Your innovation, helping Patients
When developing Medical Devices or Combination Products it can be hard to know which path to follow
Are you asking yourself:
How do I shape my product to be adoptable and competitive in the complex healthcare market?
How do I attract and work with external, internal, or investment partners?
How should I approach Quality Management and Regulatory approval?
How do I tackle uncertainty in the journey, understand my options and implement the best path forward?
You’re not alone, we’re here to help
Who we are
We’re a small specialist team of experts in healthcare innovation working across disciplinary boundaries - seamlessly covering scientific/technical, regulatory, and commercial elements from end to end, and from strategy to implementation
What we do
As seasoned healthcare innovators, we help you uncover unknown unknowns, map your strategic direction, and navigate a route that gets your innovative medical device or combination product successfully to patients
How we do it
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Working as a trusted and effective part of your team to guide you through the complex healthcare innovation journey, with you every step of the way from identifying your optimal Commercial-Technical-Regulatory strategy to implementing the processes, tools and activities that de-risk and build value into your product
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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.
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SMEs and corporates increasingly need each other to cover the full journey from innovative idea to clinically validated, approved, and distributed product. We support SMEs and corporates to better understand each other’s ‘worlds’, creating better defined, targeted, and qualified co-development projects. We help both organisations effectively partner across organisational boundaries leading to more projects successfully achieving their goals
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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
What makes us different
We have the combination of broad and deep experience needed to take your medical device or combination product from idea to patient hands. We have a long history working with everything from 100,000+ employee corporate pharma to single person SMEs, connecting strategic visions to concrete delivery, from ideation to regulatory approval across diagnostics, delivery, digital health, and more.
Unlike larger consultancies we can give you the personal support of the people who’ve been there, walked in your shoes, and want to help you do it too. Our values are to prioritise value over profit, always giving you an honest assessment of where you are and what we think you need to succeed. This includes both responding to your explicit needs and proactively helping you to address the challenges you can’t yet see.
Do you want to succeed more often in you Medical Device or Combination Product development, approval, and adoption?
Do you seeking help finding and working with innovation partners?
Are already on your journey journey, but feel uncertain or lost?
We’re here to listen to your challenges, and start providing support
Sign up for a free one hour consultation: