The advancement of medical technology has been nothing short of revolutionary. In the past few decades, we have seen the development of new drugs, surgical procedures, and medical devices that have saved millions of lives and improved the quality of life for countless others. The global pandemic brought revolutionary ideas to life, including the increase in telehealth that allows you to do things like have a doctor’s visit in the comfort of your home.
What is a Medical Device?
One of the most exciting areas of medical technology development is in the field of medical devices. Medical devices are any product used to diagnose, treat, or prevent disease. They range from simple tools like tongue depressors and bandages to complex machines like pacemakers and MRI scanners.
Why are so many medical devices being developed?
Despite the challenges, the development of new medical devices is accelerating. This is due to a number of factors, including:
- The increasing availability of funding for medical research
- The growing number of talented engineers and scientists working in the field of medical technology
- The rapid pace of technological innovation in other industries, such as electronics and computing
As a result of these factors, we are seeing a constant stream of new and innovative medical devices being developed. Some of the most promising new medical devices in development 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 than traditional surgery
- 3D-printed medical devices that can be customized to the individual patient
These new medical devices have the potential to revolutionize the way we diagnose, treat, and prevent disease. They could save lives, improve quality of life, and greatly reduce the cost of healthcare.
What are the steps in developing a medical device?
Developing a medical device is a complex and challenging process that requires a deep understanding of human anatomy and physiology, and the latest advances in engineering and materials science. It also requires extensive testing and regulatory approval processes, which can take years to complete. Here, we’ve outlined the steps needed to ensure your medical device goes to market quickly and is a beaming success.
1. Identify the Need for your Medical Device
This is the initial stage in any new product development. You need to figure out what problem your new product will solve. Is this something that can already be purchased? If so, how can your product improve what’s already on the market? You should do ample amounts of market research to find if there is a need for your medical device, and who benefits from using it. You will need to learn about potential competitors already having a leg up on the market.
2. Design and Develop with DFM in Mind
This is one of the most painstaking steps in designing and developing any new product, but it’s especially true in medical devices. This step involves taking all your ideas and designing your product, then moving it into development. You must ensure your medical device is designed with all the strict regulatory requirements already in place. If this is missed, you could fail required tests, which takes you back to the drawing board. This is one of the most overlooked steps, yet it saves much-needed time and money. If you’re unsure of your medical device’s requirements, enlisting the knowledge of a product design firm that’s well-versed in medical device design is best.
If you plan to create a product that will be available to large quantities of people, you will also need to design your product with manufacturing in mind. This ensures a faster time to market by providing an efficient assembly process and taking advantage of price breaks by ordering large quantities of materials.
3. Perform Comprehensive Testing Before Production Runs
Just as designing your medical device with the mandatory requirements is important, we will now test the design. Medical devices are under much stricter standards, therefore, a documented design process is often required to ensure safety and effectiveness. You should complete several test runs with your product to ensure all possible outcomes before mass production. This will also give great feedback on your product’s user experience, leading to greater market success and adoptability.
4. Certification and Regulatory Requirements
Once you have finalized your design and have a working prototype, now comes the process of obtaining the proper certifications for your medical device. Depending on the use of your device, there are several standards and certifications that must be passed before your product can go to market. In addition to various ISO certifications, the country to which you are selling your product might have additional regulatory requirements that must be obtained.
5. Manufacturing and Assembly of your Final Product
After passing all the required certifications, you are now ready to manufacture your final product. Most medical devices must be manufactured in an ISO-certified or FDA-registered facility. If you do not already have access to one of these manufacturing sites, partner with a company with vast medical device manufacturing experience. Establishing good manufacturing and assembly processes will ensure a faster time to market for your medical device.
Where your product is manufactured is an often-overlooked element of the product development process. If you do choose to partner with an experienced manufacturing firm, they should have full transparency in their manufacturing processes and allow you access to their facility when needed to ensure your product is on schedule.
What challenges could I face when developing a medical device?
You will face several hurdles when developing a new medical device, or any medical technology for that matter. These range from regulatory compliance, clinical trials, risk management, design and technical complications, resource constraints, market competition, and cultural differences. All of these and more can stop development in its tracks. Each of these can take valuable time to solve, which puts your product at risk of being late to market.
Partnering with a Product Development Company to Increase Your Product’s Success
The fastest and most reliable way to shorten the time to market for new medical devices is to partner with a company specializing in medical device design and manufacturing. These companies will already have the experience and can lead you through the process. This can significantly shorten the time to market for new medical devices, giving companies a competitive advantage.
Here are some of the benefits of partnering with an experienced medical device design company can bring:
- Speed: These companies already have the expertise and resources to design and manufacture medical devices that meet all regulatory requirements quickly and efficiently.
- Cost: Design companies can often manufacture medical devices at a lower cost than in-house manufacturing since they already have the skills and workforce. This can save companies money, which can be reinvested in research and development.
- Quality: Design service companies have a track record of manufacturing high-quality medical devices that meet all regulatory requirements. This can give companies peace of mind knowing their products are safe and effective. They also know all the hurdles to the development process, and most companies have an in-house quality and regulatory compliance team.
By partnering with a medical device design and manufacturing company, you can focus on what you do best – developing innovative medical devices that can save lives and improve the quality of life for millions of people. You will also gain access to new technologies and manufacturing processes that may not be available to in-house manufacturing. This can give companies a competitive edge in the marketplace.
Pivot International has over 50 years of experience designing, developing, and manufacturing a range of products, including medical devices. We have global teams of over 150 multi-disciplined engineers working together to bring our customers’ ideas to life. Once design is complete, we offer 300,000 square feet of manufacturing space spread across three continents. Whether your needs are developing a prototype or having access to scalable production runs, Pivot can be the answer to your product development needs. Contact our team to learn more about our teams and capabilities.