What are Active Implantable Devices?

Medical implants are devices that are placed on the inside or surface of the body with the purpose of delivering medication, monitoring body conditions, or supporting organ health. There are different types of implantable devices, but most generally fall into two categories: static or active. Static devices are the least complex and do not have moving parts; stents implanted in a patient’s artery are a common example of a static implant.

Active Implantable Medical Devices, commonly referred to as AIMDs, are more intricate in nature and often perform more complex functions than static devices. One of the key differences between active and static implantables is that AIMDs typically require an artificial power source, such as a battery or other electrical supply. Active implantable medical devices can be found in many healthcare applications including cardiac pacemakers, defibrillators, cochlear and other hearing aids, neuro stimulators, and infusion pumps.

As you would expect, there are key material considerations for AIMDs such as biocompatibility, stability, and durability. Medical grade silicones have long been a material of choice for implantables, including AIMDs, given their range of available durometers, extreme chemical inertness and biocompatibility, and excellent tear and heat resistance that make them ideal for parts that need to remain in the human body for extended periods of time. As this field continues to grow and expand in future years, medical grade silicones are expected to continue to play a significant role in the manufacturing of active implantable devices due to their ability to produce high volumes at low prices while meeting tight dimensional tolerances.

It is no surprise that active implantable devices have very strict and high standards that must be met in order to ensure patient safety. Compared to other medical devices, AIMDs can be more difficult to manufacture due to their intricacy and size, requiring additional considerations to achieve the necessary product specifications and tolerances. For these reasons, it is imperative that OEMs select a molding partner, like ProMed, that has both design expertise and manufacturing experience with active implantable devices, as well as an outstanding quality assurance program!

Recent Advances in Active Implantable Devices

The field of active implantable devices continues to rapidly expand and is an area of significant research and development. Below are three recent advances that give a glimpse into the not-so-distant future of AIMDs.

  • One of the issues of active implantable devices is that the electronic components are typically rigid and not biocompatible. A team of engineers are taking on this challenge by developing flexible, bioelectronic devices. Once successful, these devices will allow active implantables to expand into new treatments!
  • Another current limitation of AIMDs is battery life. Once a battery dies, the patient must undergo a procedure to replace the battery. One study currently underway is looking at methods to recharge a battery in-situ via a technology called “active photonic power transfer”. This program has tremendous implications for AIMDs as many surgeries could be avoided if batteries could be recharged remotely and did not need to be replaced!
  • Lastly, even though implants have come a long way, their size is still a challenge. The housing necessary to enclose the electronics is still larger than desired. Fortunately, a team is developing an ultra-thin coating that will allow for further size reduction of implants. The coating will encapsulate the electronics to protect them from the body’s environment and reduce the need for the traditional, bulky housing. This is an exciting time in the AIMD sector, with rapid R&D advancements!

Forecasting the AIMD Market into 2025 and Beyond

A recent report by Data Bridge Market Research projected the worldwide AIMD market will reach nearly $39 billion by 2027 with a CAGR (Compound Annual Growth Rate) of 7.8% during the period. This is an excellent growth rate, forecasting continued demand for active implantable devices in the coming years.

There are several drivers for the projected market growth. One of the main factors is the aging population worldwide. The number of people 65 years or older is expected to be nearly 1.5 billion by 2050, making up over 15% of the global population! As patients age, their need for active implantable devices grows in order to maintain a good quality of life. Additionally, cardiovascular disease and neurological disorders are becoming more prevalent, especially in developed countries, resulting in more demand for AIMDs that treat these conditions. Lastly, as the medical community continues to research and develop AIMDs, the field continues to advance, resulting in opportunities for AIMDs to expand into new areas of the medical sector.

As previously noted, the rise in cardiovascular disease is one of the factors responsible for the continued demand for active implantables, so it is no surprise that cardio products, such as cardioverter defibrillators, are forecasted to hold the largest AIMD market share. In terms of geography, North America is expected to continue to lead other regions in the demand for AIMDs in the foreseeable future.

The AIMD market does have some challenges to growth. For example, one of the key hurdles that must be addressed are the many regulatory standards that must be met by AIMDs in order to ensure patient safety; these standards can be daunting and may prevent some manufacturers from entering the AIMD market or expanding their product line.

ProMed’s Capabilities

At ProMed, we combine industry-leading medical-grade expertise with the latest developments in silicone materials and technology. From helping OEMs incorporate the latest medical-grade formulations into their designs to delivering rapid silicone prototypes, we serve as a premier silicone molding contract manufacturer for medical device OEMs.

ProMed Pharma is a leading contract manufacturer of polymer-based drug releasing molded dosage forms and combination device components. Working with both established and early-stage medical device and pharmaceutical companies, ProMed develops robust manufacturing processes and platforms for extended drug release from a variety of materials, including silicones and thermoplastics. We have garnered a reputation as the world benchmark of implantable silicone components and assemblies – and are one of few companies in the world to provide contract manufacturing of drug-eluting products.

ProMed has expertise in working with the full spectrum of silicones covering a wide range of properties and characteristics. We will assist in your material selection to help ensure all design requirements are met. Our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We currently have four divisions that are located within two manufacturing sites. All are certified class 10,000 / ISO Class 7 cleanrooms.

Contact ProMed today at 763-331-3800 to discuss your next active implantable device project.

The Latest on Active Implantable Devices – Forecasting Into 2025 and Beyond
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The Latest on Active Implantable Devices – Forecasting Into 2025 and Beyond
Description of active implantable devices, recent advances in the field, and the demand forecast for AIMDs into 2025 and beyond.
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ProMed Molding
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