Tag: medical device market intelligence

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 Assessment Study – Analyzing the Medical Device Landscape for A Leading Manufacturer

The recent market assessment study by Infiniti Research on cardiac rhythm monitoring and management devices provides actionable insights on the medical device landscape and how to increase market shares by leveraging competitor analysis and pricing analytics.

Medical device manufacturing industry – overview

The medical device manufacturers, across the globe, are witnessing growth opportunities owing to the rising importance and usage of medical devices and surgical equipment in the modern healthcare market. Medical device manufacturers have shifted their focus from transaction based selling to creation of value for providers, payers, and patients. The medical device manufacturing companies are also producing cost effective, innovative and high-quality medical devices and surgical equipment to increase their market shares. According to recent studies, the adoption of cardiac rhythm monitoring and management devices is set to grow with the increasing aging population, rising health concerns, prevalence of cardiac diseases, escalating medical costs, and increasing preference for home care treatments. Additionally, government and regulatory authority are also focusing on improving the healthcare infrastructure; thereby, resulting in the increasing demand for medical tools, imaging devices, patient monitoring equipment, and systems. As a result, it is imperative for medical device manufacturers to identify and analyze the market challenges and drivers to gain a competitive edge over the market players in the region. Infiniti’s expert analysts offer actionable insights into the market and competitive landscape of medical device manufacturing.

In spite of the growth in the industry, the medical device manufacturers face challenges such as lack of skilled workforce, expert healthcare professionals in electrocardiography, and inadequate reimbursement options for remote cardiac monitoring devices, among other surgical equipment and medical tools. Medical device manufacturers often lack the market understanding in terms of sales, revenue, competitor presence and pricing strategy, and market share.

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Solutions and recommendations

The market intelligence team at Infiniti Research offers various solutions to understand the current scenario of the medical device manufacturing industry and future growth opportunities. Some of the solutions offered include:

  • Evaluating the total sales, market share, and assess key purchase drivers for GPOs
  • Identifying the key decision makers for purchasing medical devices
  • Estimating the average selling price by value chain for medical devices
  • Developing a holistic view of the medical device market in terms of product category and segments

Read our comprehensive case study on how we helped a market assessment study on cardiac rhythm monitoring and management devices.

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Market Assessment Study on Cardiac Rhythm Monitoring and Management Devices

As the prevalence of cardiac diseases is slowly outpacing the need for conventional devices, manufacturers in the market have started shifting towards innovations to monitor the intensity of the diseases effectively. Electrocardiography is one of the most prominent medical devices, which is used to monitor the muscular and electrical activity of the heart within a stipulated timeframe.capture The increasing incidence of cardiovascular diseases, technological advancements, and rising preference for home care treatments are some of the factors augmenting the adoption of cardiac rhythm monitoring and management devices. Though the market is witnessing a surge in the adoption of such medical devices, it is hampered by the lack of skilled healthcare professionals with expertise in electrocardiography and limited reimbursements for remote cardiac monitoring devices. With years of expertise in carrying out effective market assessment studies, Infiniti’s industry experts offer actionable insights into the market landscape in terms of the market share, competitors, and average selling prices.

The Business Challenge

A multinational biomedical technology company was facing challenges assessing the market landscape for cardiac rhythm monitoring and management devices in the target region. The client wanted to understand the market landscape in terms of sales units and revenues, average selling prices, and the market share.

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Our Research Methodology

To gain an in-depth understanding of the market’s landscape, Infiniti’s industry experts carried out a market assessment study comprising of interviews and discussions with group purchase organizations, purchase officers, buyers, vendor managers, channel partners, end-users, and members of regulatory bodies. The market assessment experts also relied on proprietary and other open secondary sources such as paid industry databases, media platforms, news aggregators, industry forums, and company presentations.

Our Market Assessment Helped the Client

  • Estimate the average selling price for the devices by value chain
  • Evaluate the total sales units and market shares
  • Identify key decision makers for the purchase of devices
  • Assess key purchase drivers for GPOs

Benefits of Our Integrated Approach

In a very short timeframe, the client gained a holistic overview of the market in terms of the product segments such as implantable cardioverter-defibrillators, cardiac resynchronization therapy, and implantable cardiac monitors. The market assessment study also offered insights into the market landscape in terms of the sales units and revenues, average selling prices, and market share.

A must-read market assessment case study for strategy experts and decision makers looking to assess the market landscape for cardiac rhythm monitoring and management devices.

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Market Assessment Study on Urology Devices

According to statistics, currently over 190 million patients are suffering from chronic renal failure and undergo renal dialysis around the world. Rising occurrence of chronic renal diseases, expanding geriatric population, rapid technological advances in the medical devices sector, and increased spending on healthcare in emerging economies are some of the key factors favoring market growth. Urology has been at the forefront of adopting novel medical technologies, such as minimally invasive surgery and robotic surgery, to improve patient outcomes. Although, demographics and the growing prevalence of age-related diseases appear to support continued, even substantial market gains, urology devices suppliers are reasonably concerned about the timing and magnitude of market recovery as competition intensifies for increasingly scarce health care funds. With years of experience in market research, the research experts at Infiniti offer strategic insights into the market landscape of medical devices used in urology, in terms of market size estimation, competitive landscape, and the market segment analysis.

The Business Challenge

A leading multinational developer and manufacturer of medical devices was facing challenges understanding the market for medical products/medical devices being used in procedures specific to urinary incontinence, urological disease, femoral hernia, incisional ventral hernia, inguinal hernia, and umbilical ventral hernia across the target regions.

Our Research Methodology

To derive strategic insights into the medical devices market, our research experts carried out extensive primary research comprising of interviews and discussions with key stakeholders and business executives. As a part of the secondary research, the experts also collated information from proprietary databases such as government reports, company publications, and industry forums.

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Our Solution Helped the Client

  • Gain insights into the market landscape in terms of key metrics for each disease, procedure, and product category
  • Develop a robust and defendable prototype market sizing model
  • Obtain qualitative and quantitative insights on the leading products and services used in urology procedures

Benefits of Our Integrated Approach

In a span of 14 weeks, the medical devices client gained a holistic view of the market landscape in terms of the procedures and disease type. The engagement also provided actionable market insights on specific medical devices used for a wide array of urology procedures.

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 competitive intelligence case study for strategy experts and decision makers looking to understand the landscape for medical devices used in urology.

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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