The medical device commercialization process includes many aspects to ensure successful commercialization. To ensure that your innovation will meet market requirements, it is essential to have a deep understanding of market trends, clinical preferences, the competitive landscape and regulatory and legal requirements. It is especially important when an emerging technology may change the current standard of care. A medical device company will make best practice decisions after thoughtful due diligence.
A medical device commercialization consulting firm will provide the desired insight and deliver a professional review.
Successful development depends on the factors of a well articulated business model that surrounds the intellectual property to protect the idea. Potential investors have important questions related to the following areas:
- Market Assessment
- Business Model
- Product Pricing and Reimbursement Strategy
- What unmet market need does the device solve?
- Why will clinicians use this device over existing established technologies?
- What is the potential market size?
- What are the procedure volume and disease incidence and prevalence?
- Who is the end-user?
- Will potential users adopt this device?
- What is market penetration?
- What is the competition level?
- Is affordable development and production achievable?
- Who are the early adopters for beta testing?
- How will the company sell and distribute the device?
- What is the exit strategy?
- If a startup is launched for development, manufacturing, marketing, sale and distribution, what is the business structure?
- Who will manage the company?
- Who will fund the company?
Product Pricing and Reimbursement Strategy
- Who will purchase the device?
- What is the cost of competing devices?
- What is the target market’s purchase decision-making process?
- Are reimbursement codes currently available?
- How will the company sell the device?
- What are the pricing caps in place?
- Is the underlying technology currently available?
- Does it require new technology developments?
- What are the potential engineering challenges in device development and production?
- Does the company specifically require to manufacture components or off-the-shelf components are available?
- Is it possible to manufacture the device with biocompatible materials?
- Do the device design, development and production meet appropriate regulatory requirements?
The medical device commercialization process starts with the risk-based medical device classification that will determine the regulatory requirements.
- Class I devices are moderate to low-risk devices.
- Class II devices are moderate to high-risk complex devices.
- Class III devices are most often high-risk devices.
Initial medical device conceptualization is an important medical device development phase providing an answer to the question – Is the concept viable?
An intellectual property strategy begins with surveying previously granted patents to ensure that the innovation will be useful to the target market. Novelty is one of the primary requirements for applying for a patent. This means that the invention must be brand-new and cannot have been previously disclosed. For your invention to be novel, it cannot have appeared in prior art. This means your invention cannot have appeared in an advertisement, a patent, or a trade brochure. If the medical device that you have invented has appeared in prior art, then it is not novel and is not eligible for a patent.Research And Discovery Phase
The next step is transitioning the viable idea into the research and discovery phase. This phase consists of:
- Designing and prototyping
- Proof-of-concept testing
- Iterative redesign
Monitoring budget is important as costs often escalate quickly. Creating a large design team is very challenging. A medical device company must work with a medical device consulting firm. Research determines the pros and cons of technology. Individuals in the research time must have expertise in:
- Engineering and design
- Engineering and usability
- Finance, business and accounting
- Scientific and clinical knowledge
- Regulatory affairs
- Quality assurance
- Business law and intellectual property
The level of required expertise depends on the device classification.
Design and Prototyping
The focus is on prototype function during the research and development. The company must select the right prototyping method as cost and functionality depend on the prototyping method.
Proof-of-concept And Iterative Redesign
Proof-of-concept testing determines the device functionality. It starts with benchtop engineering tests. In case the prototype fails, the company redesigns and creates a prototype again. This revision is called iterative redesign. Making these changes later can be very expensive. The iterative redesign data defines the device characteristics and performance specifications. The research and development phase ends with a functional prototype.
Defining Design and Performance
Strictly governed Quality Management System is a framework of policies and procedures for product development and manufacturing. This system guides the entire development process. This generates a design history file. The FDA audits this file and developers and manufacturers. The design control document specifies each function and corresponding engineering specifications.
Mechanical testing and functional performance testing are very crucial in the development to demonstrate design specifications. Other types of testing include:
- Usability engineering/human-factor engineering
- Non-clinical testing
- Clinical testing
Clinical testing is highly regulated testing that involves human subjects. Depending on whether the medical device is considered a significant risk or non-significant risk device, the FDA may require an investigational device exemption before the device undergoes clinical testing.
FDA Application Type and Testing
The FDA application varies according to the type of the device. After completing the design history file, the medical device company requires to submit for regulatory clearance to market and sell the device. The FDA requires evidence supporting safety and effectiveness for use.
Post-market surveillance is the final phase of the lifecycle. The FDA requires manufacturers to monitor the effectiveness and safety of the marketed device and submit reports. The FDA tracks publicly and manufacturer-reported adverse events. In case there is an issue, the manufacturer has to recall the device and submit sufficient evidence after remediating the issue.