Medical device concept design

What is concept design?

Concept design is where your device vision becomes a functional prototype.

We translate user needs into technical requirements, explore and narrow the design options, set out a system architecture, and build the early prototypes that lead to a proof-of-concept. Requirements left vague or feasibility assumed rather than demonstrated tend to resurface downstream as:

Rework in advanced stages

Failed verifications

Regulatory gaps

Delayed milestones

From user needs to verified architecture

User needs and technical requirements

We work with you and your clinical stakeholders to capture what the device must do, as structured, measurable requirements. These become the design inputs the rest of development is tested against. Getting them right is non-negotiable.

Concept generation and down-selection

Our engineers explore multiple design directions, considering mechanical principles, electronic architecture, materials, usability, and software integration from the outset. Concepts are evaluated then down-selected to the most viable path forward.

Early prototypes

Prototypes at this stage are answers to the specific questions and risks identified in the feasibility stage. Can this mechanism work? Is it safe? Does this form factor make clinical sense? We build quickly, evaluate rigorously, and iterate with purpose to close unknowns before they become issues in later stages.

System architecture and design documentation

The output of concept design is a defined system architecture and a set of design documentation that feeds directly into detailed design. This includes preliminary design specifications, a high-level risk assessment, and the first entries in your design history file.

Proof-of-concept prototypes

A proof-of-concept prototype demonstrates that the current solution solves the problem it was designed for, that what has been invented actually works. This is the end goal of concept design and the gate into detailed design: a functional prototype that proves the principle before further engineering effort is committed.

IP generation

We assess what is genuinely protectable, run prior-art research to map the landscape you are designing into, and define a patent strategy tied to your disclosure events and target markets. We also produce the documentation you need to build a robust patent file.

A proof-of-concept prototype and a clear path forward

By the end of concept design, the idea is proven and the groundwork is in place. Here is what you receive:

Structured user needs

What the device must do for its users and stakeholders, captured as clear, measurable requirements.

Concept evaluation and down-selection report

The design directions considered, how they were assessed, and why the chosen concept won.

Proof-of-concept prototype

A functional prototype that demonstrates the core principle works

Preliminary system architecture

The high-level mechanical, electronic, and software architecture that detailed design develops.

High-level risk assessment

Early identification of hazards and use-related risks, under ISO 14971.

Initial design history file entries

The first records of a traceable, compliant development programme.

Preliminary regulatory pathway assessment

Confirmation of device classification and the standards that apply.

Design inputs: user and technical requirements

The formal requirements the rest of development is designed and later verified against.

Trusted by medical device leaders

We have helped medical device innovators turn ideas into market-ready products.

“Perdigó's risk management work, engineering documentation and expert advice have supported the successful regulatory submission and approval of the Airway Shield device."

Julio M. Alonso

CEO and Chief Medical Officer, Airway Medical Innovations

“Perdigó's expertise in healthcare engineering and product development was crucial to the progress of our device. Their technical knowledge, flexibility, and total dedication were invaluable, and were essential in ensuring the successful development of the device.”

Joan Vieyra

CTO The Blue Box Biomedical Solutions

"Perdigó showed great commitment to deliver groundbreaking technology in the field of IVF, demonstrating deep engineering and medical device expertise."

Ana García Poyo

VP Op. and Chief Industrial Officer

"Perdigo is a great partner for your device development. Their expertise and capacity to adapt to your needs makes them a great choice to work with."

Laura Andrade

R&D, Innovation & New Products Associate Director, Insud Pharma

"Perdigó has very strong device development capabilities and experience for inhalation and broader drug delivery medical devices. They are an excellent development partner."

Steven Dudley

Head of Development Invox Pharma

Clear, streamlined engagement

Working with Perdigó is straightforward by design.

01 Scoping call

We discuss your current status, your needs, and objectives. There is no commitment at this stage, simply an honest view of whether we are the right fit.

02 Needs assessment meeting

Our medical device experts assess your development needs and requirements in detail, ensuring that both teams are fully aligned before any work begins. An NDA is signed around this point.

03 Proposal

You receive a clear proposal that defines the engagement scope, deliverables, timeline, and investment.

04 Kick-off and collaboration

Our team starts working on the concepts, early prototypes, and documentation. Throughout, you receive progress updates, alongside regular checkpoints where we shape direction together and agree on the key decisions.

05 Handover and next steps

You get the deliverables and a recommended path forward, which involves moving into the detailed design stage.

Perdigó's medical device regulatory team

Medical devices are all we do

Behind these numbers is a decade of specialised medical device development, concept to submission.

Application areas

Disciplines

+100

Projects

FAQs

1. What is the difference between concept design and detailed design?

Concept design defines the device at a high level through user requirements, design concepts, system architecture, and proof-of-concept prototypes. Detailed design develops that architecture into a complete, manufacturable design, specifying every mechanical, electronic, and software detail. Concept design proves the idea can work; detailed design makes it manufacturable and scalable.

2. What deliverables does the concept design stage produce?

Concept design typically produces structured user requirements and design inputs, a concept evaluation and down-selection report, a preliminary system architecture, one or more proof-of-concept prototypes, a high-level risk assessment, and the first entries in the design history file. These become the inputs to detailed design.

3. What are design inputs in medical device development?

Design inputs are the defined requirements a device must meet, covering intended use, user needs, clinical and performance requirements, and applicable standards. They are established early and become the criteria that later design outputs are verified against, which is why concept design works to make them clear and measurable.

4. What is a proof-of-concept prototype?

A proof-of-concept prototype is an early model built to demonstrate that a device's core principle works. It answers specific technical questions, such as whether a mechanism functions or a measurement is achievable, rather than representing the final design, appearance, or manufacturing method.