The first step in defining your competitive landscape is to identify and define the technology’s current competition and how they fit into or define current standard of care (SoC). List the products or substitutes that you would aim to replace or complement with your technology or product, as well as the company that markets each of them. Analyze their strengths and weaknesses objectively to make determinations on how your technology/product might represent an improvement on existing products or SoC. How would your technology/product be differentiated from existing SoC – perhaps based on improved efficacy, reduced adverse effects, improved convenience, reduced cost …?
An important step in the process is to forecast how is the SoC landscape may shift during your technology/product development. You need to think like the quarterback who throws to where the receiver will be, not where (s)he is now.
Identify other technologies/products in development that may emerge as strong competitors in the future, and may alter SoC and the way your technology/product would fit in. You may hear about these development projects at scientific/medical conferences, but you may also have to keep your ear to the ground, collecting “gray” knowledge to inform yourself about developments underway without public disclosures. The key to competitive analysis is differentiation: how is your proposed technology/product better than current and other future options, and for what segment(s) of the patient population? In some cases, it will also be important to consider shifting demographics and disease incidence/prevalence, which may change the competitive position of technologies/products. This topic is considered more in our next article for the Specialist Series, entitled: “Defining Your Market”.
Much of the competitive landscape analysis is qualitative – simply a list of the products with their strengths and weaknesses, status on the market and comments on the opportunity or threat they represent for your product/technology. However, to the extent possible, it can be valuable to make (semi-) quantitative determinations of the relative merits of your technology/product and competitors. This may include data on efficacy, safety, factors related to convenience, cost, or any other differentiating factor. This data may be known for your competitor, but you may not yet have the data on your technology/product. In this case, the competitive comparison will help you define quantitatively the objectives you will want to set for your target product profile (TPP) or Design & Development Inputs (DDIs) to define and differentiate your technology/product.
For drugs, you should use the TPP to guide your discovery and development program design to ensure you select the product and collect the data needed to support your TPP claims. Devices must be developed under design controls and that process is typically what drives device “targets”. The first step in design controls is to define DDIs. ISO 13485, an international standard for design controls, says that inputs relating to product requirements shall be determined and records maintained. The inputs include functional, performance, and safety requirements, according to the intended use; applicable statutory and regulatory requirements; information derived from previous similar designs; other requirements essential for design and development; and outputs of risk management.