Safety at 1 in product development

Safety at 1 in product development

Source: Safety at 1 in product development | SafetyNL

A win/win situation

We are often asked to assess new products for safety. We welcome this, but it is even better to be involved right at the start of product development. Safety must be carefully considered, preferably in advance. In order to include all considerations throughout the development process. A good example is NovioCare, producer of the new sleep product PIKO. How did they approach this and what tips do they have for other manufacturers?

Mieke Cotterink, our Safe Sleep expert, spoke to Francien Mels (owner NovioCare) about this new product.

Mieke: Can you first tell what the PIKO actually is?

Francien: The PIKO is a low stimulation and safe sleeping place that you can use anywhere. It is a total solution for parents and their baby. It provides Rest, Rhythm and Regularity. To really help them sleep well. The PIKO consists of:

A frame with breathable Cap

The cap provides little outside stimuli, allowing the baby to lie in a familiar environment every time. You can use the cap in the crib, crib or playpen and also carry it easily, so you can create a familiar sleeping place for your baby anywhere.

A pod

You can attach the pod to the hood with a magnet, or later place it on your child's nightstand. It has a light that allows you to provide a day/night rhythm, and you can play familiar sounds of your choice.

The app

The app actually has 4 functions. You can use it to set up and control the pod. You can keep a logbook. The pod registers the crying behavior of your child, and you can enter when he/she sleeps, which gives you insight and progress. We also give safe sleeping advice in the app and of course the manual of the PIKO is included so you always have it at hand.

Mieke: How did you come up with the idea of the PIKO?

Francien: From a combination of factors. Being a mother of 4 children myself, I know what sleep deprivation does to your child and yourself. I also have experience as a product developer in the med tech sector and I am a sleep coach. I believe that prevention is more important than solving problems afterwards. A lot of attention is paid to nutrition and exercise, but in my opinion sleep is still a poor relation. While if everyone sleeps well, a child eats better, can be awake for a while and sleeps better afterwards. You end up in an upward spiral. Whereas if your child sleeps poorly, he eats less well, is hungry when he needs to sleep, and you end up in a downward vicious cycle. Moreover, when parents are sleep deprived themselves, they often make dangerous choices out of desperation, such as sleeping in the same bed together anyway.

Out of an intrinsic motivation to make people's lives a little better, I embarked on this adventure.

Mieke: So sleeping well was your starting point, but why specifically a "take-home bed"?

Francien: Yes that I wanted to do something with sleep was obvious, but I really had no idea at all what kind of product. I started doing market research first. What kind of problems do babies and young parents have? What solutions do they use now and what do they run into?

What emerged in all conversations with parents, professionals in child health care, maternity care, neonatology, is that the motto rest-cleanliness-regularity is still the most important principle. But you see that there is friction between this premise and how we live our lives today. We take our children everywhere, lead busy lives. What if you had a sleeping spot that shut out the stimuli, and made the child feel like they always have the same sleeping spot no matter where they are? What would that bring?

Mieke: How did you proceed from the market research?

Francien: I actually had 3 ideas right away in my head with which I went to Bregje Raap - van Sleuwen, expert on safe sleeping and excessive crying. She actually shot down 2 ideas right away because of safety concerns. Which was nice because that's why we had a very clear form in mind from the beginning. And I had been given very sharp frameworks by the experts involved. For example, I knew that air permeability is crucial. We also followed the NEN 1130 standard (the standard for cribs).

That's how the second prototype was created. Then I made contact with you and asked if you wanted to look into the design. Your explanation of the standard, for example, was incredibly enlightening. Because standards are so incredibly complex, you really have to learn to read them. You could explain the basis of such a standard, but also why certain requirements exist. Because sometimes we really didn't understand why a certain requirement was a requirement.

Mieke: Yes, those standards are indeed complex, although nowadays more and more attention is paid to the explanation of certain requirements in special annexes to the standards. The basic principle, of course, is that a product must be safe, i.e. not present any risk to the user. This is a very broad concept. Standards help with this; for each type of risk, requirements are set to eliminate or reduce this risk. To be honest, there are plenty of product developers who have no idea what risks they are facing when it comes to baby products. So it is really important that developers and producers know and understand the standards.

Francien Mels - Owner of NovioCare
"By talking to many experts beforehand as well as including the safety aspects right from the start, I saved a lot of time, effort and money."

Francien: Yes, for example, we did not understand why there should not be V-shaped openings in the product, but through your explanation we understood that this causes a risk of entrapment.
And in addition, you had valuable suggestions to make the product safer. Such as:

  • The sheet at the bottom needed to be tighter
  • The mechanics of hinging
  • Inside smooth finish (no screws)

Based on your advice, we modified the second prototype and actually made it completely correct. Looking back now, I am so glad that we involved you so early in the stage. By talking to many experts in advance and including the safety aspects right from the start, I saved a lot of time, effort and money. Because after that we didn't run into many big issues.

Mieke: A win for you, but therefore also a win for us. Because actually we are often approached afterwards and then we can't do much more. Healthcare professionals often come to us with questions about new products, because we give independent advice. If a product does not meet the safety recommendations, we will advise against its use. And that, of course, comes back like a boomerang. By putting safety first during product development, we can prevent this. And more importantly, create a safe environment for babies.

Sleeping together

Most parents know that it is safest to let their baby sleep in their own bed. Yet, it happens regularly that parents become overtired because of the broken nights and, out of sheer desperation, let their baby sleep with them in the big bed. First and foremost, you want to try to prevent this overtiredness, so parents don't end up in this situation. But if it does happen once, the PIKO is a suitable product to use in combination with the accompanying mattress in the parents' bed.

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