A modified biodesign approach (2015)

Keywords: Stanford Biodesign Innovation, nephrology, unmet clinical need, medical device innovation

Client: © InnAccel Pvt. Ltd.

Funded by: InnAccel Pvt. Ltd.

Role: Internship

In collaboration with: St. John's Medical College

In India, the incidences and risks of Chronic Kidney Disease (CKD) have been rising alarmingly due to the rising prevalence of Hypertension and Diabetes patients. The treatment for CKD is unaffordable for most of the patients suffering from this condition. The lack of access to quality care in rural and suburban India further impacts the plight of CKD patients. These inconsistencies and gaps in effective treatment are equally present in most Nephrology related disorders.

To address these issues, this study applied a modified version of the Stanford biodesign innovation process, to identify unmet clinical needs in the field of nephrology from the perspective of developing new innovative medical devices to fit the evolving MedTech ecosystem in India. A multidisciplinary team, involving a doctor, an engineer and a designer, participated in a 1 month clinical immersion held at a tertiary referral hospital in South India. The clinical immersion involved shadowing a senior nephrologist and resident clinicians through out-patient clinic duties, daily rounds through the wards and observation of invasive and non-invasive procedures.

54 unmet needs with significant negative outcomes were identified through the immersion. 4 rounds of pre-caliberated filters were applied on these needs to identify the ten most compelling clinically validated needs for the phase of invention. The study describes the research methodology and outcomes from the process.