What we do

Strategic Advice
Digital health provides opportunities for innovative products and business models. But most market segments are embryonic and commercial traction is hard to secure.

Much "cool technology" with positive feedback from doctors and patients fails to scale commercially.

Any business must carefully consider the evolving regulatory landscape for medical devices, information security and clinical trials in both Europe and the US. The commercial strategy must take as much account of the regulatory landscape, as of the un-med medical needs.

Whether your product is to be used by well people, patients or health-care professionals, and whether its market is for developing new treatments, empowering patients, or managing patients, defining a business strategy that integrates both the regulatory path and market access is an essential step.

We work with small and large companies, and investors to review and enhance business strategy.

Commercial and Regulatory collaborations
Many innovative med tech and digital health companies have great technology that addresses an important medical problem.

To succeed, however, this technology needs to be combined with a commercial and regulatory strategy. And the strategy needs to be agile to respond to rapidly changing technology and market conditions.

Our collaborations are not about telling you what to do, but about working with you and your team to define and implement a successful business strategy.

Navigating the evolving medical device regulatory landscape including EU Medical Device Regulation, FDA Software as a Medical Device guidance, FDA / EU cybersecurity guidance, FDA pre-cert program etc.
Understanding how to use risk management frameworks (eg: IMDRF)
Developing your team’s commercial and regulatory expertise
Helping plan customer engagement to test the market and generate opportunities

Once your commercial and regulatory strategy is in place, we can help you implement this through.

Setting up and enhancing your Quality Management System to enable efficient execution, and meeting regulatory expectations
Supporting regulatory engagement as a way of validating your strategy (including confirming if a product can be considered exempt from medical device regulations)
Designing smart studies for your clinical evaluation or clinical investigations
Effective use of data from products on the market to underpin the clinical evaluation for your next generation product(s)
Systems to ensure operational smoothness and compliance (GCP, medical device, privacy, etc)

We have experience in collaborations on technologies for:

clinical decision support,
patient engagement,
drug development
pharmacovigilance

Our collaborations with early stage companies refine their business strategy, augment their know-how and systems, accelerate route to market and strengthen the equity story.

Panoramic Wearable

Panoramic Digital Health has developed the Panoramic Wearable, a technology platform to support regulatory compliance of sensor technology in medical applications, with a focus on expectations on the EU and European Regulators on data integrity, validation and cyber security.

We are working with sensors and microcontrollers from ST Microelectronics, including use of the Machine Learning Core technology for edge computing.

As an exemplar of this platform we are developing a novel wearable actigraphy device, initially aimed at the clinical research market in industry and academia.

Above: the panoramic wearable in a watch form factor

Panoramic wearable (above) detecting scratching using the in-sensor Machine Learning Core to provide very long battery life while detecting complex tasks. Further details are available here.

This device is undergoing small scale evaluation and will be more widely available in future months.

Panoramic Digital Health's Technology will improve usability and data quality providing greater operational and regulatory readiness.

Who we work with

We work with companies of all sizes from start-ups to big corporates, in Europe, North America and Asia.

Pharmaceutical and diagnostic companies devising and implementing digital health strategies

Innovative young companies working in medical applications

Global technology companies

Pharmaceutical companies looking for strategic partners in Reg Tech

Early stage digital health companies in need of strategic advice

Investors and corporates undertaking due diligence on acquisitions and investments