“It's totally safe” is a poor use of the selling power of product safety in the medical devices field. Saba Hinrichs and James Ward explain how product safety information can empower the sales process.
In this age of rapid change, with converging technologies and a global marketplace, it is imperative that the medical device industry’s approach to procurement does not slip out of date. Given the increasing impact of product ‘value’ on purchasing decisions, sellers need to convince their buyers of reduced risk to the patient, increased safety, improved quality of life, and the long-term cost savings that some new innovations can bring.
But what role does procurement have to play in improving patient safety in an environment where the ‘right price’ is king? And how can medical device sales professionals make use of product safety data, and thereby make a positive contribution towards long-term benefits and safety to patients?
Purchasing for patient safety
Patient safety is steadily being raised further up the agenda for the Department of Health and the NHS Purchasing and Supply Agency (PASA), exemplified by their adoption of the term ‘Purchasing for Safety‘. Research into patient safety has been growing since the early 1990s, and the findings by the National Patient Safety Agency (NPSA) have shown the importance of good design practice in the improvement of safety.
Traditionally, patient safety has been measured through a count of medical device errors. The causes of these errors fall into several categories, such as design, environment of use, education/training, communication and management of equipment within the hospital. It has been shown that in episodes where harm has been incurred, a significant percentage of the errors can be attributed to the design of the device. Also, a significant proportion of errors can be attributed to medical professionals not using the right device in the right environment in the right way.
By identifying devices for their hospitals, purchasers can play a significant role in improving patient safety. Equally, those selling the devices can point out their safety features and so encourage purchasing for patient safety. The diagram on the right illustrates how the patient safety features of medical devices can be identified by capturing the requirements of users and articulating these as guidelines to promote purchasing for patient safety. As they are central to the introduction of devices into the healthcare setting, purchasers are also in a position to communicate user requirements back to designers – thus encouraging design for patient safety. The potential outcome is a ‘virtuous circle’, with both patient benefit and safety being improved.
From price to value
Recent changes in NHS procurement, as initiated by the HITF report, have created the opportunity to offer more integration of clinicians, purchasers and suppliers into a well-informed network. Organisations such as the Centre for Evidence-based Purchasing (CEP), Collaborative Procurement Hubs (CPH), Healthcare Technology Co-operatives (HTC), the National Innovation Centre (NIC) and other arm’s length bodies could help to address ‘value’ criteria in purchasing medical devices, and their initiatives will be worth watching. The DHL/Novation purchasing and distribution deal may also have major implications for procurement.
As the ABHI’s Director General John Wilkinson commented in On Target (June 2006), “there is, through the HITF process, a growing opportunity to get buyers, managers and clinicians constructively engaged in the procurement of products that offer best value rather than lowest price; and the message about redesigning clinical pathways and processes around opportunities afforded by new technologies will get through more broadly.” However, problems that are still limiting this approach include:
•A lack of common understanding across the NHS in defining patient safety.
•The remoteness of the user from the designer and purchaser.
•Errors caused by the design of the product or lack of knowledge of the system in which the product operates.
•Lack of influence of national
•Limited training of procurement staff.
•Lack of need-driven procurement.
•Barriers caused by current purchasing drivers, such as decisions driven by immediate cost.
•The complexity of the current procurement system (though the changes put in place since the HITF report show promise).
Questions to be answered
Given this changing landscape, some of the key questions that need to be addressed by device suppliers are:
•How can we identify and then articulate what features of a device bring improved patient safety?
•How can we convince purchasers to invest in the long-term benefits that a product can bring, rather than basing purchasing decisions solely on immediate price?
Questions about characterising device safety have been raised in other safety-critical sectors, such as the defence, aviation and railway industries, but many lessons learned from these have yet to reach the medical device industry. Medical device features that characterise safety could include: proof of the product in use, product lifespan (actual and ‘situationdependent’), cost of use (both short- and longterm), complexity, consumables required, connectivity to existing equipment in the hospital.
Sales professionals should make use of demonstration and documentation, have background knowledge of the product ‘in use’, and be aware of the long-term service and maintenance that are available with the product.
However, assessing both the financial and the health value of a product can be tricky. Depending on who is asking the question, ‘value’ can mean different things to different stakeholders.
Involving the supply chain
Such questions form part of the challenge of current research in the Engineering Design Centre. Through dialogue with key stakeholders such as PASA, NPSA and CEP and studies with purchasing departments at NHS trusts, some of these complex issues will be addressed. The key objectives are to:
•Engage all stakeholders to raise awareness and build the knowledge base around patient safety.
•Develop an understanding of the current procurement processes for medical devices.
•Identify the features of a medical device that characterise patient safety.
•Develop a model or framework of purchaser requirements.
•Raise awareness of this model through the supply chain, including sellers.
This project stems from the work of the Design for Patient Safety Initiative, whose recommendations included a systems-based, user-led approach to improving services across the NHS. For this, both the design of the products or services and the healthcare system in which these products are used need to be orientated towards maximising patient safety.
Applying this approach to medical devices in particular requires us to look at the role of procurement, and then to address the whole lifespan of the device from its design to its use in clinical practice.
This project is still in its early stages, and we would welcome your input and support in further discussion. If you would like to be involved in the study and help identify what features of the devices you are selling characterise its safety and benefit, please get in touch.
Saba Hinrichs is a research student at the Engineering Design Centre (EDC) at the University of Cambridge, supervised by Prof. John Clarkson. She can be contacted at email@example.com
. Dr James Ward is a Senior Research Associate at the EDC.