Tag Archives: Medical Device Product Development

Rapid Prototyping – A Boon for Innovators, Product Designers & Industrial Engineers

Rapid Prototyping
Rapid Prototyping – A Boon for Innovators, Product Designers & Industrial Engineers 5.00/5 (100.00%) 1 vote

Product prototype development is one of the most crucial steps in the life-cycle of new product development. As the need to build product prototypes faster increased, better techniques were developed, which eventually lead to the inception of rapid prototyping.

Developed by 3D Systems, a company providing comprehensive 3D products and services, rapid prototyping today has revolutionized the product design and development industry, allowing innovators, product designers, industrial engineers, and product manufacturers to rethink their product development approach.

Rapid Prototyping – What is it?

Rapid prototyping is a bundle of techniques, which help in crafting various materials, including plastics and metals, into models that represent the product concept. Rapid prototyping gives innovators, product designers, and industrial engineers the ability to hold, feel, and test as many product prototypes as they need in order to make the final product fully functional and safe to use. Rapid prototyping has ousted the need for conventional casting, molding, or machining in the manufacturing process.

Rapid prototyping is a common term for the process that quickly fabricates a conceived object or product with the help of three-dimensional (3D), computer-aided design (CAD) data. The 3D CAD data is uploaded to a special machine or printer that swiftly constructs the required component. The popular term, “3D Printing” is a prevalent example of the rapid prototyping technique.

Today, the rapid prototyping practice has been widely embraced by product development companies that design and develop electromechanical products, mechanical products, electrical and electronic products, medical device products, sports products, and other complex products.

Advantages of Rapid Prototyping

Due to its ability to construct an object or product quickly with the help of computer data, rapid prototyping is a resourceful tool to build product prototypes in a faster and more efficient way. Innovators rely on product prototypes to prove that their concept really works. By being able to develop their conceived item swiftly, innovators are able to share the concept efficiently with potential stakeholders and manufacturers in a real, tangible form. This is an essential step, also known as “Proof of Concept,” and it is quickly becoming an important standard in the new product development process.

Product prototypes also play a very vital role in detecting any design defects prior to the product manufacturing process. In order to eliminate design defects completely, numerous product prototypes are needed, and rapid prototyping is just able to do that, in a swift and efficient manner. After rapid prototyping an item, defects are detected, which are then corrected, and again a new prototype is created. The process is perpetual until all the design defects are eliminated. Product development companies that employ rapid prototyping techniques are eventually saving their clients substantial sums in product development by repeatedly and swiftly delivering a number of product prototypes, which are worked upon to make the final product better.

Although not a core part of the product development process today, rapid prototyping has begun to help shape and reshape the approach towards new product manufacturing. The revolutionary techniques are making things easier for product prototype development. Product designers, industrial engineers, product development companies, and product manufacturers who have embraced these contemporary techniques are already helping their clients (the innovators) in a much better way.

Need help with rapid prototyping? Perhaps with product design or product development or product manufacturing? Contact GID Development Corporation today.

We are a leading product development company in California, US, and we provide fast, efficient, and economical product design, rapid prototyping, product manufacturing, and other product fulfillment services.

At GID Development Corporation, our product designers, industrial engineers, and other personnel have vast experience and knowledge in bringing product concepts to life. No matter how complex a conceived product is, we will bring it to reality. Whether it is developing an electromechanical product, electrical product, electronic product, mechanical product, medical device product, or any other novel product, we will “GET IT DONE!”

To learn more about us, the leading product development company in the US, visit http://www.gidcompany.com/.

A free 15-minute telephonic consultation is available. Just call Jim Grimes at 714-323-1052 between 8:00 AM to 5:00 PM PST.

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.

The Costs Involved in Taking a New Product to the Market

New Product Development Cost
The Costs Involved in Taking a New Product to the Market 5.00/5 (100.00%) 1 vote

When it comes to realizing a new product idea into the physical form, many entrepreneur inventors underestimate various costs that are involved. These inventors underrate not only the product development costs but most of the other vital costs as well.

Underestimating the costs is especially true for medical device products. Inventors should never make the mistake of misjudging various costs, as it can hinder their success. Rather, they should learn and know all the different types of costs involved in bringing a new medical device product into the market.

Remember, the total cost to take a new product from just a mere concept to a mass-manufactured product widely varies. If it is a complex product, the total costs may reach to a hefty figure. Anyway, let us look at some of the most common costs that are involved when it comes to realizing a new medical device product into a physical form and taking it to the market.

Product Design Costs

The conceived product idea needs to be elaborated, and product design helps in this regard. Rough, hand-drawn sketches are carefully drawn into proper drawings by the professionals. These drawings are then elucidated even more using computer applications, like CATIA, SOLIDWORKS, etc.

While creating the drawings or 3D models using a computer application, many changes are also made and tested in order to achieve a definitive and feasible product design. Making professional drawings and computer-generated 3D models requires experience and skills, and it costs a reasonable amount of money. The computer application itself, by the way, will cost a substantial amount of money.

Product Prototyping Costs

Every new product idea needs a prototype. Based on the definitive product design, a product prototype can be made. A product prototype gives the clear understanding of how the conceived product will physically look, feel and function. At the same time, a product prototype helps test the conceived product, eliminate any defects, and enhance certain functions.

Product prototype development is a complex task as it involves creating near perfect examples of the final product. It is arduous and intellectually challenging job. It will cost a substantial amount to develop definitive product prototypes.

Product Development Costs

Based on the product prototype, the final product is developed. Since it is a medical device product, the product development costs can be broken down into (normally) three groups: the mechanical, the electronic, and the plastic.

While the mechanical and electronic do all the magic, the plastic is responsible for holding the product together. Sometimes, instead of plastic, other materials may be used, but plastic is the most common, versatile, and economical material of choice.

Normally, the mechanical and electronic will be the most difficult and expensive to develop, and they will share a big proportion of the product development costs. The plastic parts or components will, comparatively, cost less to develop.

Copyright, Licensing & Certification Costs

While the normal copyright and licensing costs may not be exorbitant, the fees that inventors have to pay, if they hire professionals, are something worth considering.

For novice inventors, the process of acquiring the copyright and other licenses may seem overwhelming. At the same time, in order to protect the invention, acquiring the copyright and licenses is essential. For that reason, inventors may need to hire professionals who would help obtain the necessary copyright and licenses. These professionals will charge fees that are worth considering.

For medical device products, inventors need to obtain certain certifications from the US Food and Drug Administration (FDA). Acquiring these certifications will also cost some money.

Production Setup Costs

Inventors need to set up production facilities in order to mass manufacture the conceived product. Establishing a production facility is no easy feat, and it requires a considerable amount of capital.

Since it is a medical device product, hybrid production facility, which can mass manufacture and assemble mechanical, electronic, and plastic components, needs to be set up. Further, because it is a medical device product, the facility also needs to have a sterile environment. Forming such a facility will cost a massive amount of money.

The inventors, of course, have the option to partner with existing manufacturers, but that will also cost – not as much as establishing own facility, but a significant, nevertheless.

Well, these are just some of the common costs involved in materializing a new medical device product into a physical form and taking it to the market. Other costs such as branding, packaging, logistics, marketing, and so on are also involved.

If you are an inventor and need help in realizing a new medical device product and taking it to the market, then GID Development Corporation can help. A product development company in California, GID Development Corporation specializes in new product design, product prototyping, product development, plastic product manufacturing, and other product fulfillment services.

Whether it is medical device product development, electromechanical product development, sports product development, generic or special-purpose product development, GID Development Corporation will surely “GET IT DONE!”

Want to learn more about the professional product development company in California, GID Development Company? Just visit http://www.gidcompany.com/.

A FREE 15-minute telephonic consultation is available! Just call Jim Grimes at 714-323-1052 between 8:00 AM to 5:00 PM PST.

Development of Medical Device Products

Medical Device Products Development
Development of Medical Device Products 5.00/5 (100.00%) 3 votes

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 (http://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 http://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.