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.

Types of Engineers – Who Can Help Develop Electromechanical Products?

Types of Engineers: It is a fact that developing an electromechanical product can be a highly-intellectual, time-consuming, and expensive task. Even if the time and money are not the barriers, the technical know-how and skill is something that, you as an inventor may not have to create your idea. For that reason, if you want to develop an amazing electromechanical product, you need to partner with professional engineers who specialize in multiple fields of engineering.

Because it is electromechanical product development, you will need to team with experts who have the knowledge in different fields of engineering. Approaching a reputable product development company that has engineers, specializing in different fields of engineering, may prove to be in your best interest after all.

In this blog, we will shed light on different types of engineers who can help you develop electromechanical products.

Product Design Engineers

Even if you have the product design for your electromechanical product, you may need to team up with skilled product design engineers. Product design engineers deal with creating viable product designs that are actually feasible and economical to manufacture.

Product design engineers also look after the aesthetic and ergonomic aspects of the conceived products. Usually, product design engineers utilize computer applications like CATIA V6, SOLIDWORKS, 3DVIA, etc. to create definitive product designs, but sometimes, they may rely on their manual drafting skills.

In order to ensure that the design of your conceived product is impeccable in every aspect, you need to partner with experienced product design engineers.

Electrical Engineers

An electromechanical product does have many electronic components, and for that reason, you need to team up with electrical engineers. The field of electrical engineering, however, is a very broad field, so you need to partner with the right electrical engineers.

For instance, if your electromechanical product consists a high-voltage system, you need to seek out for engineers, specializing in power engineering. If it consists, electronic circuits, you need to rely on engineers, specializing in electronic engineering. Likewise, there are electrical engineers specializing in control engineering, microelectronics engineering, instrumentation engineering, and so on.

Based on the nature of your electromechanical product, you may need to team up with engineers, specializing in the different fields of electrical engineering.

Mechanical Engineers

An electromechanical product will obviously have the moving mechanical parts. In order to design and develop the mechanical parts, you will need to rely on mechanical engineers. However, just like electrical engineering, mechanical engineering is a broad field.

Mechanical engineers may specialize in different disciplines of mechanical engineering, like mechanics, biomechanics, mechatronics and robotics, thermodynamics and thermos-science, structural analysis, technical drawing, CNC, etc.

As per the nature of your conceived product, you may need to partner with mechanical engineers, specializing in different disciplines of mechanical engineering.

Manufacturing Engineers

Manufacturing engineers deal with employing the appropriate manufacturing practices. Their main focus is to select the right raw material and turn that material into a new product in the most efficient, effective, and economical way.

Manufacturing engineering is also a pretty broad field, and manufacturing engineers may specialize in subfields, such as plastic product manufacturing, lean manufacturing, CNC (computer numerically controlled) manufacturing, and additive manufacturing (3D printing) to name a few.

Again, based on the nature of your conceived electromechanical product, you may need to select the right engineers who are better suited for the job.

Software Engineers

Sometimes, electromechanical products may require software to perform various functions. To design and develop the software, you may need to rely on software engineers.

Software engineers may specialize in different disciplines, but when it comes to the development of products that rely on software to function, you will have to work with engineers who specialize in embedded software programming.

Embedded software applications control the machines and only those engineers who know embedded programming can develop such software applications. So, if your electromechanical product needs software to function, you will need to hire skilled software engineers.

Industrial Engineers

Industrial engineers monitor the entire process of electromechanical product development, right from product design and product prototype development phases to product manufacturing and product fulfillment phases.

Industrial engineers ensure to minimize the waste of time, money, energy, materials, labor, machine time, and other resources that do not generate any value.

Whether it is the development of electromechanical products, medical device products, products with embedded software, or any complex products, having an industrial engineer on board always proves to be very beneficial.

The above-mentioned engineers are just some of the common types of engineers who will help you develop electromechanical products. Searching for each type of engineer and teaming them with each other to work on your electromechanical product can be a very difficult task. Partnering with a reputable product development company instead, that has a collaborative team of engineers, can prove to be very beneficial. You will be able to realize your conceived electromechanical product while saving substantially on time, money, and effort.

Want to bring your complex product ideas to life? No matter how challenging and resource-demanding your product ideas are, GID Development Corporation will help you realize them. A leading product development company in the US, GID Development Corporation provides swift, agile, and economical product design, rapid product prototyping, and product development services. They have vast experience in developing complex products, like electromechanical products, medical device products, mechanical products, products with embedded software, and so on. Utilizing state-of-the-art technologies, like the 3DEXPERIENCE Platform from Dassault Systèmes, experienced engineers at GID Development Corporation ensure to bring your product ideas to life.

Have any queries regarding electromechanical product development? Just 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 product development questions relating to electromechanical products or any other complex products.

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 the 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

Before moving the product into production, exhaustive testing of the definitive prototype is carried out 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. The general public and potential customers are also allowed 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 the 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, and 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!”

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 various questions regarding new product development.

The Costs Involved in Taking a New Product to the Market

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, or 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 https://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.

How to Take Your New Product with Electronics to the Market?

So you have a novel idea for a new product with electronics? How would you realize your product idea and take it to the market? Well, develop a product prototype, get it bulk-manufactured, and start selling! It sounds very simple, isn’t it?

The reality: nothing is simple or easy about introducing a new product into the market. And, it is even more challenging and arduous when it comes to introducing a complex product, like a new product with electronics, to the market.

Most budding innovators have the false impression that they can take a new product from concept to consumers in a short time, like within a year. That is not true for most products – even untrue for simple products.

Taking a new product with electronics to the market is expensive. Most innovators and startups do not have enough money or risk tolerance to create a definitive product in one step. If they, however, take several small steps, they can get success with their new product. Here is what an innovator or startup should do in order to realize their product and take it to the market.

Validate the Product Concept

In order to prove your product concept, the best thing you can do is create a product prototype. You will need to have a functional prototype of your conceived product. While developing a prototype, ensure to keep the cost of development as low as possible. Since your conceived idea is for a product with electronics, you will need to use breadboards as well as certain electronic modules.

A breadboard helps create an electronic prototype without the need of a specific or definitive PCB (printed circuit board). A breadboard is generic and reusable, so you can create any circuit on it again and again. It is an excellent board for creating and experimenting electronic prototypes.

To create a prototype for a product with electronics, you can also use Arduino. Arduino is a popular electronic development kit, which helps create advanced prototypes for products with electronics. Arduino is a microcontroller-based kit, and the best thing about it is, it is very inexpensive.

Electronic modules are those components that are designed to perform specific functions. For instance, electronic modules may be used to execute functions like video capture, GPS, Bluetooth, and Wi-Fi among many others.

While a product prototype is not something that you can sell into the market, it is certainly the “Thing” that helps you prove, your conceived product idea actually works.

Validate that the Product Will Sell

In order to prove that your conceived product can actually be sold in the market, you will need to create a definitive prototype – a close substitute for the final product. This close substitute or definitive prototype needs to be produced in a small quantity so that they can be sent to the market for testing and getting valuable feedback.

Innovators will never know what the customers precisely want. They can assume, but will not know what the potential users actually want. The best way to know what the customers want, however, is with their feedback!

So to create a close substitute or definitive prototype for your product with electronics, you will need to look farther than electronic development kits (breadboards and Arduino). What you will need is actual printed circuit boards, specifically designed for your conceived product. On this PCB, you will need to integrate actual electronic components. This prototype should perform all the functions that are expected in the final product.

Unlike initial prototypes, creating definitive prototypes is challenging. Therefore, partnering with a product prototype development company that has experience with the development of products with electronics is a good idea. Such a product prototype development company has the knowledge in the field of electronics, and will help create definitive product prototypes that can be put on the market for testing and getting feedback.

Now the Profit

In order to make the profit, you need to create a perfect final product or an archetype, bulk manufacture it, and send the bulk-manufactured product to the market to the actual customers. An archetype of a conceived product is created after eliminating defects and improving certain functions based on feedback received on the definitive prototype.

Once the archetype is ready, the next step is to partner with a manufacturer. Since it is a product with electronics, it will need a plastic casing. Therefore, you need to partner with a unique plastic product manufacturer who not only specializes in plastic product manufacturing but also in handling electronics. If the unique plastic product manufacturer has the experience in helping take the bulk-manufactured products with electronics to the market, then it is an added advantage. Else, you will need to find professionals who can help bring your new product to the market.

If you have a unique idea for a new product with electronics and want to realize the product and bring it to the market, then professional help is available! GID Development Corporation, an eminent product design company in California, helps innovators in designing, prototyping, and developing a wide range of products, including products with electronics, electromechanical products, products with imbedded software, sports products, medical device products, and more. Aside from product design, product prototype development, and new product development, GID Development Corporation also specializes in plastic product manufacturing. With its plastic product manufacturing specialization, GID Development Corporation can help bulk manufacture a wide range of products. The professionals at GID Development Corporation also assist innovators to take their new products to the market.

To learn more about GID Development Corporation, a leading product design company in California, visit https://www.gidcompany.com/.

You can now have a free 15-minute telephonic conference with one of the professionals at GID Development Corporation. Just call Jim Grimes at 714-323-1052 between 8:00 AM to 5:00 PM PST.

Outsourcing: The Best Approach to Introduce a New Product in the Market

A couple of decades ago, entrepreneurs and small companies had to do everything themselves when they wanted to introduce a new product in the market. These days, as the technology advances and people demanding more and more revolutionary products, doing everything in-house may not prove to be possible, at least, economically.

Hiring the right resources, that is, product design experts, product development engineers, prototyping geniuses, marketing gurus, sales whizzes, etc., on a full-time basis, is incredibly expensive, especially for entrepreneurs and small companies. Fortunately, these days, there are several good American product design and product development companies established to whom these small companies and entrepreneurs can turn to when it comes to introducing new products in the market. Outsourcing most of the requirements is a prudent solution, allowing entrepreneurs to get the very best, and only pay the outsource partner when they need its assistance. Here are some of the functions that an entrepreneur can outsource:

Product Design & Product Development

Unless you are a skilled engineer, experienced with creating new products, you will certainly want to outsource the processes of product design and development of your potential product. Even if you are a good engineer, many projects need multiple engineers with multiple skill sets. For instance, any electromechanical product typically needs, at least, a mechanical engineer, an electrical engineer, and an industrial designer who can create a suitable casing or enclosure for the potential product. If your concept is for a product with embedded software, you will definitely need a software engineer.

Further, if a certain portion of an electrical product, mechanical product, electromechanical product, medical device product, or any other product, is complex, you may need multiple engineers with different skill sets. Having such engineers permanently is expensive and not impractical, as you will not need them frequently. For that reason, outsourcing product design and product development is the best approach.

Product Prototype Development

Product prototype development is another important function that you may want to outsource. Similar to product design and product development, product prototype development is a difficult process, which requires experience, multiple skill sets, and adequate product prototyping software and equipment. Having full-time product prototyping experts with vast experience and multiple skill sets is again very expensive. Further, acquiring product prototyping software and equipment is also costly. For that reason, outsourcing product prototype development makes sense.

Bulk Manufacturing

Bulk manufacturing is one of those important functions that you should certainly consider outsourcing. Bulk manufacturing a new product means establishing a suitable-size facility, procuring expensive manufacturing equipment, setting up an assembly line, hiring different personnel, and so on. This involves a colossal investment, which may simply prove impractical or impossible for small companies and entrepreneurs. Outsourcing bulk manufacturing drastically reduces expenses as well as risks.

It will be in the best interest to outsource bulk manufacturing to a USA-based company that is capable of small production runs. Once things start to flow smoothly, you can turn to an Asian manufacturer to raise your profit margins.

Marketing

Marketing should be the least likely function to be outsourced. No one can do better marketing of your product than yourself. This function should be performed in-house. You can hire several marketing consultants who may perform some research and offer good marketing guidance. Having an in-house marketing team will also provide you a good control over your marketing efforts. Still, if you are a startup with limited capital, you can consider outsourcing the marketing to a specialized agency.

Sales

Similar to bulk manufacturing, this is another crucial function that you should consider outsourcing. Sales representatives or manufacturers’ representatives are an important component in just about every industry. They typically work on a commission, so you do not have to pay them anything until they truly generate sales. It is really a prudent decision to outsource sales.

Outsourcing sales function not only saves money, but it also helps you establish and connect to the wide sales network channels. Selling a new product to distributors and wholesalers usually requires a strong connection, which you will certainly gain by outsourcing to sales representatives.

Well, these are certain functions that are worth outsourcing. Some product design and product development companies in the USA can carry out all the functions on your behalf. For instance, check out GID Development Corporation. A vastly experienced product design and product development company in California, USA, GID Development Corporation provides complete A – Z services, from new product design to product fulfillment and everything in between. Whether you want to take a new medical device product, new electromechanical product or any other type of product to the market, GID Development Corporation will assist in every phase. Learn more about GID Development Corporation.

Currently, the leading product design and development company in the US, GID Development Corporation is offering a free 15-minute telephonic consultation with one of the veterans, Jim Grimes. You can call Jim at 714-323-1052 between 8:00 AM to 5:00 PM PST.