Medical Device Design & Development is a multi-step process involving various resources and massive investments and long timelines. The process has sequential stages of ideation, designing, development, packaging, labeling, and delivery. Your Medical Device Design must be adaptable to sustain in the competitive landscape for a long time. In the current scenario, when most of the Medical Device OEMs are outsourcing their Medical Device projects a lot depends on the Medical Device Contract Manufacturing partner they choose for mass Manufacturing of their Medical Device Design. We, Johari Digital (www.joharidigital.com) is the leading electronic medical device manufacturer catering to global clients. We design, develop, engineer, and manufacture medical devices for global markets. We are the first MDSAP, US FDA, and GMP audited medical manufacturing company. We operate from a 65,000 square foot, state-of-art medical device manufacturing facility in India. Johari innovates through its R&D Center in Europe and a Centre Of Excellence in collaboration with IIT Jodhpur. Our services accelerate medical device development and optimize manufacturing costs. Johari’s versatile product development and manufacturing portfolio includes innovative life science products, diagnostic devices, and therapeutic devices.

1. Medical Device
Development Process

2. Medical Device Development
Johari Digital is the leading electronic
medical device manufacturer catering
to global clients. We design, develop,
engineer, and manufacture medical
devices for global markets. We are the
first MDSAP, US FDA, and GMP
audited medical manufacturing
company.

3. Medical Device
Development
The medical device development process requires certain
steps that must be followed to ensure design control so
that the product is effective and safe to use. As a result,
this covers the entire product development cycle, from the
development of medical device to clinical trials, as well as
risk management to practice.

4. Medical Device
Development Process

5. 1. Conceptualization
The primary stage of conceptualization involves evaluating the idea on
multiple grounds to understand its worth and market position.
Testing
Cost Structuring
Competitive analysis
Scalability test

6. Now that you have completed the concept, you are ready to write down :-
Raw material needs plan
Potential vendors
Total production costs
2. Planning

7. • Once you are ready with your preliminary requirements, you can proceed
with the design of the product.
• The primary motive of the design phase is to give shape to the initial
rough idea.
• Each part of the designing process has a specific purpose.
• Device should be feasibility, functionality efficient.
Industrial Design
Mechanical Design
Software Design
Electrical Design
Electronics design
3. Design & Development

8. 4. Prototyping
• The prototyping stage involves multiple iterations of the
design to account of the design created:
Feasibility
Scalability
Effectiveness
• The size and shape to handy.
• Prototyping plays a crucial role in determining the scalability and
efficiency of the design.
• Once the prototype is ready it can be sent for validation.

9. 5. Validation
• In the validation phase of the product life cycle the device design is
validated for safety and effectiveness.
• The clinical evaluations determines whether the product can be moved to
the next stage.
• Once the design is validated on multiple parameters, it is transferred for
regulatory submissions.

10. • The transfer refers to the stage when all the knowledge about the Stage
I is transferred to the mass manufacturing stage.
• Before transferring the design for mass manufacturing each of the
device specific processes is validated and verified.
• The NPI validation involves checking the capabilities, machines and
production line efficiency.
6. Technology Transfer & NPI

11. 7. Manufacturing
• Once everything approved prototype is
transferred for mass manufacturing.
• Many big Medical Device companies
are outsourcing the manufacturing of
their medical devices.
• It’s important for them to choose the
right contract manufacturer who
delivers as per their needs.
Manufacturing
Packaging
Assembling

12. Conclusion:
• Finally, when the product is ready to be launched manufacturers and
marketers must be ready to receive and record feedback.
• Post Market Services involve providing service in case of any breakdown
or fault at the user’s end.
• Once the root cause is identified, the follow up studies are done to rectify
the causes and make improvements.
• As a globally acclaimed Medical
Device Contract Manufacturer,
Johari’s versatile product
development and manufacturing
portfolio includes innovative life
science products, diagnostic devices,
and therapeutic devices. Source: www.joharidigital.com

13. To Get In Touch