Helping clients transform their ideas and market opportunities into safe, cost-effective and innovative medical products: Bioana

Medical devices are considered a fundamental component of Health Systems; the benefits they can provide continue to increase as they're essential to prevent, diagnose, treat and rehabilitate illnesses and diseases in a safe and effective way. Medical device companies facilitate the lives of doctors and patients by providing cutting-edge technology solutions.

Medical device companies too face challenges like any other industry. To overcome the everyday challenges, Bioana set values that are driven by collaboration, wondering the world with their discoveries and new ideas that are always focused on serving others.​ Bioana’s goal for 2025 is to become the company with more innovations in the medical device industry in Mexico and is known for it around the world.

Bioana’s own design and development process is a methodology inspired by Stanford’s Biodesign that coupled with their medical device expertise and lean engineering methodologies; they are able to provide a broad range of services to support medical device development, which includes Class I to Class III devices in the area of Cardiovascular, Orthopedics, Sample Collection Devices and General Hospital Devices. 

From design to engineering and integration, to testing and transfer, Bioana works with their clients at any phase of the design process. Whether you are seeking to improve an existing device or to develop a completely new medical device, they are prepared for the challenge.

Bioana-tender is the company’s social initiative program that aims to provide health and wellness to their community through different activities. Their motivation to make a difference in people’s lives is reflected in every invention, product or project that they do, therefore many people that share their vision, volunteers and help them out. The name of Bioana-tender comes from the Spanish word “atender”, which means to serve others and includes the English word tender that perfectly describes the nature of this initiative: caring for others.

Bioana’s work

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, they are very expensive and non-accessible for most of the population. Additionally, one of the most common location 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.

The final design was manufactured with highly-precision laser cutting technology at a very low cost. The material was characterized in the software creating a reliable simulation model to validate the resultant stresses generated by the radial expansion and posterior pulsatile compression. 

Aeroskin: Epithelial healing is considered a complex and dynamic process in which the cellular structures and damaged tissue layers are replaced with healthy tissue. The process can take a very long time to occur depending on the degree of damage and the depth and extent of the wound. Some of the most common wounds occurring in the epithelial tissue are burns, ulcers and skin infection. The slow process of recovery is accompanied by long stages of pain and discomfort that need special care of the wound with high cost treatments procedures. Dr. Eduardo Álvaro Galue developed a novel biomaterial formulation that accelerates tissue growth and provides patients with a rapid recovery. He needed an automatic delivery device for applying his technology that was able to atomize the biomaterial without negatively affecting the results.

The automatic spraying system was designed to utilized the same compressed air source for both the atomization of the particles and for delivering two biomaterials at the same time when triggered or activated by the user. Bioana performed design iterations based on the results of the computational fluid dynamics, analyzing the behavior of the fluid inside the device and the characteristics of the effective spraying area and droplets size. The formulation divided in two cartridges is sprayed simultaneously with an automatic method triggered by compressed air flowing through an inner circuit within the device, allowing the system to be easily handled by any physician and enabling the treatment to be delivered uniformly on the patient´s skin.

The device developed for Dr. Eduardo Alvaro Galue, allowed the effective application of his technology for skin lesions treatment. The approach was focused in delivering homogeneous distribution of the cellular material and providing a very thin atomized cellular layer for an incredibly faster skin recovery.

Andrea Siller, Co-Founder & CEO at Bioana

Andrea Siller is a biomedical engineer who is passionate for helping improving people’s quality of life by applying her skills in design and engineering. She co-founded Bioana, a medical device development company that transforms ideas into safe, cost-effective and innovative medical devices. With every new project they have the chance to challenge themselves in solving complex problems with simple design solutions. This has given me experience in Product Design and Development Process, Project Planning and Management, Quality and Regulatory Compliance, and Business Development.

She certainly enjoys working each day with her team creating new products and is a strong believer that science and technology can improve people’s lives.

“We can provide complete turnkey development services for your product or we can focus on a subsystem. Either way, we become an extension of your team to ensure an optimal outcome.”