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Medical Device Product with Embedded Software – Important Things to Know

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 https://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.

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Development of Medical Device Products

Developing medical device products is in most ways no different from developing any other kind of product. Therefore, let us first look at the similarities of generic product development and medical device product development.

How medical device product development is similar

Development of any product, whether it is an electromechanical product, a product with electronics, a product with imbedded software, a medical device product, or any other type of product, involves the following necessities:

  1. Understanding the precise needs of an innovator and the stakeholders
  2. Recognizing all the constraints of new product development
  3. Implementing a coherent way of realizing the needs, i.e. creating an effectual new product design after thorough research
  4. Proving that the product development company has met the needs of realizing a new product, i.e. developing new product prototypes and thereafter finalizing the prototype based on which mass manufacturing can initiate
  5. Taking the new product to the market

The development of medical device products also faces certain specific challenges, which also affect many companies these days:

  1. Fierce competition
  2. Take the new product to global markets
  3. Shorten development time as well as time to market

How medical device product development is different

The cardinal difference between generic product development and medical device product development is the highly controlled domain in which medical device products are developed, sold, and utilized. From the very early days, the medical industry has been operating within stringent compliance structures. This has repercussions that need to be considered carefully:

  1. Regulatory agencies always demand proof of compliance, and to make things worse, regulations vary between markets
  2. Conflicts with regulatory agencies can result in substantial damage
  3. Product designers need to record and show traceability from the actual user needs through to the delivered products
  4. Product manufacturers need to have a system set up that ensures consumers’ requests and complaints are managed and resolved
  5. Everything needs to be recorded / documented and reported
  6. Ineffective product can cause injury or even loss of life

Safety has always been one cardinal aspect when it comes to the development of new medical device products. In addition, technology, especially software application, is emerging as a crucial differentiator. Medical innovations powered by technology / software application range from the robot-assisted surgery to automation of lab work and reporting of results. The imbedded software has the capability to keep up with rapid product development, because product development companies can add functionality more quickly to a software application, than to the hardware. If the product development company cannot assimilate software into its product fulfillment processes, the time to roll out new products increases. For that reason, it is crucially important to connect software development to product design and other product development processes.

Everyone needs to consider different sets of regulatory requirements when it comes to medical product development. This can get complicated because different regulations are based on different philosophies. Local regulations, for instance, the FDA, are based on results and not on proposing specific activities. Many international standards, however, propose ways of working. For that reason, medical device product manufacturers need to find a balance. It can indeed add more complexity towards maintaining compliance with applicable regulations.

Failure to comply with any of these regulations can result in grave consequences. These can include large fines, shutting down of the company, and even jail.

Best approach to the development of medical device products

As mentioned, medical product development needs absolute adherence to different regulations, pertaining to the medical industry; hence, the best approach to the development of medical device products is to partner with a reputable product development company, like the GID Development Corporation (https://www.gidcompany.com/), that has an extensive experience in the realms of product development for the medical sector.

New product development companies, like the GID Development Corporation, know the severe compliance structures of the medical industry. Complying to those structures, along with using the latest technologies, these product development companies can build medical device products that adhere to all the necessary standards of the medical industry. They have tools and technologies, for instance, Dassault Systèmes’ 3DEXPERIENCE platform, which enable them to create pragmatic product designs and prototypes quickly, accurately, and economically. With these technologies and knowledge, new product development companies not only can realize a product quickly but can also materialize a product that could prove lucrative to the innovators and stakeholders.

Thus, in order to realize new medical device products, innovators should collaborate with product development companies that have enough knowledge about the medical industry. Some companies can even help these innovators take their new medical device products to the local as well as international markets.

Learn more about GID Development Corporation, their engineering procedures, the technologies they use, and how they can help bring a product idea to life, by visiting their website https://www.gidcompany.com/.

You can also Call Jim Grimes at 714-323-1052 between 8:00 AM to 5:00 PM PST for a free consultation.