Medical Prototypes. Healthcare Product Development
Creating a medical prototype and, in general, managing the innovation process to manufacture innovative biomedical products with high chances of success is not easy. But we know how to do it, and we have done it.
Biomedical Engineering and the development of medical prototypes: Biomedical engineering addresses innovation cycles and the development of novel products that add value to procedures in the healthcare sector.
Biomedical Prototypes: Biomedical prototypes are physical and functional representations of innovative products, technologies, or medical devices that enhance the efficiency of medical procedures or their usability. They provide unique value in ensuring the safety of medical personnel and patients.
Design and manufacturing of medical prototypes.
The development of medical prototypes consists of the materialization of healthcare products, most of which simplify procedures or enhance procedural safety.
At Let’s Prototype, we have developed specialized expertise in the development of healthcare products with a high degree of innovation.
Specialists in medical product design
At Let’s Prototype, we can help you with the design of healthcare products with a high degree of innovation. We collaborate with universities, research teams, hospital administrative staff, and individual inventors, with a strong commitment to improving healthcare procedures through innovation and the development of new medical devices.
No matter what stage of development your invention is in, we can help you in the following ways:
Consulting and innovation for healthcare products
Joint search for technological solutions that can improve standardized medical procedures within the healthcare system, or through innovative designs of medical products that enhance and increase procedural safety.
Manufacturing of medical prototypes
In our invention manufacturing laboratory, we have the technical capabilities and extensive experience to tackle the challenges associated with the manufacturing of high-complexity medical prototypes. We can bring your ideas to life and manufacture medical products that, depending on regulations, may undergo special testing to demonstrate their functionality. We are familiar with some of the regulations governing the medical product sector, collaborate with certified laboratories, and prepare devices to ensure they successfully reach the market.
Management of biomedical product patents
Once the viability of the invention is demonstrated, we can assist you in developing a strategy to protect the intellectual property of the invention.
Manufacturing of medical products.
We have worked hand in hand with leading companies in the industrial manufacturing of biomedical products, especially medical products with electronics and biomedical mechanical solutions. We can support you throughout the entire process.
Developed biomedical product prototypes
Portable physiotherapy stretcher
Medical Prototype with Virtual Reality
Medical Device
What is biomedical engineering and what is it for?
Biomedical engineering studies the useful techniques for the development of innovative medical prototypes. It delves into the main regulatory restrictions that set guidelines in the development of medical products. It encompasses everything from knowledge about useful tools for mechanical design and manufacturing of medical products to digital behavior simulation scenarios, electronic design, regulatory limitations, and material compatibility.
What certifications do medical devices need?
Innovative medical devices are strictly regulated by standards aimed at normalizing safety standards for this type of devices. The regulations governing medical products vary in scope depending on the category of medical prototypes. These categories are defined based on the potential risk associated with the use of medical devices.
For example, the regulations governing a Portable Stretcher for Motor Rehabilitation Exercises have nothing to do with the safety regulations that govern an endotracheal tube, which must remain inside the body.
The regulations: CE 93/42/EEC, CE 90/385/EEC, and CE 98/79/EC are the most common within the medical products developed in our laboratory.
Are European medical device certifications valid in the USA?
In the United States, medical devices must comply with the regulations set by the FDA (Food and Drug Administration). Its counterpart in Europe is the EMA (European Medicines Agency). These regulations primarily apply to pharmaceuticals and biotechnological products. However, biomedical products, which are the focus at Let's Prototype, are regulated by CE standards.
Why is developing medical prototypes complex?
Innovation always involves an environment of uncertainty, leading to varying degrees of technical complexity. When it comes to innovation in the development of medical prototypes, in addition to finding optimal solutions, it is crucial to consider regulations, biocompatible materials, hypoallergenic materials, safety standards, and a comprehensive list of restrictions that significantly increase the level of uncertainty. Having a team with little experience in biomedical development can make the process longer and more costly.
The time to bring your ideas to life is now. We accompany you throughout the entire process: from idea to product.
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