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Follow the Rules: Developing a Product for a Regulated Market.

August 3, 2017 by  
Filed under Money/Business, Weekly Columns

(Akiit.comDeveloping a new product is always a huge effort. When that product has to follow certain regulations, such as a food or drug product, its development is a little more complicated. There are always concerns relating to safety and effectiveness when it comes to releasing a product, but they’re not all expected to follow clear rules. However, many products do need to stick to regulations, including products made for babies. If you want to develop a product that needs to pass a number of rules and regulations to be allowed on the market, it can mean development takes longer and costs more. However, it’s worth it if you think you have a profitable idea. Here are some issues to think about before you get started.

Understand the Regulations

The first thing you need to do is understand the rules and regulations your product is going to have to follow. Of course, before that, you need to make sure you actually do need to follow a particular set of regulations and which ones will apply to your product. There are usually useful resources such as manuals and guidance documents that will help you understand what you need to know. However, don’t feel that you have to know absolutely everything. You can use a regulatory compliance service to help you comply with the rules, so you don’t make any costly mistakes.

Understand the Consequences of Not Following Regulations

In addition to understanding the rules you have to follow, it’s also smart to understand what could happen if you don’t follow them. Consequences might range from having your product removed from the market and being fined to receiving a jail sentence for endangering people. There are also resources online you can read to learn about what could happen if you don’t comply with regulations. For example, the FDA provides information about the consequences of selling a non-compliant product. Understanding these issues should show you how important it is to follow the rules that have been set out.

Doing the Market Research

Before you start developing a product, it’s always essential to do your research of the market. You need to make sure there’s a target market out there for you and understand what they’re looking for. Your market research should aim to find out the needs of your target market and discover how you can meet them. You should look at how current products might not be meeting those needs to determine how your product might fill the gap. You can identify and segment markets to get a better understanding of different demographics, as well as research prices and other characteristics of current products.

See How Other Products Are Regulated

It can help to have an understanding of how products similar to yours are placed on the market. You can look at how they might be classified or what their status is to see if it also might apply to your product. You can look at their websites or even just at the labels on products to see what information they feature. Trade shows, marketing materials and published literature can all be useful sources to help you learn more about products that might be similar to yours and find your place in the market.

Know How to Test Your Product

Testing a product both during and after development is a crucial part of coming up with your final product. There might be regulations concerning how you should test your product to prove its safety or its efficacy. Knowing the best way to test your product during development, whether it’s a medication or a child’s car seat, is essential. If you are developing a drug, Herba Bio Labs can help you explore the latest methods. You will often have various options to explore, but the latest techniques can be the best because they often get you more accurate results.

Have the Right Talent

Sometimes, developing a product is a solo effort. However, there are other situations that call for a development team. If you’re developing a product that will fall under heavy regulation, having a team of talented and experienced people to help you will make things a lot easier. You might have some of the technical skills and knowhow, but it doesn’t mean you can do everything on your own.

Outsourcing Development

Outsourcing the development of your product might be the more sensible choice if it will take a lot of work. You might have a product idea, but you don’t have the technical knowledge of experience to develop it yourself. If this is the case, there are usually services you can explore to have your product developed for you. Of course, this option could be a lot more expensive, but you might think it’s right for you if you have a winning product idea on your hands.

Product Production and Manufacturing

Once your product has made it through development, manufacturing and selling it is another hurdle to overcome. Compliance with any industry regulations needs to be maintained during manufacture, whether you do it in your own production facility or outsource it to somewhere else. There might be standards concerning hygiene or methods of production that you need to follow. If you’re outsourcing production, it’s especially important to check that the service you use will comply with regulations. You don’t have as much control, so you can’t be too careful.

Compliance for Exporting

If you’re planning on exporting your product, you need to remember that rules for compliance can vary in different countries. Before you come up with an export plan, you need to ensure that your product complies with the regulations in the export country, or that you can adjust it, so it does. This could be something to think about in the initial development stage if your long-term goal is to have an export strategy. Then you won’t have to completely redesign your product.

Developing a specialized product for a regulated market takes a lot of work. Complying with the rules is essential, so make sure you keep them in mind at all times.

Staff Writer; Joseph Poole


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