Support Services
Strategic Business Planning
MPR has the in-depth knowledge and experience to plan and execute successful product and commercialization strategies. We understand how to match business objectives to market needs effectively, and how to plan out a new product that meets all technical requirements and adheres to cost, scheduling, and regulatory demands. We assist clients with prioritizing their new product pipelines according to corporate goals and are adept at assisting our start-up clients in acquiring necessary seed capital or investment funding.
Regulatory – 510(k) and PMA
Preparing the necessary documentation for FDA device approval is a complicated process that can take time away from an enterprise's core business. Our specialists know the details to prepare and submit the necessary documentation required to achieve FDA medical device classification, Pre-Market Approval (PMA), and pre-market equivalence 510(k) clearance. We can simplify and expedite what can otherwise be a lengthy and confusing process.
Supply Chain and Manufacturing
MPR is experienced in every aspect of supply chain development, manufacturing logistics, and production. Our specialists are experts at instituting and implementing rapid production methods, selecting and approving suppliers and components, verifying and validating new products and processes, managing technology transfer activities, and conducting post-market surveillance and studies. As part of our turn–key development approach, we develop the entire supply chain for a product – from identifying and qualifying new suppliers to overseeing initial full-scale production runs. In addition, we support operations teams in developing manufacturing processes for new products, as well as existing devices as part of ongoing productivity improvement strategies. We understand the FDA's requirements for current Good Manufacturing Practices (cGMPs) and Quality Systems Regulation (QSR) and have the expertise to ensure that the products and processes we design fully meet (and often exceed) those requirements.
Due Diligence
Using our integrated approach to product development and cross-functional capabilities, MPR assists investors, including venture capital firms and corporate development teams, in evaluating new technologies and products. We evaluate all technical aspects of an existing technology, including design and engineering, patentability, manufacturability, and the regulatory strategy, and also support strategic evaluations of product commercialization, taking into account the culture and organizational structures of the companies.
Market Research
Before embarking on any new product development project, MPR provides a detailed development plan with cost projections and defines design approaches and constraints. During our first phase of development, we develop market studies, including competitive analyses of existing products and systems, to assist in formalizing user and system requirement specifications.
Process and Organizational Development
Drawing upon our history of innovation and proven process for rapidly developing new innovative products, we provide consulting services to companies looking to decrease their new product commercialization times and increase productivity across their research, development, and manufacturing organizations.
Intellectual Property Development
We support our clients in developing comprehensive intellectual property strategies that effectively protect their interests and match their overall corporate goals. Because our knowledge base covers all aspects of medical device technology, we understand how complex life sciences concepts relate to others and to larger legal and corporate concerns.