A couple of years ago, AMB took the initiative for a seminar entitled:
Medical plastic parts – a guided tour from idea to product launch.
The reason was that we were often confronted with excellent potentially successful product ideas, but where there was a lack of knowledge about the realization of the project until the market entry and also a vision beyond the launch.
Regardless of whether it is a medical technology project or not, there are a lot of pitfalls when it comes to succeeding in a smooth journey to the series production of a plastic-based product.
To realize a product idea, it needs to be developed. If you do not have that competence within the company, you need a partner who can help with product design, functionality, drawings, etc. In addition, knowledge is needed about what is necessary to comply with laws and regulations.
But to produce the idea, an industrialization partner is also needed. In the best of all worlds, the person who develops the product early in the process also involves someone who is to produce the product.
Here are some tips for the journey from idea to series production, mainly from an industrialization perspective.
Experienced buyer of plastic-based products?
Even if you have a lot of experience, it can be good to think about what worked and what did not turn out as intended in previous projects. Skim through our tips, maybe there are some things that make you even more competent.
Start-up?
Especially for start-up companies, the energetic stage of ideas often means an underestimation of what awaits to bring the project to fruition. Here, competent partners are needed who can both share the idea owner’s enthusiasm and also lead the project to achieve quality assured and functional products that match the intention.
It is a fact that 80-90% of all start-ups do not survive their first five years. Of course, there are many factors that affect this. For example, a good idea does not mean that there is market demand. The need for financing is often also underestimated. Other factors can be the composition of the project team or incorrect marketing.
But in addition to this, there is often a lack of knowledge about the necessary industrial processes. This can lead to longer project times, later launch times and significantly higher costs.
Tips from the coach
We at AMB do not know everything either, but over the decades we have learned a few things.
Together with our customers, we at AMB have contributed to realizing fantastic product ideas which in many cases also contributed to improving people’s lives and well-being.
Here we therefore give some tips on how some typical pitfalls can be avoided and what to think about when it comes to realizing mainly integrated plastic products but also individual plastic components. By integrated is meant here a part of or an entire apparatus / device.
1. Afraid that the idea will leak out?
There is often a fear that the product idea can be stolen and someone else can catch up, but this can easily be solved by signing a non-disclosure agreement (NDA).
2. DIY – or an early need for an industrialization partner?
In our seminars, we usually start by presenting three phases for an integrated plastic product.
Here are just a few of the questions that must be answered for a successful industrialization. Fill in with your own questions, thoughts and product requirements. They are important for success and keeping costs down.
One can easily be led to believe that a manufacturing partner is needed only after the concept phase. But it is very valuable to include one or more possible partners already in the idea stage as early as possible. Unfortunately, the product is often further developed “as you want it to be”, just because there is a lack of knowledge about the realities of producibility.
Even if you are an expert in your niche or market segment, it does not mean that you have knowledge of the necessary production processes and the needed steps to an approved and quality-assured product. Therefore, find and evaluate a potential partner. Ask your questions and feel free to do so. A competent partner will also ask many questions. These are not meant to question you, but rather show competence and a will for the project to succeed.
Even during the idea stage, it may be worthwhile to contact one or more suitable companies to investigate at an early stage what is required for a smooth industrialization, even if a feasibility study can sometimes cost a penny.
Then ask for price indications, so-called budget quotes, and you will get an idea of what to expect. After that, or if you have all data, ask for sharp quotes when you have come this far. Project and delivery times as well as other conditions for the finished product are also good to check.
3. Specification documents – from idea to reality
A manufacturing partner needs data to be able to take a position on product design and producibility in order to then be able to bid. A schedule, the intendet use of the product and what requirements it must meet is also valuable information for a manufacturer.
Napkin sketches can work, but make the road to the final product much longer. In that case we recommend working with a development partner who can produce drawings and specifications and take into account current safety, legal and other requirements for the product.
A minimum requirement of needed documents is normally a drawing in 2D and/or 3D where the material, dimensional requirements and measurement methods appear.
The requirements regarding validations and the like are also important to state, as well as packaging requirements and the logistics of the finished product.
The list of documents for one or more cooperating suppliers can be made long, but the right partner will help you by asking questions.
4. No multitasking – appoint a project team
If you are not a one-person company, it is also recommended to appoint a project team with competent people in relevant areas. Then make sure that joint reconciliations and project meetings enable the specialists of the companies involved to have the same information and project status as far as possible.
Project managers, quality and logistics specialists etc. should have a continuous dialogue within the framework of the project.
Review which areas of expertise need reconciliations, such as:
- product design
- quality
- production (planning and control)
- economy
- sales and marketing
- supply chain / logistics
Make a joint project plan with goals and times that are agreed. The necessary time frames and complexity of the project are often underestimated. Write down what has been agreed.
5. Communication …
Communication …
… is the most difficult thing there is, according to many educators and psychologists. But it is crucial to the success of the project. Point No. 4 above is based on good communication.
But from the very beginning, it is important to convey the product idea itself and its function, as well as goals and requirements.
In addition, there is the need to learn each other’s terminology. What, for example, is an ejector or a slider in a mold?
Try to be unpretentious in all contexts. Being able to listen properly and ask questions to ensure that you have understood each other are, on the other hand, important abilities to practice. And the person who asks a question obviously expects an answer …
6. Manual work and/or automation?
Rome was not built in a day it is said and that is true. For new products in particular, it can be difficult to know the market potential in terms of realistic sales figures. It is therefore wise to carefully consider the potential in order not to miss out on a market success that requires a rapid increase in volume.
How much automation is possible and how much automation is required? When is a multi-cavity tool required?
In the trial and error phase, the manual processes can provide data that (in part) can be converted to automated processes depending on the calculated quantities. To determine the optimal degree of automation, personnel and machine costs must be weighed against each other.
Thinking from the outset about possible automations to reduce costs requires a plan for the entire production chain and the needed investments. This is especially true of disposable items in e.g. medical technology. There, upscaling to high volumes can come quickly. Make calculations that allow for a certain flexibility to find an optimal degree of automation as early as possible.
7. Integrated plastic products – a piece of cake?
Many people believe that a plastic part is easy to design and produce. But this is not always the case. There is a lot to think about already during the design phase, see above.
And plastic is not metal! There are big differences in design thinking and throughout the entire manufacturing chain. On the other hand, plastic is a very flexible and adaptable material, it is available in many technical qualities and has a relatively low weight. Most things are possible, but you should not underestimate the complexity, especially when it’s not just a single plastic part but an integrated plastic product.
A competent production partner therefore normally provides constructive criticism, a design review, as a basis for a discussion about what is needed or should be changed for a successful production.
It already starts with the choice of material. For a product to be sterilized, it is crucial to discuss a suitable material at an early stage as the different sterilization methods will affect the properties of the material. The material may also contain various additives that enhance its properties for its intended use. Fibers that reinforce and strengthen or flame retardants are some examples. Or if the plastic is to be surface-treated for decorative or functional properties: is there adhesion, does biocompatibility need to be investigated?
There are also some issues to consider when it comes to the mold tool design. Radii, draft angles, ejector pin placements are some examples.
8. Quality assurance – a never ending task
As described above, expectations and requirements for the product are important to define at an early stage. Already when planning the mold tool for an injection molded product, certain requirements must be clear to take into account.
In order to determine the optimal production parameters the injection molder work step by step. These parameters ensure a stable production where dimensions, appearance and function, etc. correspond to what has been agreed. For this, there are prepared process steps and validations, which are typical of an injection molded product.
To ensure quality even before production, a collaboration is needed not only within the producing company but also with the customer so that they agree on what applies and what is reasonable to achieve. And then, check which quality certificates your production partner has. A minimum are usually ISO 9001 and ISO 14001.
In addition to these, there are industry-specific certificates such as ISO 16949 for the automotive industry and ISO 13485 for medical technology, as well as various others for their specific areas.
9. External requirements – the Wild West no longer exists
There is hardly any product today that doesn’t have various statutory requirements. There are different requirements depending on what the product is intended for and in which country it is to be used. In the EU and the EEA, for example, a CE marking is often a requirement.
The label must ensure that a product meets the necessary requirements regarding the environment, health and safety, etc. in order to be sold on the internal market.
New directives within the EU apply to medical devices: MDR and IVDR. In the US there is the FDA but neighboring Canada has its own rules. The rules are also constantly changing and it is important to keep track of them.
Find out what applies to your product. Several of the requirements involve high costs and take time to meet. For a medical device, several clinical studies may be required that can take several years to complete.
You may also need to contact a so-called Notified body, i.e. is an independent organization that ensures and verifies that manufacturers comply with EU regulations and directives. Your development or production partner can give you more information, but the responsibility is yours.
10. Anything can happen – but you can prepare
Even if you think you have planned everything properly, the unexpected can happen. Assume that not everything always goes as planned and use the methods available to predict risks as much as possible.
Risk management begins with the existence of a perception of risk, which is the prerequisite for risks to be discovered at all.
The problem here is that different risks are perceived differently or not at all on an individual level. If the risk perception is incorrect or based solely on a selective and subjective perception, only certain risks are identified, while others are ignored.
The simplest thing is, of course, to ask yourself in groups what can happen and then evaluate the risks.
FMEA
A frequently used tool when it comes to production planning is a so-called FMEA, Failure Mode and Effects Analysis, It is a systematic method of predicting possible errors. Then the consequences of the errors are assessed, the probability of them occurring and how serious they are. A score ranks the risks so that the worst risks can be addressed by working out what measures should be implemented to prevent errors from occurring.
In manufacturing planning, a distinction is usually made between
- Design FMEA (made during the development and design phase of a product)
- Process FMEA (made to analyze and improve a manufacturing process)
A detailed risk management must be established from the beginning.
With a little help from my friends – how can AMB assist?
AMB’s business concept is to help customers achieve their goals by combining high competence with stable processes. We are thus primarily a production company. Therefore, AMB can not drive product development as such. But we have partners for this and are involved in the process from a production perspective all the way. And before it is time for the production itself, there are many other steps to complete first.
The diagram below shows some typical steps for the industrialization of a plastic-based integrated product.
AMB’s offer ranges from receiving an inquiry and assessing whether it suits our competence and equipment to managing a functioning distribution logistics after production.
We live on customers who have ideas and we love to see them come true.
Welcome with your product idea!
