center of every decision.1
right customer base MDR, risk management
to the transformation and leverage being driven by and target markets, and analytics, can lower
digital health and patient-centricity. REFERENCES guiding strategies for new total cost of quality
1. https://invivo.pharmaintelligence.informa.com/-/media/ and existing products
BUSINESS PROCESS
marketing/in-vivo/outlook-2020/sponsors/iqvia-medtech/
ORCHESTRATION
01
Why Business Process Orchestration?
iqvia-medtechmedtech_sponsored-content_final_lrs.pdf?la=
Companies will, and are, moving past a focus on
en&hash=F9CC7537CEEC8C0926528F517E062B1B8253B5FC
simply integrating disparate systems and siloed
2. https://medtech.pharmaintelligence.informa.com/MT126029/
groups to one that fosters and operates in a
MTI-Outlook-2020-Global-Health-Systems-Are-Learning-To-
true cross-functional and extended enterprise Embrace-AI-As-A-Force-For-Good

03
collaborative fashion. Operating across business Orchestration means
3. IQVIA MedTech SmartFocus Orchestrating Excellence In
processes, including the systems and technology Clinical Operations report GREATER • Commercial leverages real-world evidence
to understand the current and forecasted
to support the needed business process
4. https://medtech.pharmaintelligence.informa.com/-/media/ SUCCESS market size, players and trends
orchestration illustrates how leading companies
will further adapt to the transformation and
supporting-documents/iqvia_medtechresponding_whitepaper_
1909_final.pdf?la=en&hash=7BE5F47F6D7E874398041E6F6
IN THE • Reference, patient-level and sales data helps demonstrate
value sooner and inform R&D of any needed updates
leverage being driven by digital health, regulatory BA77D3AC9FA8373 MARKETPLACE • Real-time feedback informs all units and identifies
change, and patient-centricity. 5. IQVIA MedTech SmartFocus Orchestrating Excellence In potential safety and compliance issues
Commercial Operations report
To achieve this entails taking a business process 6. IQVIA MedTech SmartFocus Orchestrating Excellence In
view of the full medtech product life cycle, from Global Compliance Report
concept to market, and bringing together the 7. IQVIA MedTech SmartFocus Thriving In The New Medtech
ORCHESTRATION MEANS: RESEARCH & DEVELOPMENT needs the market insight and real-world evidence to make
effective strategy decisions, drive effective clinical trial programs and gain timely approvals
technology, products, services, consulting, data and Ecosystem report BREAKING DOWN COMPLIANCE requires meeting ever-changing quality, regulatory and safety requirements
THE SILOS on a local and global basis from R&D through commercial

COMMERCIAL OPERATIONS is not just getting product to market; it provides post-market


data and safety input for clinical, commercial and regulatory compliance; patient and provider
10 / February 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.) feedback drive future innovations; all while managing reimbursement, February
© Informa UK Ltd 2020 (Unauthorized photocopying prohibited.) market access
2020 / and
11 overall
commercial performance
From concept. To market.
For business orchestration across
the entire product lifecycle.

Whether you need time-sensitive MDR/


IVDR assistance, local or global clinical trial
assistance, specific medical device or in vitro
diagnostics expertise.

If you are looking to insource, outsource,


implement advanced technology and
solutions, or Real World Evidence. If you
want to improve operations efficiencies,
or just need a trusted partner to manage
processes with or for you, contact IQVIA
MedTech today. We’re here to help.

Others may offer a way forward.


IQVIA gives you a way further.

Contact us: iqviamedtech.com

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