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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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Product Development Company

The Most Common & Important Steps Involved in Product Development

Product development is all about materializing a new product from just a mere concept. Whether it is a medical device product, a product with electronics, electromechanical product, sports product, a product with embedded software or any other kind of a unique product, there are a number of steps involved in order to realize it. Here are some of the steps that entail in product development:

Step 1: Research

Performing an extensive market research is where the product development begins. A market research helps identify the prospect of the new products. Is the conceived product unique? How ergonomic the product should be? Will the product be helpful to the potential customers? Are there any alternatives for the conceived product yet? Answers to these and many other questions shape the success of the new product, and in order to get the answers, performing research is necessary.

Step 2: Product Design

A conceived idea is actually elucidated during the product design stage. In fact, all the detailed drawings, from concept to envisioned final product, are drawn during the product design stage. Product design is one very tough step of product development.

A conceived product can be simple or complex in nature. If it is a simple product with few parts or components, the product design process will be a single step. On the other hand, if it is a complex product with numerous parts or components, product design process will be broken down into two sub-steps: Preliminary Product Design and Final Product Design.

  • Preliminary Product Design: When a product consists more parts or components, like an electromechanical power unit, which has over hundreds of parts and components, then the preliminary product design step is useful. Preliminary product design is all about the appearance and function of the conceived product, and less about the product’s manufacturability. Once preliminary product designs are made, they become the frameworks for the final product design.
  • Final Product Design: Final product design is all about product manufacturability. In simpler words, it is about creating product designs in such a way that the said products are easy to fabricate or manufacture. The final product design specifies everything required to dictate production or mass manufacturing. It considers everything on a part level. The result of final product design is detailed drawings, 3D image and rendering files, a complete bill of materials, and details to source and assemble.

Step 3: Product Design Analyses / Feasibility Analyses

After realizing the final product design, detailed analyses are carried out on the design prior to product prototyping and prototype testing. These analyses verify the feasibility of the product, as well as its performance, like strength, weight, dimension, etc., prior to developing a physical prototype. This important step lowers the cost and performance risks related to prototype development and prototype testing.

Step 4: Product Prototype Development

Once a definitive product design is ready, alpha and beta product prototypes are made. This is the step where actual, physical form of a conceived product takes shape and comes into being. Product prototypes are made using suitable plastic product manufacturing techniques. If it is a product with electronics, then breadboards or generic electronic kits, like Arduino kits, are used to make prototypes. 3D printing and rapid prototyping techniques can also be utilized for product prototype development.

Step 5: Prototype Testing

Prior to moving the product into production, exhaustive testing of the definitive prototype is carried out in order to make sure that it functions and performs as expected. The prototype is used in all the possible ways it is intended to be used. General public and potential customers are also given the opportunity to use the prototype; this way, valuable feedbacks from them are taken and implemented before the product is sent for mass manufacturing.

Step 6: Hazard Analysis

The hazard analysis is performed throughout the product development process. It is, however, finalized before the product is sent for production. The purpose of hazard analysis is to identify any possible safety issues that may surface by the product, in the future. If possible, the safety issues will be addressed by the change in the product design. If not, it will be addressed by accompanying product manual and safety warning labels.

Step 7: Mass Manufacture & Release

The final step of the product development is placing the product into production. If the capital is not the constraint, then own production facility can be set up. If it is the constraint, then outsourcing the production is the sensible and economical way.

Once the product starts to roll out in larger quantities, it can be taken to the market, into the hands of potential customers.

Product development is indeed a time-consuming, mentally-challenging, exhausting task. For individual inventors, it is next to impossible to realize their dream products on their own. Fortunately, there are product development companies, like GID Development Corporation, that can help inventors with product development.

GID Development Corporation is a leading product development company in the US. Based in California, it offers swift, agile, economical, and top-quality product design, product prototyping, and product development services to inventors throughout the United States and across the globe.

With their vast experience, professionals at GID Development Corporation can help develop large, complex products, products with embedded software, sports products, products with electronics, electromechanical products, and other unique products. No product development project is too big or too small for them; these professionals at GID Development Corporation will “GET IT DONE!”

Learn more about professional product development company, GID Development Corporation, by visiting https://www.gidcompany.com/.

Have any product development-related questions or queries? 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 new product development.

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Product Design

Steps in Successful Product Design

New product design may seem like an easy process. The fact, however, is that it is not. A new product design involves several steps and processes that need due consideration. Failing to heed these steps and processes definitely will lead to unsuccessful product design. Here are some of the steps that entail in successful new product design.

Step 1 – Evaluating the Problem

This is the primary step where you need to identify the real problem in the market. By identifying the real problem, you can come up with innovative ideas, and thereafter, solutions to resolve the identified problem. Your idea could stem from the lack of an adequate product in the market, or a product in the market that does not function as well as it should.

Step 2 – Extensive Research

This step involves thorough researching to see what similar products are currently

in the market. This is important as it ensures that the new product you are thinking about introducing in the market does not already exist. On the other hand, it will also help you identify various problems with the existing products. Understanding the problems with the current products will help you design your new product better.

Step 3 – Generating Ideas

After performing in-depth research, the next step is where you can begin forming ideas and concepts to come up with a viable solution. This is where you can start sketching your ideas and jotting down a list of features for your product on a piece of paper. It will be in your best interest if you can use a computer to draw your sketches and note your list of features. Computers are more reliable than papers or sketchbooks!

Step 4 – Creating Prototypes

Once you have the perfect or near perfect product design, you can proceed to product prototype development. This is the step where you can actually begin to see your idea materialize. A product prototype is a working / non-working model of your product concept. A prototype is beneficial in numerous ways; it gives you the picture of how your product will look like; it allows you to test and analyze so that you can make any changes if required; it helps attract potential stakeholders, and eventually finance for taking your product to the final stages.

Step 5 – Final Design

After the success of the prototype, you can proceed to finalize the product design. This final product design should incorporate all the intended functions as well as aesthetic aspects of the product. This final design should also comply to various standard compliances if there are any. Think of this final design as a product that is in a real consumer’s hand.

Step 6 – Thorough Testing

This is a vital step. Before proceeding to mass manufacturing and launching the product in the market, it is of cardinal importance that the product goes through rigorous testing. Product testing should not only be performed by experts, but by potential customers, as well. In case something goes wrong during this stage, like dislikes of product aesthetics or certain functions, you can go back a couple of steps and improve your product further. It will, of course, cost you to go back a couple of steps, but it will not cost as much substantially as it would if you skip this step.

Step 7 – Mass Manufacturing

If everything goes well during the testing stage, you are ready for mass manufacturing. Simultaneously during the mass manufacturing, you should also perform marketing and establishing distribution channels so you can take your product to the market.

If you want to learn more about new product design, visit veterans at GID Development Corporation https://www.gidcompany.com/. GID Development Corporation is a leading product design company in California, USA. With a combined experience of over 40 years, the professionals at GID Development Corporation provide A – Z product fulfillment services.

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

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Electromechanical Products – They Don’t Appear Out of The Blue!

While new product development is the systematic process of designing, developing, and taking the new product to the market on behalf of innovators, electromechanical product development is the same process.

Electromechanical products are those, as the name signifies, that comprise both electrical and mechanical components. While the overall concept of electromechanical product development remains the same as normal product development, realizing or developing electromechanical products requires additional electrical and mechanical engineering. Although the addition of electrical engineering and mechanical engineering processes or procedures to product development may sound simple, it is not so.

Electrical engineering is a broad engineering genre, which pertains to the study and application of not only the electronics and electricity but electromagnetism, as well. While these are unfathomable subjects to a normal person, the end products of electrical engineering are all the things that run on some form of electricity, which we normally see around us daily. Ranging from light bulbs to power grids to computers to smartphones to automobiles to spacecraft, everything that requires some sort of electricity to operate is a result of electrical engineering.

Mechanical engineering is even a broader field of engineering than electrical engineering. It involves the study and application of mechanics, thermodynamics, kinematics, electricity, structural analysis and material science to name a few. Again, these are

difficult-to-understand concepts, but the end products of mechanical engineering are machines and devices that we see around us every day. Wristwatches, toasters, shower faucets, door locks, elevators, automobiles, aircrafts, are all some of the finest examples of machines and devices that resulted from mechanical engineering.

These days, more and more people demand new and revolutionary electromechanical products – products that could change their lives, make their everyday tasks easier. Innovators do have the potential to come up with breakthrough electromechanical product ideas, but realizing or materializing these ideas into real products on their own is something quite impossible to achieve. Fortunately, there are certain product design and product development companies that help these innovators fulfill their dreams.

New product design and product development companies, which are capable of developing new electromechanical products have extensive skill sets that innovators need. These product design and product development companies have the product designers, product engineers as well as industry leaders (think-tanks) who can utilize these engineering principles and work along with tools like CAD (computer-aided design) programs and PLM (product lifecycle management) solutions to generate designs, create prototypes, and eventually final electromechanical products. Not only electromechanical products, but using their skill sets, these product design and product development companies can create medical device products, products with electronics, products with imbedded software, and pretty much most of the unique products.

If you happen to be an innovator or have an idea for electromechanical products, medical device products, products with imbedded software, products with electronics or any other kinds of products that you would like to materialize and take them to market, the GID Development Corporation can help.

Led by industry veterans having over 40+ years of experience, the GID Development Corporation is a product design and produce development company based in California, USA. They have the in-house capabilities to complete new product design, product development, product prototype development, production setup, product manufacturing, branding, packaging and other product fulfillment services. Utilizing the latest technologies, like Dassault Systèmes’ 3DEXPERIENCE platform that includes CATIA V6, ENOVIA, 3DVIA, SOLIDWORKS, 3DEXCITE, and more, GID Development Corporation significantly reduces the product fulfillment time and cost, i.e. product design time and cost, product prototype development time and cost, etc., allowing them to accomplish their customers’ vision quickly, at reduced costs.

Whether it is the designing, prototyping and development of revolutionary electromechanical products, medical device products, products with electronics, products with imbedded software, or any other types of products, GID Development Corporation will “Get It Done.”

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 at 714-323-1052 between 8:00 AM to 5:00 PM PST for a free consultation.

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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.

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Benefits of Hiring a Product Development Company

Every business has a sole purpose of selling their products and services in order to gain maximum returns. The quality of the products and service, however, determines the success of a particular business. The products and services of an inferior quality factor towards low sales and eventually minimal returns. For that reason, enterprises are required to carry out extensive research regarding product design and development, so that they can bring something new with high quality to the market.

Most successful businesses have a separate product development and research division in their organization. However, those who do not have such a division, how can they perform research and development? The answer is quite simple. They should hire the services of a professional product development company. Here are some of the advantages of hiring a reliable product development company for the designing and development of your product.

Consumer-Centric

By hiring a professional product development company, you can be rest assured that the products and services you will introduce will be more consumer-centric. A consumer-centric design gives the consumers a reason to buy from you, rather than from your competitors. These product development companies introduce a valuable fundamental of differentiation between your products, and your competitors’ products. Therefore, you will have a product for which consumers will be willing to pay more. Also, a consumer-centric design creates a brand name, which in turn attracts more customers.

Economical

One remarkable benefit of hiring a product development company is that you do not have to worry about the operating expenses of maintaining an in-house R&D team all-round the year. Therefore, when compared to a dedicated in-house team, hiring a product development company seems to be a sensible and economical option. Overall, by hiring a professional company, you will be able to cut the costs of hiring, training and maintaining the in-house team, and at that same time, use the saved money for better designing and development of your product or for other purposes.

Experience

Usually, most product development companies are in the business of designing and developing products for years; hence, they know exactly all the factors that keep a product from being successful. They are highly qualified and have valuable experience in solving product design problems and complications.

They undergo training in product development programs on a regular basis, and they stay updated with the market trends. Aside from problem-solving skills, they also possess the ability to determine the market viability of a product and calculate the possible outcome. Additionally, they even have the capability to prepare effective marketing strategies that ensure wide product reach and better consumer acceptance.

Good Results

As mentioned in the previous point, a professional product development company has vast experience and a wide exposure in the field of product design and development. For that reason, they can produce good results in contrast to an in-house R&D division. Professional companies know the nitty-gritty of product design and product development.

Further, they also know all the mistakes and errors that needed to be avoided, which otherwise could end up costing you a lot.

They also perform market researches and surveys during the product design and development phases to understand what the consumers actually want. This enables them to design and develop products, which live up to consumers’ expectations.

So now, are you ready to enjoy the above advantages? If yes, then get in touch with a reputable product design and development company. Jim Grimes at 714-323-1052 8am – 5pm PST for a free consultation.