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PMCF for Infusion Pump

The Challenge:

➤  Our client’s volumetric infusion pump is operated day-to-day by nurses rather than the physicians who typically feature in PMCF programmes — and each pump is used across hundreds of patients and multiple clinical settings, from ICU to home care. Capturing meaningful safety and performance data meant reaching the true end users and reflecting genuine real-world variation in use

 

Our Solution:

➤  We recruited infusion nurses and clinical pharmacists across hospital and home-care settings, using a Level 4 case-record approach

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➤  The final dataset spanned multiple care environments and infusion therapies, giving our client robust real-world evidence of safety and performance across the device’s full intended use — and surfacing usability insights their design team fed into the next product iteration

PMCF via Conference + Online Survey

The Challenge:

➤  Our client faced a Notified Body deadline for PMCF data on their surgical stapler, but traditional online recruitment was progressing too slowly — the target users, colorectal surgeons with recent device experience, were proving unresponsive to standard survey invitations, and the study risked missing its submission window. 

 

Our Solution:

➤ We took the fieldwork to the surgeons. Attending a major European colorectal surgery congress, our team screened and recruited eligible device users face-to-face on the exhibition floor, verifying usage experience on the spot.

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➤  Surgeons then completed detailed case-record surveys via a follow-up online link. The hybrid approach compressed months of recruitment into a single conference

PMCF for Atherectomy Product

The Challenge:

➤  Our client needed to gather post-market clinical follow-up data for the 10F and 12F interactions of their atherectomy product. 

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➤  Since primary use of this product is with 6F and 8F, this posed a recruitment challenge to identify and then engage users of this niche product.

Our Solution:

➤  We leveraged our close network of Vascular Surgeons and Interventional Radiologists to provide referrals for known users of the niche 10F and 12F sizes

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➤ 100 x Level 4 surveys completed — delivering the real-world clinical data our client needed to meet their MDR requirement.

Indentifying Hidden Patterns in Complex Datasets with AI

The Challenge:

➤  Maintain methodological rigour in a study encompassing 108 qualitative interviews across 7 markets for a nebulization device

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➤  Identify patterns in the data across stakeholders (nurses/physicians), work setting (ED vs Wards) and device usage

Our Solution:

➤  We deployed AI-assisted thematic coding to develop a structured codeframe, eliminating coder drift at scale

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➤  Quantifying theme prevalence across stakeholder, setting and device usage gave statistical weight to our qualitative deep dive

Assess Market Opportunity for Covered Stent Concept

The Challenge:

➤  From a small but targetted sample of Vascular Surgeons in USA + Europe, uncover the impact that a new stent design will have on product cannibalization vs market expansion

 

Our Solution:

To get the most out of small samples we employ our key principles of:

a)  Direct respondent relationships (no outsourcing to fieldwork agencies)

b)  One moderator to oversee the entire study from brief to report

Utilising AI to Access Hard To Reach Samples

The Challenge:

➤  Locate European Urologists who placer radiation spacers for prostate cancer (mainly the role of Radiation Oncologist)

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➤  Respondent targets also had to be attending EAU conference to attend our in-depth prototype evaluation

Our Solution:

➤  AI tools helped us locate centers where Urologists are known placer of radiations spacers – the list was then cross referenced against the speakers list to create a targetted list of physicians

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➤  The rest relied on our human touch to engage physicans and secure meetings during the conference

Quantitative Survey at Global Cardiology Meeting

The Challenge:

➤  Achieve a total sample of 150 interviews with delegates who perform a minimum procedure volume of PCI

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➤  Gather feedback from physicians attending our clients satellite symposium

Our Solution:

➤  With an experienced team of conference interviewers we studied the conference programme to locate the optimal locations to find qualifying physicians

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➤  Relocated our team to the symposium exit to canvas physicians leaving

Linking our client with KOL for case observation

The Challenge:

➤  Gain access to the highest volume EVAR center in Germany to watch multiple complex EVAR cases live

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➤  Hold de-brief sessions with the Vascular Surgeon to discuss the procedural workflow pain points

Our Solution:

➤  We leveraged our long-standing and close relationships with heads of department to arrange a site visit for our client

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➤  Dealt with all regulatory and compliance matters to ensure our visit did not breach hospital protocol