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You’re looking to start a biomedical implant project. What are the best tools to get you started?

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Biomedical implants are devices that are inserted into the human body to replace, enhance, or monitor a biological function. They can range from pacemakers and cochlear implants to brain-computer interfaces and biosensors. If you’re looking to start a biomedical implant project, you might be wondering what are the best tools to get you started. In this article, we’ll cover some of the essential aspects of biomedical implant design and development, and the tools you can use to make your project a success.

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Nandu Surendran

Managing Director at B-Aegis Life Sciences & Research | Entrepreneur | Strategist | Exploring Advanced Biotherapeutics…
Shahrzad Shariatpanahi

EPSRC Doctoral Candidate in Bioengineering | Medical Innovation & Patient Safety | 5+ Years Industry Experience in…
Ze-Wei Tao

Senior Research Scientist at BIOLIFE4D JLABS@TMC

1 Design tools

The first step in any biomedical implant project is to design your device according to the specifications and requirements of your target application. You need to consider factors such as size, shape, material, biocompatibility, functionality, power, communication, and safety. To help you with this process, you can use various design tools, such as CAD software, simulation software, and 3D printing. CAD software allows you to create and modify your device’s geometry and structure, simulation software enables you to test and optimize your device’s performance and behavior under different conditions, and 3D printing lets you prototype and iterate your device’s physical form.

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Nandu Surendran

Managing Director at B-Aegis Life Sciences & Research | Entrepreneur | Strategist | Exploring Advanced Biotherapeutics | Accelerating Healthcare Transformation
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Before even proceeding to design, it is better to consider these major factors: ?Biocompatibility: Minimise immune rejection and ensure long-term safety. ?Functionality: Mimic natural organ function and offer lasting performance. ?Design: Prioritise biomimicry and minimise surgical invasiveness.

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Ze-Wei Tao

Senior Research Scientist at BIOLIFE4D JLABS@TMC
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For human in vivo replacement implants, such as a heart valve or a bone replacement, their sizes can be easily calculated by the host's age, height, and weight based on his anatomical structure. It is not difficult for a medical professional to draft an implant model. The size and shape of a replacement implant inside an organ, such as a certain length of trachea, can be scanned by MRI or 3D ultrasound. Once the shape and size of a defect are at hand, it will be easy to design the size and shape of the implant with a software such as Fusion 360, Solidworks, or SketchUp to be a STL file, and then get it printed via a 3D printer.

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Jo?o Oliveira

Engenheiro Biomédico | Engenheiro Clínico | Gest?o de Tecnologias em Saúde | Engenheiro de Seguran?a do Trabalho
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No estágio inicial de um projeto de implante biomédico, a escolha das ferramentas de design certas desempenha um papel crucial na cria??o de um dispositivo que atenda aos requisitos e especifica??es necessários. O uso de software CAD (Computer-Aided Design) oferece a capacidade de criar e modificar a geometria e a estrutura do dispositivo de forma precisa e eficiente. Com o software de simula??o, é possível testar o desempenho e o comportamento do dispositivo em diferentes cenários, permitindo otimiza??es antes da fabrica??o.

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2 Fabrication tools

Once you have a design for your biomedical implant, you need to fabricate it using suitable materials and methods. Depending on the type and complexity of your device, you might need different fabrication tools, such as microfabrication, nanofabrication, or additive manufacturing. Microfabrication and nanofabrication are techniques that allow you to create devices with features in the micrometer or nanometer scale, respectively. These techniques are useful for making devices that interact with cells, tissues, or molecules, such as biosensors, drug delivery systems, or neural interfaces. Additive manufacturing, also known as 3D printing, is a technique that allows you to create devices with complex shapes and structures by depositing layers of material. This technique is useful for making devices that fit the anatomy and physiology of the human body, such as implants for bone, cartilage, or organ repair.

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Ze-Wei Tao

Senior Research Scientist at BIOLIFE4D JLABS@TMC
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The fabrication tools in biomedical implants/devices area mainly consist of mold casting, 3D printing, and digital light processing (DLP). DL processing prints a scaffold with resins layer by layer and the scaffold can be crosslinked by UV light while at printing or post-printing, its resolution can be as high as 35 micron and the viability of cells inside the resin is significantly increased compared to the way with 3D printing because it takes a very short time and does not necessary let the cells pass through a printhead needle. 3D printing can offer a resolution as high as 100 micron, it prints the scaffold line by line thus it takes a much longer time to get a print done and the cell viability is lower compared to the DLP method.

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Jo?o Oliveira

Engenheiro Biomédico | Engenheiro Clínico | Gest?o de Tecnologias em Saúde | Engenheiro de Seguran?a do Trabalho
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Depois de finalizar o projeto do implante biomédico, o próximo passo crucial é a fabrica??o do dispositivo, onde a escolha das ferramentas e técnicas adequadas desempenha um papel fundamental. Dependendo das características específicas do dispositivo, diferentes métodos de fabrica??o podem ser necessários. A microfabrica??o e a nanofabrica??o s?o técnicas avan?adas que permitem a produ??o de dispositivos com precis?o na escala micro ou nanométrica. Essas técnicas s?o ideais para a cria??o de dispositivos que interagem com células, tecidos ou moléculas, como biossensores, sistemas de libera??o de fármacos ou interfaces neurais.

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3 Testing tools

After you have fabricated your biomedical implant, you need to test it to ensure that it meets the standards and regulations of your intended use. You need to evaluate aspects such as functionality, reliability, durability, biocompatibility, biodegradability, and safety. To do this, you can use various testing tools, such as bench testing, animal testing, and human testing. Bench testing is the process of testing your device in a laboratory setting using artificial or simulated environments and conditions. Animal testing is the process of testing your device in a living organism other than humans, such as mice, rats, or pigs. Human testing is the process of testing your device in human volunteers or patients, usually in a clinical trial setting.

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Ze-Wei Tao

Senior Research Scientist at BIOLIFE4D JLABS@TMC
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The testing tools of a biomedical implant include in vitro testing and in vivo testing. For example, a blood vessel replacement is fabricated. Before transplantation, this implant need to be tested at least for sure 1) suturability, 2) burst pressure, and 3) leakage. Suturability asks the blood vessel can be suturable (anastomosed to the host) at transplantation. Burst pressure testing asks the blood vessel replacement can resist host blood pressure and does not break when at exercises, the strength of a native abdominal aorta can do 500 mmHg. Leakage asks for the lumen of the implant is intact, no defects. The in vivo testing mainly looks into the biocompatible match, the immune response during the process of regenerative remodeling.

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4 Programming tools

Some biomedical implants require programming to perform their functions, such as processing signals, controlling actions, or communicating data. For example, a pacemaker needs to program the electrical impulses that regulate the heartbeat, a cochlear implant needs to program the sound signals that stimulate the auditory nerve, and a brain-computer interface needs to program the neural signals that interact with an external device. To program your biomedical implant, you need to use various programming tools, such as programming languages, software platforms, and hardware interfaces. Programming languages are the codes that instruct your device’s logic and operations, software platforms are the environments that support your device’s development and deployment, and hardware interfaces are the components that connect your device’s software and hardware.

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Jo?o Oliveira

Engenheiro Biomédico | Engenheiro Clínico | Gest?o de Tecnologias em Saúde | Engenheiro de Seguran?a do Trabalho
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As linguagens de programa??o, como C, C++, Python ou MATLAB, fornecem o código necessário para instruir a lógica e as opera??es do dispositivo, enquanto as plataformas de software oferecem ambientes de desenvolvimento e implanta??o que suportam a cria??o e o teste do software do dispositivo. Além disso, as interfaces de hardware s?o componentes que conectam o software e o hardware do dispositivo, facilitando a intera??o entre os dois e permitindo a comunica??o eficaz de dados e comandos, garantindo assim o funcionamento seguro e eficiente dos implantes biomédicos.

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5 Evaluation tools

The final step in any biomedical implant project is to evaluate your device’s impact and value in the real world. You need to measure aspects such as efficacy, effectiveness, usability, acceptability, and cost-effectiveness. To do this, you can use various evaluation tools, such as outcome measures, feedback methods, and economic models. Outcome measures are the indicators that assess your device’s performance and benefits, such as clinical outcomes, functional outcomes, or quality of life outcomes. Feedback methods are the techniques that collect your device’s user’s opinions and experiences, such as surveys, interviews, or focus groups. Economic models are the methods that estimate your device’s costs and benefits, such as cost-benefit analysis, cost-effectiveness analysis, or cost-utility analysis.

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6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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Shahrzad Shariatpanahi

EPSRC Doctoral Candidate in Bioengineering | Medical Innovation & Patient Safety | 5+ Years Industry Experience in Biomedical Engineering | Computational PhD Research in Internal Fracture Fixation in Trauma | Book Author
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Starting a biomedical implant project like an artificial shoulder joint involves tools beyond just design and testing. For example, literature review tools like PubMed provide insight into existing research. Biomechanical modelling software such as 'AnyBody Modeling System' aids in simulating joint behaviour. Material selection databases like MatWeb help choose appropriate biomaterials. Understanding regulatory standards through e.g. FDA guides is crucial. Collaborating with clinicians via platforms like ResearchGate ensures clinical relevance. Rapid prototyping services aid in creating physical prototypes; and last but not least, IP tools like Google Patents protect innovations.

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You’re looking to start a biomedical implant project. What are the best tools to get you started?

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3

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1 Design tools

2 Fabrication tools

3 Testing tools

4 Programming tools

5 Evaluation tools

6 Here’s what else to consider

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