Globalising Endoscopic R&D - Working in Partnership
Mike Drexell, Chief Technology Officer for PENTAX Medical talks about the globalised approach to product development. This year sees the introduction of three premium products across GI, ENT and Bronchoscopy and presents an important milestone in the history of PENTAX Medical, with these new product innovations benefiting from truly globalised research and development.
I joined the business five years ago and immediately began the process of globalising PENTAX Medical’s R&D process. Originally we didn’t have any facilities for R&D outside of Japan, which meant our local market expertise was not as strong as it could be. In the last five years we have established further facilities in the US (Montvale and Boston) and Germany to enable us to work closely with local markets throughout our R&D processes. This globalisation project has resulted in four R&D sites across three continents generating local market data and working with regional KOL groups. I believe this global approach to endoscopic R&D is a market first, PENTAX Medical is the only manufacturer to work on this global/regional level.
We have an ethos at PENTAX Medical which involves bringing together the elements required to deeply understand exactly what the unmet needs are in the market. The first step is to identify the requirement, by looking at data sets and talking to our global network of clinicians. It is important to consider the market requirement in this process alongside the practical capabilities of the physicians.
Through our consultation with our KOL network, we have now recognised a suitable unmet need, but what does the solution require? Sometimes the consultants are specific in their requirements and sometimes the consultant can identify the need but we need to consider the technology best employed to meet that need, it is a two way process. We are now defining the proposition in-line with all of the requirements of the application.
Once we have identified an unmet need where we feel we can engineer an effective solution, and decided on possible solutions, we then have to consider the product definition, which technologies are best suited to this application. The suitable technologies would be incorporated into prototypes which would then be bench tested against a range of tests designed to evaluate the product’s performance against a range of parameters. Our KOL network plays an important role here, as further in-the-field testing is conducted through multi centre studies.
By analysing all of the data from the rigorous testing procedure and looking at the data and feedback from our consultants we are now able to down-select from our prototypes. Multiple units of the chosen prototype are produced featuring our further defined technology and distributed to our KOL network to see if we now satisfy the unmet need.
Our engineers and clinical specialists cover thousands of miles visiting each of the test centres located in hospitals and clinics around the globe, working with consultants to ensure we have the optimum solution to the problem in focus. The development of our colon navigation system, the SCOPEPILOT is a great example of this. There was a definite requirement for this product, particularly in the UK and Nordic countries. We worked with our Japanese R&D team as well as our R&D partners in UK and USA, then consulted with our KOL’s regionally to ensure we were producing the best solution to their navigation requirements.
All of the previous data gathering, consultations, bench and field testing make up the research stage. As we start development we liaise heavily with all the departments within our organisation, clinical specialists, sourcing and quality management. We work especially closely with the quality management and sourcing teams to ensure high standards of quality engineering and components.
The full specification is now complete, and we can produce a prototype that is so close to a final production model that hopefully consultants cannot notice much of a difference. These final prototypes are then put into the hands of our KOL networks for final evaluation. As part of our continuous development we are further enhancing our KOL program with the introduction of the Black Box Innovations project which looks to build on our existing relationships with KOL’s allowing us to work even more closely and enhance our working relationships.
"One of the key products for this year brings together two technologies, digital and optical enhancement, i-scan and i-scan OE".
This year will see the fruits of our labour and the benefit of this global approach with the introduction of a number of key products across three areas of specialism. One of the key products for this year brings together two technologies, digital and optical enhancement, i-scan and i-scan OE. Our KOL’s were clear on the need to better identify both vascular and mucosal patterns with each technology having strengths in the two different applications. This new product, the OPTIVISTA is due for launch in May and we are excited to see how the market receives this world first.
This article was published in Gut magazine June 2016, Volume 65, Issue 6.
About PENTAX Medical
PENTAX Medical is a division of Hoya Group. Its mission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on QUALITY, CLINICALLY RELEVANT INNOVATION, and SIMPLICITY.
Through leading edge R&D and manufacturing, PENTAX Medical provides endoscopic imaging devices and solutions to the global medical community. Headquartered in Japan, PENTAX Medical has a worldwide focus and presence with R&D, regional sales, service, and in-country facilities around the globe.
PENTAX Medical employees represent the diverse countries where we do business, allowing us to provide innovative solutions tailored to meet local needs.
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