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Bringing Your Medical Device to Market

The field of medical technology has seen remarkable advancements in recent years, leading to the development of new drugs, surgical procedures, and medical devices that have saved countless lives and improved the quality of life for many others. The global pandemic has also brought revolutionary ideas to life, such as the rise of telehealth, which allows individuals to have doctor's visits from the comfort of their own homes.

So, what exactly is a medical device? Medical devices encompass a wide range of products used in the diagnosis, treatment, or prevention of disease. They can range from simple tools like bandages and tongue depressors to complex machines like MRI scanners and pacemakers.

The development of new medical devices is gaining momentum due to several factors. There is an increasing availability of funding for medical research. Additionally, there is a growing number of talented engineers and scientists dedicated to advancing medical technology. Furthermore, the rapid pace of technological innovation in other industries, such as electronics and computing, is contributing to the development of new medical devices.

These advancements have led to the creation of innovative medical devices that have the potential to revolutionise healthcare. Some of the most promising devices currently being developed include artificial organs and tissues, implantable devices that can monitor and treat diseases in real time, robotic surgery systems that are more precise and less invasive, and 3D-printed medical devices that can be customised for individual patients. These devices have the potential to save lives, improve quality of life, and reduce overall healthcare costs.

Developing a medical device is a complex process that requires a deep understanding of human anatomy and physiology, as well as the latest advances in engineering and materials science. It also involves extensive testing and regulatory approval processes that can take years to complete. To ensure your medical device reaches the market quickly and successfully, it is essential to follow these steps:

Identify the Need for Your Medical Device: Conduct market research to determine if there is a need for your device and to understand the existing competition. Identify how your device can improve upon what's already available.

Design and Develop with Manufacturing in Mind: Design your device to meet strict regulatory requirements and consider manufacturing efficiency. Partnering with a product design firm experienced in medical devices can be beneficial.

Perform Comprehensive Testing Before Production Runs: Test your device extensively to ensure safety, effectiveness, and user experience.

Certification and Regulatory Requirements: Obtain the necessary certifications and comply with regulatory standards before bringing your product to market.

Manufacturing and Assembly of the Final Product: Choose an ISO-certified or FDA-registered facility for manufacturing. Partnering with an experienced medical device manufacturing company can provide expertise and ensure a faster time to market.

Developing a medical device comes with its challenges, including regulatory compliance, clinical trials, risk management, design and technical complexities, resource constraints, market competition, and cultural differences. Overcoming these challenges can be time-consuming and jeopardise the product's success.

To increase your chances of success, it is advisable to partner with a company specialising in medical device design and manufacturing. These companies have the expertise, resources, and experience to navigate the development process efficiently. Partnering with such a company offers several benefits, including speed, reduced costs, and high-quality production.

Pivot International is a trusted company with over 50 years of experience in designing, developing, and manufacturing various products, including medical devices. With a global team of more than 150 multi-disciplined engineers, Pivot can bring your ideas to life.

Our subsidiary, Wideblue, based in Glasgow, UK, can take your medical device from initial feasibility concept, through the process of regulatory approval and full-scale manufacture. We have the technical and project management expertise required to manage the complexities of developing sophisticated medical devices. Mark Reeves, Managing Director, Pivot International UK, commented “We’ve helped take some extraordinary ideas and turned them into a product reality,  through design, development, engineering and finally into manufacturing, all within the Pivot Group of companies. Many of these medical devices have been life changing for their users, a fact that we are extremely proud of. We hold ISO 13485 certification for both design and manufacturing in multiple locations and we look forward to working on many more medical device projects in the future.”

Contact our team to explore our capabilities and discuss your project requirements.

Mark Reeves, Managing Director, Europe, Pivot United Kingdom - A Pivot International Company