Evidence for Claims Strategy
From an idea to evidence.
A promising medical technology starts with a hypothesis. Turning that hypothesis into substantiated product claims requires asking the right scientific questions and generating the right evidence in the right sequence.
Evidence starts long before the clinical study.
Strong product claims require the right scientific questions and the right models to answer them.
Biomech Innovations combines extensive hands on experience in biomechanics, preclinical research and medical device development with clinical, regulatory and product development expertise.
We translate intended product claims into measurable scientific questions and develop biomechanical test methods and preclinical models capable of investigating them under relevant mechanical, biological and clinical conditions.
The objective is not to generate evidence simply to confirm an assumption. It is to understand what the technology can credibly claim, what it cannot yet claim and which evidence is needed for the next decision.
01 | Proving the mechanism
Does the technology actually do what it is designed to do?
Variable Fixation Technology Provides Rigid as Well as Progressive Dynamic Fixation: A Biomechanical Investigation.
Frank et al. | Journal of Bone and Joint Surgery | 2020
The question
Can Variable Fixation initially behave rigidly and subsequently transition toward more dynamic fixation?
What we investigated
A biomechanical investigation was designed to characterize the behavior of Variable Fixation and compare it with conventional locking fixation under mechanical loading before and after degradation of the resorbable component.
What the evidence showed
Variable Fixation provided initial stability and subsequently changed the mechanical behavior of the construct, increasing interfragmentary movement as the resorbable component degraded.
Why it mattered
This established the mechanical mechanism of action. Demonstrating that a technology changes mechanics, however, does not demonstrate that the change is biologically meaningful. That became the next question.
Read the publication →02 | Connecting mechanics with biology
Does the mechanical effect produce a biological effect?
Variable fixation promotes callus formation: an experimental study on transverse tibial osteotomies stabilized with locking plates.
Plecko et al. | BMC Musculoskeletal Disorders | 2020
Proving the mechanism was only the beginning.
The next challenge was considerably harder: developing a preclinical model capable of determining whether the measured mechanical effect translated into a meaningful biological response.
The question
If Variable Fixation changes the mechanical environment during healing, does that change affect bone formation?
What we investigated
An experimental fracture healing model was used to compare standard locking fixation with different Variable Fixation configurations. Healing was assessed using complementary methods including imaging, biomechanical evaluation and histology.
What the evidence showed
Variable Fixation influenced the amount and distribution of newly formed bone callus. The magnitude of Variable Fixation also influenced the biological response.
Why it mattered
The evidence progressed from demonstrating a measurable mechanical effect to demonstrating a measurable biological response in a preclinical model.
This is a critical transition in medical device evidence generation: designing a model that connects an engineering mechanism with the biological effect relevant to the intended product claim.
Read the publication →03 | Building the scientific context
How does the evidence fit into the broader science of bone healing?
Strategies to Improve Bone Healing: Innovative Surgical Implants Meet Nano/Micro Topography of Bone Scaffolds.
Wähnert et al. | Biomedicines | 2021
The question
How does changing fixation mechanics relate to what is already known about bone regeneration?
What we examined
This scientific review examined different strategies for influencing bone healing and considered Variable Fixation within the wider relationship between mechanical conditions and bone regeneration.
Why it mattered
The technology could now be interpreted not simply as an isolated implant concept, but within a broader scientific framework connecting implant design, mechanical environment, tissue response and bone regeneration.
Building evidence is not only about performing more studies. It is also about understanding how individual results fit together into a scientifically coherent explanation of the technology.
Read the publication →04 | Refining the scientific question
Does timing matter as much as mechanics?
Promoting bone callus formation by taking advantage of the time dependent fracture gap strain modulation.
Wähnert et al. | Frontiers in Surgery | 2024
The question evolved.
The evidence suggested that Variable Fixation could change mechanics and influence callus formation. Fracture healing, however, is a dynamic biological process.
Is the amount of mechanical movement the only relevant factor, or does the timing of that movement also matter?
What we examined
The available scientific evidence was analyzed around fixation stability, fracture gap strain and the changing mechanical requirements of tissues during fracture healing.
The work explored the concept of a potential window of opportunity during which modulation of the mechanical environment may support callus formation.
Why it mattered
The scientific proposition evolved beyond simply comparing rigid and dynamic fixation. The emerging question became: how much movement is required, at what stage of healing and for which biological purpose?
This illustrates how an evidence program should evolve. New evidence should refine the scientific question rather than simply accumulate additional data.
Read the publication →05 | Moving into patients
What happens when the technology reaches clinical use?
Positive Results Using Variable Fixation in Medial Opening Wedge High Tibial Osteotomies in Patients with Unilateral Knee Osteoarthritis: An Observational Clinical Investigation.
Colcuc et al. | Journal of Clinical Medicine | 2024
The question
What happens when Variable Fixation is used in patients?
What we investigated
Patients treated with Variable Fixation in medial opening wedge high tibial osteotomy were prospectively followed to evaluate healing, safety and clinical outcomes.
What the evidence added
The clinical investigation provided the first published observations of Variable Fixation in patients and extended the evidence chain from biomechanical and preclinical research into clinical use.
Why it mattered
The evidence journey had reached a fundamentally different level: mechanical principle, biological response, scientific rationale and clinical observation.
Clinical evidence does not make the earlier biomechanical and preclinical work obsolete. It builds on it. An initial clinical investigation is also not the end of evidence generation. It creates new questions and helps determine what should be investigated next.
Read the publication →What do we want to be able to say about this technology, and what evidence would make that statement scientifically, clinically and regulatorily credible?
Developing meaningful evidence for a novel medical technology requires more than selecting a standard test from a catalogue.
The experimental model has to represent the scientific question behind the intended claim.
Biomech Innovations brings extensive experience in biomechanical research, experimental surgery and preclinical medical device development. This spans defining the scientific question, developing the experimental model, executing the investigation, interpreting the data and translating the results into scientific publications and evidence that can support product claims.
A strong evidence strategy therefore does not begin by asking which study should be run. It begins by understanding what needs to be demonstrated, what can already be supported and what evidence is still missing.
The answer may require biomechanical testing, development of a new experimental method, a purpose built preclinical model, clinical evidence or all of them in the right sequence.
Biomechanical models
Translating product mechanisms and clinically relevant questions into measurable mechanical test methods and experimental models.
Preclinical models
Developing in vivo and ex vivo models that connect device performance with the biological response relevant to the intended claim.
Evidence interpretation
Connecting engineering, biology and clinical relevance to understand what the evidence supports and what still needs to be demonstrated.
See to believe.
We can explain how evidence strategy works. Or we can show you what we did.
Our proprietary technology →