Sunil Jha, Research Content Developer, Global Market Insights11.18.20
Traction for implantable medical devices has become more pronounced than ever before, thanks to the innate features of the devices that boost the quality of life and restore body function. Lately, sustainable and safe implantation in the human body without the release of toxic products and device degradation by body fluids has come on the horizon.
When it comes to manufacturing hermetic feedthroughs between metal electrodes, metal rings, and ceramic insulators for packaging welding, power injection molding (PIM) can be a natural fit to provide an ideal treatment.
Implantable medical devices are seen as a silver bullet which can help patients with disabilities to recuperate to normal condition and can be used to bolster the existing performance of the body or replace missing tissues or organs.
Some medical implants can aid in measurements of blood glucose level, blood pressure, and electrocardiogram and subsequently help in clinical decision-making and provide a personalized medical approach for diagnosis and therapy.
With a wave of aging boomers becoming more apparent, manufacturers have upped the production of implantable medical devices. According to the U.S. Census Bureau, older adults are expected to outnumber children for the first time in the U.S. history—77 million people will be 65 years or older, while there will be 76.5 million children by 2034.
Businesspeople are likely to use Census Bureau Statistics and the geographic information system to get a holistic and refined picture and appropriately expand their footprints in the implantable medical device market.
Device manufacturers seek to boost their revenue stream by expanding their portfolios and infusing funds in technological advancements.
Active Implantable Medical Devices on the Cusp of Robust Penetration
Sustained developments in biomedical signal processing, microelectronics, packaging, and electrode technology have triggered growth in active implantable medical devices (AIMDs) that use wireless telemetry for power and data transmission.
AIMDs include a slew of devices such as pacemakers, cochlear plants, defibrillators, and infusion pumps. Since AIMDs are designed to remain in direct contact with the body, they are subject to tight standards.
Manufacturers of AIMDs are pouring funds to bolster implant stability, strength, resistance to hydrolysis, and the impacts of ionizing radiation and radiolucency without imaging artifacts in MRIs, CT scans, and X-rays.
It is pertinent to mention AIMD systems warrant additional testing and a strategy to make sure medical devices keep up with the necessary requirements.
Implantable Cardioverter-Defibrillator: A Pressing Medical Device
With the changing landscape of the implantable medical device industry, investment in implantable cardioverter defibrillators (ICDs) have surged. Considering the sudden deaths in patients with sustained atrial or ventricular fibrillation, ICDs have come up as a viable portfolio.
Studies have claimed ICDs can prevent cardiac arrest in high-risk patients at risk of life-threatening ventricular arrhythmias. According to the American Heart Association, patients will be considered as a candidate for an ICD provided correctable causes of the arrhythmia, including myocardial ischemia, acute myocardial infarction, and electrolyte imbalance and drug toxicity are ruled out. The arrhythmia must also be potentially lethal.
ICDs will be sought-after to diagnose and derail/stop the irregularity or abnormality in arrhythmia. Amid a marked rise in coronary artery disease, low-energy pacing therapy and defibrillation therapy have gained traction.
Big Bet on Pacemakers
Pacemakers have become a top-notch medical device to control abnormal heart rhythms with the help of electrical pulses to enable the heart to beat at a normal rate. Not only can pacemakers rev up a slow heart rhythm, they can also coordinate chambers of the heart and control a fast heart rhythm.
Pacemaker implantation has surged dramatically in the past few years—an estimated 1.25 million permanent pacemakers are implanted globally. Trends such as upsurge in the number of clinical indications, miniaturization of electronic circuitry, and emergence of MRI-safe pacemakers will redefine the implantable medical device market’s business outlook.
Robust advancements in microfabrication have triggered the advent of smaller implantables. Microelectronic-mechanical systems are said to have miniaturization upsides. Some of the factors such as boost in battery longevity, quality of pacemaker leads, rate responsiveness, device size reduction, and remote monitoring have brought a seismic shift in pacemakers.
Even though pacemakers have become this linchpin in the medical industry, stents have become the go-to medical device against the upsurge in the number of people suffering from high-risk cardiovascular disease.
Medtronic claims 2 million people get stents each year as stakeholders continue to infuse funds in clinical trials and studies to reduce product recalls. Meanwhile, BIOTRONIK rolled out a coronary stent system for the U.S. customers in Q2 2019. The company went on to introduce adrug-eluting stent system in February 2020.
Drug-Eluting Stents Shaping the Mega-Trend
Of late, drug-eluting stents have spurred the value chain proposition. These stents are embedded with drugs that gradually ward off the closing of the vessel by eluting into the coronary artery. As part of the 2021 Inpatient Prospective Payment System (IPPS), the U.S. Centers for Medicare and Medicaid Services provided reimbursement—New Technology Add-on Payment—to Boston Scientific in September 2020.
The NTAP designation will provide “ reimbursement on incremental basis” for the Eluvia Stent system for up to three years for eligible hospitals—the Medicare criteria is based on considerable clinical improvements, cost, and newness of the device. Favorable government policies will add fillip to the stakeholders vying to expand their footprints in North America.
Technological advancements have unlocked opportunities to develop innovative and new smart stent devices that can help treat atherosclerosis, central line access failure, and enhance the diagnosis.
Echoing the similar trends in pacemakers, low power miniaturization of devices will boost the penetration of stents. Developments in microelectronics can enable implants to be fabricated in the order of millimeters. For instance, Ada Poon’s group at Stanford introduced high-performance powering systems that could be integrated into stents.
With advancing vision research, companies have forayed into implantable medical devices. For instance, UPMC is reported to have implanted the first patient in the U.S. with a wireless retinal device—part of a clinical trial—meant to restore partial sight to patients with advanced age-related macular degeneration (AMD) disease.
No industry goes without perceived or real challenges or threats: the implantable medical device industry is no exception. With medical devices increasingly being connected to the internet to streamline healthcare services, these devices may be prone to security breaches.
The FDA noted the cybersecurity vulnerabilities in a wireless telemetry technology meant for communication between Medtronic implantable cardiac devices, home monitors, and clinic programmers in March 2019. In addition, Abbott released an additional firmware update to confirm cybersecurity vulnerabilities identified in Abbott’s implantable cardiac devices. Such actions will help companies reduce product recall and mitigate the risk of patient harm.
Technological advancements in medical devices like pacemakers, ICDs, and AIMDs will provide a win-win situation for all stakeholders in the future.
Sunil Jha has been a part of the content industry for more than 2 years now. Having previously worked as a voice over artist and sportswriter, he now focuses on penning down articles across numerous topics, ranging from business, technology, core industry, to trade and finance. With a business-oriented educational background, Sunil brings forth the expertise of intensive research and a strategic approach in his piece.
When it comes to manufacturing hermetic feedthroughs between metal electrodes, metal rings, and ceramic insulators for packaging welding, power injection molding (PIM) can be a natural fit to provide an ideal treatment.
Implantable medical devices are seen as a silver bullet which can help patients with disabilities to recuperate to normal condition and can be used to bolster the existing performance of the body or replace missing tissues or organs.
Some medical implants can aid in measurements of blood glucose level, blood pressure, and electrocardiogram and subsequently help in clinical decision-making and provide a personalized medical approach for diagnosis and therapy.
With a wave of aging boomers becoming more apparent, manufacturers have upped the production of implantable medical devices. According to the U.S. Census Bureau, older adults are expected to outnumber children for the first time in the U.S. history—77 million people will be 65 years or older, while there will be 76.5 million children by 2034.
Businesspeople are likely to use Census Bureau Statistics and the geographic information system to get a holistic and refined picture and appropriately expand their footprints in the implantable medical device market.
Device manufacturers seek to boost their revenue stream by expanding their portfolios and infusing funds in technological advancements.
Active Implantable Medical Devices on the Cusp of Robust Penetration
Sustained developments in biomedical signal processing, microelectronics, packaging, and electrode technology have triggered growth in active implantable medical devices (AIMDs) that use wireless telemetry for power and data transmission.
AIMDs include a slew of devices such as pacemakers, cochlear plants, defibrillators, and infusion pumps. Since AIMDs are designed to remain in direct contact with the body, they are subject to tight standards.
Manufacturers of AIMDs are pouring funds to bolster implant stability, strength, resistance to hydrolysis, and the impacts of ionizing radiation and radiolucency without imaging artifacts in MRIs, CT scans, and X-rays.
It is pertinent to mention AIMD systems warrant additional testing and a strategy to make sure medical devices keep up with the necessary requirements.
Implantable Cardioverter-Defibrillator: A Pressing Medical Device
With the changing landscape of the implantable medical device industry, investment in implantable cardioverter defibrillators (ICDs) have surged. Considering the sudden deaths in patients with sustained atrial or ventricular fibrillation, ICDs have come up as a viable portfolio.
Studies have claimed ICDs can prevent cardiac arrest in high-risk patients at risk of life-threatening ventricular arrhythmias. According to the American Heart Association, patients will be considered as a candidate for an ICD provided correctable causes of the arrhythmia, including myocardial ischemia, acute myocardial infarction, and electrolyte imbalance and drug toxicity are ruled out. The arrhythmia must also be potentially lethal.
ICDs will be sought-after to diagnose and derail/stop the irregularity or abnormality in arrhythmia. Amid a marked rise in coronary artery disease, low-energy pacing therapy and defibrillation therapy have gained traction.
Big Bet on Pacemakers
Pacemakers have become a top-notch medical device to control abnormal heart rhythms with the help of electrical pulses to enable the heart to beat at a normal rate. Not only can pacemakers rev up a slow heart rhythm, they can also coordinate chambers of the heart and control a fast heart rhythm.
Pacemaker implantation has surged dramatically in the past few years—an estimated 1.25 million permanent pacemakers are implanted globally. Trends such as upsurge in the number of clinical indications, miniaturization of electronic circuitry, and emergence of MRI-safe pacemakers will redefine the implantable medical device market’s business outlook.
Robust advancements in microfabrication have triggered the advent of smaller implantables. Microelectronic-mechanical systems are said to have miniaturization upsides. Some of the factors such as boost in battery longevity, quality of pacemaker leads, rate responsiveness, device size reduction, and remote monitoring have brought a seismic shift in pacemakers.
Even though pacemakers have become this linchpin in the medical industry, stents have become the go-to medical device against the upsurge in the number of people suffering from high-risk cardiovascular disease.
Medtronic claims 2 million people get stents each year as stakeholders continue to infuse funds in clinical trials and studies to reduce product recalls. Meanwhile, BIOTRONIK rolled out a coronary stent system for the U.S. customers in Q2 2019. The company went on to introduce adrug-eluting stent system in February 2020.
Drug-Eluting Stents Shaping the Mega-Trend
Of late, drug-eluting stents have spurred the value chain proposition. These stents are embedded with drugs that gradually ward off the closing of the vessel by eluting into the coronary artery. As part of the 2021 Inpatient Prospective Payment System (IPPS), the U.S. Centers for Medicare and Medicaid Services provided reimbursement—New Technology Add-on Payment—to Boston Scientific in September 2020.
The NTAP designation will provide “ reimbursement on incremental basis” for the Eluvia Stent system for up to three years for eligible hospitals—the Medicare criteria is based on considerable clinical improvements, cost, and newness of the device. Favorable government policies will add fillip to the stakeholders vying to expand their footprints in North America.
Technological advancements have unlocked opportunities to develop innovative and new smart stent devices that can help treat atherosclerosis, central line access failure, and enhance the diagnosis.
Echoing the similar trends in pacemakers, low power miniaturization of devices will boost the penetration of stents. Developments in microelectronics can enable implants to be fabricated in the order of millimeters. For instance, Ada Poon’s group at Stanford introduced high-performance powering systems that could be integrated into stents.
With advancing vision research, companies have forayed into implantable medical devices. For instance, UPMC is reported to have implanted the first patient in the U.S. with a wireless retinal device—part of a clinical trial—meant to restore partial sight to patients with advanced age-related macular degeneration (AMD) disease.
No industry goes without perceived or real challenges or threats: the implantable medical device industry is no exception. With medical devices increasingly being connected to the internet to streamline healthcare services, these devices may be prone to security breaches.
The FDA noted the cybersecurity vulnerabilities in a wireless telemetry technology meant for communication between Medtronic implantable cardiac devices, home monitors, and clinic programmers in March 2019. In addition, Abbott released an additional firmware update to confirm cybersecurity vulnerabilities identified in Abbott’s implantable cardiac devices. Such actions will help companies reduce product recall and mitigate the risk of patient harm.
Technological advancements in medical devices like pacemakers, ICDs, and AIMDs will provide a win-win situation for all stakeholders in the future.
Sunil Jha has been a part of the content industry for more than 2 years now. Having previously worked as a voice over artist and sportswriter, he now focuses on penning down articles across numerous topics, ranging from business, technology, core industry, to trade and finance. With a business-oriented educational background, Sunil brings forth the expertise of intensive research and a strategic approach in his piece.
