BioMEMS and microsystems are fueling medical device innovation

MEMS and sensors for healthcare applications are not new. The first MEMS devices to be used in the biomedical industry were reusable blood pressure sensors in the 1980s. Since then, the portfolio of innovative sensors dedicated to biomedical applications has grown dramatically. Inertial sensors, microphones, micro pumps and micro dispensers, microfluidic chips, infrared, gas and flow sensors, electrodes and many others are now used in commercial products.

Today, a flow of new applications is driving the growth of this business. They include drug delivery systems, point of care testing, and new DNA sequencing strategies and systems. Patient monitoring, including mobile healthcare, in-vitro diagnostics, pharmaceutical research, patient care and medical imaging provide MEMS and miniaturized systems endless sweet spots to solve key health related issues. Some devices are linked to solid, mature, slow-growing industries, while others are part of booming applications that are adding new fuel to the bioMEMS market. That market that will consequently triple from $2.7B in 2015 to $7.6B in 2021! This almost 20% growth rate per year has an important impact on the sensor industry. go further with Yole Développement recent report BioMEMS: Microsystems for Healthcare Applications 2016

Disruptive medical devices that have been under development for years are now hitting the market. As an example, on April 6 2016 Medtronic announced that the U.S Food and Drug Administration (FDA) had approved its Micra Transcatheter Pacing System. This product helps patients with atrial fibrillation or those who have other dangerous arrhythmias, such as bradycardia-tachycardia syndrome. Micra is a leadless, full-featured single chamber ventricular pacemaker, implanted directly in the patient’s right ventricle, rather than the subcutaneous pocket where a traditional pacemaker would reside. It is the first of its kind to get FDA approval. The device can differentiate cardiac motion from body motion occurring during activity. To do this, Micra integrates a three-axis accelerometer sensor to allow the physician to select the best axis to sense activity depending on the patient. That’s useful because the orientation of the device is dependent on implant location and will differ between patients. 

Micra Transcatheter Pacing System (Courtesy of Medtronic)

Other major players such as St. Jude Medical have also developed miniaturized leadless pacing devices. St. Jude’s Nanostim pacemaker already has the CE mark for commercialization on the European market and the company is currently seeking FDA approval in the United States.

Another class of potentially disruptive medical devices is exoskeletons. Ekso Bionics received clearance from the FDA to market its Ekso GT robotic exoskeleton in April 2016 for use with stroke and spinal cord injury patients. Exoskeletons include many sensors, including inertial and strain sensors and electrodes. That allows the system to understand the user’s will and to provide them with information about their environment while helping them to keep their equilibrium.  

Ekso GT Robotic Exoskeleton (Courtesy of Ekso Bionics)

Pacing devices and exoskeletons are just two of several new medical applications using creating market opportunities for existing sensors. However, despite being a multi-billion-dollar market, it’s important to keep in mind that technical requirements for the same component can differ from one application to another. As a consequence, the market is extremely fragmented, with numerous niche segments in which startup companies address unmet needs. The high-value devices used here include unique components which are often very expensive. Thus, the volume associated with the typical bioMEMS component rarely exceeds a million units, prohibiting cost reduction via high-volume manufacturing.

However, Yole thinks the bioMEMS industry is nearing a major turning point that will have a very important impact. There has been a flood of modules for mobile devices and wearables integrating sensors for vital sign monitoring, including for diabetes, blood pressure, and blood gas monitoring. The line between consumer and healthcare applications is therefore now fuzzier than ever. In the meantime, consumers are increasingly adopting home care devices allowing remote diagnostics and monitoring, and regulations are adapting to these new devices. Yole Développement forecasts increasing integration of bioMEMS into wearables and modules for mobile devices. This has the potential to help the industry bridge the gap between medium and large volumes, enabling significant cost reductions. Though there are still many challenges to address before wide acceptance of these mobile devices, we already see major semiconductor and electronics players positioning themselves in this market.

Explosive 20% annual growth is here for the long run. On top of the mobile care trend, all the big long-term health care industry trends are based on miniaturizing systems using MEMS devices or MEMS technology. Genome sequencing demand growth is being driven by decreasing genome sequencing price. Drugs are being delivered in new ways, and new diagnostic strategies are paving the way for personalized medicine. All the long term changes are based partially or totally on bioMEMS devices. Yole’s new report BioMEMS: Microsystems for Healthcare Applications 2016 provides all the details on these trends, applications and technology developments. It will help you understand why bioMEMS will reach $7.6B in the next five years, and where the opportunities are in this market at each level of the supply chain.

BioMEMS: Microsystems for Healthcare Applications 2016

With the barrier between consumer and healthcare blurring, an increasing number of healthcare applications are using MEMS components, resulting in impressive market growth!

You want to know more, contact David Jourdan

Source: www.yole.fr