Navigating the device development pathway – how to scale up while overcoming regulatory and manufacturing challenges
When dealing with today’s specialized drug products, whether it’s a high viscosity mAb or a different approach to a known molecule, finding a way to dose patients effectively and reliably depends on the device.
There are risks associated with using a device for a combination product, whether the device is introduced in the early clinical stages, late clinical trials or at launch. In many cases the device starts off as a concept, moving this concept to a full scale commercially ready device requires a methodical approach of refining input specifications, designing the right tools & processes to withstand the demands of high volume manufacturing and meeting regulatory scrutiny.
Selecting the right device and building a manageable supply chain with an innovative drug product can create a patient centric solution. This webinar will discuss the process and risks of industrialising a unique device concept bringing together the design aspect, manufacturing, suitability and regulatory to bring your combination product to market.
Presented by
Miles Kottman,
Alliance Manager
Miles Kottman, Alliance Manager at Bespak by Recipharm, has more than 25 years’ experience in the development and industrialisation of medical devices. His career began in in vitro diagnostics within various scientific and new-product introduction roles. After joining Bespak, he predominantly worked within programme management, leading multiple inhalation device programmes from early stage product development through to high volume production. Then, as Head of Programme Management, he was responsible for organisations programme portfolio and its new-product introduction process. Now operating in a commercial role, he manages commercial partnerships for existing and new products and opportunities as well as leading the Customer Service function.
Neil Cropper,
Head of Programme Management
Neil Cropper – Head of Programme Management at Bespak by Recipharm. Neil has over 20 years’ NPD experience and an extensive portfolio of taking new products to market and has gained Chartered status with the Institute of Mechanical Engineers. Starting out at Unilever UK as a graduate, he has worked as an expat in The Netherlands and Argentina, gaining experience of managing global FMCG projects in a fast-paced conception to market environment. Neil then worked for Philips Avent, initially heading up the Technology and Function Creation team, responsible for early stage development of new products for the infant feeding platform. This was followed by a Senior Programme Management role, managing the industrialisation of Philips Avent’s first new global breast pump launch in 15 years. Prior to joining Bespak two years ago, Neil owned his own Project Management consultancy for six years which saw him work with Linde Healthcare, Consort Medical and Philips Respironics on the late stage development, industrialisation and launch of new medical devices.
