Tag Archives: medical device product

Medical Device Product with Embedded Software – Important Things to Know

Medical Device Product with Embedded Software
Medical Device Product with Embedded Software – Important Things to Know 5.00/5 (100.00%) 1 vote

Developing a medical device product is always a challenging, time-consuming, and an arduous task. However, developing a medical device product that includes software (products with embedded software), is even a more demanding task. Today’s medical device products with embedded software are able to save lives, but there is still room for more innovative medical device products. Getting a new, innovative medical device product with embedded software into the market is certainly very lucrative, but more importantly, a revolutionary medical product can change the face of the healthcare industry by providing better healthcare treatments and services.

If you have a ground-breaking idea for a new medical device product with embedded software, then you should definitely consider bringing it to life. If you proceed carefully, you will certainly achieve success with your conceived product. Before you start with the medical device development, however, you should know about the four important things.

Is it really a medical device?

Before you initiate the medical product development, you need to first determine whether your conceived product will be considered a medical device or not. As per the FDA (Food and Drug Administration), “Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices [sic].” Therefore, a simple tongue depressor or a very complex CAT (Computerized Axial Tomography) scanner is a medical device, rather a medical device with embedded software in the latter case, but an activity tracker, like Fitbit’s wristband, is not a medical device. For that reason, it is vital to first find out how your conceived product will be classified. You need to know whether your conceived product can cause any harm. You also need to find out whether there are any safety risks involved.

If you are developing a medical device product with embedded software, knowing how your product will be classified will certainly have a major impact on the product development process, affecting factors such as assessing the development costs and timeline, creating the documents required for FDA approval, and testing the product.

Is your project scope defined accurately?

If you do not know the limits of the complexity of the project, software needs, and the security requirements, you may totally underrate or overrate the product development efforts required. Will your medical device need complex mechanical components to function, or does it need to upload data to the servers to process and generate reports?

When you are trying to ascertain the complexity of your project, think about how many components the conceived medical device product might have. This will help define the timeline and cost of the project. Also, for the software part, you will need to get a clean user interface, which is easy to understand; hence, spend some time understanding the interface part. When defining the scope, be sure to take into account the complexity of the user interface development.

Modern, complex medical device products with embedded software are often backed by mobile applications, which control the medical devices through smartphones and tablets. If your conceived product needs mobile apps, clearly define it in your scope.

Do you have any plan for the maintenance?

What is your plan for maintaining the software aspect of your conceived medical product? The FDA in its guidelines includes the corrective and preventive maintenance of the software. Having a plan for the maintenance will factor toward the development efforts and the long-term success of your product. If the new version of the OS (operating system) releases, how the software of your product will be updated? Will the update affect the functionality of your product? Will it improve the performance and fix software bugs if there are any?

For medical product development, creating a plan around such questions is vitally important.

Do you need a product development partner?

Medical device product development is no easy task, and if any step is missed, it could result in costly delays. Everything needs to be perfect when it comes to medical product development. Having a reliable product development partner will make a big difference and prove to be in your best interest.

Have a complex product idea in mind, like a medical device product with embedded software? Want to bring your idea to life? Get in touch with vastly experienced industrial engineers at GID Development Corporation.

GID Development Corporation is one of the top product development companies in the US. They provide agile and economical product design, rapid prototyping, and product development services to inventors throughout the US and across the globe. Utilizing their vast experience and technology like 3DEXPERIENCE Platform, which features BIOVIA, CATIA V6, SIMULIA, etc., the skilled industrial engineers at GID Development Corporation can help design, prototype, and develop medical device products with embedded software, electromechanical products, sports products, and all sorts of complex products.

So no matter how simple or complex your product idea is, GID Development Corporation will bring it to life. To learn more about the leading product development company in the US, GID Development Corporation, visit http://www.gidcompany.com/.

Have any questions regarding medical device product development? Call Jim Grimes at 714-323-1052 between 8:00 AM to 5:00 PM PST, for a 15-minute FREE telephonic conference. He will answer to various questions regarding medical device product development.

Rapid Product Designing & Rapid Prototyping – Advantages

3D Printing
Rapid Product Designing & Rapid Prototyping – Advantages 5.00/5 (100.00%) 1 vote

New product design and product development, both have come a long way today. Traditionally, product designs were hand drawn. Now, product designers are creating detailed, clear product designs using special-purpose computer applications, like Dassault Systèmes’ 3D EXPERIENCE 2016, SOLIDWORKS, and 3DVIA among many others.

For product development, specifically the product prototype development, engineers nowadays are utilizing revolutionary additive manufacturing (popularly known as 3D printing) processes, which include selective laser melting, fused filament fabrication, direct metal laser sintering, and stereolithography to name a few.

These modern rapid product designing and rapid product prototyping techniques are geared toward the swift, precise, and effortless development of new products. More importantly, with these state-of-the-art techniques, it is possible to minimize the cost of new product development! Let us look at some of the advantages that these computer-assisted 3D product designing and 3D printing techniques offer.

  1. These contemporary techniques radically minimize the time of turning a product concept into reality. Simple product concepts can be brought to life in a matter of days, and complex product concepts in a matter of a few months. Therefore, inventors can quickly realize their dreams of swiftly getting groundbreaking products into the market and selling them to make profits.
  2. These techniques help save money. Creating product designs using computer applications means getting definitive designs with a minimum number of attempts; hence, it avoids redundant costs of creating multiple product designs. 3D printing, on the other hand, eliminates the need for plastic product manufacturing tools or other molding tools needed for building product prototypes. This elimination of tools substantially saves money for the inventors.
  3. The modern techniques help mitigate product redesigning risks. Since the product designs are created virtually on the computer, they are, in most instances, ideal in every manner. Even if they are not, or if any changes are required, the product designers can quickly and effortlessly modify or change the product designs. These new product designs are then efficiently and economically 3D printed, saving time, money, and more importantly, the efforts of doing everything from scratch for the inventors.
  4. The techniques facilitate in the creation of the definitive product. Because 3D product designing is carried out virtually, using special computer applications, the chances of leaving out any product construction requirements are almost next to nothing. In the virtual world, the product designers and product developers can test almost every aspect of the conceived product. This way, they can add, remove, and experiment with the various features of the imagined product without actually creating any mockup or prototype!
  5. These techniques allow quick creation of product prototypes. Once the product designs are ready, they will be fed to a 3D printer (it’s a kind of an industrial robot). The 3D printer is then configured according to the required specifications. Once the 3D printer is configured, it will then extrude material into the desired shapes. The entire process, from feeding the product design into the 3D printer to the extrusion of the material into the desired shapes, is substantially swifter than injection molding techniques.
  6. These breakthrough techniques enable the creation of custom shapes. The 3D printer extrudes the material into desired shapes or geometries based on the instructions received from a computer. In simpler words, a 3D printer prints a material, instead of ink, based on the design it is provided. Ergo, it is possible to create custom, intriguing shapes effortlessly. This advantage of these techniques is very beneficial when it comes to medical device product development as well as electromechanical product development.
  7. These techniques make it possible to develop product prototypes using any material. Not only polymer and its variants, but 3D printers are capable of accepting and printing materials like rubber, ceramic, edible materials, and almost any metal alloy!

These were just some of the many advantages that rapid product designing and rapid product prototyping techniques offer. They are just ideal for new product design and new product development, especially product prototype development.

If you are an inventor and want to realize your product idea with these revolutionary product design and product development techniques, then partner with GID Development Corporation. A leading product design company in California, USA, GID Development Corporation provides rapid product design, rapid prototyping, rapid product development and other new product fulfillment services. They even have the ability to develop CNC-machined prototypes using different plastics and metals. This ability of GID Development Corporation comes in very handy, especially when the raw materials for rapid prototyping processes are not suitable or durable enough for the conceived product.

Whether you have a revolutionary idea for a medical device product, sports product, electromechanical product, a product with embedded software, a product with electronics, or any unique product, the product development company in California, GID Development Corporation will absolutely “GET IT DONE!”

Learn more about GID Development Corporation: http://www.gidcompany.com/

Have any queries regarding rapid product prototyping or 3D printing? Just call Jim Grimes at 714-323-1052 between 8:00 AM to 5:00 PM PST, for a FREE 15-minute telephonic conference. He will answer to various questions regarding product design, product prototyping, and product development.