Nanotechnology will help the development of new in situ biosensors.

A smart "chip" capable of monitoring, diagnosing, and treating diseases within the human body is a dream for both patients and doctors. Imagine that you have a joint prosthesis implanted with a sensor at the bone-implant interface during surgery. After you come home, the sensor will continuously tell you whether infection is occurring and if it is, will transmit signals to external receivers to tell you that you have an infected implant and will excite an antibiotic reservoir attached to it to treat the infected implant. As a result, you will be monitored and treated without going to the hospital which could significantly delay diagnosis and treatment.

Sounds like a far-far away future technology? Actually this scenario is becoming reality and may be a part of your life in just 10 years, if not earlier. In situ medical sensors, contrary to remote sensors, are those which are placed right at implant sites where they are needed (e.g., the brain, joints, injury sites, etc.) detecting physical, chemical, biological signals, and potentially responding to such stimuli to improve device performance (Fig. 1). Without a doubt, using nanotechnology-derived in situ sensors in the human body means higher accuracy and higher resolution in health monitoring.

There is a long history of using sensors for external monitoring, but the use of internal in situ sensors in the medical community has become promising via recent nanotechnology developments. Because in situ biosensors need to be placed in diverse environments (as small as individual cells), sensor miniaturization is a priority. Advanced micro- and nanofabrication methods make it possible to construct delicate micro/nanodevices that are fully functional as sensors. As just one of many examples discussed in this book, nanotechnology can create self-assembled nanoporous metal membranes with protruding carbon nanotubes that are able to detect cellular level, or even molecular level signals; events clearly important for determining implant success/failure.

How can all this influence the medical device industry? From a medical device industrial perspective, feedback concerning device function is key to their continued success. Such information needs to be prompt, accurate, and efficient. Conventionally, such feedback is either from the patients' subjective description or doctor's postoperative experimental observations (which currently relies on instrumentation

Fig. 1 The internal and external pathway of an intelligent in situ biosensor. Internally, the sensor will activate the combined therapeutic compartment to release drugs that treat implant malfunction. Externally, the sensor will wirelessly send the signal to a receiver so that a doctor can determine the proper treatment for the implant malfunction

Fig. 1 The internal and external pathway of an intelligent in situ biosensor. Internally, the sensor will activate the combined therapeutic compartment to release drugs that treat implant malfunction. Externally, the sensor will wirelessly send the signal to a receiver so that a doctor can determine the proper treatment for the implant malfunction not capable of determining cellular events). However, with the development and application of in situ biosensors, feedback can be provided which is no longer restricted by time and method. In situ biosensors can generate new loops of information that can make significant changes to medical device performance and, therefore, to the industry.

In situ biosensors will help us bring new medical devices to the market.

It is common sense that a tremendous amount of preclinical and clinical studies are required by the FDA to prove the safety and efficacy of new medical devices. This process is costly and time-consuming, which may be bad news for patients who are anxiously expecting new solutions. The use of in situ nanotechnology biosensors can change all of this.

Specifically, during the preclinical stage, conventional in vivo experiments obtain information of implant success/failure only after sacrificing animals (with very few exceptions, such as real-time X-rays). If biosensors are implanted within the device, it will make it much easier to obtain continuous information from such animal studies throughout the entire time period of the study. Moreover, measurements from in situ sensors will reflect the body's response more accurately. The same thing will happen in preclinical and clinical studies. The more in situ sensors are used, the more we will learn about patient recovery from implants which will help to develop even better implants. Clearly, however, the most benefit will be less extraction of failed implants from patients through the use of in situ nanotechnology-based sensors.

In summary, the use of biosensors in preclinical and clinical studies will greatly increase the efficiency of preclinical and clinical studies cutting the cost and time the medical device companies spend on these trials. As a result, we, the medical device industry, can provide new technologies and devices to patients in a more timely manner.

In situ biosensors will help us improve current sensor designs and develop the next generation of smart medical devices.

Nanotechnology-enabled in situ sensors could provide unprecedented insights into intact biological environments (from cells to tissues) by providing quantitative, semiquantitative, or qualitative analytical information. Such information will advance our understanding of basic biological interactions between the human body and a medical device (like immune cell reactions, tissue growth, etc.), which in turn will help our researchers develop products in a better manner.

The development of in situ biosensors will also eventually influence our design criteria for future medical devices. Either combined with a medical device or used alone, in situ sensors will be a necessary part of any future smart multifunctional medical system.

Whether you are a medical device engineer, a medical doctor, or a medical device researcher, I would highly recommend this book to you. In this book you will find answers to many interesting questions related to in situ biosensors learning about some already successful stories of their use in different fields. Specifically, you will be able to answer the following questions at the conclusion of this book:

How are nanotechnology, biology, and advanced materials engineering interacting and leading to the development of in situ nanotechnology biosensors? How are in situ sensors working in different biological environments, e.g. orthopedic and neural applications?

What are the major challenges of current in situ biosensors limiting their clinical use?

Last, but not least, what are the future directions of this field?

The pioneering work on developing and using in situ biosensors is meaningful for all of the medical device community including patients, doctors, medical service providers, and the medical device industry. As this book demonstrates, it is encouraging to see that greater numbers of researchers are devoting their time and energy into this field and it is promising to see that the use of nanotechnology-derived in situ sensors is becoming a large technological success, placing it at a paramount position in medical device history.

West Lafayette, IN

Chang Yao

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