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Medical device outsourcing

Weighing the Challenges and Benefits of Medical Device Outsourcing

Owing to constant cost pressures coupled with rising expectations to reduce time to market, medical device manufacturers are increasingly engaging in outsourcing their device manufacturing and assembly in full or partially. This creates room for medical device companies to focus more on their core competencies and also capitalize on opportunities for cost reduction and speed to market. But are these the only factors that companies must consider before committing to a medical device outsourcing partner? Experts at Infiniti Research believe that there is much more to evaluate and measure when it comes to medical device outsourcing, especially in terms of adhering to the required quality standards. From the common pitfalls to assessing an outsourcing partners’ vertical integration capabilities, this article encapsulates the core benefits and the many factors to consider before engaging in medical device outsourcing.

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Medical device outsourcingBenefits of medical device outsourcing

Capitalize on resources

Medical device outsourcing facilitates OEMs to take advantage of the third-party resources without having to source and store them locally or train personnel. This will ultimately result in more cost-effective production. Countries including Taiwan, China, and Korea are top medical device manufacturers. Therefore, it is more viable for a US medical device company to outsource production operation entirely overseas rather than bringing in equipment to manufacture medical devices, both in terms of cost and maintaining quality standards.  

Focus on core activities

Relying on medical device outsourcing companies gives the opportunity to give more attention to other core activities such as R&D of new medical devices and marketing and promotion of existing products. By doing so, medical device companies can also eliminate challenges relating to recruiting and training new employees in the manufacturing process.

Better cost savings and service delivery

Improved cost savings and service delivery are the key features that have fueled the growth of the medical device outsourcing market over the last couple of years. By outsourcing to manufacturers who are solely focused on production, MedTech companies can ensure that their delivery schedules are met without having to worry about resource (human and materials) related issues.

This is just one side of the coin of medical device outsourcing. Let’s delve into some of the key challenges that companies face in the process of outsourcing.

Challenges of Medical device outsourcing

Data and information security

One of the most pressing challenges in outsourcing medical device manufacturing is the threat of loss of private information. In the medical device outsourcing process, it is vital to share technical proprietary information with the manufacturer, increasing the chances of losing private information. This adversity of such risks is more in the case of information being shared with manufacturers in international locations.

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Reimbursement policies

The incessant pressure on medical device companies to reduce the product pricing coupled with cost reduction measures taken several market players are hampering the medical device market. Although there is a protuberant increase in healthcare expenditure, many healthcare providers are still reluctant to reimburse medical devices. If this situation prevails, it could affect the medical device outsourcing market at large.

Delay in contractual obligations 

Another major challenge faced by MedTech companies while outsourcing is the delay by manufacturers in meeting contractual obligations. As in most cases, medical device outsourcing is done with manufacturers overseas, there may be several communications gaps and challenges to getting work done faster within the expected time frame. Also, quality check in case of materials used and production process becomes difficult to monitor.

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medical device industry

Navigating Through the Present and Future of Medical Device Industry: In Conversation with an Infiniti Research Thought Leader

Abhishek Kumar, Manager – Custom Research (Market and Competitive Intelligence) at Infiniti Research has over 7+ years of cumulative experience. He is a thought leader in strategy consulting, market intelligence, and competitive insights. He has extensively worked with Infiniti’s clients in the healthcare and medical devices domain, specifically on topics relating to market entry, market potential, and emerging opportunities assessment. 

The medical device industry is characterized by its heterogeneous, innovative, and dynamic nature. As digital technologies are majorly transforming the healthcare sector, a revolution is underway to disrupt the future of medical device industry. However, introducing a new medical device technology in the market can be highly complex, requiring a clear understanding of premarket preparation and approval to the Food and Drug Administration (FDA). Furthermore, with the advent of various micro and macro medical device industry trends including enhanced buying power of payers or providers, complex regulatory scrutiny, and the introduction of new healthcare delivery models, medical device manufacturers are now struggling to develop effective market entry strategies. The key to dealing with the dynamism of the medical device industry and thrive in the future of medical device industry is to become agile innovators.

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What are the market dynamics affecting the medical devices marketplace?

Abhishek: Several market dynamics affect the performance of companies in the medical device industry. Let me list out a few, which according to me, have the biggest impact on companies in the sector. The level of scrutiny in regulations is seen to be increasing with each passing year. This often restricts the full flight of medical device companies. Also, emerging delivery models or business models introduced by competitors make the marketplace even more complex. For companies in the medical device industry, changing patient preferences and the emergence of new markets can undoubtedly create attractive opportunities, but they give birth to new market challenges. The future of companies in the medical device industry will largely depend on their ability to engage in constant innovations.

Although these dynamics often differ from one segment to another, collectively they lay the foundation of every medical device company’s strategy. It’s a no-brainer that every healthcare company needs to be on top of these developments so that they can better participate in this ever-changing market space. However, in my opinion, the biggest challenge is that it is not particularly easy to control or even respond to most of these factors that I have just mentioned. At a macro level, it appears that new product development is the most common response across companies and regions to deal with the market changes. No wonder R&D and new product development are top strategic priorities for most companies. Although innovations have made the medical space interesting, it has also made it extremely crowded. Several technologies are now being touted as the next best thing to hit the market and make it big in the future of medical device industry, but we will have to wait and see which of them will hit the mark.

Medical device companies that adapt to new market innovations will find enormous opportunities to grow and thrive. RFP to know how Infiniti’s solutions can help your business stay updated with the latest market trends and identify market opportunities before it’s too late!

Is it important for medical device manufacturers to track emerging technologies?

Abhishek: Absolutely. I think it is vital for forward-thinking medical device companies to keep a keen watch on the developments in the sector. Tracking new or emerging technologies can aid in decision-making relating to organic expansion of existing markets, opening up of new markets, and can even help you identify M&A opportunities. Sometimes, promoters of smaller companies are often looking for cash outs because they lack the setup needed for blockbuster success. On the other hand, sometimes large companies own important innovations but in the areas that are not really important for them. Competitors are often on the hunt to grab such opportunities and the first mover wins. So, it is important to keep track of emerging technologies in the medical devices industry. It is also a fantastic way to identify adjacent categories in the market where you can operate and even supplement the current product lines. Moreover, analyzing emerging technologies can open up a completely new market where you are not present right now.

Many companies in the medical device industry rely heavily on market research reports to study an innovative technology in the market. How reliable is it as a source of data and decision-making?

Abhishek: As rightly pointed out, most companies tend to rely on published information, market research reports or internal market intelligence data to gather information on new products or technologies in the medical device industry.

There is nothing wrong in this approach, but mostly, the information attained through these sources can prove to be insufficient and misleading. Often published resources are voiced out to what the technology owner chooses to publish outside mandatory filing. Here, the information is often scattered in bits and pieces and insufficient to deliver a complete picture. Furthermore, this data often fails to provide a country level data distillation. A common misconception is that market research reports cover all the info relating to most of the tech innovations but if u dig slightly deeper, it appears that quality of data is sometimes questionable. As we are part of the market research industry, we are aware that a lot of these reports are an outcome of market models that aim to cover several things at the same time.

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webinar (2)In that case, what is the best way to study the market for a new technology in the medical device industry?

Abhishek: When starting the study of the market for an innovative technology that has the potential to disrupt the future of the medical device industry, the very first step should be to understand the lifecycle stage of the technology. It could be a very new technology that has been just been commercialized, or a more mature but recent technology which off late has started seeing some tailwinds. This categorization is important to plan the analysis, methodology, and information sources. It also helps understand the different variables that need to be studied, the kind of questions that need to be answered, and several more other areas. In the case of a new product that has only been partially commercialized, real data that has been reported in public or private domains must be collected. This data can be in the form of patient/disease data from public registries, data from physicians’ practices, or even microdata published by global health ministries. Inputs from MedTech companies can also be collected to get supply-side information.

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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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What Are the Reimbursement Challenges Faced by Medical Device Companies?

The medical device manufacturing industry is witnessing growth due to the rise in aging population, growing health concerns, and burgeoning health care costs. However, medical device companies face several medical device reimbursement challenges such as payer coverage related issues and reimbursement setbacks. IR_BrochureMedical device companies are now willing to create value for various stakeholders in the healthcare industry such as providers, payers, patients, and practitioners by offering surgical devices and medical tools that are cost effective and score high on innovation and quality. With the presence of a saturated medical device landscape in developed countries, medical device companies have started devising effective market entry strategies to tap the growth opportunities in emerging markets.

Medical Device Reimbursement Challenges in The Healthcare Industry

Medical device companies require a proper go-to-market and execution strategy to address the stakeholder’s demands. But before devising these market entry strategies, the medical device companies must identify the reimbursement challenges related to the medical device manufacturing industry by leveraging effective market assessment services. While designing products, the device manufacturers usually make efforts to retrofit the technology to suit the medical need. Moreover, healthcare industry players are constantly on the lookout for cost effective treatments or diagnostic methods and their real life applications, which result in numerous medical device reimbursement challenges for the manufacturers as they struggle to get a proper coverage for their medical devices. Another reimbursement challenge for the medical device companies is that they invest a lot in product development and clinical trials. How to solve medical device reimbursement challenges, you ask? Here’s how.

  • Medical device manufacturers must identify the medical problem first, leverage insights from reimbursement assessment, and then design products accordingly
  • Leverage cost effectiveness and market assessment studies to analyze the economic advantage of the new medical devices and their market viability
  • Understand the perspective of the healthcare payers, identify the healthcare delivery related issues, and devise marketing strategies to attract coverage for the medical tools and surgical devices

 

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