Tag: top medical devices companies

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How Medical Device Manufacturers Can Improve Product Quality

The medical device industry continues to innovate aggressively and record stronger growth with each passing year. The key growth enablers for medical device manufacturers include the underlying demographics and the innovation and expansion in clinical applications of medical devices. Against this backdrop, it has become more important than ever before for medical device manufacturers to ensure improved quality in the design, manufacture, and distribution of devices. Furthermore, the rising regulatory compliance requirements imposed by FDA is further putting pressure of companies in the medical device market to prevent themselves from the risks of non-compliance.

Why quality compliance is paramount for medical device manufacturers

As a single error caused by a medical device can have severe consequences not only for the patient but also for stakeholders of the medical device company. One major quality related issue can significantly reduce the share price of medical device manufacturers. As most medical device manufacturers are aware of this risk, they give increased emphasis on quality.

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Improving quality can bring costs down significantly for medical device manufacturers. Request a free proposal to know how Infiniti’s experts in the medical device industry can help you identify and curtail both direct and indirect cost that you may incur.

How to ensure medical device quality

Some recent high-profile device failures have led to major product recalls that are costly and impact significantly patient care. To avoid such mishaps medical device manufacturers can undertake some of the following strategies to ensure and maintain medical device quality:

Quality assurance through regulations

Since there is increasing focus being given to value-based patient care, regulatory bodies have tightened the compliance requirements to increase transparency and ensure medical device quality and efficacy. There is also intensified compliance requirements for post-market surveillance, device submissions, quality systems, cyber security directives. With such stricter norms and greater emphasis being given to patient safety, medical device manufacturers must establish processes to achieve compliance through device identification, clinical data collation, and labeling improvements. Using a unique device identification (UDI) system backed by a centralized database will promote the traceability of each device and in turn maintain quality standards.

Maintaining quality is not the only challenge faced by medical device manufacturers. Get in touch with our experts to gain an overview of how our solutions can help you identify challenges that are most likely to affect your organization and strategize an action plan to overcome them.

Creating culture of quality in the organization

Quality begins with every employee in a medical device company and includes every process and procedure ranging from development to delivery. This involves implementing robust quality standard processes across the business. By Improving quality across operations and establishing a comprehensive control mechanism, encompassing people, process, product, and assets, medical device manufacturers can cultivate a culture of quality.

Embracing quality management best practices

The need to curtail losses due to device failure and to comply with government mandates, medical device manufacturers must give more focus on quality management. The help of innovative technologies can be used to develop high-quality products. This includes additive manufacturing for producing customized implants, lasers to facilitate precision manufacturing, micro molding of silicone to manufacture accurate minimally-invasive surgical devices, and low-friction fluoropolymer coatings to efficiently lubricate the guide wire that is used in cardio-vascular surgeries. Furthermore, a risk-based approach would be more effective in ensuring design and manufacturing accuracy for life-critical machines. For instance, in blood line tubing, higher control over cooling water temperatures after extrusion is required compared to PVC tubing to reduced low microscopic defects.

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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.

Facing difficulties in identifying a good packaging strategy and meeting packaging standards in the industry? Request a free proposal to know how our solutions can help you solve such roadblocks.

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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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5 Challenges Faced by Medical Device Companies in 2018

Over the past couple of years, FDA-regulated industries such as the medical devices industry have witnessed a myriad of changes. The advent of value-based reimbursement models and accountable care has resulted in a seismic shift in the way top medical device companies operate. In the wake of this new era, focusing on data and the value of medical devices will notAsk An Analyst be enough to boost ROI. This has forced medical device companies to look for new avenues to boost revenues and profitability.  Today, buyers expect medical device companies to offer solutions that bundle device, data, and analytics for improved decision making. And with the shift towards value-based care, medical device companies must offer solutions that can deliver actionable insights for use in existing electronic medical record systems. Our analysis of the global market landscape shows that the medical device companies are facing challenges in terms of:

  1. Adapting to the shift towards value-based models
  2. Maintaining profit margins with products that elude commoditization

Meeting such challenges can be made simple if medical companies leverage an interoperability platform to devise solutions with excellent data integration and aggregation capabilities. Apart from the challenges mentioned above, here are some of the other challenges faced by top medical device companies.

  • Increasing standards and overheads

Recently, there has been a drastic increase in the number of medical devices that are being manufactured and sent for approvals to the FDA. Studies indicate that the time taken for processing has increased by more than 55% in a span of five years. This poses a major challenge for medical device companies who are looking to outperform their competitors by launching more innovative products in the market.

  • Complexity of new medical devices

To stay on top of the competition, top medical device companies have started manufacturing products that are more complex and integrated when compared to their predecessors. This increase in the complexity results in a rise in the cost of field service and repair processes. Another point to note here is the fact that due to the increasing complexity of devices, the cost of training field service specialists and engineers has doubled.Ask An Analyst

  • Meeting customers’ expectations

Today, people all around the globe have access to the Internet and smartphones. Customers, therefore, have numerous choices and demand more from medical device companies, especially in terms of implementing more aggressive SLAs. The end-users of medical devices are also demanding more from their reduced capital and are now asking for better incentives.

  • Shift towards home-based care

With the growing popularity of home health care services and POC tests, medical device companies have had to migrate towards the production of home-based health kits. This threatens to reduce the spend on capital programs for developing new lab equipment.

  • Reimbursement reductions and rising competition

The implementation of new schemes to reduce reimbursements for medical assays by insurers is reducing manufacturers’ ability to fund capital for their new devices. In addition, high competition from emerging companies, such as start-ups, will reduce the profit margins of top medical device companies and erode customer loyalty.


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