In March 2020, Oceanz 3D Printing in Ede came up with a solution for the shortage of corona test material. The 3D-printed 'swab stick' is a test stick for removing cell tissue from inside the nostril. In only a week and a half, the company produced the test sticks and had them approved by the National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu, RIVM). With so-called 'rapid prototyping', they were able to make a first digital 3D prototype of their new product.
One week later, in April 2020, the company delivered 17,500 sticks to laboratories and to the Municipal Health Service (GGD), thanks to 3D printing and engineering. This design process entails continuously improving and refining the final design based on the initial idea. At the beginning of May, the production scaled up to 30,000 test sticks per day. CEO Erik van der Garde is proud of the fast result: “We are pleased that we were able to meet an important need with our test stick, while all supply routes from Asia were blocked.”
Do you have a new idea in mind? Develop your idea into a product in these 6 steps.
1. Check whether your idea is any good
How do you know if your idea is a good one? Ask yourself who needs your product and why. Decide on a business model and how you plan to generate revenue. Also, check if your product already exists and which products are already registered in the patent database.
When the Ministry of Health, Welfare and Sport (Ministerie van Volksgezondheid, Welzijn en Sport, VWS) called Van der Garde in March 2020, he knew their idea for the swab stick was a good one. “They asked us if we could provide test capacity as soon as possible. I was 100% certain we could fill this gap. With 3D printing, we were able to quickly deliver large numbers of corona tests and help the Netherlands get going again during the first wave.”
2. Create a prototype
When you turn your first idea into a working example, you immediately experience what works and what does not. You decide: do you make a (digital) sketch, a 3D-printed prototype, or a more advanced working prototype? As soon as you get started, you will find out which materials are suitable and whether your product does what you expect it to do.
Oceanz created its first prototype within a few days. After a change request from VWS and RIVM, the design became final. “The swab had to be able to pass through the patient's nostril and retrieve sufficient cell tissue,” Van der Garde explains. They chose to produce the swabs in plastic nylon 'polyamide' material, because test equipment in laboratories can properly process it.
Since the swab stick is a medical instrument, validation was mandatory. This means that you have to check whether the product meets the user and safety requirements. Van der Garde asked 2 other companies to pack and sterilise the swabs, and to prepare the technical documentation (in Dutch). With a technical documentation you prove that you have organised the process well.
3. Make sure you have sufficient financial resources
Once your prototype works and you start serial production, your costs will increase. Make sure you have enough financial resources. Think about how much money you need and how you will cover the costs. There are various financing options, subsidies, and tax benefits. If you have any questions, please contact the Netherlands Chamber of Commerce KVK Financing Desk.
“We made a lot of initial costs and had to cover production costs from our own resources. The government did not provide any funding in advance. We produce the sticks on a non-profit basis, but we got a decent deal.” He does advise the government to think along with SMEs about financial resources, especially if they ask SMEs for quick solutions.
“When you do something new, you always incur more costs than expected.” Therefore, Van der Garde advises not only to look at the costs. “Innovation starts with a crisis. Do not be afraid to invest, for example, in a new website or takeout service. Or find someone who wants to join you so you can share the costs of adjusting your business model.”
4. Checks before you start production
There are 2 things you need to think about before you start your production.
Do you comply with Dutch laws and regulations?
Oceanz, for example, required CE marking for their swab stick. With a quality mark or certificate you show that your product meets certain requirements. The company was already ISO certified (13485) for medical devices.
Normally, validating a medical devices takes up to 2 years. Because of the corona crisis, government regulations regarding CE marking were temporarily relaxed (in Dutch); CE marking was not required. “Of course, the process needed to be organised well,” Van der Garde explains. You may also have to comply with environmental regulations, such as the ban on single-use plastic or limiting CO2 emissions.
Product requirements do not only apply to medical devices. Protective equipment, such as face masks, are also subject to mandatory conditions.
Do you want to protect your product or register your idea in i-DEPOT?
If you protect or register your idea, competitors are restricted from using your idea. “For every product you have to ask yourself whether it contains intellectual property,” explains Van der Garde. For instance, a trademark or a patent. “The swab cannot be patented. If you make a small technical adjustment to our product, you can also produce a swab. We distinguish ourselves by offering good quality.”
5. Assemble your team
Determine who you need in order to make your product successful. Consider the entire chain: from idea to sale. Research what you can do yourself, what external knowledge you need from others, and whether you want to outsource anything. Assemble your project team with internal and external team members. And think about what you need to properly manage the process.
Oceanz manage the production of the test stick themselves. “However, production is not an everyday occurrence,” Van der Garde admits. “We have set up an internal project team. The packaging and sterilisation is outsourced to an external company. That also goes for the technical documentation of the product development process. The National Consortium for Medical Devices (Landelijk Consortium Hulpmiddelen, LCH) supplies the sticks to laboratories and the GGDs.
According to Van der Garde, the corona crisis highlights the disadvantages of outsourcing production abroad. “Maybe it saved you money in the past, but during the first wave a derailed supply chain will have caused you losses.” Van der Garde refers to deliveries from foreign manufacturers that could not take place. That is why he advises to take a critical look at your supply routes and consider what actions to take during a crisis. “3D printing is not always a solution, but it is fast and you keep production close to home.”
6. User testing
Before launching, you need to check whether your products are reliable and free from errors. Invite your future users to test your new product and collect their feedback. You can do so in-person or through a digital platform.
Before RIVM approved the production of the swab sticks, the product was extensively tested on patients and nurses. “Patients infected with corona also tested positive for corona with our test. Besides, nurses indicated that the sticks are pleasant to use, so that was very positive feedback.” After the peak of 30,000 sticks per day, Oceanz's work was done. “The stocks are back to normal. RIVM will further validate the corona test stick. It is becoming increasingly consistent.”
Lees dit artikel in het Nederlands