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medical device companies in Germany

Implications Of COVID-19 On Pharmaceutical and Medical Device Companies in Germany

Pharmaceutical and medical device companies in Germany have shifted into overdrive to help combat the coronavirus outbreak. While the pandemic continues to wreak havoc across the country, large and small corporations alike are engaged in developing strategic solutions to curb the spread of the virus. One of the key concerns that remain to be addressed is will COVID-19 exacerbate the existing drug shortage in Germany? In Germany, the supply chain for drugs is highly vulnerable. The situation has been such even before the breakout of the pandemic. Apart from this, Germany’s pharma and medical device industry are also battling with other major roadblocks including delays in clinical trials, barriers to accelerated digital transformation, and lengthy procedures for market access.  

 In this article, industry experts at Infiniti Research address a number of key issues that could specifically impact the pharmaceutical and medical device companies in Germany.

 Delay in clinical trials

Ongoing clinical trials and studies in Germany are undergoing considerable delays due to the coronavirus outbreak. This could eventually result in deviations from the existing study plan. The German Federal Institute for Drugs and Medical Devices is expected to soon publish harmonized recommendations pan EU. According to the initial guidance on the management of clinical trials during the COVID-19 pandemic that was published during mid-March by the European Medicines Agency (EMA) and European Commission and the Heads of Medicines Agencies (HMA), sponsors must critically evaluate their need to start a new clinical study or include new study participants in an ongoing study. In the case of ongoing clinical studies, sponsors are expected to consider the extent to which they can temporarily suspend the study in certain facilities and/or extend the intended overall duration of the study. Pharmaceutical companies must analyze the probable impact of the pandemic on their upcoming or on-going clinical trials and notify BfArM or EMA at an early stage to submit amendments or clarify uncertainties.

Barriers to accelerated digital transformation

Pharmaceutical and medical device companies in Germany are being expected to expedite their digital transformation process. This comes in the wake of the increasing need to enable remote consultations for medical professionals and also to enable sales and advertising outside healthcare premises. However, the digital approach raises several concerns, especially related to data protection. As pharmaceutical and medical device companies in Germany adopt new digital approaches that relate to cooperation with healthcare professionals, they must also be checked for compliance with existing applicable drug advertising, social, and professional laws and regulations.

Lengthy market entry regulations for PPE

Personal protective equipment (PPE) includes medical equipment such as protective goggles, masks, gloves, and protective clothing. Products that qualify in this category often require lengthy conformity assessment before their medical device market entry. In an attempt to adapt the supply of these products to the rising market demand, the EU has now sought to simplify the market entry process for PPE to a considerable extent. They have also requested market surveillance authorities and notified bodies to take all available measures to provide immediate access to PPE and medical devices for healthcare professionals during the prevailing healthcare crisis. As such, medical device companies in Germany must carefully evaluate and coordinate with the competent supervisory authorities and notified bodies to determine whether their products are eligible for healthcare market access facilitation in line with the commission’s recommendation.

Gain more insights on how our market intelligence solutions can help pharmaceutical and medical device companies in Germany can measure the impact of coronavirus on their business and strategize to meet the changing market needs.

The US Healthcare Industry Analysis 2019

The US healthcare industry is increasingly moving from volume-based to a value-based model wherein the key focus will be on improving patient health and ensuring that they are given good care. A value-based model in the healthcare industry would mean lesser revenues/profits for the providers. However, our healthcare industry analysis reveals that treating patients like members of the healthcare system will eventually increase the brand loyalty, help improve goodwill and brand reputation, and thereby enhance the overall health of the nation.

Why is strategic healthcare industry analysis important for providers? Read this blog to find out.

Benefits of Strategic Analysis in the Healthcare Industry

An effective healthcare industry analysis helps providers to stay updated with the latest trends and challenges coming their way. Request a free brochure to know how healthcare organizations can leverage Infiniti’s solutions to stay abreast of the dynamic market.

Top healthcare industry trends 2019

As the healthcare industry makes the shift towards a value-based system, here are some of the key US healthcare industry trends to watch out for:

Healthcare Industry analysisWant to know more? Download free resource from Infiniti Research to gain comprehensive insights into the top trends for 2019 based on our latest healthcare industry analysis.

The future of healthcare industry

The aging population, rising rate of chronic diseases, and exponential advances in innovative, but costly, digital technologies continue to increase health care demand and expenditures. Based on our healthcare industry analysis, here’s our take on key events that would redefine the future of healthcare:

Creating financial sustainability

The performance of the US healthcare ecosystem is greatly being impacted by the increased use of advanced technologies, the rising popularity of personalized medicine, and the demand for expanded care delivery sites. Furthermore, a closer look into the results of recent healthcare market research studies shows that healthcare spending is expected to rise over 5% annually from 2017-2022. Companies in the healthcare sector are now stressing rigorous financial management, efficient operational performance, outcomes-based care, and development of innovative solutions. As a result, there could be improved care provision, reduced costs, declining margins, and aligned cost structure and care models. We can also expect to see developing public-private partnerships and companies in the sector learning from industries outside of healthcare.

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Our healthcare industry analysis suggests that three out of five healthcare providers face difficulty in maintaining financial sustainability. Request a free proposal to find out how we can help you overcome this challenge.

New care delivery models

As discussed earlier, as the healthcare sector in the US is moving from volume to value based delivery models. This will require building an outcomes-based financial model and data infrastructure that will facilitate and maximize value-based care reimbursement pathways. Factors including patient preferences, clinical innovations, and changes in government program payment policies are pressurizing healthcare organizations to shift to alternative points of care. Stakeholders across the healthcare ecosystem must collaborate around new approaches to funding and delivering sustainable healthcare. Investments in advanced technological capabilities such as telehealth could expand services while also helping organizations bend the cost curve.

Regulatory compliance and cybersecurity

Data is the new healthcare currency. So, it is vital for providers to protect healthcare data. The rising market complexities and increase in the number of data breach cases have amplified the need for stringent regulatory and risk management-related government policies. Apart from this, it is critical for healthcare providers to strengthen their focus on compliance and ethics. Focus must also be provided to driving awareness throughout the enterprise.

Cybersecurity is an ongoing issue in the healthcare sector. Read Infiniti’s blog to discover five great ways to improve cybersecurity in healthcare.

5 Great Ways to Improve Cybersecurity in Healthcare

Infiniti’s healthcare industry analysis solutions

The growing healthcare market offers several new opportunities and risks for companies in this sector as well as for those that operate in the broader healthcare value chain. Today, the healthcare industry is at a tipping point, due to which leading market players are now partnering with best-in-class healthcare industry analysis providers such as ours. We provide comprehensive healthcare industry analysis and explore new avenues and markets for growth.

 At Infiniti Research, we help healthcare players to address market challenges by delivering in-depth healthcare industry analysis that highlights the key factors that drive undercurrents of change in healthcare. Our expertise in the field of market research enables us to offer tailored and incisive market intelligence solutions that empower healthcare leaders to gauge how prepared and well positioned they are for the future.

REQUEST MORE INFO to know more about healthcare industry analysis can help providers:

 

Top 3 Digital Solutions for Preventive Health Care in 2019

Today, no one can dispute the fact that technology that has enabled all of us to live healthier and longer lives. From surgical robots to smart hospitals, digitization has become inevitable and is revolutionizing patient care in innovative and exciting ways. Healthcare and technology are becoming inextricably linked with new discoveries and innovations becoming the new norm in the industry.  Many health-related services and devices have been developed in recent years with the intention of improving the quality of life of everyone. This has resulted in the implementation of innovative digital solutions for better preventive health care delivery by many international healthcare companies. In this article, we have talked about some of the most useful digital solutions for preventive health care in detail to help you serve your customers with better healthcare services.

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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.

Want to know more about what’s trending in the medical devices industry?

supplement market

Healthcare Reimbursement Scenario in China and Japan: A Nightmare for Medical Device Manufacturers

There are two fundamental working models for health insurance, the first being the out-of-pocket expenses paid by the insured, which is then reimbursed by the insurer and the second being the direct payment model, where the insurer pays the amount directly to the healtha2 care provider. Even though health insurance may seem like a relatively simple process, changes in country, governance, policies, laws, insurance agents, and healthcare acts make it a complicated affair. In the case of China and Japan, the majority of its population is covered under its universal healthcare system or insurance program. The government spends a lot of money in healthcare reforms in an attempt to bring the healthcare cost down and reduce insurance frauds with better healthcare reimbursement plans. A large chunk of this healthcare cost is spent in the sourcing and procurement of medical devices. The government tries to reduce the cost burden to the healthcare facilities by reimbursing a part of the cost of medical devices. But procurement processes for these medical devices is complicated as the reimbursement rates cannot be easily calculated.

The complexity of reimbursement plan poses a critical challenge for suppliers as well as the buyers for these medical devices. Here’s how Infiniti Research approaches this problem and offers a definitive solution to concerned stakeholders:

Understanding the Complexity of Medical Insurance in China and Japan

Japan

In order to reduce their overall government spending in the medical sector, the Japanese government has been lowering the reimbursement rates for medical devices over the past three years. They have also made attempts to promote domestically procured medical devices and doesn’t recognize CE markings or FDA certificate. Since there is a lack of private insurers in the Japanese market, suppliers are obliged to clear their products for medical reimbursement. Despite the difficulties and confusing classification of devices, if a manufacturer wants to list his device, they have to benchmark their prices with approved prices based on device classes.

China

China also assumes a similar stance to promote domestically procured medical devices. But, there exists an added complexity in the procurement of the medical devices as they employ tendering and bidding process, which is conducted at national, provincial, and hospital levels. Apart from the rigorous tender and bidding process and lengthy regulatory and reimbursement approval procedure, the system also lacks a standardization procedure as the reimbursement is based on a multitude of factors such as age, place of residence, class of medical device, type of hospital, average employee wages, and local level income. The larger portion of medical device expenses is paid by the patients, as a result of which the Chinese government is making efforts to increase coverage of their health insurance plans.

So Why Should Manufacturers be Concerned about the Reimbursement Scenario?

Gaining an understanding of the reimbursement scenario simplifies and speeds up the regulatory approval process. The manufacturera2 should have a thorough knowledge of medical device classification to benchmark imported medical products with domestic products. In some cases, it is essential to modify products to suit the local requirements and to comply with reimbursement standards. Since the government has made the procurement of imported devices unfavourable, foreign players can look for mergers and acquisitions to increase their survival chances and enjoy reimbursement benefits.

Challenges Faced by Foreign Medical Devices Suppliers in Tackling the Reimbursement Scenario

Japan

  • Presence of multiple regulatory bodies
  • Complicated medical device reimbursement application and review procedure
  • Preference towards domestically manufactured devices
  • Lack of knowledge on the dynamic Japanese medical devices market
  • Regular price revisions and lowered reimbursement rates
  • Lack of proper categorization of imported medical devices
  • Unclear grouping of medical devices for reimbursement
  • Requirement of local influence for survival

China

  • Complex reimbursement calculation methods
  • Low reimbursement for complex medical devices
  • Exclusion of multiple components by government insurance
  • Variation in deductibles and hospital tier level affects the reimbursement percentage
  • Locally manufactured devices having higher proportion of reimbursement
  • A host of factors such as age, income, city of residence, occupation, hospital locality, and family structure for consideration of reimbursement to patients

How Infiniti Research Equips Foreign Medical Equipment Suppliers to Tackle the Issue:

A lot of information is available regarding the medical reimbursement scenario in China and Japan, but it is either outdated, irrelevant, or impractical. The existing reports usually focus on a general overview of medical reimbursement scenario excluding the intricacies and don’t offer scope for new adjustment in regulatory changes. Infiniti Research addresses all these problems and provides a systematic solution for medical device manufacturers to provide product-wise reimbursement information.

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Information pertaining to medical devices is extracted from public registries, government, private databases, traditional media, internet scan, local language resources, and insurance aggregators to create a sound basis for reimbursement models. Research experts at Infiniti Research also assess the reimbursement scenario for each device and start by building models from scratch, making realistic assumptions on inputs from physicians and industry insiders. The models are then validated from KOLs, other doctors, insurance agencies, hospital departments, and regulatory bodies.

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Cosmetic packaging

Pain-Free Reimbursement Pathways for Wound Care Dressings

With path-breaking growth in innovative technologies, the medical device industry is here to stay. In terms of key products, this industry consists of medical devices like orthopedic instruments, surgical instruments, diagnostic apparatuses, stents and catheters, syringes and hypodermic needles and intravenous equipment. Hospitals and physicians use a wide array of medical devices, but it must be noted that it’s the public and private payers who reimburse and set the rules. Having the right medical device reimbursement strategy in place will help your business stay ahead of competitors by understanding the profitability of products. Not just that, it will also ensure that companies have a great revenue stream and profitability for new technologies.

In the wound care industry, getting insights into the right medical device reimbursement pathway is important for ameliorating sales growth in the future. Whether you’re venturing into the medical device industry or a medical device company, you can count on us to help you make the right decision. At Infiniti, we give you insights into the 5 top ways on how to work on your medical device’s reimbursement.

  1. Plan right from the design phase – Your medical device reimbursement assessment starts right when you design the type of wound care dressing. This is where our medical device reimbursement consultants will thoroughly analyze the impact on product design and its sales.
  1. Be prepared for the shortfalls – Fee-for-Service (FFS) medical reimbursement model and value-based purchasing (VBP) medical reimbursement are some of the limitations faced by the professionals in the industry.
  1. Think from a medical director’s perspective – If you’re having a tough time getting the right coverage for your wound care dressings, it’s time to feel their pain. Market your product to a payer. Anticipate their objections.
  1. Analyze country-specific reimbursement pathways – Though the reimbursement pathways are easier to navigate because they are often single-payer, government-based systems, coverage decisions are made by the local Medicare Administrative Contractors (MACs). Get your personalized analysis of location-specific reimbursement pathways here.
  1. Broaden your spectrum – When you develop a new wound care dressing product, try not to focus on the clearance only from the U.S. Food and Drug Administration (FDA). But, also try and meet requirements from Current Procedural Terminology (CPT, a registered trademark of the American Medical Association) and/or Healthcare Procedure Coding System (HCPCS) codes.

 

If you’re a medical equipment company, we understand how crucial it is to obtain coverage and funding for your healthcare products. At Infiniti, our medical device reimbursement consultants are here to assist you effectively. With the help of our market assessment plan, innovation tracking and stakeholder intelligence, you’re sure to get your medical device reimbursement plan in place and gain strategic insights into the wound care dressings industry.

Want to know how we helped a global medical device manufacturer improve ROIs for their products?

Read more here

Market Opportunity Study for the Surgical Disposables Segment

Getting insights into the current market scenario, analyzing the marketability of products, and identification of potential customers are key to understanding the marketability of products.

 

With the increasing affluence of the global population, most people have started caring more about their health issues than problems such as famine or hunger. Even today, many people across the globe die because of contagious diseases or infectious diseases. Can you imagine what the result will be if someone who is undergoing surgery iscapture accidentally infected with other diseases through equipment such as a blood transfusion set or bags used for blood collection? The repercussions of such instances of carelessness would be huge for hospitals using such contaminated equipment. Consequently, while providing services to raise the utilization of healthcare facilities, it becomes essential for healthcare providers to take the patient’s health and safety into consideration and enhance the utilization of surgical disposables. By doing this, instances of unnecessary death rates can be prevented and a high living standard can be assured, which subsequently will prompt the use of surgical disposables.

Since the past decade, the global market space for surgical disposables has been witnessing profound growth and has consequently resulted in the influx of products such as latex gloves, disposable syringes, and infusion or transfusion sets, including needles, catheters, and infusion bags. At Infiniti, our “market entry strategy support” team understands that due to this market’s competitive nature, suppliers are finding it difficult to develop effective strategies for market entry. The competitive nature of this industry also makes it difficult for manufacturers and strategy experts to understand the market’s competitive dynamics to estimate the marketability of their products across target regions.

The Business Challenge

With a keen eye on exploring future growth opportunities and understanding the market size for surgical disposables, the client – a global manufacturer of plastic packaging and protection products for household, food, healthcare, and industrial applications – was looking for effective market entry strategy support for its products across South America. To meet the client’s specific business requirements, industry experts carried out an in-depth market opportunity study to assess current and projected market size and demand trends for disposable surgical gowns, drapes, and back table covers across target regions.

The scope of this in-depth market opportunity study was to offer the client insights into the market today, and it’scapture2 potential moving forward. Most companies operating in this market space believe that, in regions such as South America, the current hospital infrastructure is affecting the hesitancy to move towards disposables. However, a key to understanding the extent of how large investments in healthcare laundry is affecting this uncertainty is to gain an understanding of the reimbursements offered to hospitals.

Additionally, Infiniti’s market entry strategy support team tracked recent developments and innovations in the market through secondary journals and reached out to relevant stakeholders, including industry experts, KOLs, product users, and procurement experts to understand their views on the market landscape. Our research team also spoke to stakeholders responsible for the sales and distribution of surgical disposables to understand how the market would grow in the near future to validate the market size and opportunity model developed for this segment.

Why Infiniti Research is the preferred partner for more than 55 Fortune 500 Companies

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Solution Offered and Business Impact

Based on the nature of this engagement, market entry specialists, who have considerable experience in medical devices and healthcare segments, carried out this project through a combination of research methods aimed at the accurate assimilation of market information followed by data validation and tabulation. The research methodology also encompassed an analysis of proprietary and other secondary sources such as paid industry databases, annual reports, media platforms, news aggregators, and industry forums to develop initial market hypotheses and identify key stakeholders. The market opportunity engagement also offered the client insights into medical practitioners, surgeons, hospital staff, industry experts, and key market stakeholders.

In just eight weeks, the client – a global manufacturer of plastic packaging and protection products for healthcare, and industrial applications – was able to gain a better understanding of how the current healthcare infrastructure in regions such as South America will affect the marketability of their products in the market today and its potential going forward. We also offered the global manufacturer insights into the market’s data, including but not limited to hospitals/clinics/office, procedures per year, breakdowns on procedure types, and an understanding of how to effectively access the market for disposable gowns.

To assess challenges specific to the surgical disposables market space, Infiniti’s healthcare analysts have developed an extensive proprietary database consisting of information on more than two million industry experts, doctors, physicians, key opinion leaders, medical technicians, payers, end-users, and patients.

What do the clients appreciate about our approach?

In a relatively short period of time, just eight weeks, the client saw clear benefits from our relationship. The market opportunity service offered by Infiniti’s market entry strategy support team helped the client augment their revenues by offering insights into how reimbursement policies for hospitals will affect the sale of surgical gowns, drapes, and back table covers across target regions.

Here are some of the key points appreciated by our clients

 

  • Dedicated Market Intelligence 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 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 a patient 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 case study for strategy experts and decision makers looking for market entry strategy support.

 

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Surgical Disposables Segment

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