The medical devices industry is experiencing fast growth rates of 5-15% annually due to factors like aging populations and emerging middle classes. However, growth is being constrained by rising costs pressures like tightening healthcare budgets and lack of consumer willingness to pay high prices. To address this, medical device companies need to differentiate their products, optimize their portfolios, and streamline their operations through measures like process improvements and organizational redesign. Innovation strategies also need to adapt to the new challenges around shorter product lifecycles and the need for higher per-innovation returns.
2015 trends in global medical device strategy and issues for the supply chain...Tony Freeman
This presentation reviews critical business trends shared by major medical device companies and the implications for their manufacturing supply chain. Consolidation of device OEMs, product line and marketshare changes brought on by accountable care, and OEM desire for larger outsource partners are the dominant themes.
Business Intelligence (BI) in Pharmaceuticals - An aid in informed decision making
Currently, the demand for BI solutions is largely driven by MNCs & large enterprises. BI solutions seem to have gained more acceptance and significance in pharma industry where time plays a pivotal role in the future of the company. The article from Modern Pharmaceuticals, reviews the importance of BI solutions to the
Indian pharma industry.
- Sanjay Mehta, CEO, MAIA Intelligence Pvt. Ltd.
Thinking Beyond Compliance Medical Device WhitepaperJenna Dudevoir
This white paper is based on a research study with leading medical device companies - from startups to multibillion dollar enterprises - to explore how they are balancing new product development with compliance requirements.
Pharmaceutical Contract Manufacturing Opportunities Published In Chemical W...jeffry6666
Thought Note on Emerging Opportunities in Pharmaceutical Contract Manufacturing in India. Published in Chemical weekly magazine and IndiaChem 08 International Conference and Exhibition
2015 trends in global medical device strategy and issues for the supply chain...Tony Freeman
This presentation reviews critical business trends shared by major medical device companies and the implications for their manufacturing supply chain. Consolidation of device OEMs, product line and marketshare changes brought on by accountable care, and OEM desire for larger outsource partners are the dominant themes.
Business Intelligence (BI) in Pharmaceuticals - An aid in informed decision making
Currently, the demand for BI solutions is largely driven by MNCs & large enterprises. BI solutions seem to have gained more acceptance and significance in pharma industry where time plays a pivotal role in the future of the company. The article from Modern Pharmaceuticals, reviews the importance of BI solutions to the
Indian pharma industry.
- Sanjay Mehta, CEO, MAIA Intelligence Pvt. Ltd.
Thinking Beyond Compliance Medical Device WhitepaperJenna Dudevoir
This white paper is based on a research study with leading medical device companies - from startups to multibillion dollar enterprises - to explore how they are balancing new product development with compliance requirements.
Pharmaceutical Contract Manufacturing Opportunities Published In Chemical W...jeffry6666
Thought Note on Emerging Opportunities in Pharmaceutical Contract Manufacturing in India. Published in Chemical weekly magazine and IndiaChem 08 International Conference and Exhibition
Fostering the Quality Based CMO-Sponsor RelationshipAjinomoto Althea
Althea Technologies' Sr. VP of Quality and Regulatory, EJ Brandreth, talks about life in the CMO world from the quality perspective. In this presentation, he discusses the regulations involved in biologics manufacturing and fill finish operations, and the importance of establishing a quality based partnership between CMOs and sponsors.
A brief introduction of the outsourcing methods in Pharma Supply Chain, Types of Outsourcing, Framework to decide correct outsourcing partner, factors to consider while selecting a partner, Process of outsourcing and Outsourcing models.
The Innovation Gap in Pharmaceutical Drug Discovery and New Models for R&D Su...Michael Hu
Whitepaper exploring the root causes behind Pharma Industry's widening Innovation Gap and discusses several R&D innovation models for addressing the productivity conundrum.
Delivering Next-Generation Commercial Capabilities within the Pharmaceutical Industry
This Point of View paper, aimed at life sciences Executive Management and leaders in Commercial Operations and Commercial Excellence, provides a blueprint for how forward-looking pharmaceutical companies can build a transformative commercial engine for strategic advantage. Key to this process is the collection and interpretation of the vast array of healthcare data now available. The paper explains how companies can use the insights derived from this information to develop globally consistent, yet locally relevant, customer solutions. It also explores a new collaborative model that partners external analytical, technological and functional area expertise with the client’s internal resources to create cost efficiencies, build internal capabilities and improve commercial processes that fuel growth.
Early asset development and commercialization: Partnering for successCello Health
To be successful in developing an asset you have to identify the need and define the commercial value early on in the development process, as well as revisiting and refining the value as you progress through the phases of development. This means understanding what else is coming onto the market from a competitive perspective and the clinical relevance from a patient perspective. Being mindful about value throughout development is also important because, at each phase more investment will be needed, especially in smaller companies. Often times the need for investment results in a licensing agreement or a partnership.
This is a follow up webinar to "The value of early asset development and commercialization." The slides take a deep dive into how to find the right partner for developing and commercializing your asset.
How to Add Agility and Customer Focus to the Healthcare Supply ChainUPS Longitudes
The global pharmaceutical and healthcare industry has
experienced a number of severe shocks to the system in
recent decades. What was once a sector where profits flowed
from ‘blockbuster’ drugs and a customer base willing to
pay premium prices has transformed into a quite different
world as a consequence of competition from generics along
with reduced budgets available to healthcare providers.
Compounding these problems are increasing regulatory
constraints and more challenging logistics requirements as
bio-pharmaceuticals and related products increase the need
for stricter control of temperature and shelf-life as they move
through the supply chain.
As a result there is now a significantly greater focus across
the sector on supply chain management. Previously, when
margins were higher and logistics costs were a relatively
small proportion of total costs, supply chain issues tended
to take a back seat. Now things have changed. Recent
research by UPS® has highlighted that many companies are
finding it difficult to develop supply chain capabilities that
can simultaneously take out costs whilst ensuring regulatory
compliance, track and trace, product security and stricter
temperature and shelf-life control.
Because of these pressures, a new approach to the design
and management of supply/demand networks in the industry
becomes imperative. In today’s marketplace, there is a need
for supply chains that are cost-effective, efficient and agile.
Companies operating in every industrial sector and in
every market around the world have been confronted in
recent years with significant challenges. These challenges
have come from numerous sources – economic recession,
demographic changes, geo-political upheavals to name but
a few. The healthcare and pharmaceutical industry has been
no exception and has been impacted by major changes in the
competitive and market environment.
Reliability, quality and a competitive price are table stakes in
the business of maintaining and repairing industrial facilities
and equipment, commonly known as Maintenance, Repair
and Operations (MRO). Given the nature of MRO, urgency can
often catapult to the top of the list of requirements. Sellers
who cannot consistently come through will almost certainly
be dropped from future consideration.
Shedding Some Light on the Insights Lurking in the PMA DatabaseRevital (Tali) Hirsch
May 28, 2016 marked forty years of modern day federal authority over medical devices in the U.S. Not only is this period brief in and of itself, but it’s also shorter by half compared to the duration of federal authority over pharmaceuticals, which began with the Food, Drug and Cosmetics Act of 1938. In the past several years the FDA has been the target of much criticism with regards to the approval of high-risk medical devices. Some of that critique is likely merited, but it is important to keep in mind that the medical device arm of the FDA is a work-in-progress that has had considerably less time to invent itself in the larger context of history.
This paper compares and contrasts different stakeholders’ perspectives and takes a deeper dive into the data. In doing so, this paper outlines practical changes and enhancements to the PMA database that can be carried out in the immediate present to increase transparency between the FDA and Industry.
The deeper dive also identifies several potential avenues for follow-on research, including PMAs that do not reach a positive conclusion and PMAs that are sponsored by early-stage and/or inexperienced filers. Insights from such research may hold the key to longer-term regulatory process improvements within the existing framework to promote high-risk medical device innovation and shorten these devices’ time-to-market without compromising the higher standards of the domestic regulatory system or the safety of patients.
Fostering the Quality Based CMO-Sponsor RelationshipAjinomoto Althea
Althea Technologies' Sr. VP of Quality and Regulatory, EJ Brandreth, talks about life in the CMO world from the quality perspective. In this presentation, he discusses the regulations involved in biologics manufacturing and fill finish operations, and the importance of establishing a quality based partnership between CMOs and sponsors.
A brief introduction of the outsourcing methods in Pharma Supply Chain, Types of Outsourcing, Framework to decide correct outsourcing partner, factors to consider while selecting a partner, Process of outsourcing and Outsourcing models.
The Innovation Gap in Pharmaceutical Drug Discovery and New Models for R&D Su...Michael Hu
Whitepaper exploring the root causes behind Pharma Industry's widening Innovation Gap and discusses several R&D innovation models for addressing the productivity conundrum.
Delivering Next-Generation Commercial Capabilities within the Pharmaceutical Industry
This Point of View paper, aimed at life sciences Executive Management and leaders in Commercial Operations and Commercial Excellence, provides a blueprint for how forward-looking pharmaceutical companies can build a transformative commercial engine for strategic advantage. Key to this process is the collection and interpretation of the vast array of healthcare data now available. The paper explains how companies can use the insights derived from this information to develop globally consistent, yet locally relevant, customer solutions. It also explores a new collaborative model that partners external analytical, technological and functional area expertise with the client’s internal resources to create cost efficiencies, build internal capabilities and improve commercial processes that fuel growth.
Early asset development and commercialization: Partnering for successCello Health
To be successful in developing an asset you have to identify the need and define the commercial value early on in the development process, as well as revisiting and refining the value as you progress through the phases of development. This means understanding what else is coming onto the market from a competitive perspective and the clinical relevance from a patient perspective. Being mindful about value throughout development is also important because, at each phase more investment will be needed, especially in smaller companies. Often times the need for investment results in a licensing agreement or a partnership.
This is a follow up webinar to "The value of early asset development and commercialization." The slides take a deep dive into how to find the right partner for developing and commercializing your asset.
How to Add Agility and Customer Focus to the Healthcare Supply ChainUPS Longitudes
The global pharmaceutical and healthcare industry has
experienced a number of severe shocks to the system in
recent decades. What was once a sector where profits flowed
from ‘blockbuster’ drugs and a customer base willing to
pay premium prices has transformed into a quite different
world as a consequence of competition from generics along
with reduced budgets available to healthcare providers.
Compounding these problems are increasing regulatory
constraints and more challenging logistics requirements as
bio-pharmaceuticals and related products increase the need
for stricter control of temperature and shelf-life as they move
through the supply chain.
As a result there is now a significantly greater focus across
the sector on supply chain management. Previously, when
margins were higher and logistics costs were a relatively
small proportion of total costs, supply chain issues tended
to take a back seat. Now things have changed. Recent
research by UPS® has highlighted that many companies are
finding it difficult to develop supply chain capabilities that
can simultaneously take out costs whilst ensuring regulatory
compliance, track and trace, product security and stricter
temperature and shelf-life control.
Because of these pressures, a new approach to the design
and management of supply/demand networks in the industry
becomes imperative. In today’s marketplace, there is a need
for supply chains that are cost-effective, efficient and agile.
Companies operating in every industrial sector and in
every market around the world have been confronted in
recent years with significant challenges. These challenges
have come from numerous sources – economic recession,
demographic changes, geo-political upheavals to name but
a few. The healthcare and pharmaceutical industry has been
no exception and has been impacted by major changes in the
competitive and market environment.
Reliability, quality and a competitive price are table stakes in
the business of maintaining and repairing industrial facilities
and equipment, commonly known as Maintenance, Repair
and Operations (MRO). Given the nature of MRO, urgency can
often catapult to the top of the list of requirements. Sellers
who cannot consistently come through will almost certainly
be dropped from future consideration.
Shedding Some Light on the Insights Lurking in the PMA DatabaseRevital (Tali) Hirsch
May 28, 2016 marked forty years of modern day federal authority over medical devices in the U.S. Not only is this period brief in and of itself, but it’s also shorter by half compared to the duration of federal authority over pharmaceuticals, which began with the Food, Drug and Cosmetics Act of 1938. In the past several years the FDA has been the target of much criticism with regards to the approval of high-risk medical devices. Some of that critique is likely merited, but it is important to keep in mind that the medical device arm of the FDA is a work-in-progress that has had considerably less time to invent itself in the larger context of history.
This paper compares and contrasts different stakeholders’ perspectives and takes a deeper dive into the data. In doing so, this paper outlines practical changes and enhancements to the PMA database that can be carried out in the immediate present to increase transparency between the FDA and Industry.
The deeper dive also identifies several potential avenues for follow-on research, including PMAs that do not reach a positive conclusion and PMAs that are sponsored by early-stage and/or inexperienced filers. Insights from such research may hold the key to longer-term regulatory process improvements within the existing framework to promote high-risk medical device innovation and shorten these devices’ time-to-market without compromising the higher standards of the domestic regulatory system or the safety of patients.
A Rhetorical Identification Analysis of English Political Public Speaking: Jo...Bahram Kazemian
Since political discourse reflects the close relation between politics and language, it has attracted many scholars’
attention at home and abroad. Therefore, English political public speaking (EPPS for short), the subcategory of political
discourse, has been chosen as the subject of the study. Based on the findings of Kenneth Burke’s new rhetoric and classical
rhetoric, the identification strategies of EPPS in John F. Kennedy’s Inaugural Address from the perspectives of rhetorical content and rhetorical form were probed. Since EPPS is always well-prepared rather than impromptu, the identification strategies via rhetorical content and form are always employed by the speaker to accomplish their purposes.
Advances and investment in digital health is growing at an incredible rate and Contract Manufacturing Organizations and Contract Development and Manufacturing Organizations are becoming an essential part of the new pharma value chain. From wearables, to apps, to digital platforms, the data and efficiencies generated by these innovations are opening up important avenues across the pharma ecosystem. As pressure on improving drug development heats up, data, digital and technological innovations are critical to delivering the desired business and patient outcomes, promoting significantly more networking and outsourcing strategies. CMOs are evolving from service providers to strategic partners. CMOs now cover the entire value chain of pharma production, including specialized services such as R&D.
Is your company ready to meet today’s challenges?Lidia Gasparotto
Visit us online at:
www.ibm.com/electronics/medicaldevices
Is your company ready to meet today’s challenges?
Ask yourself the following questions:
Are your products linked to clinical information systems? •
Is your supply chain optimized to track inventory, handle complaints and •
recalls and manage assets?
Can you comply efficiently with divergent security and privacy regula- •
tions?
Does your company get new products to market as quickly as your •
competitors?
Are your operations efficient and profitable? •
Does your company’s IT environment facilitate the formation of strategic •
alliances with insurance companies, HMOs, hospital buying groups and
supply chain logistics companies?
Can you reduce your tax liabilities through the use of commissionaires?
IBM has developed and refined the tools you need.
Medical Devices - Servicing Medical Device CompaniesIBMElectronics
The medical device industry is in the midst of fundamental change. IBM’s approach to servicing medical device companies is designed to meet real-world needs today and in the future.
The Global Ventilator Market is projected to grow at around 13% CAGR during the forecast period, i.e., 2023-28. Most of the market expansion would be driven by the mounting incidence of chronic & acute respiratory disorders, especially among the rapidly rising elderly population, coupled with the subsequent increase in ICU admissions to treat such illnesses.
Digital pathology market is expected to grow from US$ 952.62 million in 2022 to US$ 1,892.40 million by 2028; it is estimated to grow at a CAGR of 12.1% from 2022 to 2028.
The digital pathology market is expected to grow from US$ 952.62 million in 2022 to US$ 1,892.40 million by 2028; it is estimated to grow at a CAGR of 12.1% from 2022 to 2028.
Read More: https://www.theinsightpartners.com/reports/digital-pathology-market
Bioreactors market was valued at US$ 2,958.50 million in 2019 and is projected to reach US$ 5,169.01 million by 2027; it is expected to grow at a CAGR of 7.3% from 2020 to 2027
Unlock your content, FirstSpirit, CMS, e-Spirit AG, Best-of-Breed, Internet, Intranet, Extranet, Management, CIO, CEO, CMO, Digital Marketing, Integration of third part technology, SEO, Analytics, Strategy, Customer Experience
Whitepaper: Patent strategies in the 2012 economic environmentSagentia
Difficulties and changes in the macro-economic climate have forced companies to alter the way they carry out their research and development. This, in turn, has had an effect on the approach of many organisations to intellectual property.
http://www.sagentia.com/IP
The digital pathology market is expected to grow from US$ 952.62 million in 2022 to US$ 1,892.40 million by 2028; it is estimated to grow at a CAGR of 12.1% from 2022 to 2028.
The digital pathology market is expected to grow from US$ 952.62 million in 2022 to US$ 1,892.40 million by 2028; it is estimated to grow at a CAGR of 12.1% from 2022 to 2028
1. emerging markets, and the
(unfortunate) spread of the “Western
diet” are some of the key factors
creating the tremendous pull in this
industry. Particularly, cardio and
orthopedic devices, but also high-tech
supplies and certain lab equipment
contribute to double-digit growth in
many sectors of this industry. With
market penetration as low as 20% in
several areas (e.g., ICD), the race is on
for the leading firms to grow
significantly — while smaller firms are
protecting their crown jewels,
exploring valuable niches, or
preparing to be acquired.
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Hardly Any Other Industry is
Enjoying as Many Growth
Prospects
Ageing baby-boomers with active
lifestyles, emerging middle
classes in
Medical Devices Industry:
Growth Opportunities and
Cost Pressure
November 2006
Life Sciences the way we do it
2. Cost Pressures are Emerging as
a Major Challenge to Medical
Device Firms
While growth prospects are the
predominant theme, numerous
distractions are clouding the bright
future of this industry. Prominent
product recalls, visible subpoenas, and
first cracks in the public’s positive
image have distorted the perfect picture
which was emerging only until recently.
However, while these irritations are
serious obstacles now, they’re only
short-term tests in a long-run game.
What’s increasingly becoming a
significant challenge is the confluence
of tightening healthcare budgets in key
developed markets, lagging
reimbursement schedules in the U.S.,
and a lack of consumer willingness to
invest top dollars in personal health. In
short, medical device firms may soon
be facing what big pharma has come to
live with for several years now — less
cash to spend, and ultimately fewer
dollars to invest in essential R&D.
Back to Basics of Strategy:
Differentiate and Optimize
So, what does this mean? At the core,
the industry must renew its efforts to
create differentiated products and
services while optimizing portfolios in
order to achieve better returns. Any
perception of commoditization needs to
be countered by more sophisticated
efforts to differentiate against the
competition. Such differentiation will
come from innovation, customization,
and acceleration for both, products and
services. Related, many firms still have
an opportunity to perform rigorous
portfolio assessments in order to build
and defend value-generating franchises
while cutting down on ageing and
costly product lines, services, and R&D
programs.
Traditional innovation will not
suffice anymore
With less money to spend on R&D,
with increasingly sophisticated
customers, and with an ever shorter
product life cycle, traditional innovation
is no longer sufficient to win in this
competitive game. New approaches are
needed in order to consider the impact
on R&D of a more differentiated
customer base, of changes in the payer
environment, and of advances in related
life science sectors. Such advances, for
example, come in the form of
convergence of diagnostic devices,
pharmaceuticals, and biologics in a
number of development areas. As a
consequence, many executives feel the
need to bridge important knowledge
gaps (regulatory, reimbursement, etc.) as
new development paths are being
explored. Going forward, early-on
market intelligence will be even more
important to success than today. Higher
per-innovation costs will require more
carefully placed innovation bets — and
ultimately higher realized prices.
Importantly, once innovative products
are ready to market, the right capabilities
need to be in place for rapid launch and
market uptake. After all, physicians may
still be digesting the last wave of
innovation when the latest wave hits
the ER!
The Time to Streamline
0perations is Now
Even though the
predominant industry
focus is still on
external
Offerings Specific to the Medical
Device Industry
Capgemini practitioners are partnering
with medical device players as well as
with clients in related industries to resolve
some of the industry’s most pressing
issues.
Examples include:
■ Cost reduction
■ Product Launch
■ Growth Strategy
■ Merger integration
■ R&D Transformation
■ Portfolio Management
■ Product Lifecycle Management
■ Sales & Marketing Effectiveness
■ Organization Change Management
■ Pricing and Reimbursement Strategies
Technology Strategy
Our teams collaborate with you to build
and implement the right technology
strategy — in national or global programs,
through incremental or “turn-key”
solutions, involving technology alliance
partners as needed.
■ ERP
■ Systems architecture
■ Custom development
■ IT Strategy development
■ Business systems validation
3. Medical Devices Industry: Growth Opportunities and Cost Pressure
Life Sciences the way we do it
“This is the best consulting
engagement I have ever been
involved with!” — VP Commercial
Operations (North America),
leading diversified European life
sciences company
“I felt like we got a lot of good
work done and I thoroughly
enjoyed both you and the journey
along the way.” — Director
Global Marketing, major U.S. life
sciences company
“Best compliments to you and
your team.” — Director, Contract
Administration, mid-size global
pharmaceutical company
Last But Not Least: Find Smart
Ways to Understand and
Implement Tough Regulatory
Requirements
With regulators, the public, and the
media focusing more and more
attention on the medical device
industry, long-term sustainable
solutions are needed to control risk and
ease regulatory management. Effective
business processes, smart electronic
records, and continuous vigilance are
essential building blocks in creating the
state-of-the-art regulatory organization.
growth, now is the time to start
thinking about how to streamline
operations. Such streamlining can take
several forms: process effectiveness and
efficiency improvements; organizational
design, governance, and decision-
making alignments; removal of
operational bottlenecks; tightening of
manufacturing schedules; etc. With big
pharma caught by surprise when
growth started slowing and pressure on
margins increased five years ago,
players in the medical device sector
have an opportunity right now to
initiate hands-on efforts to identify and
remove unnecessary operational cost.
Importantly, Build an Adaptable
Technology Platform
In this era of growth opportunities and
cost pressure, enterprise technology
platforms are confronted with an entire
host of new challenges: New market
segments are being targeted, new
products launched, new customers
served, acquisitions are implemented,
international expansion supported, and
new systems brought online. What it
comes down to: Technology is at the
centerpiece of the enterprise, enabling
and facilitating responses to a plethora
of market-induced challenges. Some of
the key success factors include well
conceived technology architecture, an
efficient IT process and organization
model, and seamless systems
integration.
Supply Chain Challenges
As the volume of product and supply shipments is increasing, as supply chains are
becoming more and more global, as the distribution of high-cost high-risk products is
proliferating, many executives are confronted with a new set of challenges: How can
processes be better integrated, advantages of specific locations leveraged, and products
more closely tracked? Capgemini has a leading practice assisting clients with effective
approaches to optimize distribution networks, to manage the supply chain, and to
implement RFID systems — proven in the medical device sector.
M&A in Medical Devices
An average of over 60 M&A deals per
year, over the past decade, demonstrate
the attractiveness of non-organic growth
in the medical device industry. This M&A
trend is driven by the need for favorable
product development and commercial
product performance. Acquirees benefit
from access to cash for costly R&D, from
strong global marketing capabilities of the
bigger partner, and from improved clout
vis-à-vis payers — while acquirers gain
valuable complements to their existing
portfolio, augment their product pipelines,
and add R&D capability. However, just
like in any other industry, only the quick
realization of intended benefits will yield
the payout company boards urgently
demand.