Tag: medical device

medical device packaging

Debunking Three Common Myths About Medical Device Packaging

The lifecycle of launching a new medical device into the market includes a significant number of milestones that can either facilitate or hinder the launch date of the product. One of these milestones that has a critical impact on the time-to-market strategy is medical device packaging. Although it may seem that medical device packaging is the last thing on the mind of manufacturers, this is not the case. Packaging is a highly crucial element of the final output of medical devices. This is largely because the packaging not only ensures that the medical device is protected from any external damage, but it also plays a vital role in upholding the quality standard of the product till the time they are put to use.

In this article, we put some common misconceptions about medical device packaging to rest and also explain the key best practices involved in an ideal medical device packaging.

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Medical device packaging only needs to be tested once

If a particular medical device packaging pouch or box is already in use, there are chances that you tend to ignore testing this packaging again. Although it might be possible to leverage the previous testing results partly, it is important to re-perform these tests. This is because there is more to testing medical device packaging than merely testing whether the pouch seals meet a minimum peel strength requirement.  It is also vital to test the chances of the device puncturing the pouch or whether the packaging can damage the medical device. In addition, while undertaking transit testing, if your device is sterile, it must be proved that the device packaging will maintain sterility for the shelf-life of the device.

Medical device packaging is easy

It is a common misconception that medical device packaging is easy and does not require a lot of thought. But the truth is, if medical device companies wait till the end to decide on their packaging strategy, chances are that their time-to-market is going to be delayed. Medical device manufacturers must understand that packaging it is critical to keep the device sterile and functional, and packaging plays the most important role here. The first design drafted for the medical device packaging might not pass testing or may be cost-prohibitive. It may require several complex iterations.

Medical device packaging decisions can wait until the end

It is a common misconception that since packaging is one of the last stages before launching the product, the decisions relating to packaging can wait till the end. However, as mentioned earlier, medical device packaging decisions might not be as easy as you expect it to be. Pushing these decisions to the last minute could delay the product launch. Furthermore, for the US as well as the European market it is imperative for medical device packaging to adhere to ISO 11607-1 and ISO 11607-2 standards.

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The US Medical Device Industry: How to devise a Market Entry Strategy

With an enormous market size of $156 billion, the medical device industry in the United States remains the largest in the world. Companies in the medical device industry consist of articles, instruments, apparatuses, or machines that are used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting, or modifying the structure or function of the body for some health-related purpose. Although patients are the end-users of medical devices, manufacturers ideally focus their efforts towards selling their products to healthcare providers who in turn use them to serve the needs of patients.

Majority of the companies in the US medical device industry are concentrated in regions known for other high-technology industries, such as microelectronics and biotechnology. The states with the highest number of companies in the medical device industry include New York, California, Florida, Michigan, Pennsylvania, Massachusetts, Minnesota, Illinois, and Georgia. Compared to several other industries including telecommunications, automotive, and defense, the medical device industry invests a higher percentage of their yearly revenues into product innovation, reflecting the competitive nature of the industry and constant innovation and improvement requirements of existing technologies.

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3 Key Medical Device Reimbursement Challenges Manufacturers face Globally

Medical device reimbursement is the payment made by a third party private or public insurer to a health care provider in exchange for the costs or payments incurred by the provider for performing the required procedure or using a medical device. There are three goals for any medical device reimbursement strategy, universal coverage from all insurers in all patient care settings, adequate physician and institutional reimbursement, and unambiguous coding. Reimbursement is the primary issue on every investor’s mind, and it is one of the first things healthcare companies think about when developing new products or medical devices. If the coverage under medical device reimbursement has no certainties, it becomes very difficult for companies to analyze the return on investment. This obstructs venture funding and also limits innovation. Consequently, it pulls back the patients from leveraging the benefits of advanced and new technologies. Thus, medical device reimbursement and coverage of payers play a very important role in making or breaking a medical device. There are several challenges associated with medical device reimbursement for manufacturers, which varies from countries to countries. In this article, we hGet More Infoave listed down some of the most common challenges that every manufacturer faces in medical device reimbursement. Also, we have suggested a few solutions to deal with those challenges.

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Top 3 Medical Reimbursement Challenges for Medical Device Manufacturers and Their Impact

With respect to medical devices, reimbursement can be defined as the payment paid by a third-party public or private insurer to a health care provider in return for the payments or costs incurred by the provider for using a medical device or for performing the required procedure. If the coverage under reimbursement has no certainties, it becomes difficult to analyze return on investment. This creates obstacles in securing venture funding and also limits innovation. This, in turn, pulls back the patients from getting the advantage of new technologies. Thus, reimbursement and coverage of payers have a crucial role to play in making or breaking a device. There are many challenges associated with medical reimbursement for medical device manufacturers, which varies greatly from country to country. But there are a few common challenges that are shared by many countries. Here are the top three.Contact US

Medical Reimbursement Challenges

The gap between the value of a technology and reimbursement levels

In many countries, rates of medical reimbursement are not based on value, rather it is cost-based. The rates of reimbursement are fixed by the government body in most of the countries. This body mainly comprises of government officials or clinicians and they decide on what the rates of reimbursement should be for specific medical devices and procedures. Such decisions are not based on the technology of the manufacturer or the feature of the device but are driven by standing formulas. This means that such a medical reimbursement is a reflection of the cost to use a certain device or procedure and does not reflect the technology used in it. But here is the challenge to match reimbursement levels with the kind of technology used in the medical device because this balance is very essential to get a positive outcome and ensuring the availability of advanced medical technologies to the patients in the future.Request Proposal

Cuts in government medical reimbursement spending

The government in countries like E.U, U.S, China, and Japan are looking for various ways to cut down on their expenditure to prevent the costs of healthcare crossing their limits. This also includes cutting down on medical reimbursement amounts. Several governments have already initiated the process to reduce their spending on the reimbursement of medical devices and this has reduced the total healthcare spending.

Opacity and complexity of reimbursement process

Medical reimbursement process is considered to be the most opaque and complex process that stops medical devices from getting exposed to advanced technologies. In many countries, there are even many stakeholders involved in the reimbursement process who interact with the companies. Many times, medical reimbursement decisions can be lengthy, uncertain, opaque and even unpredictable. Therefore, for companies to invest in new technology without knowing the amount of reimbursement becomes very difficult.Get More Info

Impact of Medical Reimbursement Challenges  

#1. Difficult to get good ROI

The gap between reimbursement rates and technology makes the investment risky for the manufacturer. The risk of ROI makes them apprehensive towards experimenting and working on innovations in medical devices.

#2 Providing quality

The opaque and lengthy system of the medical reimbursement process makes it quite difficult for the manufacturer to produce quality medical devices and provide valuable services.

#3 Difficult early diagnosis and preventive care

The government’s decision to cut down on healthcare expenditure, especially when it comes to medical reimbursement for devices and procedures, leads to difficulty in diagnosis at the early stage of disease like breast cancer, which needs a screening.

Therefore, to avoid such instances manufacturers need to take steps for their participation in the formulation of medical reimbursement rules. This will further help in advancing the innovation process in medical devices and attaining financial goals.


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Market Entry Strategies

Future of Medical Devices – Technological Advances in Healthcare

With the rapid pace of technological advancements in the healthcare industry, the future of medical devices looks promising.

The new-age medical technology has transformed the way doctors and patients participate and interact with each other. Obtaining real-time information, tracking past health records, identifying potential health issues, and devising a treatment plan are allAsk an analyst signs of the gradual shift from traditional methods to smart medical devices. The future of medical devices is influenced by technological trends and opportunities that promise to revolutionize the operations of the healthcare providers and the medical technology companies. The medical device market space is driven by innovation, and the development of state-of-the-art medical devices and technologies has shown an unparalleled growth and advancement in the healthcare services industry.

The Future of Medical Devices Impacted by the Changing Market Dynamics

A medical device is an apparatus that helps prevent, diagnose, detect, restore, or treat diseases. According to our specialists, the future of medical devices is affected and influenced by the ever-changing market dynamics and other factors such as innovation, growth of emerging markets, advent of new business models, evolving healthcare delivery models, health information technology (HIT), and rapidly changing regulations and compliance standards.

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Today, the medical device market is driven by innovation, which has coerced the medical device manufacturers to invest in research and development. As a result, the medical device manufacturing companies are contemplating new business models and market expansion strategies in emerging markets such as the APAC, Africa, and LATAM. With the technological advancements and revolutionary changes in the medical device market, manufacturers and healthcare service providers have started offering personalized patient care and access to complete end-to-end medical device products and services. Med-tech companies are also focusing on new medical device development and are expected to invest a significant amount of the organization’s revenue on research and development. However, the future of medical devices looks interesting but crowded as manufacturers and med-tech companies are launching several new technologies and products.

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Medical Device Manufacturers and Emerging Technologies

Medical device manufacturers are seeking to develop and enhance product prototyping, minimize operation costs, and be responsive to product developments and latest market trends. Emerging technologies in the medical device space have revolutionized the way surgical tools and medical equipment is formulated, improved, and manufactured to cater to the demands of the healthcare service industry. Why should medical device manufacturers track the development of emerging technologies, you ask? Here’s why:

  • By tracking the development of emerging technologies, med-device manufacturers can enhance existing product lines or create adjacent product categories, thereby offsetting the potential impact on existing product lines and categoriesmedical device manufacturers
  • Targeting new markets is the future of medical devices and manufacturing that allows companies to expand market and devise market entry strategies for emerging markets. A medical device manufacturer can either enter a new product category or a new region. Companies can leverage the benefits of low-cost country sourcing and manufacturing, thereby reducing operational costs and providing the highest quality products at the best possible price
  • The emerging technology market space has witnessed a surge in M&A activities over the past years. Med-tech companies are participating in mergers and acquisitions to gain market shares and acquire patented medical technology. This allows companies to gain the first mover advantage and operate in new areas.

Emerging medical device technologies are driven by the internet of things (IoT) and are equipped with wireless communication technologies such as the Bluetooth and internet connectivity to facilitate machine-to-machine communication. Interconnectivity between these tools and equipment with cloud-based platforms that capture, store, and analyze patient data and health information is the next step in the future of medical devices. These systems will enable remote patient monitoring, tracking of previous medical prescriptions and patient locations, monitoring patient progress, and providing access to caregivers.

Tracking The Potential of Emerging Technologies

To stay ahead in the market, it is essential for med-tech companies to track the potential of emerging technologies at an early stage. Traditionally, medical device companies relied on internal intelligence and syndicated research reports that provide insufficient data, invalid assumption, and offer findings that often misleads the organization. Besides these, companies scan the web and media such as magazines, trade journals, industry published reports and brochures that provide limited, outdated, and biased information. Organizations who follow the traditional way of assessing emerging technologies and their potential face the following three issues,

future of medical devices

Assessing The Future of Medical Devices, The Infiniti Way

Infiniti’s team of expert analysts understand the shortfalls of the traditional method of assessing the potential of emerging technologies and present new market models that are fine-tuned to track the latest developments and emerging technologies in the medical device market space. The Infiniti market assessment model categorizes product into three categories namely very new, moderately new, and existing products. The process entails extracting real time data, building realistic market models, and validating the models, framework, and assumption with physicians, patients and others in the med-tech industry to provide accurate and relevant actionable insights.

future of medical devices

We assist healthcare service providers and med-tech companies by providing actionable insights that help them in strategic decision making and assess the future of medical devices. These insights enable the companies to answer the following questions,

future of medical devices

 

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Market Intelligence Study to Assess the Healthcare Market Access Landscape

Amid recent innovations and tightening budget constraints in the healthcare sector, most industries are relying on market access to increase the availability of the products to the patient population. Market access assists the right patients to get timely and seamless access to a medical device at an affordable price. It evaluates the implications of the newly introduced product in the market and helps in preparing a positive healthcare environment, thereby supporting the uptake of the products. It requires a comprehensive understanding of pricing and reimbursement mechanisms and requirements at national and regional levels.

In the healthcare sector, market access is primarily about packaging data in the right way, for the right customer, at the right time. With experience covering every stage of product discovery, development and commercialization, Infiniti is uniquely positioned to deliver customized market access solutions to dynamically explore and unlock the product’s market potential.

The Business Challenge

A global healthcare consulting company was facing challenges understanding the healthcare market access landscape in the Middle East, South East Asia, and African regions. The client wanted to identify key trends, potential drivers, and challenges to create an effective corporate strategy. The company also wanted to shortlist the key competitors and the potential stakeholders in the market.

Our Research Methodology

To create an evidence-based, relevant, and effective corporate strategy for the client, the industry experts at Infiniti carried out extensive primary research comprising of interviews and discussions with leading market stakeholders, business executives, consultants, researchers, analysts, and key opinion leaders. As a part of the secondary research, our experts collated information from proprietary databases such as company publications, relevant websites, and industry forums.

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Our Solution Helped the Client

  • Understand the current healthcare infrastructure and forecast over the next 5-10 years
  • Assess the size of the market
  • Identify potential clients in the market and tap relevant market access opportunities
  • Identify the key competitors and their service offerings in the market

Benefits of Our Integrated Approach

In just about 10 weeks, the client derived insights into the healthcare landscape in terms of the insurance, reimbursement, and access programs. The competitive intelligence study also brought into limelight the potential competitors including the local and international affiliates. Moreover, the client was able to tap potential market opportunities and make informed business decisions.

Here are some of the key points appreciated by our clients

  • Dedicated Consumer Research Assessment Portal. A centralized platform for the collection, storing, processing, reporting, and dissemination of information with the specific purpose of assisting the decision-making process and developing actionable insights. This portal includes comprehensive information on quantitative and qualitative aspects on target markets, competitors and end-users.
  • Collaborative Learning. We leveraged the experience of our healthcare team and our technical capabilities to enable report-sharing and other collaborative features appreciated by client teams.
  • Database Access. Access to a patient database containing information about 60+ medical diseases and conditions, such as patients undergoing treatment, untreated patients, and patients with chronic conditions.
  • Interactive Dashboard. Using our portal based solution for healthcare professionals, we took a design-first approach to problem-solving and helped break through previously held assertions.
  • Value for Money. Infiniti’s dedicated client management team customizes reports to suit business requirements and offers the best insights for every dollar spent.

A must-read market intelligence case study for strategy experts and decision makers looking to understand the market landscape for healthcare market access.

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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.

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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.

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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

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Health Economics for Medical Device Developers

The medical device industry is driven by optimistic device companies in the U.S., Europe, and Asia that seek innovation. With new innovations, the key stakeholders in the medical device market will keep funding research and new ideologies to bring about product differentiation. From the demand for self-medication to in-home healthcare services, the medical device industry is witnessing a change in preferences. Currently, the industry is going through a huge strategic change with respect to the development and launch of new products. And our health economists are here to help decode the trends for all the medical device developers.

Health economics plays a vital role in demonstrating the value of new products launched by medical device manufacturers. In general, there are two main areas to focus – Medical Device Reimbursement and Market Access. Involving health economics early in the process will help businesses assess product development opportunities. At Infiniti Research, our experts will leave you with compelling reasons to choose health economics for the medical device industry.

Let Data Do the Talking

Create a comprehensive reimbursement plan for medical devices with the help of health economics analysis from a payers’ perspective. A detailed health economics analysis will give you insights on providing quality care for more people by reducing costs. This will help decision makers to conclude how effective the proposed medical device is over the existing ones and its value for money. This will also prevent the development of technologies and devices that have doubtful value in the future.

Make Well-informed Decisions

Expenditure in the medical device industry is substantially growing. There is an extensive government intervention when it comes to norms and regulations to promote the efficient use of medical devices. This is where an economic evaluation of medical devices will keep every medical device manufacturer informed about the pricing and reimbursement plans. Not just that, it will demonstrate the cost-effectiveness of new and emerging medical devices to make sound decisions.

Rethink Reimbursement

Cost-effectiveness of medical devices plays a huge role when it comes to reimbursement. If there exists therapy A and a new therapy B and they both seem to have similar clinical outcomes, preference will be given to the therapy that is more cost efficient. However, this choice of treatment can be debated if therapy B is much more effective than A. As a medical device manufacturer, you can save time and money when you rethink reimbursement.

As a medical device manufacturer, it is a wise choice to analyze the health economics for the newly developed medical device. Right from assessing the commercial viability of the device to avoiding frugal innovations, the device will have its reimbursement strategies explored. Other than that, a developer can make a better, informed product design ruling out unpromising technologies.

Whether you’re a strategy expert or a decision maker, here is our case study.

Medical Reimbursement, Health Economics, and Market Access Mapping for Wound Care Dressings.