Medical device innovations require world-class expertise. No matter whether a company has a dozen or a thousand researchers, however, their involvement is one part of a complex system. Many organizations and agencies are involved in each device’s journey to the market.
Although it all begins with a single vision, the repercussions of this work spread widely.
As a device moves closer to commercialization, it is important for the enterprise to be truly ready for the road ahead. Understanding the complex interplay of stakeholders in design, development, and launch is an essential part of that preparation.
Let’s take a close look at them.
Your Medical Device Company
Although large multinationals have set the tone for the industry in the past, that is changing. Smaller organizations can muster agility and vision to achieve breakthroughs that would take far longer for larger players. The company must apply standards for best-in-class quality and navigate changing market conditions. Still, they are but the nucleus of a challenging process.
Suppliers, Manufacturers, and Other Partners
Under ISO 13485 quality management standards, the medical device firm is responsible for the quality adherence of its partners. These include, for example, manufacturers who fabricate the components and call centers that provide ongoing care after customer acceptance. Partners should be selected based on their ability and enthusiasm toward a truly rigorous compliance process.
The Food and Drug Administration (FDA)
The FDA is the principal regulatory agency that certifies a device’s fitness for commercialization in the United States. Although it has moved toward greater efficiency and transparency in recent years – with approval rates for high-risk devices hitting a 15-year high in 2015 – the FDA’s vetting process is known as one of the most comprehensive in the world.
Healthcare Organizations & Administrators
Even after approval, quality management excellence is required to maintain trust and develop a strong relationship with customers. In general, healthcare administrators and practice leaders tend toward a conservative approach: They take “acceptable risk” for their patients seriously and often wait to see how a device performs in the market before entertaining the possibility of using it.
Physicians & Other Healthcare Providers
Physicians often serve as internal advocates who can push for the adoption of a device when they feel confident it will improve patient outcomes. Physicians represent the voice of their patients to administrators – patients, in turn, are often amenable to innovative therapies. It is a good idea to begin making inroads with physicians early in development.
Each community of patients faces their own unique challenges and constraints. It is vital that new devices take these into account and offer both efficacy and convenience. For devices that patients will need to interact with, attention must be paid to ergonomics. Patients place their trust in device manufacturers and will litigate fiercely if they feel that trust has been violated.
Investors can serve as the lifeblood of an organization, equipping it with the resources to drive development forward. Investors tend to demand process maturity and a record of results – this makes adherence to globally-recognized standards, such as ISO 13485, all the more crucial. A growing portfolio of reliable, effective medical devices is key to attracting investment dollars
Technosoft Innovations Helps You Meet High Standards and Balance Stakeholder Needs
Each step you take in device development reverberates throughout your enterprise in countless ways. The decisions you make today could affect millions of people in the future. There is, however, one factor that cuts across all these concerns and stakeholder groups: Quality.
To know more: download our guide
Technosoft Innovations can help you enact stringent, ISO 13485-based quality management practices at all levels.
For any additional questions, a proposal request or to book a free consultation, contact us