Creating a custom implant using 3D printing involves converting a CT scan into a bone model, planning the surgery based on that model, and producing guides and implants tailored to a specific patient. Tailor Surgery, a spin-off from the Hospital Parc Taulí in Sabadell, performs this work for complex fractures and orthopedic prostheses. In chapter 60 of “Toque de Ingenio,” Joan Amat explains how the process works, the cost compared to a standard implant, and the regulatory requirements for custom medical products.
Guest: Joan Amat, who is introduced in the episode as the CEO of Tailor Surgery. Interview published: September 9, 2025. Episode: 60. Duration: 55 min.
In this episode:
- How to transition from a Computed Tomography (CT) scan to a surgical plan, utilizing 3D-printed guides and implants.
- What is the cost of a custom implant compared to a standard one, and who approves it in a public hospital?
- What licenses, certifications, and traceability requirements are involved in manufacturing custom medical products?
The interview was recorded when the company had been active for approximately three and a half years, following a round of investment from business angels in April, and with ISO 13485 certification currently underway. This particular moment allows us to observe the decisions made regarding processes, costs, and regulation before the company moves out of Catalonia.
3D Surgical Planning: Eliminating the Improvisation in the Operating Room
Joan first describes a traditional surgery. The patient arrives in pain, and the surgeon requests an X-ray, and on the day of the operation, they decide on the specific size of prosthesis to use. According to him, surgeons are trained to improvise.
Tailor Surgery specializes in 3D surgical planning. Using CT scans, they create a three-dimensional image of the bones, propose a diagnosis and treatment plan, draft step-by-step instructions, and manufacture bespoke surgical guides and implants/prostheses tailored to each individual patient.
“Traditional surgery adapts the bones to the implant. We make it so that the implants adapt to the bones.”
Joan Amat, 05:26.
The origins lie in Dr. Fillat’s doctoral thesis on 3D printing applied to orthopaedics. This research led to the hospital’s 3D laboratory, and when doctors from other centres requested the technology, it resulted in a spin-off company, established at the end of 2021. Testing with cadavers and with patients was conducted at the hospital prior to the transfer of the technology.
From the bone model to the segmentation: protocol and consulting physician.
TAC involves taking cuts from the person’s skin, muscle, and bone. The initial step, segmentation, involves isolating only the bone and generating a 3D model. There are specific healthcare programs designed for this, but it requires an engineer who knows how to use them.
That engineer applies the company’s protocol to each case: including cutting plans, screw direction, and comparison with a symmetrical image of the other arm, or, if that’s not available, with a standard bone model. Afterwards, a consulting physician reviews the proposal and makes any necessary corrections, for example, if the patient has osteoporosis.
According to Joan, it’s not necessary to come up with a new approach every time when it comes to creating a hip joint; the cutting plans and screw directions are standardized. Therefore, he believes the product is scalable – by hiring engineers and, with increased volume, automating part of the process.
The surgeon receives a patient’s study, along with step-by-step instructions which the surgeon compares to those for assembling furniture. These instructions, along with guides and implants, are displayed in the operating room. In hip surgeries, which often involve a significant amount of blood and limited visibility, a anatomical model is added to aid navigation through touch. The company provides support to the surgeon during initial procedures.
Surgical guides and implants: the case of a poorly consolidated arm.
Joan demonstrates a radio and a fibula in the interview, with a fracture that was previously repaired with a standard implant, but in a twisted manner. The traditional solution involves cutting again and installing another standard implant, without guaranteeing proper alignment.
The printed guide fits against the deformed bone and indicates where to cut and where to drill. The screw holes are made while the bone remains misaligned; when the implant is fitted precisely, the bone remains in the planned position. The implant itself is responsible for aligning the bone.
The same principle applies to the column. In scoliosis, surgeons fix vertebrae with screws, which are typically inserted manually. Tailor Surgery produces guides that clearly mark the exact direction of each drill, while the screws themselves remain standard, as modifying them doesn’t offer any advantage.
Joan explains that they also produce guides for standard implants from other brands. The major manufacturers are capable of making these, but their operations are geared towards the standard product and it can take up to four months to deliver a guide. He insists that the expertise lies in the initial planning.
Materials and manufacturing: polyamide, resin, and titanium (outsourced).
The guides and models are printed in polyamide or resin, depending on the situation. Tailor Surgery does not have its own titanium printers; instead, they generate the 3D file and subcontract the manufacturing to regulated suppliers for medical products.
Many of these suppliers come from the dental sector, which was a pioneer in personalized implants. Joan is investing around half a million euros in a certified titanium printer, along with the machining and cleanroom facilities. The printer’s precision, with a deviation of just a tenth of a millimeter, is sufficient for the application.
Outsourcing the regulated manufacturing process and retaining the design concentrates investment in clinical and engineering knowledge. This is a way of separating what adds value from what can be purchased as a service, a decision that also appears in prototyping from other devices.
Costs, timelines, and who approves the implant in a public hospital.
Following the receipt of the necessary approvals, the company submits a first proposal to the surgeon and the purchasing department within 48 hours. Once the detailed budget and printing are approved, the process takes between one and two weeks – a timeframe that aligns with scheduled surgeries.
Joan estimates the price of a custom radio implant to be around 30% higher than a standard one. For a bespoke hip implant, competitors can sell it for €25,000, while Joan’s clinic manages to do it for less than half that. Despite being more expensive than the standard option, some clinics are opting to avoid it. In response to surgeons who don’t feel it’s necessary, Joan uses an analogy to Formula 1 racing.
“You can be a very good doctor, but you need to plan the surgery”.
Joan Amat, 22:23.
Sales are primarily in public hospitals, related to justified cases such as hip revision surgeries. The surgeon decides, and sends purchasing a justification explaining why the initially offered implant isn’t suitable. The hospital pays 60 days after the operation, which can be several months after the procedure, and this necessitates financing the payment for the procedure.
Edgar raises the question of why this procedure isn’t more widely used. Joan responds that 3D printing with titanium is not widely known, that a custom hip replacement could cost €25,000 compared to €5,000, and that many companies require a significant amount of time from the operating surgeon – something Tailor Surgery addresses by working with its consulting physicians. In the private sector, the main obstacle is often that the insurance company doesn’t cover the additional expense.
Regulation, traceability, and growth.
The company holds a license to manufacture custom medical products, including implantable and non-implantable devices. During the interview, they were in the process of being certified to ISO 13485 for medical devices, which they consider a quality benchmark for sales. One person is responsible for regulatory affairs: any changes or incidents are recorded, and full traceability must be maintained for every screw, in case a batch proves to be defective.
Joan puts growth at around 100% a year and expects to end 2025 with turnover of about €400,000 or €500,000, representing roughly a hundred operations. Around twenty surgeons from the founder’s network funded the first round; business angels joined in April, and he plans another round for international expansion. He cites a market of around 5,300 million in 2032 and points to AI-based automation as a way to reduce costs.
Joan, an industrial chemical engineer formerly working in banking consultancy, joined the company due to his childhood friendship with Dr. Fillat. His most important professional lesson is to never assume an investor’s funds are secure until the transfer is confirmed in the bank.
What can another development team learn?
The Tailor Surgery case offers four lessons for anyone developing a custom, health-related product:
- To standardize the design process. A repeatable procedure for each type of case is what allows for scaling without relying on an expert’s intervention.
- Integrating clinical knowledge into the process. A doctor who carefully reviews each proposal avoids wasting the surgeon’s time.
- Outsourcing the regulated manufacturing process. A certified supplier is replacing an investment of half a million euros and is bringing relevant healthcare expertise.
- Design for the purchasing process. A proposal within 48 hours, with a defined budget, streamlines the approval of purchases and the scheduling of operating room time.
At the time of the interview, Tailor Surgery was primarily selling through public hospitals in Catalonia, with the aim of consolidating its position in Spain and expanding internationally in the next stage.
At i-mas, we develop products that combine mechanical design, materials, prototyping, and manufacturing preparation – also within the healthcare sector. If your product needs to move from the digital model to the finished piece, Tell us about your project..
To continue reading: How is artificial intelligence applied to medical imaging validated and regulated?.
Source of article: Interview with Edgar Guerrero on Toque de Ingenio with Joan Amat. The excerpts cited link to the minute of the conversation. The recommendations for other projects are a summarised editorial from i-mas.
