Medical Device Development Process – The Full and Only Guide You’ll Ever Need

There are plenty of medical device types and technologies in the market, but there is one thing in common- All medical devices’ development l begin with an ingenui idea.

The medical device is a large family that includes products designed to diagnose and prevent diseases or other medical conditions used to treat humans or animals.

Medical devices can be an instrument, apparatus, machine, appliance, implant, reagent for in vitro use, medical software, medical mobile/cellular application, or material.

The medical device industry is a unique one.

It combined many areas such as mechanics, electronics, biomaterials, software, chemistry and physics, and even biology.

There are also medical device combination products working together with pharmaceutical products. On the other hand, mobile apps and even video games are used to treat patients and different medical conditions.

How does developing a medical device differ from a non-medical product?

Medical device development engineers, who have worked in other industries besides the medical one, know that developing a medical device is more complex and challenging than developing non-medical products.

The medical device is intended to treat sensitive and vulnerable populations (mostly patients) and may affect health conditions and endanger human life. As a result, the Quality By Design approach and extensive documentation level should be implemented in early medical device development.

Knowing the regulatory requirements and establishing the relevant Quality Management System and technical documentation will give the company an advantage in later stages.

Medical device development challenges

The final goal of every medical device development process is to receive the official marketing authorization in global markets such as Eu. and the US following CE mark and FDA 510K/PMA approval.

Developing a medical device and regulatory marketing authorization is a relatively complicated process. Achieving this critical milestone and avoiding time delays and budget issues along the way is challenging. It is essential “to do it right” in the medical device development and design phase.

This medical device design and development process requires exceptional capabilities. It combines safety, regulatory, quality, and technology challenges and requires a multi-disciplinary set of skills the company should have in this journey.

Medical Device Development Phases

Generally, there are 12 main phases in the medical device development process:

Phase No.	Medical device development phase description
1	The opportunity and business goals
2	Medical device Risk Analysis
3	Medical device Proof of concept
4	Medical device Feasibility study
5	Medical device Design and development
6	Medical device Regulatory strategy
7	Medical device Clinical evaluation
8	Medical device Verification & Validation
9	Medical device Technical file
10	Medical device Submission
11	Medical device launch
12	Post marketing surveillance

Medical Device Classification and risks

Every medical device is risky and classified based on the risks and level of concern and categorized accordingly.

Every medical device classification category and intended use have specific regulatory requirements that must be implemented as early as possible, from the first stages of the medical device design phase.

The process of a new medical device development

A typical medical device development process can be described as follows:

Step No.	Step name	Description
1	The need	Define what idea stands behind the medical device What problem does it solves? What is the business opportunity?
2	Device intended use and target audience	Define a clean device intended use Who will use the device? For what purpose? When? Where and How? (Hospitals, physicians, clinics/health professional, patients)
3	Device discovery	Create the initial design of the medical device Create device prototype
4	User need	Describe the need your device is related to. What is the problem it needs to solve?
5	Design Input	Define the design and technical requirements based on the user needs Verify the product satisfy the user needs to be defined in previous steps
6	Prototype	Develop and manufacture your medical device prototype that will be used as part if the pre-clinical and POC stages. The design should be simple at this stage, and detailed design is not necessary
7	POC	Define the proof of concept stage How will it be examined? What are the success criteria?
8	Intellectual property	Protect your device/technology and idea Sign NDAs with third parties Protect your medical device from the competition using patents registration in relevant territories
9	Pre-clinical studies	Write pre-clinical studies protocols Examine the safety and functionality of the device based on pre-approved studies protocols and acceptance criteria
10	Regulatory strategy	Discover how is your medical device is classified according to the regulatory requirements in the target market based on the intended use. Identify what market routes are optional for your device and choose the best route in terms of budget, territory, time lines, and regulatory capabilities.
11	Regulatory standards	Based on the regulatory strategy, define what standards are relevant to be in compliance with Be aware of the regulatory requirements in the pre-submission stages after advising internal/external QA/RA consultancy
12	Business plan	Create a detailed business plan Check what other alternatives exist in the market Search for potential competitors Use the regulatory strategy outcomes as a supportive information
13	Risk management plan	Create a detailed plan for risk management. Identify, document, analyze, assess and mitigate the risks of your device in terms of patient risk, safety, functionality, information security, and patient confidentiality.
14	User specification	Define device’s specifications based on the user requirements, patient, medical condition, and risks. The user specification will be the basis for the usability engineering requirements
15	Medical device development plan	Create a detailed medical device development plan based on previous stages’ outcomes. Hire the relevant development personnel and consultants
16	Design control	Document, track, manage and control all medical device design and development stages Create an organized device master record
17	Clinical studies/clinical investigation	Write clinical studies protocols Test the device on humans as part to make sure it is safe and effective
18	V&V plan	Write detailed Verification and Validation plan and protocols Verify protocols are based on the design requirements and user requirements of the device
19	Detailed design	Complete the medical device detailed design phase. Establish essential information such as engineering specifications, mechanical and electrical drawings, raw material and component specifications, label design, package, user manuals, and instructions
20	Design transfer plan	Create a detailed plan Define how the design will be transferred from the development team to the production phase
21	Technical file	Organize the technical file of the device. The technical file should meet the relevant regulatory body’s regulatory requirements.
22	Submission	Check the device technical file content against the regulatory requirements Submit the technical file to the relevant health authorities submission route based on the regulatory strategy.
23	Post-market surveillance	After your medical device is sold in target markets, collect and document the relevant information from the market Follow, monitor, manage and control all information and activities throughout the entire medical device lifecycle

Medical Device Development Timeline

The medical device development timelines vary, depending on the medical device type, intended use, complexity, risk, and classification.

A typical medical device development time line can be from 2-6 years in total.

Medical device development documents

Besides the medical device development documents plans, plenty of documentation should be created towards the medical device submission.

Examples of documents that should be created as part of the medical device development and design process:

Quality Management system policies
Quality management system procedures
Information Security Management System procedures
Risk analysis
Pre-clinical and clinical protocols
Verification protocols and reports
Functional testing protocols and reports
Electrical safety testing protocols and reports
Biological evaluation protocols and reports
Shelf life verification protocols and reports
Validation protocols and reports

Why do you need consultancy in the medical device development process?

The process of developing a medical device requires combined knowledge and skills such as medicine, health, engineering, quality, and design.

Given the complex multidisciplinary approach, I saw many medical device development processes lacking communication, knowledge, prioritization, and compliance with requirements.

To bring your medical device to the markets with minimal unexpected delays and financial risks, you should use consultants who have already done it several times with other companies and successfully.