Sean MacLeod

Device manufacturers face numerous challenges and uncertainties in the current healthcare environment. Broad shifts in regulatory oversight, downward pressure on costs, aging patient demographics and sun-setting intellectual property all are high-level concerns. However, at the end of the day, companies still need compelling new products to support growth—or perhaps even survival—in these changing times. Simply organizing a discrete market research project, setting a relevant clinical outcome target, authoring device specifications, tactically executing development and gaining supportive clinical data for regulatory submission (wash, rinse, repeat) doesn’t cut it. Creating compelling, comprehensive health system solutions that demonstrate measurable, clinical and economic benefit is a must. These solutions require a cross-functional understanding as well as a combination of market and technical competencies not seen before by most organizations.

Companies have undertaken major efforts to get lean since the financial crisis in 2008. They have optimized efficiencies around a core competency focused on delivering incrementally improved devices with discrete clinical endpoints. This optimization strategy runs counter to the diversity required to meet the needs of the above-mentioned comprehensive system solutions. If the new strategic imperative for device companies is to provide value beyond slim, incremental improvement, they must face the need for external expertise and abilities in order to create meaningful innovations.
There are several approaches companies are taking to overcome this challenge that are worth further elaboration: knowing and focusing on an organization’s own strengths; proactively mapping and sourcing outside partners identified across an opportunity topology; and strategically investing in relationships well in advance of their tactical impact. These activities, once combined, have tremendous influence on the success of overcoming the challenge of creating meaningful innovation in today’s healthcare environment.