Implementation Strategy for an Innovative Medical Device

Summative Assessment: Innovation Implementation Strategy

For a manager to successfully execute a strategy for a product or process innovation, they must have a strategy for the implementation, which requires flexing their skills in information analysis. Understanding the impact of regulatory requirements and the ethical considerations for the rollout are key factors to developing strategies for a successful launch. Each innovation will have its own considerations, such as protecting intellectual property rights, complying with federal regulations and local laws, or issues affecting the community.

This week, you’ll present the implementation strategy for your innovation to the executive leadership team and the project management office (PMO) so they can assign resources and put a project team together.

Assessment Deliverable
Complete a 700- to- 1,225-word implementation strategy for the innovation you selected.

Identify the organizational resources necessary to implement and assess whether the organization has the resources or must hire or contract to get there.

Explain any ethical, legal, and regulatory implications related to the implementation.

Identify regulatory stakeholders that may influence the approval and implementation of your innovation.
Identify legal mechanisms to protect the innovation through patents, copyrights, trademarks, and trade secrets.
Identify any ethical issues related to the implementation of the innovation.
Establish a timeline for deploying your innovation. Include at least 5 major tasks or milestones that must be accomplished to roll out your innovation. Consider formatting your timeline as a chart.

Cite any references to support

Format your assessment according to APA guidelines

Implementation Strategy for an Innovative Medical Device

Our organization has developed an innovative medical device that promises to revolutionize how healthcare providers diagnose and treat certain conditions. However, for this innovation to be successfully launched and integrated into the healthcare industry, we must carefully consider the resources required, regulatory requirements, ethical considerations, legal mechanisms, and the timeline for deployment.

Organizational Resources
The successful implementation of this innovation requires a team of experts in different fields, such as medical research, engineering, and marketing. Therefore, we will need to hire additional staff, outsource some tasks, and provide training to existing employees. Additionally, we will need to invest in technology and infrastructure, such as laboratory equipment and software for data analysis.

Ethical, Legal, and Regulatory Implications
There are various ethical considerations, legal requirements, and regulatory implications related to the implementation of our innovation. One of the key ethical considerations is ensuring the safety of patients who will use the medical device. We must also consider the potential impact of our innovation on existing healthcare providers and ensure that it aligns with their ethical standards.

In terms of legal requirements, we must comply with federal regulations and local laws related to the development, manufacturing, and distribution of medical devices. Failure to comply with these laws can lead to legal repercussions, such as fines, lawsuits, or even criminal charges.

We must also consider the regulatory stakeholders who may influence the approval and implementation of our innovation. These stakeholders include the Food and Drug Administration (FDA), which regulates medical devices in the United States, and other regulatory bodies in other countries where we plan to market the device. We must work with these stakeholders to ensure that our innovation meets their requirements for safety and efficacy.

Legal Mechanisms to Protect the Innovation
To protect our innovation, we will use various legal mechanisms, such as patents, copyrights, trademarks, and trade secrets. We will file for patents to protect the design and function of the device, copyrights to protect the software used in the device, trademarks to protect the brand name, and trade secrets to protect confidential information related to the development and manufacturing of the device.

Ethical Issues Related to the Implementation of the Innovation
There are several ethical issues related to the implementation of our innovation, such as the potential impact on existing healthcare providers, the affordability of the device for patients, and the accessibility of the device for underserved populations. To address these ethical issues, we will work with healthcare providers to educate them about the benefits of our innovation and how it can complement their existing practices. We will also work with insurance providers to ensure that the device is affordable for patients, and we will explore ways to make it accessible to underserved populations.

Timeline for Deploying the Innovation
To deploy our innovation, we will need to complete several tasks and milestones, as outlined below:

Obtain FDA approval for the device – 12 months
Develop a marketing plan and materials – 3 months
Train existing employees and hire additional staff – 6 months
Manufacture and distribute the device – 9 months
Monitor the device’s performance and collect feedback from users – Ongoing
The successful implementation of our innovation requires careful planning and consideration of the resources, regulatory requirements, ethical considerations, legal mechanisms, and timeline for deployment. By working closely with our stakeholders, we can ensure that our innovation is safe, effective, and accessible to patients who need it.


Food and Drug Administration (FDA). (n.d.). Medical devices. Retrieved from
Kornbluth, J., & Plunkett, J. (2018). The innovation imperative in healthcare: How to innovate and thrive in an era of change. John Wiley & Sons.
United States Patent

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