Our Services
The Spalding Focus
research & development, manufacturing, commercial and federal distribution channels, and customer support.
research & development, manufacturing, commercial & federal distribution, & customer support.
research & development, manufacturing, commercial and federal distribution channels, and customer support.
Research
Spalding spends months, if not years, working with medical experts on defining patient needs.
Manufacturing
Spalding processes years of research to determine the right manufacturing process.
Distribution
Spalding will utilize every channel available to make its products available to all viable marketplaces.
Support
Spalding promises that supporting customer needs is as important to making the product.
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We Are provide
The supply chain of a typical product starts with material input, followed by production, and finally distribution of the end product to customers. The cost of a product includes not only the cost of factory resources to convert materials to a finished item but also the cost of resources to make the sale, deliver the product to customers, and service the customers. Consequently, in order to reduce cost, firms have to plan all the activities in the supply chain in a coordinated manner. It is well recognized that there is a greater opportunity for cost saving in managing supply chain coordination than in improving individual function areas.
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What We can do for you
How much does it Cost to Develop a Medical Device?
The exact costs associated with developing a medical device will vary according to what is being developed. There are clear differences in complexity for a tongue depressor and a defibrillator, and this will be reflected in the relative development costs.
Furthermore, it is very difficult to skip any of the iterative development, design and testing stages in order to save costs. A device manufacturer will need to be able to show technology, industrial design, safety, usability, proof of concept, manufacturability, packaging concepts and many other factors before reaching the marketplace.
Although it is difficult to put an exact figure on medical device development, research has shown that the total funding costs for a Class 2 medical device is around $30 million, of which development and engineering makes up $2-5 million.
Does a Medical Device need FDA Approval?
All medical devices that are manufactured, repackaged, relabelled or imported for sale in the United States need some level of FDA approval.
The FDA’s ‘Center for Devices and Radiological Health’ are responsible for regulating these products as well as medical and non-medical radiation-emitting electronic products such as lasers, x-ray systems, ultrasound equipment, microwave ovens and even colour televisions.
The required level of regulatory control increases with each class of medical device, from one to three. Most class one devices do not require Premarket Notification 510(k); most class two devices require Premarket Notification 510(k); and most class three devices require Premarket Approval.
In each case, a submission needs to be made to the FDA, increasing in complexity with each class. As a result, the time to gain approval will also increase from days to months.