We work with a lot of medical device companies, of various stages, from Fortune 100 businesses to pioneering startups. Often, the challenges are the same. Below is a collection of what we've learned about product development for medical devices, although of course, everyone's experience is unique.
What to Expect: Developing a New or Improved Medical Device
Product development for a medical device company typically involves several distinct phases, each with its own set of activities, goals, and challenges. These phases are crucial for bringing a medical device from concept to market. Below are the typical phases of product development for medical device companies, and the primary focus areas for each phase.
Concept and Ideation
The concept and ideation phase is when you identify a product idea, articulate the product requirements and wishes from a customer's perspective, and verify people want it and will pay for it.
- Identification of a healthcare need or problem to be addressed.
- Initial brainstorming and concept generation.
- Preliminary market research to assess the commercial potential of the device.
- Feasibility studies to determine if the concept is feasible from a technical, financial, and regulatory perspective.
Feasibility and Planning
During the feasibility and planning phase, initial requirements and wishes are expanded and all aspects of a proposed product are evaluated, including technical, economic, financial, legal, and other considerations.
- Detailed market research and competitive analysis.
- Technical feasibility studies and proof-of-concept development.
- Regulatory and intellectual property assessments.
- Initial budgeting and resource allocation.
- Development of a project plan and timeline.
Design and Development
During the design and development phase, an idea is taken through the prototype phase and iterated on to get to a final design that will be submitted for approval and ideally commercialized. Most of our customers are in this phase when they come to us because they don't know the best way to power their device, or how that will affect their device's design, and they know that having confidence in the device's design coming out of this phase is essential.
- Detailed product design, including engineering, materials, and technology selection.
- Prototyping and iterative design refinement.
- Verification and validation testing to ensure the device meets design specifications.
- Design for manufacturability and assembly (DFMA) considerations.
- Creation of detailed design documentation.
Regulatory Submission and Approval
This phase is when a device is prepared and submitted for approval to the proper organizations, such as the FDA for devices intended to be sold in the U.S.
- Preparation and submission of regulatory documents, such as the FDA 510(k) or PMA application.
- Interaction with regulatory authorities for reviews, questions, and clarifications.
- Clinical trial planning and execution if required.
- Addressing any regulatory concerns and obtaining necessary approvals.
Manufacturing and Quality Control
During this phase, medical device companies often seek a trusted contract manufacturer, typically a company that specializes in medical device design, development, and manufacturing.
- Establishing manufacturing processes and supply chain.
- Implementation of a Quality Management System (QMS) compliant with ISO 13485.
- Validation of manufacturing processes and equipment.
- Ensuring compliance with Good Manufacturing Practices (GMP).
- Regular quality control and testing to maintain product consistency.
Clinical Trials (if applicable)
During this phase, trials are conducted to collect safety and efficacy data.
- Monitoring patient outcomes and managing trial protocols.
- Data analysis and reporting.
- Submission of clinical trial data to regulatory authorities.
Market Launch
This phase involves preparing for and executing a market launch, including marketing, sales, and distribution strategies.
- Training sales teams and healthcare professionals.
- Ensuring proper packaging and labeling compliant with regulations.
- Rollout of the medical device to the target market(s).
Post-Market Surveillance and Lifecycle Management
This phase includes continuous monitoring of device performance in real-world settings.
- Addressing post-market issues and safety concerns.
- Implementing product updates or improvements as needed.
- Managing the device's lifecycle, including potential product line extensions.
Commercialization and Market Growth
This phase involves selling your product and developing plans to increase market share.
- Expanding market presence and exploring additional applications.
- Engaging in partnerships or collaborations to increase market penetration.
- Continuous market research and customer feedback to guide improvements.
Regulatory Post-Market Requirements
This phase involves staying current with medical device regulations involving products that have been sold and are in use currently.
- Complying with post-market regulatory obligations, such as reporting adverse events.
- Managing any required regulatory submissions for product changes.
There are different ways to approach each of these phases, often depending on the level of experience in each area. Often the areas in which our customers find most helpful to leverage specialized expertise are the first three phases, from proof of concept to feasibility and planning and finally identifying the optimal design and development of their device. While all phases are important, these initial decisions and milestones lay the groundwork for future success or challenges, such as when technical feasibility isn’t considered with a specific design component, like medical device power.
Whether you’re just starting out, or are a seasoned medical device professional, if you have questions about power for your medical device, we would love to talk. Contact us today to discuss your goals.
