Medical device feasibility & innovation

Early medical device feasibility saves you time, effort, and money

Without early feasibility

Critical questions remain unanswered for too long.

Months of development and significant funding are invested before key issues are identified.

Regulatory pathways turn out to be longer than expected.

Devices fail to fit the intended clinical workflow.

Competitors may already occupy the target market.

Changing direction late in the process becomes costly.

With Perdigó

Your concept is assessed early, while changes are still inexpensive.

Critical assumptions are tested before major resources are committed.

You gain a clear understanding of what your device must do.

You identify who the device serves and how it will reach the market.

Risk is assessed from the beginning.

Greater clarity helps accelerate the stages that follow.

A complete view of your concept's viability

A rigorous feasibility assessment looks at your device from every angle that matters, spanning the technical, clinical, regulatory, commercial, and legal. We examine these together because in practice each one shapes the others. The result is a single, coherent view of whether your concept is ready to advance and what it will take to get there. Our work covers six connected areas.

Feasibility study

Technical viability, regulatory pathway, and product-market fit are assessed before significant resources are committed, so that early investment rests on evidence rather than assumption.

Intended purpose definition

Here, the device's precise intended purpose takes shape: what it must do, and for whom, expressed in language that satisfies your team, your stakeholders, and regulators alike.

User profile and needs analysis

We identify your users and stakeholders, their clinical environment, and their day-to-day workflows, thereby ensuring the device fits real-world practice rather than an idealised version of it.

Regulatory context mapping

Classification, the relevant standards, and the regulatory route are established early, ensuring that costly surprises never emerge further downstream.

Risk assessment

From the outset, foreseeable hazards and use-related risks are identified, which shapes a safer and more approvable design direction.

IP landscape review

A review of the surrounding patent and intellectual property landscape reveals where you have freedom to operate and where existing claims may require you to design around them.

Establish clear foundation for what comes next

Feasibility work is only valuable if it leaves you with something you can act on. Our feasibility support gives you exactly what you need for informed decision-making:

Product vision feasibility assessment

Technical, regulatory, and commercial viability evaluated in the round.

Product definition document

Intended purpose, user profile, and use environment formally documented.

Preliminary regulatory strategy

Classification rationale together with clear pathway recommendations.

Initial risk considerations

Early identification of hazards and potential use-related risks.

Project plan

A realistic assessment of timeline, effort, and investment for the stages ahead.

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 clinical need, objectives, and constraints. 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.

03 Proposal

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

04 Kick-off and collaboration

Our team runs user research, regulatory analysis, technical feasibility studies, and risk assessments. Throughout, you receive weekly progress updates, alongside regular checkpoints where we shape direction together and agree on the key decisions.

05 Handover and next steps

You get full documentation and a recommended path forward, which may include moving into the concept 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 early feasibility study or assessment in medical device development?

A feasibility study is a structured evaluation carried out before serious development begins. It examines whether a device concept is technically achievable, clinically useful, commercially viable, and capable of meeting regulatory requirements. In short, it confirms that you are building the right product before you invest in building it well.

2. What does a medical device feasibility study involve?

A thorough study looks at four connected dimensions. Technical feasibility asks whether the device can be built and made to perform reliably. Financial feasibility weighs the cost of development against the expected return. Market feasibility, often described as product-market fit, tests whether the device meets a genuine clinical need. Legal and regulatory feasibility maps the approval route and the standards that apply. Assessed together, these four give a complete picture of both the risk and the opportunity.

3. What comes after a feasibility study in medical device development?

Once feasibility is confirmed, the natural next stage is concept design, where the validated idea takes shape as a defined, testable design. Because the groundwork is already in place, this stage tends to move faster and with far fewer costly reversals.

4. How long does the feasibility and innovation phase typically take at Perdigó?

Most engagements run between 6 and 12 weeks, depending on complexity. We provide a realistic timeline during the needs assessment meeting.

Expert medical device feasibility & innovation