European IP Helpdesk

12

Bulletin No. 2 Go-to-Market

trials have said that using DBLG1 means they are not afraid to walk alone, that they have peace of mind because they are no longer being woken in the middle of the night with hypoglycaemia symptoms when blood sugar levels get too low. What DBLG1 achieves is not perfect, but it is life-changing.

What factors have contributed most to your success?

Listening has contributed greatly to our success. We have really tried to understand the different physiologies of people with type 1. Each of our developers sat with patients to understand their need and 20 per cent of the people working for us are living with type 1 either directly or through family members. Our team is very strong, too. We have the luxury of being able to offer work on a very interesting topic and, as a result, have been able to attract people who are really good not just in R&D, but across all domains. And we’ve given the team the freedom to really contribute.

How would you like to see support for inventors in Europe evolve?

IP is a broken system in many ways and this is frustrating, but you have to live with it and learn how to work with it. Large companies have the ability to put out many patents that can be deliberately vague. These patents become a barrier to innovation as opposed to a form of protection. The system needs to monitor quality and precision.

There are challenges in the nature of reimbursement systems, too: slow processes; a lack of uniformity across Europe. You can’t change these systems, but they do impact speed to market, so you have to understand and work with them.

What insights has Diabeloop given you about turning an idea into a product that might help other inventors?

Get protection, find a good lawyer and make sure you know what needs to be done regarding the remit of protection. You can very easily run up a huge bill trying to enable freedom to operate. Remember too that you can’t change or avoid the system. It is necessary to

spend the time it requires because you need to do it. Don’t be discouraged, IP is a strategy that needs to be played.

The views expressed in this feature are those of the interviewee and may not reflect the views of 4iP Council or its members. The purpose of this feature area is to reflect thinking on the topic of intellectual property and enable open discussion.www.4ipcouncil.com

Contact

Diabeloop SA

HQ 155-157 cours Berriat

38028 Grenoble

www.diabeloop.com

About 4iP Council

4iP Council is a European research council dedicated to developing high quality academic insight and empirical evidence on topics related to intellectual property and innovation.

www.4ipcouncil.com

An Open Innovation Test Bed for Medical Devices:

the Case of the EU Research Project TBMED

Written by Iraida Loinaz, Fundación CIDETEC

The EU research project TBMED has set out to tackle two of the most pressing issues in the EU healthcare system: the large variation in patient outcomes and the continuous increase in costs which result in an urgent need to create and incorporate value in healthcare. However, new EU regulations regarding medical devices impose great challenges especially on smaller European companies in global competition.

The Horizon 2020-funded project will support them by reducing the time-to-market of high-risk medical devices (MD). An Open Innovation test bed (OITB) for the development of devices with a high-risk classification (IIb and III) will provide expert support from an early development stage to the optimised transformation of prototypes into valuable and innovative products.

TBMED targets the adaptation of the Quality-by-Design (QbD) approach currently used in the pharma industry. The QbD concept enhances product and process understanding together with process control, based on robust scientific knowledge and quality risk management. The use of statistically designed experiments for process validation will reduce the costs and variability of the manufacturing process. Counselling and advisory sessions with experts on clinical investigations and an advisory health technology assessment team will make sure that important evidence on the safety and efficacy of the new devices and adequate comparators is generated during preclinical development.