In today's challenging medical device market, the introduction of a new product is becoming increasingly difficult. Clinicians are looking for effective products that meet their needs and which are comprehensively supported by the company supplying them. Procurement teams in both the NHS and Private hospital groups have to balance the wishes of the clinicians with their responsibility to rationalise and standardise the range of products purchased.
Medical device manufacturers invest heavily in bringing new and innovative products to the market and in offering training and product support to users. In order for the needs of both the clinicians and the manufacturer to be met, it is vital that the process of launching a new product involves all stakeholders.
This article will examine the role of the customer in a typical medical device development process and will feature the development and recent launch of the Summit HiVac™ 7 bone cement mixing system as a case study to illustrate this discussion.
Understanding the needs of the marketplace is a key starting point for the development of a new product and input from relevant stakeholders should be sought at this early stage. In the case of the HiVac™ 7 bone cement mixing device, consultations with Theatre Staff, Surgeons and Procurement personnel were critical in the formation of the Product Design Brief. With this product, initial focus groups were held with Theatre Nurses to gain feedback on their experiences of mixing bone cement and clinical practice. The focus groups consisted of scrub staff, some of whom currently used Summit mixing devices and some who used competitor systems. The discussions were centred on current techniques, the strengths and weaknesses of the mixing devices currently used and trends in surgical technique.
Focus groups can be invaluable in setting the requirements for a new product design, highlighting areas of concern to the users rather than the manufacturers. For example, with the HiVac™ 7 focus groups some significant limitations were highlighted with many of the bone cement mixing devices currently being used. In particular, reliability issues with devices where a mixing rod has to be snapped after mixing, the potential for unmixed powder to be generated in devices that are opaque and the physical effort required to use some devices, were amongst the identified problems. Simple to use designs were also favoured by the group as this has a significant influence on ease of use and the training requirement for a new product.
At this early stage of the development process surgeons were also interviewed with regard to their needs from a bone cement mixing & delivery device. Although theatre staff do the mixing, surgeons identified key requirements which were also added to the design brief. In particular, surgeons highlighted the need for good mix quality and a requirement for good feel and pressure generation from the cement delivery gun.
In many of today's medical device markets Procurement personnel are having an increasing role in deciding which medical devices are used by clinicians. With the HiVac™ 7 project, Procurement professionals were consulted and their needs added to the Product Design Brief. Cost effectiveness was highlighted as the key issue to this particular group. Discussions highlighted that the product price, the surgical benefits of the product, being able to buy a range of mixing devices from one supplier and training / product support were important elements in the cost effectiveness calculation.
Once all the stakeholders have been consulted, market share and projected return on investment calculated, the decision can then be made on how to progress with the Product Design Brief, based on the market research results.
The design and development of a new product is a dynamic process balancing innovative ideas and market feedback with practical issues such as manufacturing the product robustly and to a consistently high quality. The next phase of this process usually involves the creation of prototype product designs. Development engineers will use the Product Design Brief to guide the development of prototype devices. With the HiVac™ 7 product the intent was not only to produce a device that was as good as the other products in the market place but also to overcome the weaknesses that were apparent in some of these devices, as highlighted in the market research.
Once prototype designs are created they are converted into product models which should then be shown to clinicians. In the case of HiVac™ 7 a number of different design ideas were shown to nurses, surgeons and Procurement Personnel to guide the development programme. During this stage some ideas were rejected but others were highlighted as significant improvements over products currently being used.
For example, the HiVac™ 7 product is made from a transparent material. This allows clinicians to view the mix quality during mixing but is also strong enough to reliably resist the high levels of force that it would be subjected to during cement delivery. When shown to clinicians, this feature was viewed as being beneficial as clarity allows the user to maintain control