Tag: medical devices manufacturers

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 Medical Device Industry is Revamping Itself: Here’s Why!

The medical device industry is embarking on a new phase of change. In this blog, our industry experts discuss some of the key factors influencing transition in this sector.

The expectations of stakeholders in the medical device industry are changing over time. Patients expect superior service and care models, physicians require data from multiple sources to be brought together in one place, and payors seek lighter financial burdens and better real-world outcomes. Such mounting pressure is urging companies in the medical device industry to revamp their offerings and stand out in today’s increasingly crowded market.

The rapid technological growth rate in the medical device industry is undoubtedly the backbone of this sector. But not long ago, the industry was wrestling several challenges and struggling to implement and adopt advanced technologies. Some of the impediments leading up to this included the paucity of talent, incomprehensible technical complexities, constantly changing regulations, and limited leadership mind-share. In fact, just a decade ago, the integration of new and advanced technologies in the medical device industry was far behind when compared to other industries such as Telecom, Retail, and Automotive. The reality still remains that companies in the medical device industry still lag in tapping into customer and business model-led opportunities and adopting advanced technologies such as IoT, big data, artificial intelligence, augmented reality, and robotics. With only a handful of key players in this sector building sizeable businesses by leveraging the available opportunities and the upsurging competition from non-traditional players such as start-ups, players in the medical device industry are in the dire need to revamp their strategies.

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Change in customer expectations

Earlier, the delivery of digital healthcare had limited reach, was of low quality, and highly expensive. However, modern healthcare consumers are tech-savvy and expect the digital intervention to transform their healthcare experience. This shift in consumer behavior has elevated the focus on patient-centric health care and has become a major driver for the adoption of advanced technologies among OEMs. Players in the medical device industry are focusing on personalized healthcare solutions and devices to gain a bigger slice of the market.Get More Info

Shift in business models

The modern day medical device industry is going through a tectonic shift in business models. The increased connectivity between devices, physicians, and consumers are inflating the demand for high quality, personalized, and patient-centric care. Today, the volume-based fee-for-service models in the medical device industry are shifting to new incentive models that focus on value-based metrics. Though traditionally the OEMs have been able to compete with conventional business models without much differentiation, a long-term strategy would necessitate OEMs to create innovative and sustainable business models that will result in efficient healthcare delivery, reduced costs, and improved medical outcomes.

There is a colossal amount of patient and healthcare data being generated each day. This spawns fundamental questions about patient privacy and safety. Albeit the incrementally, regulatory authorities are still evaluating out the implications of new technologies on patient security and care. In reality, apart from becoming heavy on the pockets for healthcare companies, data breaches also give rise to serious concerns regarding patient safety. Therefore, the need to strike a balance between advancements and protecting patient security and safety is, therefore, paramount.


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Market Opportunity Assessment for a Medical Devices Startup

Despite the recent technical developments in the medical device industry, leading manufacturers of medical devices face challenges pertaining to regulatory compliance, product quality, and market expansion.

The 21st century has ushered in an era of business which plausibly is the most challenging in history. Since the market for medical devices has weakened globally, several players looking to enter newer markets face several challenges including – international competition, financial crisis, and changing government policies. However, medical devices manufacturing firms should cope with these challenges to withstand the growing competitive pressure.

However, for a startup that is relatively new in a particular market, it is best recommended to invest in a detailed market opportunity assessment to gain comprehensive insights into the market conditions prior to expansion.

The Business Challenge

  • The Client: A medical devices startup

To understand the market expansion opportunities in the Asia Pacific region, the client – a medical devices startup – approached Infiniti to engage in a market opportunity assessment. The client wanted to gain detailed insights into the market landscape of the target region. Their primary objective was to evaluate the viability of market expansion based on the competitive environment and regional players.

Also, with the help of the market opportunity assessment, the medical devices client wanted to gauge various factors affecting market expansion in the specific region.

How Can Market Opportunity Assessment Help Players in the Medical Devices Market?

Market opportunity assessments offer detailed insights into the market landscape, which help businesses to identify the market opportunities and risks prior to expanding their business offerings.

In today’s business scenario, medical devices manufacturers are under inexorable pressure to stay relevant in a rapidly evolving marketplace. Infiniti’s market opportunity assessment enables medical device companies to gain a detailed understanding of the industry barriers, challenges, and opportunities to devise precise business expansion plans.


Summary of Our Market Opportunity Assessment Engagement

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Client Journey

With the help of Infiniti’s market assessment, the medical devices client was able to expand their business by gauging the growth projections in the Asia Pacific region. The solutions offered also helped the client to identify relevant data and use it to establish a competitive position within the geographical segment.

Furthermore, to help the client identify the market dynamism and future potential in the Asia Pacific region, the market opportunity assessment experts at Infiniti conducted a detailed market survey to help them gain a better understanding of the medical device industry. The approach included primary and secondary research methodologies coupled with qualitative and quantitative data collection procedures. The experts also reached out to various stakeholders in the medical devices market.

Solution Benefits and the Business Impact

Infiniti’s market opportunity assessment experts offered detailed market insights that helped the medical devices firm to identify barriers to entry and market requirements and gain a stronger foothold in the new geographical segment. Also, with the help of our solutions, the client was able to understand the market for the particular product group and devise effective strategies for long-term success.

The Future

The medical devices industry has witnessed a rollercoaster of changes, new challenges, and impressive growth. Owing to the rapid medical advances, the medical devices sector is set to experience massive growth in the coming years. While the wearable medical devices segment is still in its relative infancy, leading medical devices manufacturing companies are already focusing on delivering new and innovative solutions in an attempt to improve business growth.


A must-read case study for strategy specialists and decision makers looking to develop an understanding of the medical device industry.

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Top Five Robotic Surgery Companies Redefining the Future of Medical Surgeries

All doctors take in a lot of information about the human anatomy, diseases, surgeries, and health from books. However, when it comes to performing surgeries, books won’t be as helpful as surgical precision depends on the expertise of the medical professional performing the operation. Robotic surgery or robot-assisted surgery allows the doctor to perform a variety of surgery with higher precision, flexibility, and control. Currently, they are widely used in minimally invasive surgery, which can significantly speed up recovery times. Robotic surgery companies are looking at innovation to extend its scope beyond minimally invasive surgeries and incorporate artificial intelligence to improve surgical efficiency.

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Intuitive Surgical

Intuitive Surgical is an American corporation involved in the development and production of medical robots that improve the patient outcomes through minimally invasive surgeries. The most commonly known robot, da Vinci Surgical System, introduced 17 years back, is a product from Intuitive Surgical that has been used for more than three million minimally invasive procedures across various surgical specialties. The product features a high-res 3D vision system and tiny wristed instruments that have a higher degree of movement and flexibility than a human hand. As of 2017, 4,271 units of this medical robot have been installed worldwide.

Hansen Medical

Hansen medical is one of the top robotic surgery companies based out of Silicon Valley, California. Hansen’s Magellan robotic system’s robotic catheter can navigate the peripheral vasculature and provide a channel for the placement of therapeutic devices. Magellan™ Robotic System, Auris, and Sensei X Robotic systems are two of its medical robots used in vascular and cardiac arrhythmia related surgeries.

Medrobotics

Medrobotics is a Massachusetts-based company that recently announced a US$20 million in financing to expand into general surgery and build next-generation robotic system. Its product Flex Robotic System received FDA clearance in 2015 and allows physicians to access anatomical locations such as ear, nose, or throat with its snakelike design and 180° path.

Verb Surgical

Verb surgical is one of the most innovative robotic surgery companies in the world and was formed as a strategic partnership between Google’s Alphabet and Johnson&Johnson’s medical devices subsidiary, Ethicon. They are focusing on building a digital surgery platform that combines robotics, advanced instrumentation, advanced visualization, data analytics, and connectivity. Such robotic surgery companies bank on big data and machine learning expertise from Google to develop a digital surgical platform, which will cost less than the current medical robots.

Microbot Medical

Microbot Medical is a US-based robotic surgery company that offers nanobot technology (ViRob and TipCAT) to assist in surgeries. One of its platform, ViRob, is capable of crawling and navigating through blood vessels, digestive tract, and the respiratory system. Such abilities enable it to treat hydrocephalus, water in the brain disease, successfully.

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Market Opportunity Assists a Renowned Medical Implants Manufacturer to Devise New Product Offerings

In recent years, the relentless growth of technologies has brought about numerous innovations in the medical devices manufacturing space. Also, with the growing preference for better healthcare services among the populace, renowned medical implants manufacturers are poised to scale new heights. Furthermore, with the easy accessibility of healthcare services, consumers are looking out for promising healthcare solutions with better accuracy and lower costs. To shift toward service-oriented models and meet the rising demand for healthcare services across niche market segments, leading manufacturers in the medical implants space are facing the need for market opportunity assessments. Market opportunity assessments can help organizations to discover potential market opportunities and evaluate the unmet needs of the customers. Also, companies can efficiently monitor their competitive advantage and allocate adequate resources to meet the needs of the customers.

Infiniti’s market opportunity assessment helps companies analyze the business environment in terms of the legal and compliance issues, economic conditions, and trends. Moreover, companies can analyze the key competitors and create a new market profile to understand different product attributes and its effect on the customer’s decision-making process.

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The Business Challenge

A renowned medical implants manufacturer with a considerable number of manufacturing units spread across the globe was facing certain predicaments profiling the target customers and setting sales projections. Moreover, the client wanted to describe key value propositions and gain a better outlook on the market. With the help of market opportunity assessment, the client wanted to identify the impact of new disruptive technologies on the market and find best possible ways to acquire potential customers. Through this engagement,  the medical implants client wanted to address the vulnerabilities or limitations that can hinder the client’s growth.

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Our Approach

With the aim of identifying potential opportunities in the medical implants manufacturing space, Infiniti’s market opportunity assessment experts carried out extensive research comprising quantitative and qualitative research with the leading stakeholders in the medical implants manufacturing space. To discover better marketing practices, market opportunity experts also compiled information from a wide array of proprietary sources such as paid industry databases, company presentations, and industry forums.

Benefits of the Market Opportunity Assessment:

  • Profiled potential customer segments and differentiated products and services
  • Identified the unmet needs of the customers and discovered future opportunities
  • Analyzed the strengths and weaknesses of the products and viewed different distribution channels
  • Identified the disruptive technologies in the market and their impact on the business
  • Established partner relationships and devised an effective go-to-market strategy

Benefits of Our Integrated Approach

With the help of the market opportunity assessment, the client was able to revamp the existing customer base and chase different customer segments. Moreover, the engagement also assisted the client to identify and address competitor threats and analyze potential market opportunities. Also, the engagement further helped the medical implants firm train their sales force to market their products effectively. The renowned medical implants manufacturer was further able to tap different market opportunities and gain better returns on their investment.

A must-read case study for strategy experts and decision makers looking to develop an understanding of  the healthcare industry.

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ACA vs. AHCA and its Impact on the Medical Device Industry

Thanks to the ongoing healthcare bill debate between the Affordable Care Act (ACA) and the American Health Care Act (AHCA), the market space for health care in the US has been the center of attention across the globe. In the year 2010, a new healthcare bill named the affordable care act, more commonly known as the Obamacare, was brought into effect by the president of the US. The affordable care act was introduced with the objective to improve health care in the US by making health insurance coverage accessible and affordable to all. Through the affordable care act, the United States was one of the few developed countries to offer universal health care to its residents.

However, when the political reign shifted to president Trump’s administration, the Republican party introduced a legislation to repeal the affordable care act and replace it with the American health care act, with certain reforms. While the AHCA plan looms under the clouds of uncertainty, groups of doctors, nurses, hospitals, and patients have contested against the GOP’s health care plan to repeal Obamacare with the AHCA. One group missing from the opposition against the new health care bill are the medical device manufacturers organization.

What is the difference between the Affordable Care Act and the American Health Care Act

The American health care act, the GOP alternative health care bill that aims to repeal Obamacare (ACA), has been introduced with certain amendments to the latter. There are certain similarities and differences between the affordable care act and the AHCA; let’s have brief look at each. The similarities between the ACA and the AHCA are as follows,

  • The pre-existing medical conditions such as pregnancy or cancer will still be covered under the new coverage options, and insurancea2 companies cannot refuse the coverage for the same
  • Both the legislative pieces, the affordable care act and the American health care act, offer coverage to young Americans under their parent’s insurance till the age of 26
  • The affordable care act and the AHCA still prohibit the insurance plans from setting a lifetime limit and also offer tax credits to the citizens who buy insurance coverage

 

While a few aspects have been retained, there are few amendments made by the Republican party in their quest to repeal Obamacare through the GOP health care bill, replacing it with president Trump’s proposed health care reforms. The differences between the two are as follows,

  • AHCA eliminates the individual and employer mandate and the resulting penalties by making health insurance coverage optional for both the parties
  • Under the GOP alternative, Medicaid expansion is brought to a halt and restricts federal funding to facilities that offer abortions and planned parenthood
  • The proposed bill intends to repeal the taxes on health care and related services such as the over-the-counter medications, prescription drugs, health insurance and the medical device manufacturing industry, which was used by the affordable care act to pay for their plans

AHCA and Its Impact on Medical Device Manufacturers

Under the AHCA, the medical device manufacturers are set to witness sustainable growth that was capped by the excise tax of up to 2.3 per cent on the annual sales to help fund Obamacare. Under the affordable care act, this tax amount would be used to extend coverage to millions of American citizens without a health insurance coverage. The medical device manufacturing industry in the US develops, produces, and sells medical devices and surgical equipment such as high tech devices such as pacemakers and hearing aids across the globe. However, with the introduction of the affordable care act, the medical device manufacturing industry saw a significant loss of American jobs within a span of two years and scaled back their investment in research and development, and other related capital spends.

The drug, biotech, and medical device makers are set to benefit under the new reformed health care bill proposed by President Trump’s administration as it eliminates taxes worth billions of dollars on the industry. The medical device manufacturers have deemed the health care bill by the Republican party as a positive step towards eliminating medical device tax completely.

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