Joel Cotten

Integrated Development of a Disposable Autoinjector to Serve Patient Suffering from Chronic Disease

Joel Cotten

BD Medical
11, avenue Aristide Bergés, FR- 33801 Le Pont De Claix
Tel: +33. 476 68 36 64 Fax: +33. 476 68 3505

Biography

Joël Cotten holds an MBA from EDHEC (Lille, France) with a specialization in Industrial Marketing.
He is a graduate engineer in agro-industrial processes from ENITIAA (Nantes, France) with specialization in cold chain and Lyophilisation.

Joël joined BD Medical - Pharmaceutical Systems (BDM – PS) a unit of BD in 1992 after having performed in product management successively at Heraeus (Germany) and Perstorp (Sweden).

Joël occupied various positions in Sales and Marketing at BD Headquarter of Le Pont de Claix (France). He is European Product Manager within the self injection platform.

He has acquired a good understanding of the prefillable containers and self injection markets from the end users point of view but also from the manufacturer perspective. Joël has participated during the last decade to the launch of several combinations of drugs and devices in cooperation with pharmaceutical leaders.
System approach in development as well as quality by design is familiar to him as Joel is an active member of development core-team beside his role of commercial facing activities.

Company Profile

BD is a medical device company based in New Jersey, registered on the NYSE (BDX) and focusing on 3 segments: Medical, Biosciences and Diagnostic.

BDM – Pharmaceutical Systems is a worldwide leader of high-quality, clinically proven prefillable parenteral delivery systems. The main products of BDM - PS are prefillable BD Hypak SCFTM syringes as well as BD ReadyfillTM and self injecting systems like BD Pens, Pen needles and autoinjectors.

Abstract

The analysis of market needs and unmet needs is a key phase in the development of a novel injection device. In our case of a disposable auto-injector we carefully reviewed the new therapies for chronicle diseases, the pharmaceutical industry requirements, requests of the actual and future patients, human factors, the primary containers trends towards prefilled containers like syringes as well as the regional registration trends.
Several sources of information have been used for such purposes like databases, market surveys, advices of experts, ergonomic tests…
A robust procedure of development exists and a multifunctional coreteam is gradually put in place to conduct the different stages of development.
Concept is checked on the market place through market surveys in coordination with a preselected primary container.
This is permitting the definition of the novel device and the creation of prototypes (design input specifications are now in place)
Prototypes are tested and one is selected for the development stage.
The new disposable auto-injector is checked carefully on the market via quantitative tests (technical and marketing) and after some iteration the final design is selected.
The final design is validated through numerous technical tests in accordance with the ISO standards or other standards when necessary. Obviously the selected design is tested with the final primary container to ensure a perfect integration of the 2 products.
The validated version is ready to be tested in a clinical trial. In this particular CT we tested the disposable auto-injector with a syringe prefilled with a saline solution.
We present the performances of the novel disposable auto-injector vs the same prefilled syringe used by a nurse.
The final step of development is the registration before the launch phase and we present our recommended proposal for Europe.
A good development is anticipating the ramp up in production and this presentation is giving an overview of our plan for such a production.
We conclude by giving some information on the current status of the development of the BD Physioject™, disposable auto-injector.