„From illness to recovery” – how implants are made
It all starts with the patient. The drive to create a new implant arises from the need to solve real health problems faced by people around the world. Analysis of musculoskeletal disorders, injuries, congenital defects and degenerative diseases that affect an increasing proportion of the population. With an aging society, sedentary habits, and the rise of civilization diseases, the need for effective spine treatments continues to grow. At this stage, doctors and engineers define the problem, identify its causes and look for gaps in current solutions. This is the moment when they determine what is missing in the medical arsenal and what requirements a new solution should meet. All this is done to improve the effectiveness of treatment and the quality of life of patients.
Once the problem has been identified, the next step is to assess the feasibility of the idea. This involves combining the knowledge of specialists from various fields – medicine, materials engineering, biomechanics and manufacturing technology. Reports from scientific conferences are analysed, publications are reviewed, and the latest trends in orthopaedics and neurosurgery are assessed. Benchmarking is carried out, comparing existing solutions around the world and evaluating available technologies and raw materials. At the same time, the economic potential is examined and the cost-effectiveness of the project is estimated. The aim is to build a solid knowledge base and collect all the necessary data to move on to the design stage, minimising the risk of failure.
With a complete picture of the problem and its possible solutions, the project team begins to develop a concept. A brainstorming session begins, during which engineers and designers, in collaboration with doctors, work together to develop possible implant variants. Conceptual sketches and 3D visualisations are created, followed by computer models of solutions that take anatomical conditions into account. At the same time, a concept for the surgical instruments required for implantation is developed.
The design takes into account functional requirements, safety standards, ergonomics and ease of use in the operating theatre. This stage requires precise cooperation between different teams, supported by expert knowledge, in order to achieve a solution that is not only innovative but also practical.
From visualisations and computer models, we move on to the material world. The first illustrative versions of implants – prototypes – are created. For this purpose, advanced technologies are utilized, such as EBM (Electron Beam Melting) – which is vacuum-based 3D printing using Ti6Al4V titanium alloy powder, CNC milling and laser processing. Prototypes allow us to assess the dimensions, shape and anatomical fit. At the same time, prototype models of surgical instruments to be used during the procedure are created. At this stage, it is important to capture every detail – from surface smoothness to the method of assembly. Prototyping is a key step in verifying whether the developed concept will work during surgery.
The prototypes are sent to research laboratories, where they undergo a series of strength, biomechanical and ergonomic tests. We analyse how they behave under load, whether they are resistant to abrasion, corrosion and biological factors. We also check whether the shape of the implant allows for safe and effective implantation. The test results allow us to detect any design flaws and make the necessary corrections.
This process can be repeated many times until the optimal shape and parameters of the implant are achieved.
This is the stage at which the design takes on its final characteristics and becomes ready for final validation.
It is a formal confirmation that the implant meets all safety and functionality requirements. Tests are carried out in near-real conditions – on anatomical models, animal specimens or human cadavers. Risks are analysed, compliance tests are conducted, and the safety and expected durability of the implant are examined. Validation also includes an assessment of the surgical instruments and the entire surgical procedure. The aim is to ensure that the product is ready for clinical use and does not pose a risk to the patient. This is the final stage before mass production begins.
Once positive validation results have been obtained, full-scale production of implants and the necessary instruments begins. It takes place at the LfC company, following the fulfillment of restrictive standards prescribed for the manufacturing of medical devices. Production includes precision machining, multi-stage quality control, marking, cleaning and packaging under sterile conditions. Each implant is thoroughly checked for dimensional accuracy, surface quality and compliance with technical documentation. This stage ends with the creation of the finished product, which then goes through the registration and certification process.
Before an implant reaches the patient, it must undergo a complex registration procedure and obtain the appropriate marketing authorisation certificates. The subsequent stages of the procedure include, among others: clinical trials, verification of technical documentation, and confirmation of compliance with safety and quality standards. The certification process is demanding, but it guarantees that the medical device is completely safe and effective. For the company, it is also a passport to international markets. This stage culminates in obtaining the Certificate and granting the CE marking (Conformity European) for the medical devices.
The new implant requires appropriate preparation of surgical teams. To achieve this, a comprehensive teaching system is being developed, including instructions, procedures, videos, 3D animations, training models and procedure simulations. Doctors practise surgical procedures in conditions similar to real life in order to improve their skills in using the instruments. Training takes place during dedicated workshops, courses accredited by the Supreme Medical Chamber and scientific conferences, aimed at ensuring that the implant is used in accordance with best practices.
The final stage is the introduction of the implant to domestic and foreign markets. Participation in international medical trade fairs, presentation of research results in scientific journals, and at industry conferences. Establishing cooperation with clinical, scientific, and technical centers, as well as with Key Opinion Leaders (KOLs) from the medical world. Scientific marketing is not advertising in the traditional sense, but a reliable presentation of evidence of the effectiveness and safety of our solution. The goal is for the new implant to become the so-called ‘gold standard of treatment’ in its field.
The culmination of the entire process is the moment when the implant and instruments are taken to the operating theatre and implanted in the patient. The procedure is performed by trained surgeons using dedicated instruments, in accordance with best medical practices and surgical procedures. As a result of the surgery, the patient gains a chance to regain mobility, find relief from pain, and return to their daily activities. Recovery is faster thanks to the innovative design of the implant, which promotes accelerated bone fusion, and the user-friendly surgical technique. This is the stage at which the original need for treatment is fully met and innovation translates directly into an improvement in the patient’s quality of life.