Many inventors and physicians have experienced an “ah-ha” moment. The stars align and they’re ready to present the world with a great idea, and potentially make a lot of money selling it from hospital to hospital. However, it’s not as simple as grabbing some material and going to your garage.

First, you need to understand how medical device development from prototype to regulatory approval works.

The path to commercialization of a medical device is long, expensive and takes an engineering mindset. Here are the phases you must pass through to have your medical device breakthrough hit the open market.

Phase 1: Initial Ideation and Getting a Patent

Phase one of the medical device development process is a more extensive deep-dive into defining your new invention. The best way to accomplish this is by answering questions about 3 main pillars in trying to sell a brand new product in the healthcare industry.

1. Market assessment: What problem in the medical industry is your device addressing? How is it different than other devices trying to address this problem?
2. Business model: How much will production cost? How will you sell it and who are your investors?
3. Engineering: Are you using existing technology to develop this product? Are the components available for you to use or do new components need to be manufactured to help create your invention?

New medical inventions also need to meet the right classification by the Food and Drug Administration (FDA). There are 3 classes based on the potential harm a device can have on a user. Depending on the class, some devices may take longer to become market-approved than others. Luckily, the FDA provides a thorough guide for classifying your device.

Does your device already have a patent?

At this point in the process, you have a pretty good idea of what steps you will need to take to turn your dream device into a reality. Before you get your hopes up, an essential step is getting a patent.

Patents aren’t handed out once a prototype is built. Patents are used to exclude others from creating your product. So, in theory, people have received a patent for something not yet available on the market. They’re essentially patent squatting.

To get a patent your idea needs 3 things:

1. The ability to provide some utility
2. Needs to be novel
3. The person needs the skill in that area of invention

Applying for a provisional patent before developing your new device will help give you time — and the right — to develop your invention.

Phase 2: Research, Discovery & Prototyping

The digital era has made it easier for inventors and manufacturers to work in lockstep with each other when creating a design for a new part. While hard, paper copy blueprints may still exist, 3D CAD files allow product development and research to move at a much faster pace.

You can buy software to build and examine CAD files or you can work with a prototyping company that gives you access to this convenient technology.

These CAD files will allow you to focus on the function of your design, not necessarily the design and how it will look. Once you pin down the functionality of the device, you need to utilize the most practical method for prototyping your new medical device.

What kind of prototyping does your medical device need?

After researching and discovering the best way to create your part, you need to bring it off the computer screen and into something tangible. This is called prototyping and there are several methods.

• 3D Printing: Great functionality and already doing wonders in the medical community
• Injection Mold Tooling: Used to ensure all the parts will fit together in your new device without wasting resources on the material you will use
• CNC Milling: Makes extremely accurate parts for designs that have specific angles and provides a fully-functioning part you can test
• Casting: Makes your part flexible so it can replicate the bend and twist you will ask the final part to perform

Creating your first prototype will be an exciting experience as you see your invention come to life. But making a life-sized model will also highlight the deficiencies with your design. This means a redesign and proof-of-concept will be needed.

Phase 3: Proof of Concept and Redesign

During the medical device development process, proof of the part’s functionality is needed before it can be sent anywhere to get approved. These tests generally happen with the engineers at the test bench. Here is where they verify the correctness of the device’s design by simulating its use.

For example, something like the Sapien transcatheter aortic valve — used as an alternative to open heart surgery — needed to be planted in a simulated heart during the POC testing phase. If it doesn’t pass testing, another round of design is needed.

The iterative redesign process

The iterative redesign process is initiated when a prototype fails a benchtop engineering test. The iterative redesign accounts for the failure of the prototype and identifies data points to build a better holistic perspective on the medical device and the intricacies it may have. It’s also less expensive to initiate a redesign at the prototype level rather than making a change once the completed part is built.

By gaining an understanding of the device’s characteristics through the iterative redesign process, the inventor can determine the viability of device commercialization.

Phase 4: Market Approval Steps

The steps for market approval are established by a quality management system (QMS) which provides a framework to ensure your medical device is legit through policies and development procedures.

The QMS is regulated by Good Manufacturing Practices to guide the device’s development process and create a design history file (DHF). A DHF documents when a part was tested and provides background information about the design and manufacturing process. The DHF is created so the FDA can audit the process to ensure it is safe and effective for users of the new medical device.

Once the DHF is completed and the FDA testing requirements are met, you need to submit your device for regulatory clearance. The DHF will prove to the FDA your medical device is safe, and then you can begin to market and sell your product.

For a more thorough evaluation of the FDA certification process, you can find their medical device development process on their website.

If you’re ready to take your first steps toward your entrepreneurial dream, consider partnering with TenX. We offer the capabilities and industry know-how to get your medical invention out of your head and into the hands of patients who need it most.

Have you been looking for an alternative to traditional steel molding? Are you interested in reducing cycle time and costs? Aluminum tooling may be the answer for you. Aluminum tooling has many benefits that make it a viable option these days. What are these benefits?

1. Aluminum is easier to cut than steel which allows for faster machining and shorter lead times.
2. Although Aluminum is perceived to be too soft for high volume production, this is simply not true. Some Aluminum molds are capable of producing parts after 2 million cycles!
3. Aluminum cools at a much quicker and even rate than Steel. This reduces cycle time and saves money.
4. Since Aluminum is so light it can be machined on smaller equipment and also at a faster pace.
5. Aluminum dissipates heat at a very even rate, which allows for great dimensional stability due to less distortion.
6. There is far less scrap because there is far less cracking and warping.

Aluminum is often looked at as weak, soft material that is no good for high volume production. However, Aluminum can in fact be used for high volume. It can also be machined faster and dissipates heat at a much quicker, even rate than Steel does. As a result of this, often times lead times are shortened and money is saved. Who doesn’t want to save money?

As for the longevity of Aluminum tooling, surface coatings can extend the already impressive life cycle. Many companies are now using Aluminum for production instead of just prototype work.

TenX Manufacturing offers low-cost aluminum and steel tooling. Most of our inserts are created using Aluminum. Our in-house capabilities allow for aggressive lead times on tooling and a quick response to tool modifications.

Our knowledge of the benefits of Aluminum tooling has helped our customers save time and money. Give us a call today to find out if Aluminum tooling can do the same for you!

Stereolithography (SLA) is an additive process that uses a vat of liquid UV-curable photopolymer resin and a computer controlled UV laser to build parts one thin layer at a time. The UV laser cures, or, solidifies the part layer and adheres it to each additional layer.

After each layer has been cured, the SLA machine lowers the platform by a single layer thickness, typically 0.002″ to 0.006″. A resin filled sweeper blade then moves across the cured layer recoating it with another layer of uncured resin. Each layer is cured by the laser, curing it and adhering it to the previous layer. This process repeats until the 3-D part is completed. Once complete, the SLA machine raises the platform from the vat of resin and the part can be removed, cleaned and final cured in a UV “oven”.

One advantage of stereolithography is that a functional part can be built in a relatively short period of time. The amount of time required depends on the size, complexity and layer thickness the part will be built with. Parts can take anywhere from a few short hours to a day or more. Parts built with an SLA machine can be used as master patterns for RTV molding, finished and painted or simply lightly sanded and may be used for shape studies or final presentation models.

The Stereolithography process can help you decrease costly mistakes by detecting design flaws before the manufacturing process. It can be a cost-effective option for low-volume production and also provides quick lead times.

Contact TenX today and get a high-quality prototype fast! 715 235-8474.

CNC machining stands for “computer numerical control” machining. It is a relatively new process in the world of machining which allows for increased efficiency through higher levels of automation and by allowing the machine and it’s computer controls to do all the work. While CNC machines are expensive and complicated, they quickly pay for themselves by reducing the workload and preventing errors.

The first major advantage of CNC machining is that it improves automation, removing the need of an operator for all but a few parts of the work. CNC machines can be left unattended for hours or even days if necessary, allowing operators to focus on other tasks. This also allows for a company to retain fewer operators, thereby saving on overhead. By removing the operator, safety is also increased, since should there be a jam or other potentially dangerous machining error, the operator will not be holding the tool and the only thing damaged will be the tool itself. CNC machines can also work much faster than human machinists, since they are faster, stronger, and do not need to take breaks. They can also be run late at night, when most of the workers have gone home, since machines do not need to worry about being sleepy or getting paid overtime.

The second big advantage to CNC machining is that it produces an exact result every single time. Even the best human operator will have minor variations between finished results, whereas a CNC machine will produce exactly the same result each and every time it is run. This is very important in the modern world of standardized and interchangeable parts, where a single defective cut can make an entire machine wholly unusable. All that is necessary is for a single program to be developed and placed into the machine. Then the machine can toil away at however many work pieces are needed, producing an exact replica down to thousandths of an inch each and every time.

The third big advantage to CNC machining is the flexibility of the machine itself. While humans are much more flexible and trainable than machines, a CNC machine can be completely reprogrammed in a matter of hours to produce a completely different product. It is thus possible to refer back to old programs or install new programs when a different work piece is required. This gives CNC machines a big advantage over other machines, since they can quickly shift to producing a completely different product without the installation of many new parts or a major overhaul of key components. This also ensures that CNC machines can keep up with customer demand, since they can very quickly shift from making a part that is in surplus to a part that is lacking should a need arise.

To learn more, check out this great resource for CNC Machining.

Whatever the item a person or a company intends to produce, creating a prototype is a crucial step in the design process that cannot be glossed over. Why is prototyping important? There are several main reasons; testing and evaluating the design, clarifying production issues and costs, selling it to others, as well as making clear any patentable details.

Evaluating and Testing the Design
Unfortunately, ideas and drawings of a design can sometimes be a far cry from the real world in which the product will be used. By creating a prototype it is possible to sit down with a real version of the product and determine which aspects are worthwhile and which parts need to be revised, changed, or discarded. In the process, it may be possible to find glaring omissions that, on paper, weren’t noticeable.

Additionally, creating a prototype will allow the design team to not only evaluate, but also test the product before going into full production. Imagine ordering tens of thousands of units, only to discover one part isn’t as strong as it needs to be. If corporate giants can make mistakes, it is all the more important for smaller companies to not forget the importance of prototyping before beginning production.

Clarifying Production Costs and Issues
Once production begins, it is costly and time consuming to make changes. By prototyping before production begins, it is possible to take a glimpse at the production process and see if any steps can be changed, combined, or even removed. This not only streamlines production, but keeps the?cost of the actual production to a minimum. Subsequently, if there are any difficulties in production or perhaps processes that can create problems for the final product, it is much better to see these before production starts. It can also help the design team ascertain the optimal method for production; injection-molding, silicone molds,?stamped metal, etc.

Selling the Product to Others
Just like it is far easier to see if there are any problems with a design by holding an actual working model, it is also far easier to sell to potential customers when they have a prototype to hold and manipulate at a marketing presentation. Without a prototype it’s only a concept. It can be difficult to get a?client to commit to a purchase of a concept. With a prototype in hand, the concept instantly becomes real and it is far easier to sign a purchase order.

The customer needs to be taken into consideration during the prototype phase as well. No matter how great the designers and testers think a prototype may be, real consumers may not like certain aspects of it. If the end customer doesn’t like it, they won’t buy it, which is why focus groups and external testing with prototypes needs to be addressed before production begins.

Patents
If a product is new enough or unique enough, patents need to be considered. It’s no use to design and manufacture a great product only to have another company start producing a remarkably similar product because the original company failed to patent key aspects of the design. By having a working prototype, it is much easier to sit down with a patent attorney and see what design aspect may be patentable. On the reverse side, it is possible to see what parts of the prototype and design violate patents of other individuals and how they can be changed before production, and the chance of a lawsuit, begins.

Contact TenX today and get a high-quality prototype fast! 715 235-8474.

Rapid Prototyping is a term used to describe many manufacturing processes that are able to quickly convert 3D CAD models into physical parts. Some of the technologies used in rapid prototyping are stereolithography (SLA), CNC machining, urethane casting and quick-turn tooled injection molding. Many of these rapid prototyping processes produce parts that are at or near production quality, which can be very beneficial at many points during product development.

The greatest benefit of rapid prototyping is the ability to test various part concepts quickly. Even the best engineers and designers are regularly surprised by what can be learned by evaluating and testing a representative part. Details that may not be apparent on a CAD system or on paper will show up readily in a rapid prototype. This eliminates costly mistakes, improves the quality of the design, and allows more valuable iteration cycles of concept to prototype.

Rapid prototyping is often a very low cost option for constructing prototypes, especially when the cost of the time to manufacture a prototype using more traditional methods or waiting for first tooled pieces is factored in. While the cost for rapid prototype parts is almost always higher than production parts, tooling outlays are minimal. When it is time to move to production tooling, rapid prototyping will likely have minimized mistakes that would otherwise have resulted in costly tooling revisions or remakes.

Rapid prototyping also provides the opportunity to conduct market studies with prototypes that have a realistic look and feel. Gaining early data on how the market accepts or reacts to the product is valuable information which can be used to improve the design and ultimately increase sales.

Product development is often very sequential, but rapid prototyping places efforts in parallel. Once a design has been completed, rapid prototyping can be used to push a product to market quickly capitalizing on any window of opportunity while long lead-time tooling is underway. This yields greater control over a product’s launch and early market adoption.

Rapid prototyping should be an integral part of almost any modern manufacturing organization’s new or sustaining product plan. The benefits of speeding iteration, improving design quality, lowering costs, providing a tool to evaluate the market, and going to market quickly provide more efficient development cycles which will result in better products with better profits and revenues.

The old saying, “first come first serve” can hold true in many scenarios, and it is clearly evident in the competitive marketplace we function in today. That’s why being the first one to market with a new product has proven to be a winning move, and its being done by utilizing cutting-edge rapid prototyping methods. A big buzz word in the ‘Rapid Prototyping World’ right now is 3D-Printing, if you haven’t heard of it by now, you’re living under a rock! The process isn’t exactly new, but the advancements in technology over the last 30 years have been substantial, and the forecast for the next 5-10 years looks to be nothing short of amazing. 3D-Printing has quickly evolved into the most commonly used form of prototyping for companies looking to push their new products to market, but it’s certainly not the ONLY.

In the shadow of 3D-Printing we’ve lost some sight of some tried and true methods that continue to give companies a competitive advantage in the manufacturing process, and probably the most overlooked and unknown is Urethane Casting.

• Urethane Casting & it’s benefits
  • This process starts with a 3D Printed part to create a master pattern, the master is then encapsulated with silicone, once the silicone is parted into 2 halves and the master removed, the ‘soft tool’ is created. That ‘soft tool’ can now be used to create urethane parts; urethanes can be of nearly and durometer and mimic most injection molding materials. The casting process allows for difficult geometries due to the forgiveness of (silicone) soft tooling.
  • The cost and creation time of a soft tool is significantly less when compared to a standard injection mold.
  • The limitations companies experience with some lower-end 3D-Printers yield to the advantages of Urethane Casting in terms of material, size, & color.
  • Small or Large cast parts can produced in one solid piece, as opposed to many
  • One ‘soft tool’ can be used to produce the same part in numerous materials and in-office 3D-Printers that have small build platforms. colors.

In the ‘market-race’ keep in mind that time peels off the clock at the same rate for everyone, and the person who utilizes every tool possible to save time will often be a step ahead of the competition.