Program and Technical Project Management

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Effective program and technical management is crucial to successfully advancing health innovations in drug, medical devices, software as a medical device (SaMD), and digital therapeutics development.

Innovenn’s team of industry experienced medical device development project management experts work closely with clients to plan and execute global product development services, including the coordination of key work streams such as Regulatory, Quality, Legal, Software and Product Development, Cybersecurity, Commercial and Clinical.

Our technical project managers assist our clients by providing drug development consulting and medical device development consulting, as well as managing resources and timelines to bring products to market efficiently and effectively. We work with clients to tailor a program to their product’s unique path to commercialization.

Project Initiation

Upon initiation, your project will be assigned one of Innovenn’s technical project managers who not only have the skills to manage the project’s work streams, but also have the experience and technical industry knowledge to understand the details and nuances of drug, medical device and SaMD development. In the project initiation stage, the project manager will work with you to develop a project plan and communication plan and any other relevant plans to align and set expectations across all stakeholders. Innovenn’s project manager will guide the process moving forward so that you and your team know what to expect with each step on the way to your goal.

To fully scope your project, a gap assessment will be performed to identify missing information or potential roadblocks in the product development process. This includes assessing the current state of the product, and identifying gaps in knowledge, data, documentation, resources, and quality. Innovenn’s team will collaborate with you to assess the steps necessary to fill those gaps and draft a development plan that considers the regulatory submission strategies, data and content deliverables, launch considerations, and key quality system requirements.

Risk Management

Risk management is a critical component of program and project management. Our team uses technical knowledge and experience to implement a comprehensive project risk management plan for any potential challenge to ensure pre-defined mitigation strategies are lined up to support the success of the project. This includes identifying potential risks early in a project, developing strategies to mitigate those risks, and regularly monitoring the project to evaluate and effectively manage process and/or scientific risks.

Project Execution

During project execution, Innovenn’s assigned technical project manager will work closely with you to guide your team through the project phases. With regular meetings, open communication streams, documented plans, and task tracking, Innovenn’s team stays ahead of action items, decisions to be made, and potential project issues to proactively navigate your project and goals. The technical project manager assigned to your project will help your team organize and coordinate project activities. Throughout project execution, the status of budget, timeline, and project scope will be reported on a regular basis.

Regulatory Positioning & Filings

The technical project manager will work with the cross-functional team to understand the specific details of your product to coordinate with Innovenn’s regulatory team to recommend the most appropriate regulatory pathway for your product. The Innovenn team will manage the cross functional team in the preparation and filing of necessary documentation for regulatory body registration including pre-submissions, 510(k), PMA, and De Novo. Our team has extensive experience communicating with the FDA and international regulatory bodies and will help your team position your product for success.

Why Choose Innovenn for your Program and Technical Project Management Services?

Effective program and technical project management, as well as a thorough product definition process are crucial for the successful design, development, verification, and validation of drugs, medical devices, software as a medical device (SaMD), and digital therapeutics. Innovenn’s team of experienced project managers offers a range of services, including coordination of resources and timelines, gap assessment, risk management, vendor evaluation, and Human Factors and usability planning to support evaluations to demonstrate that your product is safe, effective, and user-friendly while meeting relevant regulatory requirements. Let us help bring your product’s benefits to patients and users efficiently and effectively.

To learn more about Innovenn’s Drug and Medical Device Development Project Management consulting services, contact us to discuss your specific needs.

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Where healthcare innovation intersects with improved patient outcomes

Contact Innovenn

6410 Enterprise Lane
Suite 230
Madison, WI 53719

608-203-9748

info@innovenn.com