We have an in-house multidisciplinary team of human factors and market research specialists, which means that, unlike most other agencies, we provide research services that cover the entire product development cycle. We have a unique hybrid of Human Factors and Market Research expertise. This hybrid ensures that in Human Factors studies we always have a commercially sensitive mindset, and when conducting Market Research studies we ensure product safety and usability are at the forefront of our minds.

 

1.

EXPLORATORY RESEARCH

 

We believe that, in order for truly great medical device designs to emerge, patients and healthcare professionals lived experiences, needs and ill-met needs must first be fully understood. This immersive, exploratory phase of research, when we first begin to explore and understand patients and healthcare professionals lived experiences and needs, put medical device teams on the right path; to design much needed, user-friendly and impactful medical devices.

 

Ideally, this phase of research is conducted before a design concept for a block model has even been developed!  This User-Centric approach ensures that user’s needs and preferences drive product design, from the outset. 

2.

FORMATIVE TESTING

Here at Harvey Medical we pride ourselves on conducting robust formative studies, that ensure our partners will know which way the design should evolve next. We think it is important companies conduct smaller studies more frequently throughout the design process as opposed to one large study. Our lean cost model makes this possible even for the smallest start-ups.

 

Our formative studies are typically small in sample size but extremely in depth. As such our rigorous recruitment process is pivotal to ensuring a solid conclusion. We work in accordance with IEC 62366 (Part 1 and Part 2) and the FDA Guidelines. In addition to standard formative tests we perform a whole host of anthropometric testing too, and have lots of test equipment on site.

3.

HEURISTIC REVIEW

This is a much simpler process than the name suggests, and an extremely valuable one! It is recommended by by the FDA and IEC 62366. We conduct these reviews in house, where two members of our specialist team review your design, or prototype, alongside commonly known design principles and using our professional judgement. 

 

After assessing the designs, each usability specialist estimates the degrees of the design shortcoming and describes in general terms a potential solution. Then our usability specialists compare their findings, develop consensus findings, and document this in a report.

4.

SUMMATIVE/VALIDATION TESTING

We conduct summative/validation testing all over the world, and pride ourselves on the rigour we apply to this process. We have conducted a wide variety of summative testing from injection pens through to surgical robots. We ensure that the right participants are recruited and are fully informed throughout the process. Above all we ensure our studies are conducted ethically.

 

During a summative test we ensure that the design of the medical device is verified and validated alongside the training, labelling and other documentation. 

5.

PRODUCT LAUNCH

Through in-depth market research, our team will equip you with insight and direction to maximise uptake of your product, all over the world.

Whether your need is to understand the type of marketing collateral that will resonate most with your target audiences (i.e. format, tone, content and mediums), or establish the best price point for your product, our team will ensure you are armed with actionable insights.

In addition we can test sales force materials, to ensure they are fit for purpose and will be used appropriately.

6.

POST MARKET

The need to maintain a close eye on the medical device landscape has never been more important. Which devices are currently being used in your therapy space, and how are they being utilised? What ill-met or unmet needs exist? What lifestyle, emotional and health economic impact do current devices have on the end user?

 

Real-world insights such as these will ensure your organisation design devices that are necessary, user-friendly and impactful, and that communication materials present enticing and appealing product benefits. 

 

We can also include Health Economic questions into our studies which can show improvements in Quality of Life, and health outcomes, due to the implementation of your product.

 
 
 
 
 

© 2020 by Louisa Harvey.

Harvey Medical Consulting Limited