Emerging technologies of collecting data on nano level are booming in health care research. More and more physiological and biological data from the body can be collected. The key is that it is validated, that data is representative for a certain condition and an action can be formulated to change the condition if necessary.

And the other way around is if known which data is representative for a certain condition is it possible to measure this data in a reliable way. Collecting data digitally is done with digital biomarkers.

A digital biomarker can be any physiological or biological signal that is captured digitally to provide objective measurement of a patient’s condition. For instance, to characterize the environment inside the body. Neurological, muscle activity (tension), biological processes like glucose levels or blood pressure, intraocular pressure, electroencephalogram (EEG) data, heart rhythm, sound, visible light, stroke monitoring, and healing processes, scar tissue, energy transfer, temperature, and parameters in relation to the implant (materials).

Clinically, biomarkers can be applied in different ways during the patient care pathway. At the early stage sit susceptibility or risk biomarkers, which indicate the potential for an individual to develop a disease. Cognitive changes in healthy subjects could denote a risk of developing Alzheimer’s, for example. Then there are diagnostic biomarkers that are already in common use to detect the presence of conditions such as asthma. Further up the pathway are pharmacodynamic response biomarkers used to show that a biological response has occurred after a patient has taken a medical product.

“non-instrumented, microfluidics-based diagnostics” biomarkers will give data on the condition of the patient and can be used as input for AI to generate data on patients as input for future developments of treatments. The definition is as follows:

1. The device requires only a disposable component and no external reusable instrument for operation. The disposable device can have several subcomponents that may include low-cost electronics if the character of the device clearly remains that of a disposable.
2. The device includes at least one microfluidic feature—such as a microfluidic mixer, aliquoted, separator, concentrator, or reactor—that contributes to its functionality.

Smart implants are a type of medical device that use smart technology. ‘Smart’ technology refers to the integration of computing and telecommunication technology into other technologies that did not previously have such capabilities. What makes a technology ‘smart’ is its ability to communicate and work with other networked technologies, and through this ability to allow automated or adaptive functionality as well as remote accessibility or operation from anywhere.

Two general definitions of ‘smart’ in relation to medical devices

Smart technology is a technology which uses big data analysis, machine learning, and artificial intelligence to provide cognitive awareness to objects which were in the past considered as inanimate.

By ‘smart’, we mean they exhibit one or more computational intelligence, autonomous operation and responsiveness to environmental changes (i.e. they monitor, transmit, and potentially initiate a treatment action).

In this vision document the focus lies on the use of smart technologies in treatments concerning implants in the human body

Smart technology concerns collecting data, processing (analyzing), sending and receiving and interpretating and using it to change an actual situation. The word ‘big’ points to the amount of data that can be collected in a relatively short time and by using Artificial Intelligence the data can be analyzed relatively quickly and is reliable to be representative.

Developing apps as medical devices for health care professionals and patients, that are dedicated for certain treatments on implants or orthoses is an open product development area. The measurement on the patient outside of the body before, during and after a treatment with wearables and existing validated biomarkers, among others, non-instrumented, microfluidics-based diagnostics, will increase the success rate of existing implants and orthoses. At the moment wearables are already in the market as consumer products and collect general health care data. Although already used by health care professionals it appears that the existing wearables are not designed to collect and process data for professional use. Apart form the reliability of data and if they are validated for a certain condition the applications are not yet developed dedicated for a particular treatment.

Although emerging technology allows us to collect big data the processing and interpretation of this data is still minimally organized globally for health care in general. International regulations restrict the freedom to innovate. Only after in depth research and validation changes are applied. And political and commercial factors take away reasons for large distributors to adopt innovation. As emerging technologies imply an opportunity to innovate, the down side is that multimedia gives access to how health care professionals are operating and on results of treatments. This development has lead to even more regulations on how they operate and minimize risks. Meaning that there is a risk avoiding attitude while it is common sense that not all procedures lead to success and patient safety cannot be guaranteed in general. The upside is that the patient can be informed better and is not only the confessor of the treatment, but also has a responsibility to make the treatment successful.

To make full use of continuously produced, large-quantity health data from everyone, artificial intelligence (AI) needs to be built into data-processing algorithms. For faster speed and better reliability, such AI algorithms should be implemented by human-compatible computational chips, which require development based on emerging architectures (e.g., neuromorphic) that are especially efficient for AI.

The variety of human beings as a mechanical system is enormous. Getting more insight in the individual patient by using emerging technologies on big data and manufacturing technologies (3D printing) opens the opportunity to customize implants. For the development of implants, implants can be adjustable before implanting or during implanting becoming smart active implants.