Category: Healthcare

remote patient monitoring

Remote Patient Monitoring: The New Tool for Enhancing Healthcare Systems

Taking healthcare services to the masses in the most cost-effective manner is the prime focus of governments across the globe. Stakeholders in the healthcare system have realized that the traditional healthcare models fail to provide effective medical services. It is in this scenario that technology is seen as a possible option to improve the overall functioning of the medicare systems. Telehealth, remote patient monitoring (RPM), and mHealth are some of the examples of how technology can provide value-based medical care.

Remote patient monitoring: Filling the distance between patients and doctors

Through RPMs, the health related data of patients in one location is digitally transmitted to health care providers in a different location.  the patient need not travel all the way to a clinic to consult the doctor. Rather from the comfort of his home he can interact with the healthcare professional and get timely help. The system is extremely beneficial for those who are physically handicapped or cannot travel alone due to old age and other disabilities.

By leveraging cloud and big data, RPM systems make it easier for the healthcare providers to access all the medical details of a patient. Right from the management of diabetes and hypertension, to helping cardiac and asthma patients, RPM has touched all the major areas of the healthcare industry. The technology also plays a vital role in bringing down the cases of long hospital stays and cuts down the cost of clinical trials as well.

From the point of view of hospitals and clinics, medical professionals can now dedicate more time on patients who need very close physical monitoring. Timely detection and quick intervention also reduce the hospitalization and readmission rates. Just by providing their services through the online medium, hospitals gain additional revenues. Most of all, the data collected for RPM can be used in clinical trials for new drug discovery.

Infiniti’s take on remote patient monitoring

Our market intelligence shows that in spite of several advantages, there are some major challenges which are hindering the adoption of RPM throughout the globe. Though at present its quite in demand in the US, the initial investment in this technology is quite massive. Also, regulations like HIPAA, make it rather difficult to access information which falls into the category of protected health information. At the same time, there is no denying the fact that RPM is the future of the healthcare industry. By bringing medical help right into the homes of the patients, this technological innovation has emerged as a powerful tool in the healthcare industry.

ETFs and Medical Devices

Exchange Traded Funds and the Growing Market of Medical Devices

Investopedia defines exchange traded funds (ETF) as a marketable security which tracks bonds, commodities, or a basket of assets like an indexed fund. In layman’s language, ETF is a fund which owns assets like stocks, bonds, and gold bars, and divides their ownership into shares. The shareholders in ETFs, therefore, have only indirect ownership of the assets. Also, though a lot similar to the mutual funds, ETFs have lower fees and higher liquidity when compared to the mutual funds.

Medical devices ETFs

The medical sector is the latest industry to open up to ETFs. Medical devices ETFs involves investment in the stocks of those companies which are involved in manufacturing and distribution of medical devices. The main focus of ETF is to encourage manufacturers of medical devices to venture into technological innovations so as to come up with better quality medical products.

Just like the pharma industry, the medical devices companies too struggle with the high costs involved in long testing processes, R&D activities, as well as getting approval for their products. This is one major reason why many manufacturers prefer using the existing technologies rather than investing in R&D activities. Through ETFs, manufacturers who do not fall under the category of public companies too can take the risk of investing in R&D projects.

As of now iShares US Medical Devices and SPDR S&P Health Care Equipment are the two medical ETFs available in the market. IShares was launched in 2006, and at present holds 50 big names from the medical devices industry. For instance, Medtronic PLC, Abbott Laboratories, Thermo Fisher Scientific, and Danaher Corp are some of the major companies under iShares. SPDDR S&P Health Care Equipment, on the other hand, is much smaller than iShares – but has some major names like Globus Medical, Alere, and Varex Imaging under it.

Infiniti’s take on medical devices ETFs

ETFs, no doubt, are not as intimidating as mutual funds. By bringing a variety of companies under a single stock trading market, ETFs makes it easier for players in the medical devices industry to gain access to the stock market. It also allows investors to keep a track on the companies which are performing well in the share market, and thereby helps in boosting the credit inflow.

Pharma Industry

Top 5 ways in which Big Data is Transforming the Pharma Industry

The use of big data is no longer limited to transforming customer-facing functions such as sales and marketing alone. Manufacturers in the pharma industry, are constantly struggling with stagnant pipelines and low success rate in R&D activities – big data has emerged as a major game changer. Pharmaceuticals is one industry where immense amount of data is generated from sources like patients, retailers, and R&D processes. Big data enables easy understanding of the complex business processes, which in turn results in improved clinical trials, better risk management by pharma companies, increased patient safety, and enhanced collaboration between pharma companies.

Here are the top five ways in which big data can transform the overall functioning of the pharma industry:

1. Better sales and marketing

Until recently the sales and marketing was a grey area in the pharma industry. But by integrating the big data analytics to their strategy building, companies can easily focus on specific geographical areas to promote their medications. This way, pharma companies can come up with extremely targeted marketing and sales goals, thereby saving both on time and effort. Today, more than 30% of the marketing is done on the digital platform and this number will only increase in the next five years. The role of big data becomes even more critical in building marketing and sales plans.

2. Enhanced clinical trials

Clinical trials are an integral part of the pharma industry. The patients undergoing these trials must meet some prerequisites before undergoing the trials. Big data merges the databases from multiple sources, to filter out patients who do not meet the basic requirements. It also helps researchers monitor the patients on a real-time basis and predict the side-effects of drugs.

3. Predictive Analysis

Early detection of drug toxicity, along with improving the chances of patient survival are the two main goals of every pharma company. Predictive analysis provides a clear picture if a drug will suit a patient by taking details like genetics, lifestyle, and existing diseases into account. The algorithms used by predictive analysis considers all the minute details on the patient’s health and helps deliver personalized care to the patient.

4. Emergence of digital apps

It is imperative for the pharma industry to go digital and reach out to their end-users in a better manner. Digital apps are one of the best solutions for building relations with the target audience. The data collected on these apps is linked to various verticals of the pharma and healthcare industry which provides a first-hand data on patient compliance and instant feedback on patient’s health.

5. Cross-industry collaboration

The pharma industry, the healthcare sector, the insurance companies, as well as the data management firms – these are all inter-related. The need of the hour is to bring all these various industries on a common platform so that information sharing gets easier and pharma companies can seamlessly widen their database for future clinical trials.

medical device

Steps to Keep Your Medical Devices Ransomware Proof

As hospitals in the UK and Indonesia grappled with the Ransomware attack, the susceptibility of medical devices to cyber attacks again made news across the globe. One of the most conservative verticals of the life sciences industry, the manufacturers of medical devices are gradually adopting technology to provide a better diagnosis of health conditions. No doubt digitization has transformed the overall performance of the medical devices, but at the same time, it has exposed the industry to events like hacking, malware, and cyber attacks as well.

Hacking of medical devices – What is at stake?

Most medical devices have electronic records of the patient’s medical history, the medicines prescribed, as well as information on allergies and other vital facts. Any compromise on this data will not only attract huge financial loss for the hospitals but will also cost the very lives of the patients. Medical devices like insulin pumps and pacemakers have higher exposure to hacking and malware attack. The wireless technology employed in these devices make them an easy target for the hackers.

Medical devices manufacturers – Bracing up to the challenge

With more than 100 million personal health records being compromised, the Food and Drug Administration (FDA) has rolled out a set of guidelines for the device manufacturers as well as healthcare facilities.

As a medical device manufacturer, the FDA recommends that:

  1. The medical device inventory, change management systems, and other networked servers and workstations are monitored closely
  2. All the devices which are running on unpatched version of Windows should be upgraded to the relevant security patched version of the Windows
  3. Conducting vulnerability scans on a regular basis. Though not a foolproof procedure, vulnerability scans do help in identifying devices which are liable to malware attack
  4. Involving the third-party managers and medical device vendors in the risk management process
  5. Prioritizing patches for medical devices and involving the IT department to update the affected medical devices

Lastly, the FDA also wants medical device manufacturers to build response mechanism to handle incidents of cyber attack and see to it that the other devices and medical facilities do not get infected.

medical devices

New European Medical Devices Regulations: How can Manufacturers Deal with It?

The new European Medical Devices Regulation (MDR) will replace the existing Active Implantable Medical Device Directive (AIMDD) and the Medical Device Directive (MDD). As the new regulation is all set to take over, the manufacturers of medical devices will have to diligently identify areas which might affect their products’ market access in EU.

Given the fact that since the 1990s no major change has taken place in the European medical devices market, the new MDR is being seen as a major game changer in the industry. By adding elements like transparency and product traceability, the new regulation will simplify the rather complex medical device environment in the European Union.

Why MDR?

Since 2010, Europe has witnessed a huge number of hip replacement recalls and breast implant crisis. The high rate of these incidents not only highlight the loopholes in the existing regulations but also underline the need for a new set of guidelines which can address the present-day medical complexities. And this is how the idea for the new MDR came into being. The goal of the new regulation is to provide:

  1. Impartial assessment of the safety and performance of the medical devices before being sold in the EU market
  2. Standardized rules for unproblematic trading between the members of the Union
  3. Specific needs of medium and small-sized manufacturers to be considered
  4. Transparency of information and patient-oriented innovation, along with comprehensive assessment of the risk-benefit aspect of the devices
  5. Greater responsibilities on “Notified Bodies” when it comes to the evaluation of the medium and high-risk medical devices

Infiniti Speaks – How to adapt to the new regulations?

The key to make a mark in the European market and leverage the regulations to one’s advantage is – early preparation and adoption. Depending on their product portfolio, manufacturers of medical devices must adhere to a well-structured approach in the upcoming three years.

It is advisable that manufacturers start by understanding the compliance data at the micro level for at least two to three of their products. The technical documentation of these devices needs to be submitted to the Notified Bodies to get a clear picture of the areas which need focused attention. By undertaking a gap analysis, manufacturers can figure out areas which need to be fixed to comply with the new regulations. Once the product gets evaluated, it gets easier to make changes to the wide range of medical device portfolio – way before the MDR comes into force. Also, there will be a pressing need to update and review all the technical documentation along with product labeling.

The whole process can get a little tedious and time-consuming, but starting early on is sure to help manufacturers to stay competitive and operational in the EU market.

For more information on medical devices regulations

 

data analytics for patient monitoring

Top 3 Ways in which Big Data Can Transform Patient Monitoring

As the traditional healthcare industry is moving towards an era of open information, big data has emerged as a potent tool to provide smart, data-driven thinking. Until recently, most stakeholders in the medical industry had underinvested in information technology. However, with technology seeping into the life sciences industry, there has been an enormous collection of data which can be used to bring down the treatment costs, prevent diseases, and improve the overall quality of life.

Big data in patient monitoring: The tipping point

The quest for innovation in patient monitoring, along with the convergence of several changes in the health care industry are the two reasons for the adoption of big data. Five major changes which created a tipping point for the adoption of big data are:

  1. High demand for better data
  2. Availability of relevant data in the form of EHRs
  3. Adoption of analytical tools for patient care
  4. Market-friendly policies by governments across the globe

Top three ways in which big data is transforming patient monitoring

  1. Electronic health records (EHRs)

EHRs use big data on a huge scale. These digital records store crucial patient information like their medical history, results of lab tests, demographic detail, among others. The data collected in these electronic documents, enable doctors to get a clear picture of the patient history and facilitate better and timely delivery of the healthcare services.

Another major advantage of adopting big data is that now patients can easily keep track of their prescriptions and lab tests. So, by integrating the EHRs across various medical facilities, patients have experienced reduced number of unnecessary hospital visits and lab tests.

  1. Telemedicine

Digitization, smartphones, wireless devices, and online video conferences have set the ball rolling for delivery of remote clinical services. Telemedicine is in full bloom today, all thanks to these technological innovations. The data collected from these devices can be easily shared which makes diagnosis a lot easier. Apart from remote patient monitoring, big data also helps in predicting acute medical events and prevent deterioration of patient’s conditions.

Another major way in which big data has changed telemedicine is by providing real-time data with which operations from remote locations using robots.

  1. Predictive analytics and informed strategic planning

Quick decisions need to be taken when it comes to treating patients suffering from multiple complex conditions. The role of data becomes even more important in this context. Big data provides insights which help doctors make informed decisions and improve the overall treatment process. These insights also help in predictive analytics, as it becomes easier to foresee which patient is at the risk of diabetes or cardiovascular diseases.

Most of all, the use of big data in patient monitoring enables academics and care managers to review the healthcare delivery strategy and work towards informed strategic planning.

For more information

medical device security

Medical Devices Security: New Challenge in the Life Sciences Industry

Cyber criminals are not just looking out for your bank and credit card details alone. In fact, there are good chances that your medical devices might get hacked as well. Hacking of medical devices is no longer just a chapter of some popular sci-fi novel; rather it has emerged as a growing concern for all the stakeholders in the healthcare industry. The situation has turned critical with the recent Wannacry ransomware affecting the British healthcare services.

The Internet of Medical Devices

The evolution of wireless technology has hugely influenced medical technology as well. No doubt mHealth and networked medical devices have transformed the delivery of medical services, however it has also exposed the entire medical system to cyber attacks as well. Apart from issues related to a patient’s safety, hacked medical devices can be used for identity theft, tax frauds, as well as buying medications which can be later sold on the dark web.

Complex software and network capabilities have transformed medical equipment into sophisticated devices. The need of the hour is to build a strong and secure network which will protect the equipment from hacking and other cyber malpractices.

Medical device security: A shared responsibility of every stakeholder

The onus of medical device cyber security falls on every stakeholder within the industry. Right from device manufacturers, healthcare providers, regulators, to the patients – each and every one of them need to take essential steps to avoid cyber attacks.

For instance, device manufacturers should work towards:

  1. Platform and server hardening
  2. Foolproof inscription and code-signing
  3. Protecting manufacturing integrity

Providers of healthcare services, on the other hand, have to work towards holistic asset management, risk mitigation, and detection of anomalies in their network.

Cyber proofing medical devices: The only way ahead

Apart from issuing several alerts, the Food and Drug Administration (FDA) has released an industry guidance document titled Postmarket Management of Cybersecurity in Medical Devices. This guide enables the manufacturers to identify issues during the design and development of the devices. Similarly, regulations like HIPAA and the ISO/IEC 80001 series of standards provide frameworks which need to be compiled by medical device manufacturers.

Lastly, it is important that serious thought is given to the lifecycle of medical equipment and the entire procurement process of these devices. Transparent procurement along with diligent contract and lifecycle management is sure to enhance the security standards of the medical devices.

Infiniti Research offers healthcare intelligence solutions to help clients tackle key challenges in the healthcare industry

Health economics

Understanding the Health Economics Behind Medical Devices

Traditionally, health economics studies the manner in which limited resources are allocated to provide better health care services. It also takes into consideration how medical services can be better distributed among individuals and groups. Currently, the healthcare industry is becoming more cost-conscious, which is why medical devices manufacturers are looking for the best solutions that would bring down the cost of production without compromising on quality.

The two key focus areas for every medical device company, regardless of their size, are:

  1. Better access to the market
  2. Increase in reimbursement

Often small-sized organizations, adopt health economics to boost the sale of their tools and gain higher acceptability for their diagnostics. The major players, on the other hand, adopt health economics initiatives to reach the best value – for both medical devices as well as patient outcomes. Our market intelligence studies show that manufacturers are sure to benefit if health economics is put into play right at the initial stages of product development. This strategy helps companies to commercialize their products in a better manner and thereby disrupt the market to their advantage.

Benefits of health economic analysis in the medical devices market

Health economics analysis (HEA) enables the manufacturers to gain a clear understanding of the direct as well as indirect costs of medical intervention. Different models are adopted to understand how a particular medical device would get a better access to the market as well as meet the manufacturer’s reimbursement goals. HEA provides a clear picture on the sustainability of the business strategy of any medical device company. It does this by examining:

  1. Cost-functionality: By taking technology costs and utility outcomes of the medical devices into consideration, HEA indicates how functional is the product for the patient. Cost-functionality also brings into perspective if the patient is keen to pay for high-cost devices without guaranteed high clinical benefits.
  2. Cost-minimization: Health economics is all about finding the best viable alternative medical solution at the least possible cost. For instance, if a low cost technology can provide the same benefit as an existing high-cost one – it is beneficial for both the patient and the manufacturer.
  3. Cost-effectiveness: Here the clinical outcome of the alternate technologies is examined in a detailed manner. While the cost of technology is measured in monetary terms, an increase in life expectancy determines the overall health benefits of the product.

The focus of healthcare systems across the globe is on reducing the cost of health services per person. Advances in medical technology and higher dependency on medical devices has made it imperative for those in the medical devices industry to take health economics into serious consideration.

Infiniti Research are leading providers of life sciences and health economics solutions

 

medical devices

Role of Quality Medical Devices in Effective Delivery of Medical Services

‘Compliance by inspection’ is no longer the only standard medical devices must meet. As the medical device industry enters its mature stage, manufacturers have understood that regulatory compliance and quality are altogether two different things. The growing complexity of medical services, innovative medical equipment, and an increase in competition has placed a greater focus on the quality of medical devices.

Shift from speed to quality

Traditionally the medical device industry gave utmost importance to ‘speed to market,’ i.e. how quickly can a company come up with a new product launch. Rather, there used to be a rat-race on who would be the first one to roll out the most innovative products. However,according to the latest medical device market intelligence, this trend seems to be changing. It is found that manufacturers can increase their profits by nearly 15% on an annual basis by assuring better quality devices through adherence to cross-industry best practices. And this  is not just about the profit figures – high quality medical devices play a vital role in the faster delivery of medical services, help patients recover sooner, thereby improving the overall market value of the manufacturers.

How do you define ‘quality’ in the medical devices industry?

Anything which will have a positive or negative impact on the manufacturer’s goodwill and competitiveness in the market comes under the definition of quality. It can be something as simple as durability of the device, to a difficult situation where product recalls must be undertaken.

Quality, therefore, is a sum of factors like robust materials, superior design, ease of use, and great end-results. Losing out on any one or more of these aspects is sure to damage the reputation of medical device manufacturers.

Infiniti’s take on the case for quality medical devices

There is immense pressure on medical device manufacturers to improve the quality of their products without raising prices. The situation gets rather tricky with cut-throat competition and the emergence of constant media scrutiny. Even a minor quality event has the potential to wipe off at least 10% of a company’s market share. Moreover, the effect of a defective device on a patient’s health is sure to damage the manufacturer’s reputation beyond repair.

Our medical device market intelligence shows that the medical industry value chain has failed to keep pace with the growing demand for eliminating quality issues. To achieve the goal of delivering top-class medical services, it is essential that medical device manufacturers implement quality best practices at the earliest. There is a pressing need to hire quality engineers, adopt statistical tools like Quality Function Deployment (QFD), and most important of all have a full-fledged quality management system in place.

Infinti Research provides in-depth analysis on different aspects of the medical devices market

 

medicine vials and syringe.

Immunization and Health Economics– Best Friends in the Making

Health is not just the absence of illness– rather it is the ability to grow and develop to one’s full potential. Several elements go into the making of a healthy workforce– and it is health economics which closely analyses the connection between health and resources. Resources are not just about money; it also covers materials, time, and the people involved in making the process of healthy living easier. Especially in the case of developing countries, the debate often spirals on how to make a lasting impact with the limited availability of resources.

Relation between health and economic growth

According to noted American economist Robert Fogel, a good part of England’s economic growth in the past 200 years is the result of improvements in the population’s food consumption. Thus, the relation between health and economic growth is a rather strong one. Improved productivity and less burden of illnesses is in fact the direct effect of health on economic growth. At the same time, health also has an indirect impact on economic growth. For instance, a generation of healthy children are sure to raise the future income potential of any country – and this is the indirect and long term impact of health on the economic progress of a country.

Another report published by David Bloom and colleagues outlines how the labor productivity of a nation can improve by 4% just by increasing the life expectancy of its citizens by one year. All this shows how health and economics are deeply connected to one another – any change in one aspect is sure to influence the other.

Better immunization, greater economic gains?

Adopting the right vaccines is one of the major agendas of those involved in public-health decision making. Often there is a lot of brainstorming done on if it makes economic sense to promote and use expensive vaccines in a low-income country. The debate gets an even more serious angle when traditional cost-effective solutions are taken into consideration. But the fact remains that despite being expensive, these vaccines have broader benefits which often goes unrecorded in the traditional calculation formats. For instance, most traditional methods fail to consider the fact that lessening child mortality rate results in families having fewer children that enables the parents to spend more on their children and take better care of them.

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Lately, due to immense research and field studies, it has finally been accepted that immunization is the stepping stone to building a healthy family, vibrant community, and a strong nation.

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