Our Services

Looking for something specific?

We provide a mix of services to support you in developing your medical device or combination product. Our specialty is in integrating the technical, regulatory, and commercial aspects of your product, helping you develop a strategy that gets your innovation to patients, and to implement that strategy hands on

Our commonly used services are listed below, but please get in touch for something specific

Get in touch
An image of a needle being threaded with an orange thread. Representing how Full Spectrum Innovation support you strategically to thread the needle of your Medical Device and Combination Product innovation journey

Strategic or hands-on development support

With you every step of the way as a trusted and effective part of your team, leading you through the complex healthcare journey.

Our specialty is helping you shape and implement your holistic technical-regulatory-commercial strategy.

We also help support specific elements of the journey, including:

  • Target Product Profile, product-market understanding and fit

  • Regulatory strategy and implementation (EU and US)

  • Quality management system implementation

  • Clinical evaluation plan and report

  • Technical development, experimental planning and execution, verification and validation

Find out more
A rendered image of a large protein in orange, yellow, and red representing advanced therapies such as biologics and cell and gene therapies

Advanced Therapy Combination Products

Advanced therapies - including biologics, gene therapies, and cell therapies - need a new combination product approach.

All too often these powerful but sensitive treatments fail to live up to their potential, due to negative interactions such as sorption, aggregation, or denaturation.

These interactions lead to reduced efficacy and a worsened safety profile, meaning unexpected clinical failures, reduced reimbursable value, and limited patient benefits.

We help organisations in to address these issues, optimising the holistic performance of the drug and device components of a combination product, allowing them to operate as a unified therapeutic system, and delivering their full potential for developers, patients, and society.

Find out more
A coloured pencil drawing of two hands reaching out to each other - representing how Full Spectrum Innovation support SMEs and Pharma in partnering for innovation in Medical Devices and Combination Products

SMEs and corporates must work together to bridge from innovative idea to clinically validated and adopted product

We support SMEs and corporates to better understand each other, and effectively partner across organisational boundaries.

This creates better defined, targeted, qualified, and implemented projects for co-development, licensing, or acquisition.

Key areas we help with include:

  • Cross boundary understanding and translation

  • Alignment of goals and definition of success for best outcomes

  • Cross boundary team selection and optimisation - hard + soft skill focus

  • Technical, regulatory, and operational due diligence

  • Management of co-creative working across teams

Partnering for Healthcare Innovation

Find out more
A black and white photo of a group of people roller blading - representing dynamic resourcing from FSI to support those who need specific regulatory, technical or commercial skills in their medical device or combination product development journey

Need a specialist skill or experience, to support a project for a short period or over the long term?

We can supply capabilities that seamlessly integrate into your team, as and when you need them, and without the need for committing to a full-time employee

We can provide skill sets covering:

  • Project planning, management, and leadership

  • Commercial strategy, unmet need shaping, and Target Product Profile (TPP)

  • Regulatory strategy and implementation (MDR, IVDR, 510(k), De Novo)

  • Quality Management (ISO-13485, 21 CFR 820)

  • Risk Management (ISO-14971)

  • Clinical evaluation plan and report

  • Software as a Medical Device (IEC-62304)

  • Compliance standards (IEC-60601, IEC-62366, etc.)

  • Experimental planning and execution

Dynamic Resourcing

Find out more

    • Innovation Benchmarking and Process Mapping

    • Optimising Innovation Processes and Culture

    • Innovation Adoption Strategies

    • Innovation Leadership

    • Partnering and Consortia (membrane)

    • Organisational Structures and Change Management

    • Knowledge Management for Innovation

    • Innovation-Led Regional Development

    • Technology Feasibility, Filtering, and Staircases

    • Market and Customer Analysis

    • ‘Fuzzy’ Requirements and Product Ideation

    • Target Product Profiles (TPP)

    • Technical Product Definition

    • Technology Convergence

    • Innovation Project Management

    • IP, FTO, and Patents

    • Market Entry, Adoption and Reimbursement

    • Creativity Benchmarking

    • Creativity Needs Assessment

    • Co-Creative Team Capability

    • Team Functional Roles

    • Team Building

    • Creative Team Facilitation and Leadership

    • Creativity Processes and Training

    • Developing a Creative Culture and Environment

    • Quality Management: ISO-13485, 21 CFR 820

    • Design Control

    • Risk Management: ISO-14971

    • Regulatory approvals: EU (MDR, IVDR), US (De Novo, 510(k))

    • Regulatory Authority Interactions: EU, US

    • Software as a Medical Device: IEC-62304

    • Medical Electrical Equipment: IEC-60601

    • Usability and Human Factors Engineering: IEC-62366, ANSI HE-75

    • Biocompatibility: ISO-10993

    • Needle-based Injection Systems: ISO-11608

    • Clinical Trials: ISO-14155

    • Etc.

    • Business Development

    • Client/Investor Relationship Management

    • Investor Packs and Acquisition

    • Grant Engagement

    • Product Pitching

    • Demonstrations and Installations

    • Funding Strategies

    • Key Opinion Leaders

    • Papers and Publications

    • Design Requirements and History Files

    • Prototyping and Technical Skills (Electrical, Mechanical, Software, Optical)

    • Experimental Planning (DoE), Delivery and Analysis

    • Clinical Trials

    • Human factors, Ergonomic and Industrial Design

    • Design for Manufacture and Cost of Goods

    • Certification, Verification and Validation

Expanded Capabilities List