It’s estimated that 30,000 new products are introduced to the market each year — and that 95% of them fail. These numbers can be fairly sobering for product development teams in any niche, but this doesn’t mean that failure is guaranteed. Quite often, it simply means that the development teams didn’t perform their due diligence before launching their product.
As Navneet Kaur, Senior Manager of regulatory affairs at a leading pharmaceutical company in Boston, MA, explains, product development — particularly in heavily regulated areas such as pharmaceuticals — must strongly consider several key factors during the development stage to ensure a successful launch.
1. Customer Needs
“You always have to start by evaluating the actual needs of the customer,” Navneet says. “Is the solution you are trying to provide with your product actually needed? Or are you essentially trying to create a solution for a problem that doesn’t exist? It’s also worth considering whether the need is widespread enough to warrant the creation of a new product.”
Indeed, as an analysis by the Harvard Business Review notes, even the most revolutionary products are doomed to failure if there isn’t a market for them. Similarly, products that aren’t distinctly different can also face an uphill battle in making an impression.
In fields such as pharmaceutics, this often requires looking at the needs of multiple “customer” groups.“When we bring a pharmaceutical product to the market, before it goes to the patient, all the information regarding safety, efficacy, and quality of the drug goes to the regulatory agencies,” Navneet explains. “Therefore, regulatory agencies like the FDA, EU, and Health Canada become our primary customers as they review information and allow us to even begin with clinical trials.”
2. Target Market Evaluation
In addition to considering customer needs, product development teams should also evaluate their target market. Products targeting a general market must be more price-aware. On the other hand, products targeting a high-end market have a much narrower audience, but that audience is usually willing to pay a higher price.
If your product provides a niche solution, you must consider whether your pricing strategy would enable you to turn a profit. A mismatch between the target market size, pricing strategy, and overall desirability of the product will make it difficult to succeed.
As Navneet explains, “In the pharmaceutical industry, where product approvals can take over a decade from inception, market evaluation plays a critical role. It goes hand in hand with understanding patient needs and where the patient population is. For example, if the treatment is meant for a rare disease, you could assess whether your product is eligible for orphan drug designation, generally awarded to drugs aimed at treating conditions that impact fewer than 200,000 individuals in the U.S. Securing this designation can offer advantages like tax incentives, lower fees, and prolonged market exclusivity.”
3. Regulatory Concerns
As a pharmaceutical industry expert, Navneet quickly notes the importance of regulatory considerations when developing a product. Pharmaceuticals are understandably subject to a wide range of regulatory requirements to ensure safety for the end user, but this is hardly the only field where government regulations apply.
“Government policies can influence everything from the materials and packaging you use to the warnings you need to list for the product,” Navneet says. “These regulations can come into play during the development phase before you even have a finished product, so you must be aware of the regulations that affect your industry and the type of product you plan to create.
“For example, in 2018, the FDA revised the Q3D guidance for elemental impurities, requiring manufacturers to conduct a risk assessment for elemental impurities in all prescription and over-the-counter drug products distributed in the U.S. As a result, I now perform elemental impurities risk assessments for the various drug substances produced by my company in alignment with this guidance and submit them to the FDA to ensure there is no risk. This is a huge effort, but it ensures that our existing products do not go off-shelf due to impurity issues.”
Examples of this are quite varied in the pharmaceutical industry, with government fines levied for reasons such as distributing adulterated or unapproved medications, violating environmental regulations or running afoul advertising policies.
4. Existing Competition and Market Trends
Navneet advises, “You must also look at the existing competition in your space and market trends as a whole. For example, you can’t produce a generic equivalent of a brand-name medication until 20 years after the patent was filed. This could limit the type of pharmaceutical products you are able to create. Being aware of what your potential competition is already selling — and any patents they hold — will help you avoid legal compliance issues or issuing a product that doesn’t successfully differentiate itself in the market.”
Evaluating the performance of your existing competition can also provide crucial insight into the market as a whole. This could help you understand whether a particular niche is growing or declining or uncover sub-niches that aren’t being served sufficiently by current offerings in the market. Evaluating the competition can prove valuable in fine-tuning your product or redirecting your efforts to something that will prove more successful.
5. Marketing Plan
Finally, no product development is complete without a robust marketing plan. Understanding your target audience and their wants and needs is an important first step. You should also understand the state of your competitors and the market for your niche. However, this information is only a start.
“For every product, you must consider how you will actually reach your target audience,” Navneet says. “What type of messaging will appeal to them and communicate the value of your product? Which platforms are going to be the most effective for reaching them? For products that may have multiple audiences — such as how many pharmaceutical products are marketed to both doctors and patients — you’ll need to consider how to adjust your marketing efforts for each group.”
Without solid marketing behind it, even the best-developed product will struggle to find its audience. Getting the word out using methods that are tailored to your audience will prove crucial to building a market and generating word of mouth.
Building for Success
While you can never guarantee the success of a particular product, putting in the extra effort before launch can greatly increase your likelihood of making an impact on the market. Alternatively, you might discover that you need to go in a different direction before heavily investing in a product that is unlikely to succeed.
By evaluating these critical criteria early on, your team will be positioned to make better development decisions and launch products that have a stronger chance of success.
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