Approximately 30,000 new items enter the marketplace annually, yet an alarming 95% of these ultimately do not succeed. These statistics can be quite disheartening for teams involved in product development across various sectors. However, this does not imply that failure is inevitable. Oftentimes, it indicates that the teams involved did not conduct thorough research and planning prior to their product’s launch.
According to Navneet Kaur, Senior Manager of Regulatory Affairs at a prominent pharmaceutical firm in Boston, MA, it is crucial for product development—especially in fields that are tightly regulated, such as pharmaceuticals—to take several essential elements into account during the creation phase to facilitate a successful roll-out.
1. Understanding Customer Requirements
“The assessment of actual customer requirements must always be the starting point,” Navneet asserts. “Is the solution your product offers genuinely necessary? Or are you essentially attempting to address a non-existent problem? Additionally, it’s important to ascertain whether the need is significant enough to justify the launch of a new product.”
Indeed, an analysis conducted by Harvard Business Review highlights that even the most groundbreaking products can fail without a corresponding market. Moreover, items that do not significantly differentiate themselves can also encounter difficulties in gaining recognition.
In sectors like pharmaceuticals, this often involves addressing the needs of several distinct “customer” groups. “When we introduce a pharmaceutical product to the market, prior to reaching the patient, all relevant safety, efficacy, and quality data is submitted to regulatory bodies,” Navneet clarifies. “Consequently, regulatory organizations such as the FDA, EU, and Health Canada essentially serve as our primary customers, as they review the provided information before allowing us to commence clinical trials.”
2. Assessment of Target Market
Alongside gauging customer requirements, product development teams are advised to analyze their target market. Products aimed at a broad consumer base must exhibit greater sensitivity to pricing. Conversely, offerings aimed at a luxury market tend to target a narrower demographic, yet this audience is often prepared to spend more.
If your product addresses a specific niche, it is essential to evaluate whether your pricing approach will allow for profitability. An inconsistency between the target market size, pricing strategy, and overall product appeal can hinder success.
Navneet further elaborates, “In the pharmaceutical sector, where obtaining product approval can span over ten years from the initial concept, evaluating the market is critical. This evaluation is closely linked to understanding patient requirements and the demographics of the patient population. For example, if the treatment addresses a rare condition, it is worth examining whether your product qualifies for orphan drug designation, typically granted to drugs developed for ailments affecting fewer than 200,000 individuals in the U.S. Achieving this designation can provide benefits such as tax breaks, reduced fees, and extended market exclusivity.”
3. Regulatory Considerations
As a specialist in the pharmaceutical field, Navneet emphasizes the paramount importance of regulatory factors during product development. Pharmaceuticals are rightly subjected to numerous regulatory stipulations to guarantee safety for the consumer; however, this need for compliance is not exclusive to this industry.
“Regulatory frameworks can impact everything from the materials and packaging employed to the warnings you must include for your product,” Navneet notes. “Such regulations may come into effect during the development stage before a finalized product is even available, necessitating an understanding of the rules that pertain to your sector and the type of product you aim to develop.
“For instance, in 2018, the FDA amended the Q3D guidance regarding elemental impurities, mandating that manufacturers perform risk assessments for elemental impurities across all prescription and non-prescription drug products distributed in the U.S. Consequently, I now conduct risk evaluations for elemental impurities related to the various drug substances produced by my organization, aligning with this guidance and submitting them to the FDA to mitigate any risk. This represents a significant undertaking, but it guarantees that our existing products remain available and free of impurity concerns.”
Instances of such regulatory issues are diverse in the pharmaceutical industry, with companies facing fines for distributing compromised or unauthorized medications, breaching environmental regulations, or noncompliance with advertising standards.
4. Analyzing Competition and Market Dynamics
Navneet advises, “It’s crucial to evaluate the competitive landscape in your domain as well as the broader market trends. For instance, producing a generic version of a branded medication is not permissible until 20 years after the patent registration. This timeline can restrict the types of pharmaceutical products you can develop. Being cognizant of what potential competitors are already marketing—and any patents they hold—will aid in evading compliance issues and prevent the introduction of a product that fails to stand out in the market.”
Examining the performance of established competitors can yield valuable insights regarding the overall market landscape. This evaluation can help in determining whether a particular niche is on an upward or downward trend, or reveal under-served sub-niches that may benefit from enhanced offerings. Analyzing competition can be instrumental in refining your product or redirecting efforts towards more promising opportunities.
5. Development of a Marketing Strategy
Lastly, nothing finalizes product development like a solid marketing plan. Grasping your target demographic and their preferences is a key initial step. It is also vital to comprehend your competitors’ standing and the overall landscape of your particular niche. However, this knowledge is merely a starting point.
“For each product, contemplation is necessary regarding the methods to connect with your intended audience,” says Navneet. “What kind of messaging will resonate with them and convey your product’s value? Which platforms will be the most efficient for engagement? For products that address multiple audiences—like how many pharmaceutical products cater to both medical practitioners and patients—you must determine how to tailor your marketing strategy for each segment.”
In the absence of effective marketing, even the most well-designed product is likely to struggle in attracting its target audience. Utilizing strategies that are customized for your audience’s preferences will be critical for establishing market presence and generating positive word-of-mouth.
Strategizing for Success
While guaranteeing the success of a specific product is impossible, dedicating extra effort prior to its release can significantly enhance your chances of making an impact in the market. Additionally, this process may reveal the need to pivot before making substantial investments in a product that may not succeed.
By scrutinizing these essential criteria from the outset, your team will be better equipped to make informed development choices and introduce products that hold a higher probability of success.
