Personalized medicine is on the rise – the German government has also recognized this and confirmed the research funding focus on personalized medicine as part of the “High-Tech Strategy 2020 for Germany”.
Personalized Medicine can no longer be limited to drugs
Personalized Medicine supports the optimal patient-specific treatment plan in every phase of treatment, from diagnosis to the right therapy – in other words, treatment is always individually tailored to the patient and considers his or her anatomical and physiological characteristics.
This comes very close to the vision of predictive, preventive, participatory and personalized medicine (“P4”), long advocated by Leroy Hood and other pioneers of systems medicine.
However, in the context of personalized or individualized medicine, thanks to advances in information technology, computer modeling, and engineering, one must now consider much more than stratified medicine with the patient-specific use of drugs.
Advances are enabling a fundamentally new approach to the prevention medicine, diagnosis, and treatment of human disease.
In this context, the term personalized medicine is broadly defined as a set of in silico methods used in healthcare with the fundamental intent of building and maintaining digital patient twins.
The “in silico” part includes all types of methods and techniques based on extensive use of computational modeling and simulation (CM&S), while the “personalized” part indicates that the approach explicitly considers patient-specific data.
Among all aspects of personalized medicine and in silico methods, we focus here on physics-based, patient-specific modeling of the human body, its functions, and medical devices that interact with the body, such as prostheses and implants. Personalized medicine in this context only works in the context of simulation. This is also referred to as personalized physics-based modeling.
Data-driven applications and pharmacogenetics/pharmacogenomics are thus not considered in this contribution to personalized medicine. This also includes precision medicine, which is based on modern diagnostic methods such as genome sequencing or molecular imaging.
How can medicine be personalized and what are the advantages of personalized medicine?
Computer-aided modeling and simulation are powerful tools for improving the quality of medical care. Following geometric design in 3D, simulation is the next logical step towards verification of personalized medical devices.
Numerical simulations provide important information that can be used both a priori, e.g. for virtual evaluation of the desired therapeutic outcome, and a posteriori, e.g. for clinical follow-up. For example, simple virtual proofs of the safety and performance of personalized implants can be performed.
Access to sometimes complex physical simulations in personalized medicine opens up many new possibilities and advantages for personalized treatment of patients:
- Cost and time savings for medical device manufacturers: the virtual test setup and use of medical simulation can eliminate the need for costly animal and human testing. The safety of the medical device is tested in the digital patient twin, thus accelerating the approval process.
- More innovation: by testing medical devices in the digital patient, even ethically difficult experiments can be carried out and innovative treatments can be developed
- Tailored & safe: personalized medicine enables patient-specific treatments and better adaptation to individual patient needs. This often results in shorter treatment times and less invasive interventions with personalized medicine. This leads to shortened follow-up care, if needed at all. In addition, the risk of implant failure is reduced while tolerability is improved.
Meanwhile there are many fields of application for patient-specific in-silico models in personalized medicine:
- Virtual product development
- Virtual testing / virtual test procedure
The applications differ depending on the general maturity, readiness, user group, complexity, capability and degree of automation of the simulation.
Using the example of our software docq VIT for virtual implant testing with the help of simulation, it quickly becomes clear what is meant by personalized medicine. docq VIT is the first, easy-to-use software for the digital verification of patient-specific implants. By virtually applying physiological or standardized loads to a patient-specific situation, performance and safety can be tested quickly and efficiently using objective criteria. Computer tomography or magnetic resonance imaging scans of the patient are used for this purpose and the implant designer can personalize the implant for the respective patient based on the individual situation. This ensures optimal patient care and increases quality and safety for medical device manufacturers and patients at the same time.
In addition to strength testing of implants and implant fitting, there are already other field-tested possibilities for personalized medicine in the areas of manufacturing of devices, support of diagnoses and the most appropriate selection of treatment methods, as well as surgery planning.
Regulatory perspective/future prospects of personalized medicine
The approach of personalized medicine through in-silico methods has the potential to be used as an approval method for medical devices in various fields in the future.
In addition, simulation will not only be used primarily to support diagnoses in the future, but will also be used for therapy and planning and thus be classified as a medical device. Potential examples of this are docq OSA and docq RPE.
With the help of docq OSA, we aim to optimize the diagnosis for obstructive sleep apnea (OSA) using patient-specific data and numerical flow simulation, and to support the treating physician in finding the most suitable therapy for the respective patient.
Our medical software docq RPE is already in use as a preoperative planning tool for forced palatal expansion. Here, simulation-based optimization is used to specifically optimize the surgical incision in order to achieve a symmetrical result for all patients.
Furthermore, there are already approaches for verification & validation (V&V) for patient-specific models and software as a medical device (SaMD) using in-silico methods. Of particular note is ASME V&V 40, which provides a framework for evaluating the relevance and adequacy of completed V&V activities that establish the credibility of a computational model. In addition, there is the FDA 1807 guidance. The purpose of this guidance is to provide recommendations to industry for the formats, organization, and content of computer modeling & simulation (CM&S) study reports used to support medical device submissions.
Medical simulation will also provide quality management relevant reports and documentation for medical device manufacturers and physicians and support post-market surveillance (post-market surveillance) of medical devices with objective data.
Until we can fully exploit the aforementioned benefits and application areas of personalized medicine and thus further improve patient care, acceptance and the necessary regulatory requirements must be created.
Currently, we see the following challenges for the use of personalized medicine with the help of in-silico methods:
- No requirements for Notified Bodies on how in-silico methods should be evaluated in the approval process. The current Medical Device Regulation MDR only confirms that they can be used for evidence generation.
- There are no guidelines yet for medical device manufacturers in the EU on how simulations should be documented for regulatory approval.
- No certainty whether guidelines from US FDA (1807 Guidelines describing recommended documentation) or ASME (all V&V documents) will be accepted by notified bodies.
- No harmonization between US-FDA and EU MDR guidelines, for example.
In addition, several barriers currently stand in the way of integrating simulation-based personalized medicine into clinical workflows. One of them is the accessibility of numerical simulations to non-CAE engineers (medical professionals and medical device manufacturers). We at CADFEM Medical have recognized this problem and are working to make personalized medicine accessible to the widest possible audience.
How do CADFEM Medical’s solutions help with personalized medicine?
Personalized medicine is the central approach of CADFEM Medical’s software products. Numerical simulation is used to open up new possibilities for personalized treatment of patients.
Our solutions are all based on our docq CORE platform, which also enables physicians and medical professionals to use state-of-the-art Ansys simulation technologies within predefined workflows without any prior computer-aided engineering (CAE) knowledge.
To enable personalized medicine, we convert specific medical questions into docq modules. The modules work as a stand-alone product together with the docq CORE platform. Our goal is to provide an easy-to-use, scalable and secure SaaS solution that allows medical professionals to benefit from highly complex numerical simulations.
A prerequisite for personalized medicine is the use of individual patient data such as computed tomography (CT) or magnetic resonance imaging (MRI) scans. Of course, the security of this patient data is always our top priority.
What else should I know about CADFEM Medical and personalized medicine?
CADFEM Medical is a certified simulation service provider and software manufacturer in the field of medical technology and is one of the pioneers of in silico medicine.
CADFEM Medical products and services enable medical device manufacturers, physicians and medical staff to practically apply numerical simulation and use it for more effective, safer and personalized patient care.
CADFEM Medical is committed to the standardization and broader application of in silico medicine as part of the Avicenna Alliance, thereby ensuring safe, affordable and cost-effective healthcare.
Personalized Medicine means that each patient is treated in the best possible way according to the individual circumstances of the disease diagnosis. This also includes the effective adaptation of therapy.
Personalized Medicine offers cost and time savings for medical device manufacturers by eliminating animal and human testing. Furthermore, it gives innovative treatment methods and is tailor-made as well as safe.
Simulation will be used for therapy and planning in the future. In the future, medical simulation data will also be relevant in the area of quality management for medical device manufacturers as well as physicians.
In order for there to be uniform methods in the approval process for medical device manufacturers in the EU, the necessary guidelines must be created. In addition, there is no guarantee whether guidelines from the US FDA will be accepted. Furthermore, the guidelines vary between the US FDA and the EU MDR.
CADFEM Medical’s software solutions enable physicians and medical professionals to use state-of-the-art Ansys simulation technologies without prior computer knowledge. With predefined workflows, new possibilities for personalized patient treatment emerge. The goal is to make highly complex numerical simulations as easy as possible to use, scale and offer secure SaaS solution.
Personalized medicine at CADFEM Medical stands for effective and safe patient care. With our products/services, patient data security is paramount and we are committed to standardization as well as broader application of in silico medicine.