Life of a Device: From the Imagination of a Developer to the Hands of a Caregiver
Many healthcare professionals pick up their product and put it to use before they have a chance to think about how the device came to be. For example, when a surgical nurse hands the surgeon forceps, she thinks of the purpose of the instrument, but not how it was developed. At MED Alliance, we think of both – how a product is made, when it will be on our shelves, and where it will be used. We offer a wide variety of products in the acute care and cardiac care realms, which means our manufacturers could all go through a slightly different process when developing a product, but overall, the process is very similar.
First, the manufacturer must prove that an unfulfilled market exists, which is no easy task in today’s healthcare marketplace. Many ideas start from the manufacturer’s recognition of a product’s deficiencies that keep them from succeeding and improving upon those to create a new, better product.
Once the manufacturer has accomplished this, research and development and market testing come into play. A concept known by many startups is relevant at this phase: prototype, learn, iterate, repeat.¹ This process could take many attempts, but it is vital to getting the right product into the intended end-users hands. The sooner end-users are involved, the less work the engineer will have, because concerns are known quicker and resolved before he or she gets “too far.”
Next steps include regulatory reviews, quality considerations, patent and or/trademark filings, manufacturing considerations, sourcing, label and documentation procurement, and packaging development. These processes can involve many phases of 3D printing prototyping. For each phase, clinical testing and feedback is performed to gain additional response on the product.
Once the device is classified and submitted to the FDA, and hopefully approved, the manufacturer can then look for distribution in their approved territories. If a manufacturer can successfully navigate their way through these complex processes, they can look forward to managing a high-quality and well-known product, like the many manufacturers working with MED Alliance.
For more information about the manufacturing partners and high quality medical devices MED Alliance is dedicated to delivering, visit www.medalliancesolutions.com.
Our partners: https://medalliancegroup.com/products/