Where does Medtech Project Planning fit in with Product Development and why is it important? Let’s review the basic steps for successful Project Planning.

 

What is Project Planning?

Project planning, also referred to as “Phase 1” at GCMI, follows directly after the feasibility phase, “Phase Zero.”  Phase 1 is the beginning of the formal product development process that complies with medical device regulatory requirements and with business strategy. This phase is all about determining the resources, the timing, and the work that’s required for product success. 

 

What are the Goals of Medtech Project Planning?

The medtech innovation planning process results in a structured, documented framework to take a technology from prototype to product. This plan is critical for the project team to work efficiently together towards the identified goals. The plan acts as the project “trail map,” guiding the project team as they “climb the mountain” on the same path to reach the “summit” safely together. Critical decisions made here will fundamentally drive the project planning process and project direction. 

 

Business Strategy

From a business point of view, project planning provides the foundation for successful market entry from a clinical and financial standpoint. Business strategies are not compliance activities, but they inform the design control work by answering the key question: “How are you going to compete in the market?” 

 

Business strategy decisions should include:

  • Marketing and distribution strategy 
  • Patent strategy 
  • Project schedule    
  • Project budget  

 

Design Control Planning

Design control planning phase documents provide the foundation for both successful product quality as well as regulatory compliance. These technical strategies then inform the schedule, budget, and product cost targets.    

 

Design control documentation includes:

  • Project and Regulatory Plans    
  • User Needs and Design Inputs        
  • Product Overview and Design Concept    
  • Manufacturing, Packaging and Labeling Strategies    
  • Risk Assessments    
  • Testing Strategy 

 

The resulting project plan is a framework of activities, assigned to a team of knowledgeable experts who are focused on executing the business and compliance strategies. 

 

Why GCMI for Project Planning? 

Our team spends focused time in this phase because we know the value of answering key questions to increase the odds of “summiting the mountain” safely together. Poor medtech project planning and lack of team collaboration, communication and agreement leads to far more unexpected detours (from technical to fundraising) than taking the time to execute a thoughtful project plan. GCMI serves as your comprehensive project planning, research and development team, taking an integrated view of product strategy and design. Our phase gated medtech design and development process gives promising technologies the best chance to achieve commercialization in a cost efficient manner. 

 

The medical device design services and product development team at GCMI facilitates medical product development process through all phases – from initial concept generation through transfer to production and manufacturing. We guide and execute along a strategic pathway, focusing on service excellence, product excellence and regulatory compliance. Our team works with a variety of innovators: individual physicians, researchers and engineers, start-up companies and publicly traded industry leaders. 

 

If you would like to know more about medtech innovation project planning or the process in its entirety, start the conversation by contacting us through the form below.

 

“If we worked with another design and development firm, we wouldn’t have had the flexibility to do what we needed to do in the time frame we set. GCMI is unique in that we were able to choose the services that we needed precisely at the time we needed them. The way GCMI engages with their customers is unlike any other firm.” – Lou Malice, CEO, NFANT Labs