Medical device program management

NextPhase Medical Devices is committed to providing thorough and comprehensive Program Management Services. Our experienced Project Managers leverage their skills and knowledge to navigate customers' development and manufacturing projects through the rigors of the ISO-13485 and FDA QSR regulatory environment. The most current medical device program management techniques and tools are efficiently implemented. 

The Project Manager integrates engineering talent, technology solutions and vended services into our project models ensuring that these resources are efficiently allocated, providing "Concept to Customer" solutions. 

Each project is assigned a Project Manager. The Project Manager's responsibilities include scheduling, budgetary reporting, partner management and asset resource allocation.    

For Manufacturing services, the Project Manager is supported by an NPD engineer and key manufacturing engineering, Quality, Supply Chain, and production resources. 

For Engineering services, the Project Manager is supported by the Engineering Team Leader who is dedicated to one project only and manages the workflow, vendor relations, technology development, task development, and schedule. 

The Project Manager and/or Team Leader interacts with the customer daily as needed. He or she will be responsible for weekly scheduled formal project updates for all stakeholders. NextPhase Medical Devices leadership is included in our program management model as they are routinely updated by the Project Managers. Monthly management meetings are scheduled where higher-level scheduling, budgetary and technology issues are discussed.

medical device project management consulting
Project planning module

NextPhase Medical Devices employs a time-proven management model whereby each medical device development project is structured into distinct phases, and within those phases very specific tasks are delineated and scheduled. Our robust project model is intended to prevent late-in-program changes that may be prohibitively costly and difficult to integrate into designs and/or the manufacturing process. 

NextPhase Medical Devices leverages more than 20 years of operations, solely focused on Medical Devices, to plan projects which elevate the performance of individuals, who then collaborate in teams, to conceptualize, design and build devices approved for global distribution. 

The project teams may consist of engineers and technicians from several disciplines working in tandem with manufacturing operations personnel. These teams will work together in collaboration with customer stakeholders, to complete targeted tasks within the defined parameters of each designated phase. The ultimate results are well designed, regulatory approved and manufacturable medical devices. 

Concept to customer

Our Concept-to-Customer process guides your medical device seamlessly from a nascent idea to a feasible concept, then on to final design, verified and through the regulatory process. Additional value is added as NextPhase Medical Devices is able to manufacture, manage any aftermarket issues the medical device may encounter. We take the time to thoroughly understand and properly specify the requirements of your device and design it with manufacturability in mind. NextPhase Medical Devices is structured to complete pilot and full-scale manufacturing demands, as well as clinical study design and management. Our fully staffed Regulatory Assurance Group can handle all facets of FDA and EU regulatory submissions. 

Guided by 20 plus years of medical device design, development and manufacturing experience, our medical device design capabilities accelerate your device's approval process. Our Product and Design Verification processes ensure your new medical device meets domestic and international standards. 

From concept through design, product approval and production, our NextPhase Medical Devices provides transparency, collaboration and the assurance of on-time and on-budget market delivery.

Customer needs assessment

A thorough Customer Needs Assessment is the initial step in the development of a medical device. NextPhase Medical Devices assembles a team of managers and engineers that investigate the gaps between our customers' current product design and the desired use, performance, and cost point of manufacture. A technology and regulatory assessment is conducted collating user needs, human factors, design demands, predicate outcomes and global regulatory requirements for the proposed diagnostic, surgical or therapeutic device. For this effort, NextPhase Medical Devices will collaborate with our customer to demonstrate that suitable technologies and processes exist which meet the various demands. 

A Customer Needs Assessment is vital so that all follow-on phases of the development can be programmed to fulfill the ultimate goals of all stakeholders. 

Potential innovations will be identified, schedules will be planned, and costs proposed to manage a program that will bridge the defined gaps to produce marketable devices. Core to the Customer Needs Assessment is the accurate identification of key stakeholders within the process, as well as transparent, concise, and timely communication of the project's progress.

Multiple partner management

Medical device development and manufacturing projects require the integration of multifaceted custom technologies, highly specialized testing services, commodity components and regulatory support services. These highly complex projects require project management expertise that can develop and sustain vital supplier partner relationships so that critical tasks are completed on schedule and on budget. NextPhase Medical Devices expertly and efficiently manages diverse partners who collaborate well with in-house and customer R&D, engineering, quality, and management teams. These teams develop innovative technologies and manufacturing processes which are professionally managed with transparent reporting, duly communicated to all stakeholders. 

Our firm has implemented state-of-the-art electronic Quality and Document Control Management and ERP tools. NextPhase Medical Devices manages a robust supply chain of approved vendors, who must adhere to our strict supplier metrics which are continuously updated, governed by the protocols of our quality policy. Initiatives for continuous improvement, supplier audits, training and decades of program management experience assure successful product designs and manufactured devices for our customers, clinicians in the field and patients receiving treatment.

Quality assurance

The hallmark of NextPhase Medical Devices’ success in the medical device and marketplace is our Quality System. Our company assures customer satisfaction and product safety through a robust and proven Quality System that is 21 CFR 820 FDA Quality System (QS) Regulation compliant and EN ISO 13485:2016 certified. Our comprehensive quality management system encompasses the essential elements necessary for the design, production, and distribution of innovative medical devices that meet today's challenging healthcare and cost containment needs. 

From controlling and defining product design, production and processes, non-conforming product, and instituting corrective and preventive action to applying the ISO 14971 risk management system for medical devices, NextPhase Medical Devices’ foundation is quality suitable for Class III medical devices and systems and applicable to all classes of medical products. 

Milestone, cost, & metric tracking

NextPhase Medical Devices leverages several metrics methods to ensure that development and manufacturing projects proceed on schedule and remain within proposed budgets. Critical milestones and the associated tasks for projects are established during our proposal process and initial project phase. Progress and performance measurements are defined, collated, and communicated to all stakeholders.

Measurement is a crucial project component as the data collected and analyzed, informs project teams on the critical path adjustments needed to meet program requirements. 

Product Development Program Managers continuously monitor project metrics dashboards which measure scheduled task completion performance, technical achievements, product performance milestones, regulatory compliance, and costs vs. budgets. These metrics are communicated frequently with transparency to all levels of stakeholders, ensuring swift decisive alterations to a project model to achieve the expected milestones. 

Manufacturing floor managers also monitor performance metrics for our contract manufacturing medical device production floor. The critical dashboard metrics implemented for our lean manufacturing group measure quality, on time performance, process costs, adherence to regulatory controls and continuous improvement efforts. NextPhase Medical Devices operates its manufacturing process with an open book policy. Our customers are urged to monitor our metrics, fostering a collaborative culture that continuously searches for process adjustments that lead to a high-value product built at marketable costs.

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