Program and Technical Project Management
To ensure the successful design, development, and validation of drugs, medical devices, software as a medical device (SaMD), and digital therapeutics, effective program and technical project management is crucial. Our team of experienced technical project managers work closely with clients to plan and execute global product development services, including the coordination of key work streams, resources and timelines to bring products to market efficiently and effectively.
Product Definition
Project management in the product definition stage involves assessing the feasibility, regulatory strategy and compliance plans, and potential commercial success of a product. Our team conducts a thorough gap assessment to identify they key strategies that will support clinical, development, clinical, regulatory and commercial success. We also implement a comprehensive risk management plan to including identification of success enabling contingencies.
Feasibility: Clinical, Regulatory, and Commercial
The first step in the product definition stage is to evaluate the clinical, regulatory, and commercial feasibility of the product. This includes assessing the potential benefits and risks of the product, as well as its potential market size and competition. Various business cases are considered to evaluate the full scope of the products commercial viability.
Gap Assessment
A gap assessment is performed to identify any missing information or potential roadblocks in the development process. This includes assessing the current state of the product, identifying any gaps in knowledge,resources and quality processes. Our team will collaborate with your team determining the steps required to fill those gaps by designing a development plan that considers the regulatory submission strategies and data and content deliverables, launch considerations, and key quality system requirements.
Risk Management
Risk management is a critical component of product definition. Our team implements a comprehensive risk management plan to mitigate potential issues and support the success of the project. This includes identifying potential risks, developing strategies to mitigate those risks, and regularly monitoring the project to ensure that risks are being effectively managed.
Design Inputs/Requirements
Design inputs and requirements are established during the product definition stage. This includes identifying the functional and performance requirements of the product, as well as any relevant design constraints.
Vendor Evaluation
Evaluating potential contract organizations and vendors is an important aspect of product definition. Our team has extensive experience in evaluating contractors and and vendors to ensure that they have the necessary capabilities, capacity, and quality systems to successfully support product development.
HF & Usability Planning
Human factors (HF) and usability planning are crucial in the product definition stage. Our team has extensive experience in designing the human factors programs and conducting formative and summative usability testing to ensure that the product is user-friendly and easy to use. This includes identifying the target user population, conducting user research, and developing usability specifications.
Development
As part of our global product development services, we offer a range of support for the development phase of your medical device, drug, SaMD, or digital therapeutic. Our team of experts will work with you to define relevant regulatory requirements and studies to demonstrate that the product is safe, effective, and user-friendly.
Design Control / DHF
Design control is an important aspect of the development phase, and we will work with you to establish and implement a design history file (DHF) that meets all relevant FDA and international guidelines. This will include documentation of design inputs and outputs, design verification and validation, and design transfer.
QMS Implementation
Quality management systems (QMS) are crucial for ensuring that your product meets all relevant regulatory requirements. We will work with you to establish and implement a QMS that meets FDA and international guidelines, and that is tailored to the specific needs of your product.
Regulatory Positioning & Filings
Innovenn will determine the most appropriate regulatory pathway for your product, and to prepare and file all necessary documents, including INDs, NDAs, Pre-submission, 510K, PMA, De Novo. Our team has extensive experience in navigating the FDA and international regulatory landscape, and we will ensure that your product is positioned for success.
Verification Studies
We will collaborate with you to conduct verification studies, which are studies that demonstrate that a device or product meets its design specifications. These studies may include laboratory testing, bench testing, and/or animal testing.
Formative Human Factors Studies
In this step, Innovenn conducts formative human factors studies, which are studies that assess a device or product’s usability and user-friendliness. These studies may include cognitive walkthroughs, usability testing, and/or focus groups.
IFU Development
We will work with you to develop an Instructions for Use (IFU) document that clearly and accurately communicates the proper use and maintenance of your device or product.
Packaging User Evaluation
We will work with you to conduct user evaluations of your device or product’s packaging to ensure that it is user-friendly and safe. These evaluations may include mock-ups, prototypes, or actual packaging, and may include both formative and summative testing.
Conclusion
Effective program and technical project management, as well as a thorough product definition process, are crucial for the successful design, development, 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 all relevant regulatory requirements. Let us help bring your product to market efficiently and effectively.
