
Freeform Injection Molding Eases the Path to Medical Device Product Testing - in
Author:gly Date: 2024-09-30
So investors in Voxeljet can see it as a bet of additive manufacturing finding its place inside the traditional manufacturing supply chain but not replacing it entirely. And calculating that at the recent low stock price, with a very low price-to-sales ratio of 0.36, Voxeljet's financial issues are already priced in.
Additive manufacturing slowly adds layer-by-layer material into the final design instead of pouring molten materials and waiting for them to take the shape of the mold. It allows it to create complex shapes and products that traditional methods simply cannot achieve.
Velo3D is a 3D printing company primarily working on metal 3D printing. The company has successfully entered this market, achieving almost 20% of the market share in metal 3D printing in 2023, from almost nothing 2 years prior.
Quality Issues—What They're All About Finally, consider how your new plant will develop and assess product quality. During the past decade, quality issues as a part of good business operations have become a top concern for custom and captive molders. The OEM-custom molder relationship has always been one of interdependence, but until recently, custom molders had free rein when it came to matters of production.
The merger with EnvisionTEC also helped Desktop Metal to develop its Desktop Health 3D printer. It is more of a scaffold printer than a full cell/organ 3D printer, but if bioprinting turns out to permanently require hydrogel or other polymers as a scaffold, this will be a strong technological advantage for Desktop Health.
Xometry's AI allows for instant pricing and receiving quotes in seconds (instead of days doing it alone), as well as 3D geometry and feature recognition, enhancing the quotes' accuracy and pricing. It also offers a payment system for suppliers to manage their cash flow.
Generally, space for secondary operations is designed in one of two ways—either as a separate area or room designated for such activities, or beside the press. The choice depends on the types of secondary operations to be performed and the space available. Some molders prefer to do secondary operations alongside the press after each cycle in order to minimize handling and maximize operator time. This can also increase efficiency in that parts don't have to be boxed, moved, unpacked for the secondary operation, and then repacked. Less handling is also easier on the parts and results in lower scrap rates—another important consideration. This requires that all operations be considered together and set up in cells, usually dedicated to a single product or assembly, sometimes with multiple parts.
Proto Labs has almost quadrupled its revenues since its 2013 IPO, for a total of $488M in 2022. The company's customer base is diversified, with the main industries being medical, electronics, and aerospace.
Injection molding auxiliary equipmentThe central material drying/handling system, including five insulated drying hoppers, dehumidifying dryer, pumps, filters, and conveying system would cost about $115,000. Beyond that, at right are typical prices for other auxiliary equipment.
Another factor to consider when investing in a molding press is the type of mold(s) it will be running. Will they be large, multicavity, hot runner molds that require larger-tonnage equipment, or single-cavity, conventional molds that require smaller-tonnage machines? Controls and the speed of system response must be also considered. Do you need a press that provides versatility, or are you investing in a press that will just run one job continuously?
The company's strongest position is in medical, especially footwear, eyewear, and dental. In these segments, it competed efficiently with the larger 3D companies and grew its medical revenues by 20% year-to-year in Q2 2023. It also grew its EBITDA by 12.2%.
You must also determine what services you will offer, and what equipment will be needed to supply such capabilities. For example, even if you decide not to have a moldmaking facility in-house, you will need a certain amount of equipment for mold maintenance and repair. Will you do any type of secondary operations? If so, what type of equipment will that require? See the box above for a list of equipment in a 15-machine shop. Equipment costs are shown below.
Jonathan is a former biochemist researcher who worked in genetic analysis and clinical trials. He is now a stock analyst and finance writer with a focus on innovation, market cycles and geopolitics in his publication 'The Eurasian Century".
Voxeljet is a small German manufacturer of 3D printers. Voxeljet technology relies on “binder/ink jetting,” a process that is able to quickly produce parts, allowing for larger production batches and more diverse materials. It also allows to mix 3D printing and traditional manufacturing methods like casting.
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Nano Dimension is active in aerospace, automotive electronics, and other sectors. The company has grown its revenues by 258% CAGR since 2020, or a 12x growth. Part of this growth was driven by a series of acquisitions since 2021, bringing multiple electronic 3D printing technologies under the same roof.
In addition, entering custom injection molding with two or three presses and minimal capabilities means entering a highly competitive market already crowded at the low end with several thousand molders. Because many of these molders, with sales less than $1 million annually, offer little in the way of secondary services, they compete on the basis of price. This results in thin margins and a low survival rate.
Its focus is producing tissues and organs without any artificial scaffolding, only the cells themselves, through its S-Spike platform, making it the most advanced bioprinting solution on the market. This is an ambitious goal, but also the final form of 3D bioprinting will likely be adopted over time.
While impressive technically, Voxeljet's financial performances are less so, with a massive net income loss in Q2 2023 of $3.6M on revenue of $6.8M. This has weighed heavily on the stock price, as the company is expected to raise more money through debt or selling shares.
The company's main business comes from injection molding and CNC machining, but with a quickly growing 3D printing activity as well.
Several factors must be considered to determine the return on investment (ROI) for a press. One of the biggest factors driving machinery investment is the amount of energy used. Estimates put energy costs at about 5 to 7 percent of a molder's total operating budget. Considering the amount of energy a typical 15-press plant can consume, energy has become an enormous cost issue. A-c variable-speed pumps and motors offered on most newer equipment, and as a retrofit for older equipment, can save energy by using it only when called upon during the machine's cycle.
A newcomer in the industry, Velo3D has achieved impressive results in the space industry and advanced metal 3D printing. It might be a strong beneficiary of the growing new space race between the US and China and the growing space private sector.
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So this is as much a biotech company as a 3D printing company, with a very ambitious goal and a massive addressable market if it can improve its technology to “print” full organs on demand.
This sector also became extremely popular in 2013-2014, leading to a high valuation that subsequently crashed. 10 years later, the sector is now more mature and becoming more and more part of everyday industrial processes. You can read more about 3D printing applications in our dedicated article as well.
When the demand for world-class molding facilities is added to state-of-the-art manufacturing capabilities, the bar for entry into the custom injection molding business rises considerably. Instead of being able to enter the molding business on a shoestring, as many did 30 years ago, a large financial investment is now required. This generally requires the cooperation of a bank, an equipment leasing or lending institution, and financial backing from private investors to pull together the funds needed to succeed. Likewise, the barriers to entry for a captive operation to provide a good return on investment are high. It's not enough to buy molding machines and auxiliaries and leave them in place without improvements for the long haul. Captive operations also must not only make an initial investment, but also be prepared to stay technologically attuned.
It also can produce larger components, with Voxeljet having achieved the largest single-piece titanium casting in the world manufactured using 3D printing (hypersonic grid fin) and the world's largest 3D printer for offshore wind applications.
The Japanese company was founded in 2010 and started selling 3D printers to researchers in 2013. What is unique about Cyfuse is that its 3D printers are printing not with ink, metal, or composite but with living cells.
Most additive manufacturing companies focus on metal and plastic, with an eye for complex mechanical parts. Nano Dimension is instead focused on 3D-printed electronics. This includes very specialized technologies like conductive or dielectric inks & ceramics.
Investors will need to examine the company's prospect of reaching profitability and might want to understand deeper the market position of CFF manufacturing.
If material handling will be done manually, that is, by using forklifts to convey gaylords, or 1000-lb containers of resin, to presses, then adequate space must be allowed to accommodate the forklifts. If pneumatic conveying systems are to be used, then you might consider an enclosed material-storage aisle between the rows of presses, which keeps bags and gaylords of material out of sight yet handy to the presses.
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Other investment factors include the performance history for the machine under consideration, shot-to-shot repeatability, and whether the machine is geared toward high-volume, high-speed applications or low-volume, slow-cycle requirements. Ultimately, at the end of the day, what is its yield? Determining your ROI is application dependent. Some things can be quantified up front, but others can't until the mold is in the press and parts are running.
Some molders prefer lower-volume parts molded for high-dollar products, which tend to offer better profit margins. For example, the box that houses the instrumentation monitoring an IV drip must meet tough cosmetic standards, and it's only produced in quantities of 100,000 a year. Others prefer to mold component parts such as gears that remain out of sight, which means that although fit and function still are critical, cosmetic requirements are less stringent.
This company is for patient investors, counting on this technology to become more mainstream and improve to the point where it can build full organs at once in one block.
Large OEMs—specifically, the automotive and computer industries—adopted the philosophy of manufacturing with quality as they began seeking greater market share for their products. They recognized, however, that the quality of their products could be no better than the quality of the products' component parts. For this reason, much of the responsibility for improving quality has been laid directly at the feet of custom injection molders who supply the vast number of components.
Warehousing: A Hidden Requirement You will need space for storage of molds not in use, bags and gaylords of material, the finished-goods inventory customers most likely will request be held, and other equipment. Typically, molders use an average of 10 percent of their total floor space for warehousing. This will vary depending on the size of your molded parts, how many different materials must be kept on hand, and the size of the molds to be stored.
The company is active in additive manufacturing but also CNC machining cutting. It is active in multiple industries, including aerospace, medical, automotive, industrial, government agencies (including defense), and robotics.
As an employer, you will also quickly discover what many molders know already: In 2001, finding and keeping reliable production employees is very difficult. The competitive job market is a significant challenge for many molders. One way to combat this problem is to rely more on robotics and automation to perform the tasks that might otherwise be done manually. Robots can be used to pull parts from the mold, remove sprues, and do some assembly work. Most robot systems mount on top of the press and by themselves may not affect plant layout. But you may elect to use conveyors or other parts handling equipment press-side in conjunction with robots. Make sure to allow enough space to accommodate such equipment.
For example, disposable medical components such as injection syringes are manufactured and used in the millions daily. However, the return from each one of these devices is in the tenths of a cent. Quality and manufacturing requirements are extremely stringent, and the parts generally are made from clear or clear-tinted material, which compounds the difficulty of molding. In order to make a profit, molders who choose this type of high-volume medical work must find ways to keep manufacturing costs at a minimum and efficiency high.
This technology is expected to be more and more adopted by the industry. Research reports envision additive manufacturing to maintain a compound annual growth rate (CAGR) of 21% and boast a market size in excess of $77B. Ark Invest even declared that “3D printing will be a $500 billion market opportunity”.
For example, these technologies can be used for building optical or radio components. The company claims it can reduce the ecological footprint of manufacturing, with a reduction of 94% in CO2 emissions, 100% in water, 98% in materials, and 82% in chemicals.
Find a Niche and a Focus Most custom molders in business today have found a niche. Through experience, the molder became good at molding a particular type of part or at molding a particular kind of material, or became astute in working in a specific segment of the marketplace. In other words, he acquired an expertise and stuck with it. A captive molder inherits a market or a range of products, but must develop the same expertise and focus that a custom molder does.
Two decades ago, a $30 million custom molding company was considered a top business. Today, as a result of mergers, acquisitions, and growth that has outpaced the national average, a company that size is considered small. So although an individual can set up a small injection molding operation for less than $1 million, unless the company has a special capability to offer or establishes a sound financial relationship with one or two customers, chances for success are slight.
Materialise is a 3D printer with a strong software component, with its ranking as #1 among additive manufacturing (3D printing) software.
It is also active in healthcare, starting from acquiring German EnvisionTEC, which includes dental care technology. This comes in tandem with a strategic partnership with the leading orthodontic firm Align Technology.
If you require some level of cleanroom molding—often required by medical and electronics parts—then you must decide how you will achieve it. The various types of cleanrooms include Class 100, Class 1000, Class 10,000 and Class 100,000. Each level has its own criteria and must meet certain requirements as established by FDA guidelines. Class 100 is the most stringent and Class 100,000 is simply a "clean environment," and therefore the easiest to achieve.
Still, investors will need to be cautious of the company's cash position and expect some level of dilution by new capital raise at some point in the future.
47% of the company's clients in 2021 were new clients, showing the quick growth of the industry and 3D Systems client base. In 2021, the company's revenues were equally split between industrial and healthcare (mostly prostheses and dental).
Finally, it's usually not enough to just mold parts anymore, package them in a box, and send them to the customer, traditionally called "shoot and ship." Many manufacturers go to molders now looking for design and engineering services, tooling assistance, and postmold decoration and assembly expertise. Captive molders, as well, are more likely to have several secondary functions integrated with the molding of the basic parts.
Plant Layout Assuming you have the capital to support a startup, or have a budget from corporate headquarters, you start physical construction with the plant. Whether you build or buy, the layout of your plant is a crucial consideration if you're going to have an efficient, profitable operation. Allow approximately 1000 sq ft of space for each molding press; this accounts for offices, molding/production, secondary operations, quality control, storage of materials, and a mold maintenance and repair area.
More than 1/3 of the company's revenues come from the space sector (with NASA a new customer in Q2 2023), with the rest being made in most contract manufacturing and automotive.
The mix between 3D printing and traditional manufacturing allows for drastically reduced costs and quicker production while still allowing for the advanced designs of 3D printing.
The Molding Machine: Cost Justification More than just a purchase, an injection molding machine is an investment. As with any investment, you want to know what your return will be. What value will the machine contribute to your overall operation? Where will your break-even point be? Will the machine pay for itself in a year? Two years?
Cyfuse is, for now, not profitable (after a brief period of profit in 2021) but is already registering a few million dollars in revenues.
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The company derived a bit more than half of its revenues from the sale of 3D printers and the rest from “services,” where Voxeljet directly printed parts after receiving an order. This creates a sales funnel for Voxeljet, where 90% of customers start ordering services before buying a 3D printer to produce directly in-house.
As with most any major capital purchase, the price you pay for a particular unit depends on a lot of variables. In injection molding the variables are too numerous to list here, but generally, whatever you buy will vary by application. Much depends on what kind of material you'll mold, how much you'll use, and how large the parts are. But let's say, just for grins, that you do want to start up your own molding shop, based on the list above. And let's say you make some broad generalizations about how material will be handled, how much material you'll use, how long your cycles will be, and other considerations. About how much would the primary equipment cost for such a startup facility?
Machinery manufacturers say that molders use a variety of criteria when looking at a cost-justification evaluation. Some base their decision purely on the lowest price, without taking into consideration the "cost" of the machine. Price is what you pay for the machine now. Cost is what you will pay for the machine long-term, including such things as energy use and maintenance.
Its specialization in advanced composite is the company's main strength, with a clear goal to change manufacturing practices and see many parts moving away from metal and using lighter, more advanced materials.
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This makes the stock a good pick for investors uninterested in profitless growth and looking for a smaller, safer stock pick. They will nevertheless be cautious that the bigger players do not manage in the long run to take away market share from Materialise.
Selecting the Best Equipment Presses with up to 100 tons of clamping force, which mold small parts, constitute the second largest group of presses used by molders in the United States. The majority of molders operate with presses in the 100-ton to 350-ton range. Presses in the 350-ton to 750-ton range represent the third largest group. Most injection molders enter the business with small to midsized molding presses.
Desktop Metal is another large 3D printing leader, with 650+ patents, 250+ possible materials, and 6,000 customers. One of its key centers of focus has been metal 3D printing, a target long sought after by the 3D printing industry.
While many molding companies have rushed to implement the latest and greatest with regard to quality standards, others balk at the idea of so much money spent without the assurance that a particular level of quality is actually needed. In some ways, too, these so-called levels have made the playing field more uneven and are knocking smaller molding shops out of competition.
For ages, the way to manufacture metal or plastic items has relied on forging or molding technologies. In recent years, an entirely new concept emerged: 3D printing (also called additive manufacturing).
Proto Labs is a pioneer in digital manufacturing, launched in 1999. It combines in-house manufacturing capacities (1 million square feet of factories) and a growing network of manufacturing partners.
Xometry is currently mostly focused on the US but has rapidly expanded its international footprint, with 11% of revenues coming from Europe and Asia. The European expansion is partly driven by the acquisition of the on-demand marketplace Tridi for $3.8M, following the previous acquisition of manufacturer database Thomasnet for $3000M in 2021.
If you were starting a new facility, it would be unlikely you'd pay this list price for any of this equipment. If you are molding a highly sophisticated product mix, these prices might be low. They also don't represent the prices of the most basic imported molding machine, either. But these prices at least offer a glimpse at what a good starting point might be.
Where Xometry is more generalist and targets the whole manufacturing industry, Proto Labs is a more established player with direct control over most of its manufacturing capacity. This should help it stay strong in its prototyping and small-batch manufacturing niche, where speed, quality, and precision are the most important factors above price.
It targets 4 segments: articulations, liver, nerve, and blood vessels. It could also be used to create “training” organs for surgeons, helping them learn without risking a patient's life. This is likely the first market reachable for Cyfuse, as well as biomedical researchers needing testing on part of organs instead of cell cultures.
While most molders accommodate the requirements of their customers, some question the necessity of all the quality bells and whistles like SPC, SQC, ISO 9000, and Six Sigma (a term coined by Motorola that refers to a quality level of three defective parts per million), given the variables of the molding process.
IMM made some big assumptions and got ballpark figures from a few manufacturers who were willing to share their cost data. The tables below list some basic prices for injection molding machines and auxiliary equipment. For the purposes of this list, we assumed this 15-press facility would orient the machines in two side-by-side rows on 15-ft centers. We also decided that material handling would be central, designed to accommodate five different resins, each used in equal amounts, each with an average drying time of 3 hours. Hypothetical average cycle time would be 60 seconds at maximum shot capacity for all machines, which would consume 562 lb/hr of resin. Material would be pulled from gaylords, dried centrally, and delivered to each machine via machine-mounted vacuum receivers.
The larger the press, the more it costs, so the size of the majority of parts that will be molded is an important consideration. In a custom operation try to give yourself some flexibility on either end of the spectrum to also mold somewhat smaller or larger parts. This is an area where your business plan and marketing strategy, which determine the direction of your business, will also help you decide on the size and amount of equipment you'll need.
Xometry is an AI-enabled marketplace for industrial manufacturing. Its goal is to create a massive and liquid marketplace for industrial components and on-demand design. This is known as a very inefficient market, with a lot of time consumed by finding vendors and then requesting and comparing quotes.
Today it's increasingly apparent that if you're starting a plant or a business, you are either given or must find a niche—a specific market or product line—and focus on molding for that market or customer. Will you mold large parts? Small parts? Do you want to be a molder of low-volume, high-dollar parts? Or high-volume, low-dollar parts? Most people would answer that they want to be a molder of high-volume, high-dollar parts. If only it worked that way.
You should also consider whether or not cleanroom molding will be needed; if material handling will be done manually or via automatic pneumatic conveying systems (or a combination); where storage areas for materials will be; and whether the layout for manufacturing will promote production efficiency and minimize part handling in molding, assembly, and any other secondary operations.
It is also working on a 3D bioprinting technology, which could be used to create synthetic organs, with a target for 2026 for the human trial in lung transplant. The addressable market is estimated at $4B.
It is also a company with a strong component of healthcare, making up 39% of revenues, much higher than comparable 3D systems or Desktop Metal. Materialise is doing most of its business in Europe, followed by the Americas.
This lower cost structure helps Voxeljet to be active in sectors not usual for a 3D printing company, like architecture, props for the film industry, museums, or even statues.
While competitors are focused on growth, and as many materials and offers as possible, Materialise has instead focused on profitability and smaller niches like medical products and software.
Recently, the company has been at the center of a battle for control between the current management and the asset management firm Murchinson. Management claims that Murchinson’s intention is to acquire the company at a discount and liquidate the company to “liquidate its cash assets.” The situation could be resolved soon, but until then, investors might want to wait and see that the company will continue to innovate in 3D printing instead of being liquidated.
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Even in the case of a failure of merger with Stratasys, it is likely that the 3D market will be dominated by the 2 leaders, 3D Systems and Desktop Metal. With the market growing quickly, it is likely that both companies can thrive and take over more of the industrial supply chain equipment market, especially in the context of “re-shoring” industries closer to home and out of China.
The absence of scaffolding could prove crucial to producing “premium” organs as close as possible to native organs. The technology can only 3D print 2-3cm organ pieces at a time.
No matter the result of the merger, Desktop Metal has recently launched a $100m cost reduction program. It is still loss-making and has relied on selling convertible bonds to make ends meet.
As far as molders and quality are concerned, size doesn't necessarily mean that a company is better. A large company or plant can be run poorly and have low productivity with below-average profits or ROI. A small plant can be well run and have high productivity and good profits. It's generally known, however, that all molders, whether they have $100 million or $1 million in production or sales, fight the same battles—only the scale is different. The bigger the company, the bigger the problems.
Desktop Metal is competing with 3D Systems for a merger with Stratasys. Would that fail? It might end up much smaller than the resulting 3D + Stratasys and potentially struggle to achieve the right scale.
Some molders elect to use storage silos for resin; these molders usually specialize in one or two closely related markets and mold large parts from one or two materials or millions of parts from the same material. Resin from a silo can be pneumatically pumped to a machine, so little or no shelf space is required for its storage. Other molders, because of the nature of their businesses, opt to store raw materials on the shelf, a procedure that has been known to lead to overcrowding.
In recent years central material handling systems have grown in popularity. Such systems locate resin, dryers, hoppers, and blenders in one place, often in a basement below the presses, or on a mezzanine above the presses. Vacuum pumps and small pneumatic loaders at each machine move resin from the centrally located hoppers to the press via a network of tubing. Such a setup keeps bulky gaylords and dryers out of the way, allows machines to be spaced closer together on the floor, and makes material handling simpler as all resin can be managed from one location. A central system is more expensive to buy and install, but is usually more efficient in the long run.
The following is an edited excerpt from The Business of Injection Molding, by Clare Goldsberry. The book is the first title in the IMM Book Club Injection Molding Management Series, published by IMM. While much of the focus in the book is on a custom injection molding operation, many of the points about plant layout, machinery and equipment required, and staffing apply to captive molding operations as well.
Another factor is strong hardware/software integration, allowing for easier training in additive manufacturing and a more efficient design process.
Part of the success of Velo3D comes from proprietary advanced alloys, like HASTELLOY C22 (chromium, molybdenum, tungsten, and iron) or GRCop-42 (copper/chromium/niobium), offering unique features for rocket engines or chemical production.
Proto Labs' main selling point is very quick lead time, up to just 1 day to receive the freshly ordered parts. This makes it an excellent partner for prototyping or for parts needing to be produced in small volumes, such as urgent repairs, maintenance of rare equipment, or unique and advanced equipment like space probes.
The company is still early, with negative EBITDA and net income. It has been improving its gross margin quickly but might still need some extra cash injection before reaching the scale it needs to be cash flow positive.
A key technology of Markforged is Continuous Fiber Fabrication (CFF). This unique method of 3D printing allows fiber (plastic of carbon) to achieve physical performance like directional strength equal to or even superior to metal.
Investors in Desktop Metal will be hoping for a turnaround in profitability, potentially driven by a merger with Stratasys. They will also want to pay close attention to financial data and cash available.
How a facility is set up and attendant decisions depend on the type of markets you are serving, the type of parts you need to mold, and what your customers (internal or external) dictate you have. Right at the start, also consider future expansion, either of the plant itself or of production floor space. While a 10,000-sq-ft facility might seem enormous when it's empty, it can become crowded when 10 presses and auxiliary equipment are installed. A rule of thumb is to lease or purchase a building twice the size you figure you'll need to start.
While not a pure play on 3D printing, the flexibility of Xometry's quotes system makes it a prime candidate for benefiting from more widespread adoption of 3D printing and its flexible design capabilities. The company is now looking to acquire the scale and international reach to become the “Amazon of manufacturing,” and if the recent growth can be sustained, it could well achieve that.
3D Systems has recently announced the proposal for a merger with its competitor Stratasys. This would put 3D Systems much ahead of its closest competitor, Desktop Metal, also competing for Stratasys. In the case of a merger failure (you can read more about the latest news here), investors will need to re-evaluate which of Desktop Metal or 3D Systems ends up in the best competitive position.
3D Systems can print 130 materials, producing over a million parts daily. 64% of revenues are recurring (material, software subscription, etc…).
The company has been growing quickly, with revenues and GAAP gross margin up 50% CAGR since 2015. Still, it is expected to experience large losses in 2023, with $54M operating losses on revenues of $101M.
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