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.
Global Trends in Medical Device and Diagnostic OEM Strategy and Implications ...Tony Freeman
Manning Advisors is pleased to announce the publication of its 2017 Global Trends in Medical Device and Diagnostic OEM Strategy and Implications for the Supply Chain. As in past years we looked at the major issues facing medical device OEMs and how those issues drive their relationship with their suppliers.
Our findings this year include:
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 bring product to market more quickly
Opportunity also exists for specialized manufacturers
Feel free to contact me to discuss the issues or to arrange for an onsite presentation to your Board or management team. I look forward to an intriguing discussion.
You may reach me at tfreeman@manningadvisors.com or at (917) 868-0772 directly.
Best regards,
Tony Freeman, Managing Director
Manning Advisors LLC
90 Park Avenue, 17th Floor
New York, NY 10016
Emerging Trends In Medical Device ManufacturingEWI
To continue a trajectory of steady growth, the global medical device industry must adapt to the dynamic changes disrupting the healthcare landscape. An aging population, a push for more personalized treatment, and the increasing availability of healthcare are some of the factors driving new markets and an expanding consumer base. In addition, regulatory scrutiny and federal initiatives like the medical device excise tax have levied extra pressure on R&D budgets.
Health Policy Supporting Innovation in Korean Medical Device Sector (July 11,...Sung Yoon Bae
Presented in the AMCHAM Healthcare Innovation Seminar, held in Seoul, Korea on July 11, 2012.
Title: Toward Better Health Policy Supporting Innovation in Korean Medical Device Sector
Date: July 11, 2012
Speaker, Sung Yoon Bae, Professor of Healthcare Management, Inje University, Busan, Korea
Mercer Capital's Value Focus: Medical Device Manufacturers | Q4 2015 | Five T...Mercer Capital
Mercer Capital provides medical device manufacturers, related start-up enterprises, and private equity funds with valuation services, including purchase price allocation, 409a compliance, goodwill impairment testing, and other transaction and valuation advisory services.
Trends in Global Medical Device OEM Strategies and Issues for the Medical Dev...Tony Freeman
Presented at the February, 2013 mdmX Conference, Manning Advisors' Tony Freeman reviews issues facing the largest medical device manufacturers and implications for their supply chain.
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.
Enterprise Labeling for the Medical Device IndustryLoftware
IT’S TIME FOR POWERFUL NEW SOLUTIONS IN MEDICAL
DEVICE LABELING. For medical device manufacturers, labeling is growing in importance, and there are a number of reasons why.
Global Trends in Medical Device and Diagnostic OEM Strategy and Implications ...Tony Freeman
Manning Advisors is pleased to announce the publication of its 2017 Global Trends in Medical Device and Diagnostic OEM Strategy and Implications for the Supply Chain. As in past years we looked at the major issues facing medical device OEMs and how those issues drive their relationship with their suppliers.
Our findings this year include:
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 bring product to market more quickly
Opportunity also exists for specialized manufacturers
Feel free to contact me to discuss the issues or to arrange for an onsite presentation to your Board or management team. I look forward to an intriguing discussion.
You may reach me at tfreeman@manningadvisors.com or at (917) 868-0772 directly.
Best regards,
Tony Freeman, Managing Director
Manning Advisors LLC
90 Park Avenue, 17th Floor
New York, NY 10016
Emerging Trends In Medical Device ManufacturingEWI
To continue a trajectory of steady growth, the global medical device industry must adapt to the dynamic changes disrupting the healthcare landscape. An aging population, a push for more personalized treatment, and the increasing availability of healthcare are some of the factors driving new markets and an expanding consumer base. In addition, regulatory scrutiny and federal initiatives like the medical device excise tax have levied extra pressure on R&D budgets.
Health Policy Supporting Innovation in Korean Medical Device Sector (July 11,...Sung Yoon Bae
Presented in the AMCHAM Healthcare Innovation Seminar, held in Seoul, Korea on July 11, 2012.
Title: Toward Better Health Policy Supporting Innovation in Korean Medical Device Sector
Date: July 11, 2012
Speaker, Sung Yoon Bae, Professor of Healthcare Management, Inje University, Busan, Korea
Mercer Capital's Value Focus: Medical Device Manufacturers | Q4 2015 | Five T...Mercer Capital
Mercer Capital provides medical device manufacturers, related start-up enterprises, and private equity funds with valuation services, including purchase price allocation, 409a compliance, goodwill impairment testing, and other transaction and valuation advisory services.
Trends in Global Medical Device OEM Strategies and Issues for the Medical Dev...Tony Freeman
Presented at the February, 2013 mdmX Conference, Manning Advisors' Tony Freeman reviews issues facing the largest medical device manufacturers and implications for their supply chain.
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.
Enterprise Labeling for the Medical Device IndustryLoftware
IT’S TIME FOR POWERFUL NEW SOLUTIONS IN MEDICAL
DEVICE LABELING. For medical device manufacturers, labeling is growing in importance, and there are a number of reasons why.
This whitepaper provides an overview of medical device manufacturing in Asia. This paper includes key information on the global medical device market, global medical device market trends, Asia medical device market trends, Asia medical device manufacturing, setting up manufacturing facilities in Asia, and examples of manufacturing facilities in Asia. This whitepaper is intended for anyone interested in setting up or acquiring medical device manufacturing facilities in Asia.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
2016 trends in global medical device strategy and issues for the supply chainTony Freeman
In its 2016 annual review of the global medical device supply chain Manning Advisors identifies two core trends driving both OEM and supplier strategy. The first trend, consolidation, has paused to allow integration of large acquisitions made in the last three years. The second trend, changing products to compete in a fee-for-value rather than fee-for-service reimbursement environment, drives new technologies and capabilities. These trends continue to redistribute favored firms in medical devices.
Design for reimbursement in medical device developmentAmber Hol Horeman
In medical device development it is essential to start with reimbursement strategy from day one to enhance the chance to successful implementation in the healthcare system. This presentation shows the outcomes of a 5 month graduation project to the role of reimbursement in medical device development. The design for reimbursement framework proposed provides an overview for starting entrepreneurs in the complex field of medical devices.
Insights about changes to the EU's MDR (Medical Device Regulations) by Ulf Grundmann, Partner, King & Spalding, August 17, 2020. Includes scope and definitions, classification and conformity assessment, placing a device on the EU marketin, UDI and EUDAMED, supply chain obligations, PMS, compliance and vigilance.
As UDI deadlines roll out, OEMs are left with many questions on implementation and compliance, including:
How does FDA recommend we direct mark screws and small implants?
How should we proceed as we await the guidance on the Convenience Kit exemption?
What are best practices for entering submissions to GUDID?
How is FDA enforcing UDI?
FDA officials will speak on UDI adoption and UDI data quality. Bring your questions. Ample time will be saved for Q&A.
This is a comprehensive report on medical devices interoperability in India
This report covers global developments in interoperability of medical devices
This is a Dean's Case Competition project in Som-Binghamton University. I did it with my team in Spring 2014 to present our the overall situation of Medtronic Inc.
This whitepaper provides an overview of medical device manufacturing in Asia. This paper includes key information on the global medical device market, global medical device market trends, Asia medical device market trends, Asia medical device manufacturing, setting up manufacturing facilities in Asia, and examples of manufacturing facilities in Asia. This whitepaper is intended for anyone interested in setting up or acquiring medical device manufacturing facilities in Asia.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
2016 trends in global medical device strategy and issues for the supply chainTony Freeman
In its 2016 annual review of the global medical device supply chain Manning Advisors identifies two core trends driving both OEM and supplier strategy. The first trend, consolidation, has paused to allow integration of large acquisitions made in the last three years. The second trend, changing products to compete in a fee-for-value rather than fee-for-service reimbursement environment, drives new technologies and capabilities. These trends continue to redistribute favored firms in medical devices.
Design for reimbursement in medical device developmentAmber Hol Horeman
In medical device development it is essential to start with reimbursement strategy from day one to enhance the chance to successful implementation in the healthcare system. This presentation shows the outcomes of a 5 month graduation project to the role of reimbursement in medical device development. The design for reimbursement framework proposed provides an overview for starting entrepreneurs in the complex field of medical devices.
Insights about changes to the EU's MDR (Medical Device Regulations) by Ulf Grundmann, Partner, King & Spalding, August 17, 2020. Includes scope and definitions, classification and conformity assessment, placing a device on the EU marketin, UDI and EUDAMED, supply chain obligations, PMS, compliance and vigilance.
As UDI deadlines roll out, OEMs are left with many questions on implementation and compliance, including:
How does FDA recommend we direct mark screws and small implants?
How should we proceed as we await the guidance on the Convenience Kit exemption?
What are best practices for entering submissions to GUDID?
How is FDA enforcing UDI?
FDA officials will speak on UDI adoption and UDI data quality. Bring your questions. Ample time will be saved for Q&A.
This is a comprehensive report on medical devices interoperability in India
This report covers global developments in interoperability of medical devices
This is a Dean's Case Competition project in Som-Binghamton University. I did it with my team in Spring 2014 to present our the overall situation of Medtronic Inc.
The traffic light sequence works on the specific switching of Red, Green and Yellow lights in a particular way with stipulated time form. The normal function of traffic lights requires sophisticated control and coordination to ensure that traffic moves as smoothly and safely as possible and that pedestrians are protected when they cross the roads [1].This Traffic Light sequence is generated using a specific switching mechanism which will help to control a traffic light system on a road in a specified sequence. This paper focuses on the fact that the traffic lights can be varied in the day and night mode depending on the intensity of the traffic. It plays a vital role in supervising and running the metropolitan traffic and evade the possibilities of any unfortunate mishaps happening in and around the cities. It is a sequential machine to be scrutinized as per the requirements and programmed through a multistep development process. The methods that are used in this project are proposing the circuit, write a code, simulate, synthesis and implement on the hardware [8]. In this project, XILINX Software was chosen to devise a schematic using schematic edit, write a code using Verilog HDL (Hardware Description Language) text editor and implements the circuit on Programmable Logic Device [PLD].The system has been successfully tested and implemented in hardware using Nexys 2 Digilent FPGA.
IJERA (International journal of Engineering Research and Applications) is International online, ... peer reviewed journal. For more detail or submit your article, please visit www.ijera.com
International Journal of Engineering Research and Applications (IJERA) is an open access online peer reviewed international journal that publishes research and review articles in the fields of Computer Science, Neural Networks, Electrical Engineering, Software Engineering, Information Technology, Mechanical Engineering, Chemical Engineering, Plastic Engineering, Food Technology, Textile Engineering, Nano Technology & science, Power Electronics, Electronics & Communication Engineering, Computational mathematics, Image processing, Civil Engineering, Structural Engineering, Environmental Engineering, VLSI Testing & Low Power VLSI Design etc.
Quickshift providing best transport services from top movers in Pune. We offer logistics solutions for individuals & enterprises. We are best logistics companies in Pune.
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.
Refurbished medical equipment Market PPT 2021: Size, Growth, Demand and Forec...IMARC Group
According to the latest report by IMARC Group, the global refurbished medical equipment market reached a strong growth in 2020.
Refurbished medical equipment are devices that are restored to their original safety and effectiveness.
Medical Document Management Systems Market by Product Type, Distribution Chan...IMARC Group
The global medical document management systems market size reached US$ 551.0 Million in 2022. Looking forward, IMARC Group expects the market to reach US$ 1,111.7 Million by 2028, exhibiting a growth rate (CAGR) of 11.9% during 2023-2028.
More Info:- https://www.imarcgroup.com/medical-document-management-systems-market
White Paper - Internet Marketing Strategies For The Medical Device Industryjerryme5
This is a White Paper that I wrote, while employed at Exemplum, that talks about various marketing strategies that medical device companies can use to leverage the Internet to market their products more effectivelty.
Global Electronic Health Records Market Intelligence, Market Share, Market Size, Industry Trends, Industry Analysis; Historic period (2017-2020); Base Year (2021); Forecast, 2022 – 2032
Data-driven Healthcare for ManufacturersLindaWatson19
Medical Device Equipment and Hospital Supplies Manufacturers also face increased pressure to comply with strict regulatory procedures to ensure patient safety. Product transparency and efficient end-to-end processes that optimize the manufacturing process and decision making are very important.
Data-Driven Healthcare for Manufacturers Amit Mishra
Data-driven healthcare empowers the providers with a common data platform to discover untapped data-driven opportunities. Healthcare data and its impact on the patient care decision process via accurate, real-time, reliable data from disparate sources is creating a digital health revolution. Physician groups, nursing facilities, hospitals, pharmaceutical companies, clinical researchers, and medical equipment manufacturers are all churning out vast amounts of data during their daily operations. This data has tremendous value and can revolutionize patient care, diagnosis, real-time decisions and help deliver new, unimagined innovations with quality of patient care. Know more about data-driven healthcare at https://www.solix.com/solutions/data-driven-solutions/healthcare/
McKinsey Sağlık Tedarik Zinciriyle, FMCG Tedarik Zinciri karşılaştırıyor. Sağlık Tedarik Zincirindeki iyileştirme fırsatına ve toplumsal boyutuna dikkat çekiyor.
New Medical Device Regulation Implications For Medical Device ManufacturersPEPGRA Healthcare
Pepgra offers regulatory consulting for Medical device and IVD companies. We help you in Market entry strategy, risk management, device classification and clinical evaluation reports. Let our team of regulatory experts work to ensure your compliance with all national regulations.
Learn more: https://www.pepgra.com/device-manufacturers/
Need Help:
Uk: +44- 7424810299
Email: sales@pepgra.com
Whatsapp: +91 9884350006
Hospital Information System Market PPT: Demand, Trends and Business Opportuni...IMARC Group
The global hospital information system market size reached US$ 22.3 Billion in 2022. Looking forward, IMARC Group expects the market to reach US$ 41.1 Billion by 2028, exhibiting a growth rate (CAGR) of 11.3% during 2023-2028.
More Info:- https://www.imarcgroup.com/hospital-information-system-market
With this presentation I wanted to highlight a number of trends in the healthcare sector and some major challenges born out of the current healthcare delivery model. I’d then like to propose an alternative model in which the combination of distributed patient and diagnostic data collection, cloud technology and AI would support better healthcare tailored to the individual at lost cost to payers. I would conclude by highlighting opportunities for AI-led innovation.
2016 IBM Interconnect - medical devices transformationElizabeth Koumpan
Emerging technologies such as Internet of Things, 3D Printing are driving the creation of new business models and forcing the Industry for transformation. The product centric model where the Industry main objective was to develop the device, is moving to software and services model, with the focus on Big Data & Analytics, Integration and Cloud.
The maturation of technologies such as social, mobile, analytics, cloud, 3D printing, bio- and nanotechnology are rapidly shifting the competitive landscape. These emerging technologies create an environment that is connected and open, simple and intelligent, fast and scalable. Organizations must embrace disruptive technologies to drive innovation
Medical Device Cleaning Market PPT: Overview, Dynamics, Trends, Segmentation,...IMARC Group
The global medical device cleaning market is expected to exhibit a CAGR of 10.27% during 2022-2027.
More info:- https://www.imarcgroup.com/medical-device-cleaning-market
New technologies and faster market launches are driving the medical wearables market.
More information on that report at: https://www.i-micronews.com/produit/medical-wearables-market-and-technology-trends-2019/
Similar to Is your company ready to meet today’s challenges? (20)
Discover the features and benefits of IBM i 6.1 to help cost-justify your upgrade to the latest release and learn about the outstanding ISV support that accompanies this new release.
Topics include:
Support for virtual IBM i partitions
Expanded support for IBM Storage Solutions
Significant performance enhancements for Java and WebSphere applications
New web based management with Systems Director
Enable consolidation of i and x86 servers with an IBM BladeCenter solution
Support for disk clustering with PowerHA
Encryption of data at rest and backups
And much more….
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
1. IBM Global Business Services
Executive Brief
Electronics
Industry
Medical Devices
The intersection of healthcare
and technology
2. The medical device industry is in the midst of
fundamental change. Mature and emerging markets
are growing at very different paces. Disparate regional
and country-specific regulations are on the rise and
subject to rapid change. And industry consolidation is
reshaping the entire sector.
These factors demand greater agility and a more
strategic approach on the part of medical device
companies. IBM’s approach to servicing its many
medical device clients is designed to meet real-world
needs today and in the future by stimulating the flow
of information, improving speed to market, making
operations more efficient and profitable and forging
strategic alliances for long-term success.
2
3. Introduction
Evolutionary and transformational changes are becoming major challenges in the
medical device industry.
The 1990s saw technological advances and international expansion take its toll on
the small entrepreneurial businesses that had characterized the medical device
industry. As the cost of research and development doubled, larger corporations with
deeper pockets came to dominate the industry. Economies of scale became even
more important with the growth of regulations worldwide.
The 21st century has ushered in explosive growth in the demand for medical
devices as the populations of many industrialized countries have aged. Market
growth and the incessant demand for better, and often less costly, devices are
challenging enough, but meeting these demands in the face of global regulatory
proliferation and continued industry consolidation leaves little room for error.
Forces of change
While the overall market for medical devices is growing, some mature markets are
growing at a much slower rate. Traditional cardiac rhythm management devices
and cardiac surgery devices experienced slower growth within the United States.
Products such as new drug-eluting stents offer alternatives in this area. Products in
the ear, nose and throat market experienced slower sales growth. Expansion into
emerging markets has offset reduced growth in mature markets.
The pace of new product development is critical to medical device manufacturers.
The high cost of R&D and securing regulatory approvals have helped fuel the trend
toward consolidation and strategic partnering.
Technology is not only at the heart of medical device products themselves, it is
critical to the management of any dynamic, complex global enterprise. In addition to
the need for systems integration, intellectual property management and supply chain
efficiency, medical device manufacturers must also comply with a host of heightened
regulations unique to the healthcare industry, such the U.S. Health Insurance
Portability and Accountability Act (HIPAA) and European patient privacy laws and
data retention requirements.
To make matters even more complex, medical device companies often face higher
than typical legal exposure to patient lawsuits, patent infringement claims and
product recalls.
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4. IBM’s strategic approach for the medical device industry
IBM is meeting the challenges of medical device manufacturers in four strategic
areas.
1. Stimulating the flow of information
To circulate critical information, the medical device industry needs to:
• Link various medical devices to clinical information systems
• Use wireless technologies and radio frequency identification (RFID) to improve:
- Inventory management and tracking
- Complaint handling and corrective action/preventive action (CAPA)
- Asset management of medical devices, such as programmers, imaging
equipment, surgical tools and sterilizers that may be owned by the manufac-
turer, but installed at client facilities
• Connect patients, doctors and suppliers using electronic healthcare records
• Ensure information security and privacy
2. Improving speed to market
Speed to market can be improved with:
• Good manufacturing practices implemented with efficient technologies
- Advanced supply chain planning assists with efficient inventory availability of
surgical kitting processes.
- Global product availability checking increases the product delivery speed
while lessening the need for increased inventories.
• Accurate and complete documentation to create an audit trail
- The ability to isolate potential production issues to a batch or serial level
versus a much wider product or regional level
- Increased speed and accuracy for product recalls
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5. 3. Keeping operations efficient and profitable
• Medical device companies have traditionally maintained excess inventories for
products with low production costs because an inability to provide devices on
demand may result in lost sales, not to mention lost lives. But as products mature,
maintaining high inventories becomes significantly less profitable.
• Effective product lifecycle management (PLM) can enable better, more informed
decision making to enhance profitability.
• Enterprise resource planning (ERP) and automated tools can ease the burden of
validation. Testing tools run against validated requirements, regression testing for
completeness on major changes in functionality, and ISO standards implemented
across an ERP all assist in this area.
• Remote disease management uses a variety of technologies that allow for outpa-
tient monitoring and disease management to assure efficient, timely treatment.
4. Forging strategic alliances for long-term success
• Medical device manufacturers are finding it increasingly challenging to go it alone
because the core competencies required of them now go well beyond the devel-
opment, manufacture and distribution of primary devices.
- Medical device companies often need to maintain their own assets on site
at medical facilities for product sterilizations, surgical tools, device program-
ming and patient-specific adjustments and monitoring, to name several
examples.
• Strategic alliances are being formed in numerous areas:
- Healthcare payers, such as major insurance companies and health mainte-
nance organizations establish limits on procedures and products collectively.
- There are a growing number of hospital buying groups, such as Premier and
Novation, in addition to traditional purchasing organizations, that are working
closely with medical device manufacturers.
- Supply chain and third-party logistics companies like Schneider, C.W.
Robinson, Penske and Maersk offer operations to run warehouses and
provide transportation management.
- Many of these alliances are providing synergy between medical devices
and pharmaceutical products, as with new drug-eluting stents.
• Medical device customers are consolidating, leading to the emergence of
intermediaries and a change in traditional providers.
- Improved technology, less invasive surgeries and other advances have
shifted the demand for healthcare to outpatient and walk-in facilities.
- These new facilities can provide patient services more efficiently and
profitably.
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6. IBM’s history of serving the needs of the medical device industry
IBM has worked with many clients in the industry. Our involvement has ranged
from detailed process design workshops to providing hosting and support of
validated instance environments. IBM has managed ERP implementations at some
of the largest medical device companies to providing strategy workshops on new
technologies, such as remote patient monitoring. IBM has served the needs of
companies that collectively account for over 50 percent of worldwide medical device
revenue.
Leveraging this experience, IBM has taken the initiative to create asset-based
solutions and develop white papers that create a “proof of concept” (POC) that
targets a medical device industry solution. They include such topics as:
Global Complaint Handling
Complaints about medical devices are subject to regulation. They may take the form
of customer dissatisfaction expressed to the company directly or a communication
from the U.S. Food and Drug Administration (FDA) or International Organization for
Standardization (ISO) alleging deficiencies related to the identity, quality, durability,
reliability, safety, effectiveness, or performance of a product after it is released for
distribution.
Many medical device companies utilize an SAP solution for ERP “Bolt-on”
.
functionality, such as Global Complaint Handling (GCH), is often used to address
industry-specific requirements. But by developing a solution within the core ERP,
medical device companies can save the cost of additional software, integration
and maintenance. SAP’s Customer Relationship Management (CRM) module can
be used as a solution for GCH, integrating the ERP Central Component (ECC) with
key components of the CRM module such as: Enterprise Service, Business Partner
Management, Products and Services and Complaints and Returns.
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7. SAP GCH Component Overview
CRM GCH
(CRM Service
Component)
Business Products
Partner & Services
Management Management
(CRM and/ (CRM and/
or ECC) or ECC)
Installed
Base
Management
(CRM and/
or ECC)
• SAP CRM contains the GCH components
• GCS can be implemented independently
or in addition to a larger SAP footprint
• Key interfaces can be developed from legacy
systems or seamlessly integrated from ECC (or R/3)
CAPA – Corrective Action Preventative Action
Corrective Action Preventative Action (CAPA) identifies, tracks, reports, escalates
and records the resolution of actions requiring formal regulatory oversight. IBM built
a CAPA “proof of concept” using an SAP ECC foundation. The Quality Management
(QM) module acts as the process foundation for CAPA functionality while the
Workflow (WF) engine and SAP e-signature functionality address many of the
needed elements.
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8. The IBM SAP CAPA solution provides the following benefits:
• Data integration with sales, procurement, manufacturing and R&D processes
• Identification of existing or potential causes of problems
• Ability to define and implement action(s) using standard SAP transactions
• Facilitated investigation of identified risk
• Demonstrated effectiveness of action and quality systems
• Conformity to product, process, and quality system requirements
• Lower total cost of ownership (TCO) by utilizing existing SAP infrastructure and
investment
• Reporting and analytics facilitated by SAP BW
QM Notifications as “events” or CAPAs
Recording and
Quality planning processing internal or
external problems that
are primarily caused
Quality by poor-quality goods
inspection or services
Quality
certificates
• The IBM CAPA POC relies
Quality on Quality Notifications
as messages to capture
notifications “events”
• After investigation and
Quality control planning, these events
could be converted into
Test equipment CAPAs
management • IBM provides an easy-
to-use front-end for the
casual user
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9. Field Inventory/Trunk Stock Controlled by RFID
Medical device companies’ sales forces call upon hospitals, physicians and other
medical establishments with an inventory of available products, commonly referred
to as “trunk stock.” SAP offers solutions to track and account for trunk stock and IBM
has built RFID solutions that trace the movement of tagged items throughout the
supply chain.
IBM offers a full range of RFID solutions to help design, construct, evaluate and
adopt an RFID strategy that makes sense for medical device companies today and
down the road. They include:
• RFID Solution Development Workshop – a fast way to learn how to assess and
focus your RFID efforts
• RFID Quick Start Testing – provides initial tag evaluation and recommendations for
unique products, including packaging, packing configurations and use cases
• RFID Site Surveys – validates the ability of RFID equipment to function properly on
location
• RFID Quick Start Value Assessment – creates a business case model based
on operational data and related financial and sensitivity analysis based on IBM
benchmarks
• Pilot Planning and Execution – provides key lessons learned from IBM to meet
integration needs and enable validation of business case assumptions
Reaping the tax benefits of using commissionaires
The commissionaire distribution model has grown in popularity in Europe because
it can offer significant advantages over traditional direct sales from product owner
to buyer. In its simplest form, the commissionaire (the seller of the product) and the
principal (the owner of the product) are part of the same overall corporation, but
distinct legal entities. Commissionaires earn lower profit than full-fledged distributors
because they typically hold no inventory and, therefore, assume fewer risks and
functions.
In addition to paying smaller sales commissions to commissionaires than traditional
distributors would charge, certain activities may be shifted to lower-taxed countries,
resulting in significant tax savings when this business model is used in Europe.
Since the commissionaire model is particularly attractive to businesses that produce
high-cost items with significant mark-ups, medical device companies are prime
candidates for using this distribution technique to their advantage.
Despite the benefits, the commissionaire model adds several layers of complexity to
the distribution process because it requires additional detailed tracking of product
movement to achieve the tax savings sought. This heightens the importance of
accurate and efficient supply chain management – one of IBM’s many specialties.
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10. Global Service and Repair Management
IBM has developed an integrated customer sales and service proof of concept
that improves visibility and streamlines the processes of contract and order pricing,
service management and in-house repairs, field service repairs and scheduled
maintenance. Some of the highlights of this solution include:
• Complex contract and order pricing management
- Management of multiple, complex contracts
- Contracts established across buying groups and overlapping organizations
- New automated contract management tools reduce the time, resources and
cost of managing contracts and orders
• Service management functions and challenges
- In-house repairs complicated by legal and regulatory requirements to track
product serialization and OEM sub-items
- Additional challenges with inventory parts management, billing and financial
costing
• Field service repairs and maintenance
- Service contracts, warranty management and maintenance
- High number of customer complaints
Patient Privacy Requirements
Privacy and tracking regulations that apply to medical device companies doing
business in Europe and the United States differ significantly. IBM has experience in
implementing solutions that address these differences.
One of the major challenges and differences between these geographies is the
amount of required detail tracking while safeguarding patient privacy. But patient
privacy requirements differ significantly in each market. In the United States, it
is necessary to track implanted devices to the implanting facility and the actual
patient receiving the device. In Europe, on the other hand, it is forbidden to maintain
information on the patient receiving the device.
Each scenario requires very different processes and a deep understanding of how
to implement the different mandates with shared global solutions. Understanding
how to issue a sale, block patient information, track device implants and apply
security technologies are several of the key areas in which IBM expertise has
provided critical assistance.
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11. Summary – The IBM Advantages
IBM has a long and successful history with clients in the medical device sector. Our
experienced consultants understand the unique requirements of the industry and they
understand how technology and process solutions can create benefits for our clients.
Improve your information flow with IBM
• IBM’s Health Information Framework is based on industry open standards and a
service-oriented architecture (SOA) to connect information from disparate systems.
• IBM Global Business Services is the leader in global implementations for a wide
range of systems.
• IBM is pioneering new wireless and RFID technologies that can streamline your
supply chain.
• Our Clinical Data Warehouse solution includes electronic health records.
• IBM is a solution leader in information security and privacy.
You can count on IBM to get your products to market quickly
• IBM understands how innovation leads to business success: For the past 13 years,
IBM has been awarded more U.S. patents than any other company—patents that
have changed the world – and have made IBM an industry leader.
• IBM can help you spot the biggest opportunities in your development pipeline.
• IBM HealthLink can enhance knowledge sharing and reduce redundant efforts.
• IBM’s IT experience can help you build the powerful, secure infrastructure you need
to manage your research and development data.
• IBM PLM solutions offer a strategic approach to creating and managing product-
related intellectual capital.
IBM can help