You are a medical device OEM with a groundbreaking idea for a medical device that would transform the lives of several patients. How well does that idea translate into the real world? How fast can this idea be converted into a product and released in the market? What are the practical challenges in manufacturing and delivering this medical device? What about regulatory bottlenecks?
Medical device prototyping provides the answers to all these questions and more. Prototyping is a learning process wherein challenges and opportunities are identified in the design and development of medical devices. It enables medical device manufacturers to validate and verify their design using exact replicas of the envisioned product. It involves analyzing the design on different parameters including function, material, performance and so on and iterating the design before going into production. These prototypes may be tested in the clinical environment, apart from presenting it as a proof of concept to clients.
Why do Medical Device OEMs and Startups Need Prototyping?
Risk Minimization
Developing, manufacturing and launching medical devices involve several risks. With prototyping, medical device manufacturers can see how the product looks, feels, functions and performs in the initial stages of development itself.
Medical device manufacturers can evaluate the efficiency and functionality of the medical devices in the end-user environment and accordingly, make iterations to the design. They can identify flaws, challenges and issues at the prototype level and ensure that minor errors/ ignorance do not spiral into larger complications during manufacturing or make the entire manufactured batch of medical devices redundant.
In either case, the company would end up with significant financial losses. With rapid prototyping, they can optimize on time and costs, while keeping their risks within their desirable tolerance levels.
Improving Patient Safety
Medical device prototyping is crucial to improving patient safety. It ensures that medical device OEMs do not rush into manufacturing the product and that they evaluate the product’s efficiency and functionality in the end-user environment, highlighting potential dangers that can be fixed.
Every year millions of medical devices get recalled every year owing to patient injury or death. This causes significant financial losses to medical device OEMs. As manufacturers keep developing prototypes and testing them, they can keep refining the product and ensure only a safe end-product reaches the patient, thus, avoiding the costly recalls.
Product Iteration and Improvement
Not every problem with medical devices creates health and safety concerns. There could be several other flaws or inefficiencies in medical devices that could be corrected before the production, thus, optimizing product design. It is also easier to communicate between design, manufacturing and marketing teams with a physical model in hand rather than a virtual design. They can choose the best prototype from the multiple prototypes to transfer into full scale production.
So, medical device prototyping gives medical device manufacturers the opportunity to iterate their design and keep enhancing the product until one arrives at a winning product.
Developing Customizations and Variations
With rapid prototyping, medical device companies have the opportunity to tweak the product into various shapes and designs. They can evaluate the functioning, and the economic, industrial and manufacturing feasibility of each of the variations of the medical device. They could further develop customizations for clients based on their need.
Medical device manufacturers can use prototypes to also infuse flexibility and efficiency into the packaging of products. They can develop variations of packaging that enable quick and efficient transportation, minimizing the risks associated with faulty/ inefficient packaging.
Regulatory Testing and Compliance Purposes
Prototyping enables medical device companies to ensure that their product and processes are in line with the regulatory frameworks and compliance standards such as ISO, US-FDA, etc. If something is not in line with these standards, they can make the necessary changes before the product goes into manufacturing. They can submit their prototypes for regulatory testing to check for potential violations before manufacturing.
Further, different regions/ countries have different regulatory requirements. Prototyping enables global medical device OEMs to develop variations for different countries/ regions rather than going through arduous and time-consuming processes to get regulatory clearance in different countries with a single, standard product.
Revolutionizing the Supply Chain with Rapid Prototyping
Rapid prototyping helps revolutionize the supply chain for medical device companies. The rapid prototyping and iterative design processes enable medical device companies to achieve unmatched speed to market. It ushers greater flexibility into the manufacturing, enabling manufacturers to swiftly accommodate unprecedented changes to the product or customizations, thus, effectively responding to market/ demand shifts.
Identifying Patent Overlap
In a highly competitive medical device market, developing and manufacturing unique products is critical to business success. With rapid prototyping, medical device companies can ensure that their products do not overlap with existing patented technology. If patent overlaps exist, the design can be iterated.
The Best Practices in Prototype Development
- Choose rapid prototyping instead of more conventional approaches to accelerate the process and bring products to the market faster. The use of premium CNC machines enables faster casting, molding and precise prototype development.
- Match the right prototyping technique to your specific need to save time, money and effort. For this, you need to clearly define what purpose you are looking to prototype – is a proof of concept? Is it a functional prototype? Do you need a life testing prototype? Do you need a prototype for regulatory testing? Each of these would require a different kind of prototyping method and so define your purpose to choose your prototype.
- Collaboration is key in medical device prototyping. Different stakeholders must be part of the design and prototyping process makes the process more efficient with lesser back and forth and better product development.
How Does Gesco Help?
Gesco is a trusted, award-winning medical device manufacturer and a contract manufacturing partner of choice for global medical device OEMs. The company offers fully-integrated, end-to-end, in-house manufacturing expertise, right from design and rapid prototyping to production and delivery. Gesco is powered by world-class prototyping labs with avant-garde machinery, cutting-edge technology, top-notch experts and 6 decades of experience that enable the company to turn groundbreaking ideas into award-winning medical devices.
