Research and development (R&D) for medical devices encompasses more than just calculations, drawings, and tolerances; it's about making a meaningful impact on patients' lives. The R&D process begins by defining requirements that are crucial for product feasibility and those that are secondary but still important. This approach allows for quick and efficient solutions to primary requirements. It requires expertise in design, access to cutting-edge technology, comprehensive testing facilities, and a deep understanding of end-users and the market.

When closely aligned with end-user needs and healthcare concerns, teamwork and technology collaboration are essential. Bioana, a medical R&D company, exemplifies this ethos. With a dedicated, creative, and skilled team, Bioana prioritizes improving people's health by addressing problems with simple designs and innovative engineering solutions. The company assists clients in translating their ideas and market opportunities into safe, cost-effective, and groundbreaking medical products through a streamlined design process.

Leveraging Products for Better Quality of Life

Multi-functional Dental Instrument: Dental care procedures are commonly associated with the use of many different instruments for a single intervention which are often referred as expensive tools that require additional skills for handling and maneuvering between each procedure. The dentist’s work table is mounted with a wide variety of tools having all a different purpose and operation techniques. It is time consumable and difficult to organize all of the instruments that are needed for the intervention to be done. Dentist Norberto Pérez needed a multifunctional device able to provide him with all the required tools for use in his patients.

A simple approach for solving this issue is the incorporation of different tools within a single instrument. This will allow the dentist to handle only one tool while being able to rotate the device with a single hand either horizontally or vertically to exchange the instrument that is needed in that specific procedure. Bioana performed 3D modeling iterations of a dental multipurpose restoration instrument that molds the resin to obtain the anatomical shape of the teeth. In this design all four of the most used tools for frontal and posterior restoration were integrated into a simple and aesthetic single instrument with an ergonomic grip handle that allows greater precision to the user.

Recopad: When suspecting urine infections or chronic diseases, a urine analysis is needed for diagnostic purposes. The normal procedure for collecting urine samples is a simple method in which a clean container is used to collect the sample while the person urinates. Unfortunately people with cognitive or physical disability, elderly people with limitations in mobility or neonatal patients, are completely dependent on someone else for the sample collection, therefore their alternatives include invasive methods such as Foley catheter and pubic puncture or ineffective techniques like the use of adhesion of urine bags. All of these techniques have significant drawbacks including low effectiveness rate, the need of specialized medical personnel for the procedure to be done, high risk of infection and especially patient discomfort.

Most of the patients that depend on someone else for their daily activities are usually diaper users. Bioana incorporated an innovative device inside a regular diaper that allows the collection of the urine sample in a safe, effective and non-invasive way. The materials utilized for the construction of the collection device were tested to preserve the integrity of the urine components assuring an accurate diagnostic. The innovative design works as a unidirectional membrane being able to effectively contain the urine sample collected inside the reservoir once it comes in. Then an indicator in the diaper alerts for the presence of urine. The sample is then extracted using an external component pre-charged with negative pressure suctioning the urine through a flexible tube to the container that can be taken to the laboratory for analysis.

Cardiovascular Stent: Cardiovascular disease is one of the main causes of death around the world. The devices used to restore the blood flow in coronary arteries, due to arthrosclerosis, are very expensive and non-accessible for most of the population. Additionally, one of the most common locations for plaque formation is within the arteries bifurcations, thus doctors normally need to place two overlapped stents to cover the lesion, making the procedure more time consuming and expensive.

Bioana developed a single stent device having two mesh structures, each with the ability to expand at the same time at different diameters with the same opening pressure. The two meshes are connected with a bridge that promotes flexibility to properly place and secure the stent in the site of the lesion. Using finite element analysis software, the iterations of the proposed designs for the stent were evaluated identifying the opening pressure required to reach the needed diameters and ensure the structure was stable enough to remain open at a constant loading.

Meet the Visionary Leader Upfront

Andrea Siller is a co-founder and the Chief Executive Officer of Bioana. She is a biomedical engineer who is passionate for helping improving people’s quality of life by applying her skills in design and engineering. Ms. Siller's expertise includes product design and development process, project planning and management, quality and regulatory compliance, and business development.

“At Bioanaa we believe that success in medical research and development lies not just in the pursuit of innovation, but in the relentless commitment to improving the lives of those who need it most.”