Denise Odenkirk, Vice President, Supplier Sales, GHX04.22.24
The medical device market is poised for continued growth during the next decade, thanks to the ongoing development of new technologies. These devices, ranging from life-saving pacemakers to cutting-edge diagnostic tools, are designed to enable healthcare professionals to provide more personalized care and improve patient outcomes.
With a projected compounded annual growth rate of more than 5%, the market is expected to reach nearly $800 billion by 2030. Despite the rosy forecast, medical device manufacturers face a changed landscape. Rising healthcare and supply costs, inflation, consolidation, and competition from new entrants mean manufacturers must adapt their businesses, including how they deliver new solutions to the market.
A standardized process for bringing new devices to market can help manufacturers fulfill the mission of improving patient care while generating revenue to fund the next round of research and development.
Today, medical device manufacturers rely on sales representatives to disseminate that information to healthcare providers. But it’s a time-consuming and cumbersome process. Despite their best efforts, sales representatives can’t reach every hospital and clinician to educate them on a new device. When clinicians are aware of a new device, there often is not a comprehensive or cohesive process for addressing their questions. Typically, questions are addressed individually by representatives and, when necessary, passed off to the medical affairs office. Adding to the complexity, sales representatives can only discuss on-label information. It’s easy to imagine that many hospital value analysis teams and clinicians are unaware of new devices or innovative applications of existing devices because of these process constraints.
The answer isn’t removing the guardrails; they exist for a reason. Instead, the focus must be on improving information sharing and accessibility. This way, providers can make more informed choices when building their formulary and selecting a device to achieve optimal patient outcomes. A standardized approach is needed to address this issue, both for new devices and ongoing use, to reduce unwarranted care variation and improve outcomes.
The scenario is all too familiar. A sales representative may offer a new medical device to a surgeon during a procedure. However, if the new device isn’t listed in the hospital’s item master or EMR, properly recording usage and generating a purchase order will be difficult. This can create extra work for hospitals and manufacturers as staff search for the necessary information for invoicing and reimbursement, such as pricing and purchase order numbers. Sometimes, a hospital may even deny payment because the device is not in their formulary or on contract.
The industry must create a standardized approach that ensures new product information is seamlessly updated to all necessary systems before or at the time of the product launch.
While the prospect may be daunting, the past several years have proven that the healthcare industry can collaborate at scale to yield positive results. During COVID-19, every stakeholder, including the government, came together to solve supply issues. Collectively, stakeholders helped providers identify bad actors and find equivalent substitutions when supplies were back ordered.
In thinking about ways to improve new device launches, a critical first step will be to standardize and streamline processes, using automation to eliminate manual work and break down information silos. Efforts should focus on three areas:
The question, of course, is where to begin. As with anything in healthcare, the best place to start is with the patient. Keep the patient at the center. Rather than boil the ocean, consider starting small and rally around a common goal to pilot this approach, such as tackling a chronic condition like heart disease. Medtech can answer the macro questions, such as what we should be doing as a country, manufacturers, and providers to enable the industry to improve patient care and outcomes. Then, we could aggregate, validate, and disseminate clinical and supply chain data supporting our goal so the industry works in lockstep. Once we prove the approach works, it can be applied to tackle another chronic disease and continually repeat and improve the process.
It's true that currently, some clinical data and device information are aggregated, validated, and disseminated efficiently. However, that approach doesn’t reach every clinician at every hospital. There is room for improvement. Medical device manufacturers are committed to developing innovative new products and getting them into the hands of physicians to improve the quality of care and life of the populations they serve. To drive measurable change, we must expand and use technology to advance existing processes and leapfrog to the next level. By coming together to implement automation and a unified approach to new device launches, the medtech industry can better serve all stakeholders and drive revenue while improving patient outcomes.
Denise Odenkirk is a vice president at GHX, working with manufacturers, distributors, and hospitals to improve their business processes. Odenkirk brings more than 20 years of experience in healthcare from a manufacturing, distribution, and third-party logistics perspective. Her career began in IT leadership roles at Warner-Lambert, and Aventis and expanded to include operations while at Bracco Diagnostics, Owens & Minor and Symmetry Surgical. Her passion is to improve healthcare supply chain business processes and help companies improve their overall healthcare supply chain efficiency.
With a projected compounded annual growth rate of more than 5%, the market is expected to reach nearly $800 billion by 2030. Despite the rosy forecast, medical device manufacturers face a changed landscape. Rising healthcare and supply costs, inflation, consolidation, and competition from new entrants mean manufacturers must adapt their businesses, including how they deliver new solutions to the market.
A standardized process for bringing new devices to market can help manufacturers fulfill the mission of improving patient care while generating revenue to fund the next round of research and development.
A Two-Pronged Approach
Launching new devices is challenging due to the complexity of the healthcare ecosystem, which includes manufacturers, distributors, healthcare providers, policymakers, and patients. As we consider making the process more efficient, we must also consider how to manage clinical data, a key component in achieving regulatory approval. The challenge before the industry is improving how medical device information is shared and accessed.Today, medical device manufacturers rely on sales representatives to disseminate that information to healthcare providers. But it’s a time-consuming and cumbersome process. Despite their best efforts, sales representatives can’t reach every hospital and clinician to educate them on a new device. When clinicians are aware of a new device, there often is not a comprehensive or cohesive process for addressing their questions. Typically, questions are addressed individually by representatives and, when necessary, passed off to the medical affairs office. Adding to the complexity, sales representatives can only discuss on-label information. It’s easy to imagine that many hospital value analysis teams and clinicians are unaware of new devices or innovative applications of existing devices because of these process constraints.
The answer isn’t removing the guardrails; they exist for a reason. Instead, the focus must be on improving information sharing and accessibility. This way, providers can make more informed choices when building their formulary and selecting a device to achieve optimal patient outcomes. A standardized approach is needed to address this issue, both for new devices and ongoing use, to reduce unwarranted care variation and improve outcomes.
Now, the Supply Chain
The supply chain also presents barriers to smooth launches. When a new device hits the market, it can often take a year or more to realize projected revenues. This delay is usually attributed to how well the supply chain is prepared before the device is released to market. Too often, the item data is not entered into the MMIS, EMR, and ERP systems until after the product launch or when a new device has been used onsite for the first time. Once again, there isn’t an industry-agreed-upon approach to ensure how and when new device data is entered into a hospital’s operational and clinical systems, and it has a negative downstream effect.The scenario is all too familiar. A sales representative may offer a new medical device to a surgeon during a procedure. However, if the new device isn’t listed in the hospital’s item master or EMR, properly recording usage and generating a purchase order will be difficult. This can create extra work for hospitals and manufacturers as staff search for the necessary information for invoicing and reimbursement, such as pricing and purchase order numbers. Sometimes, a hospital may even deny payment because the device is not in their formulary or on contract.
The industry must create a standardized approach that ensures new product information is seamlessly updated to all necessary systems before or at the time of the product launch.
Creating a New Model for Information Sharing
Medical device manufacturers can play a crucial role in driving more successful device launches for the benefit of all healthcare stakeholders. Just as the industry came together to implement electronic data interchange automation across the order process, it can also use automation to advance the dissemination of clinical data and device item information.While the prospect may be daunting, the past several years have proven that the healthcare industry can collaborate at scale to yield positive results. During COVID-19, every stakeholder, including the government, came together to solve supply issues. Collectively, stakeholders helped providers identify bad actors and find equivalent substitutions when supplies were back ordered.
In thinking about ways to improve new device launches, a critical first step will be to standardize and streamline processes, using automation to eliminate manual work and break down information silos. Efforts should focus on three areas:
- Aggregation. To streamline the process of storing, accessing and updating clinical data, it’s imperative to establish a centralized repository that can serve as a one-stop solution for all hospitals. Every hospital follows a different approach to value analysis, which can lead to discrepancies and information silos. By creating a single repository that all hospitals can access, healthcare providers can more easily find the necessary clinical data.
- Validation. Medical affairs teams are tasked with ensuring that all product use guidelines are strictly followed and any concerns related to product use are effectively addressed. These offices provide medical and scientific expertise to various stakeholders, including healthcare professionals, regulatory authorities, and patients. They are a vital part of the process and should be the source of data shared for both on-label and off-label use of medical devices.
- Dissemination. To aid new product adoption, manufacturers must make it simple for value analysis and clinical teams to evaluate the device. However, it’s critical to recognize that there is variation in how this evaluation takes place, so understanding customers’ workflow is paramount. For providers with more mature systems, manufacturers should consider using API integration to ERP and EMR systems to disseminate clinical evidence and vital item information that seamlessly feeds into MMIS, ERP, and EMR systems.
The question, of course, is where to begin. As with anything in healthcare, the best place to start is with the patient. Keep the patient at the center. Rather than boil the ocean, consider starting small and rally around a common goal to pilot this approach, such as tackling a chronic condition like heart disease. Medtech can answer the macro questions, such as what we should be doing as a country, manufacturers, and providers to enable the industry to improve patient care and outcomes. Then, we could aggregate, validate, and disseminate clinical and supply chain data supporting our goal so the industry works in lockstep. Once we prove the approach works, it can be applied to tackle another chronic disease and continually repeat and improve the process.
It's true that currently, some clinical data and device information are aggregated, validated, and disseminated efficiently. However, that approach doesn’t reach every clinician at every hospital. There is room for improvement. Medical device manufacturers are committed to developing innovative new products and getting them into the hands of physicians to improve the quality of care and life of the populations they serve. To drive measurable change, we must expand and use technology to advance existing processes and leapfrog to the next level. By coming together to implement automation and a unified approach to new device launches, the medtech industry can better serve all stakeholders and drive revenue while improving patient outcomes.
Denise Odenkirk is a vice president at GHX, working with manufacturers, distributors, and hospitals to improve their business processes. Odenkirk brings more than 20 years of experience in healthcare from a manufacturing, distribution, and third-party logistics perspective. Her career began in IT leadership roles at Warner-Lambert, and Aventis and expanded to include operations while at Bracco Diagnostics, Owens & Minor and Symmetry Surgical. Her passion is to improve healthcare supply chain business processes and help companies improve their overall healthcare supply chain efficiency.