DESIGN
Biomaterials and Tissue Engineering Centre of Industrial Collaboration, Leeds, UK
Capturing the need
Martin was involved in a serious car accident and suffered multiple fractures and a head injury. He was rapidly taken to a nearby intensive care unit, but it was six days before clinicians could fully understand the nature of his injuries. A computerised tomography (CT) scan requires a patient to be horizontal, but Martin had to be kept inclined to avoid a dangerous rise in intracranial pressure. “Anyone making a CT scanner that could work at an angle would make a fortune,” observed a busy clinician in passing. This assertion may be right or wrong, but there is no doubt that there a clinical need here.
This is a true story. It is also a generic one that is repeated daily in many clinical scenarios. A patient has some highly specific needs that available methods of treatment somehow do not meet. Based on years of experience, the clinician improvises and provides the best care possible with existing therapeutic techniques. At the end of the procedure, over coffee, one may hear, “Wouldn’t it be great if we had …” Then the next patient arrives and the idea disappears forever with the coffee aroma, because clinical demands generally must take priority over a desire to explain the shortcomings of a particular technology or how a particular procedure could be improved.
Now there is a new means to capture this essential information. Statements of Clinical Need (SOCN) is a tool for health-care professionals to express real needs and to communicate those needs to industry effectively and efficiently. In response, industry will have the opportunity to develop new products with a defined need, which increases the likelihood of market success.
The Problem Space
An important step in identifying clinical need is to completely uncouple the problem from the solution. There is a huge untapped, expert resource of problem appreciation within the professional health-care community. Many health-care professionals are frustrated by the lack of a method to easily present the clinical difficulties they encounter to those who could solve them.
What is needed is an effective means to transfer information on a problem into a “Problem Space” and make this information accessible to the many organisations and individuals interested in providing a solution. This would benefit patients, health-care professionals and health-care companies.
Definition of the problem should not be prejudiced by any assumptions of what an effective solution may be. There is a vast community of scientists, technologists and designers who can focus their expertise on the problem from outside conventional clinical practice. All that is necessary is to state the problem in a solution-neutral manner, which can be understood by the educated nonexpert. As part of an initiative organised by the new Health Technologies Knowledge Transfer Network (HT-KTN),1 tools are being developed to do this, these include:
• A SOCN fax-back form to be distributed to every clinic and operating room
• Clinical problem definition events organised with clinical societies often as part of an established meeting
• Online SOCN input and dissemination through www.clinicalneed.com
• Video statements of clinical need, focussing on a specialist clinical area in which an expert clinician can describe the problems he or she encounters.
HT-KTN also welcomes new ideas for better ways of working.1
The Solution Space
In health-care technologies there is a sophisticated innovation infrastructure. In the United Kingdom (UK) this infrastructure extends through a “Solution Space” that includes the medical device industry supported by Knowledge Transfer Networks, Medilinks, National Health Service (NHS) Innovation Hubs2 and the proposed Healthcare Technology Co-Operatives.3 However, this comprehensive innovation infrastructure can do nothing if the real clinical need is not properly defined and assessed.
Although SOCN must operate only in the “Problem Space,” the tool offers an opportunity to help innovators better understand the potential value of their solutions. Information can be collected and ordered with respect to potential clinical impact. Market-size information can be added to indicate the potential commercial value of the innovation. These are areas in which HT-KTN will be working in the future.
An interesting example currently operating in the “Solution Space” is at Stanford University in the United States.4 There, the local identification of clinical needs is used to guide postgraduate research projects that are linked to venture capital opportunities, which allows seamless development from clinical need to concept then to clinical product.
Intellectual property protection
A problem cannot be patented, but it can be the stimulus that leads to valuable intellectual property (IP). This is why it is essential to uncouple the problem from the solution and rigorously restrict SOCN to the “Problem Space.” In this way, the problem can be available for wide review.
The health-care business is global and it is important to understand clinical problems from a global perspective. Of course, different national markets have special characteristics and these must be recognised. It is also essential that solution development is not prejudiced by artificially constraining awareness of a problem. To engage the clinical community fully, the problem needs to be exposed to diverse technology sectors. Their active involvement will drive the clinical involvement and will be the critical factor in reaching a successful outcome. To obtain the clinical engagement and wide exposure across a diverse solution provider community, it would thus be counter productive to restrict access to the problem-definition statements. However, a difficulty could arise when the problem-aware clinician may also be the solution-aware innovator. In that case, SOCN must not be used. Development in the “Solution Space” must be conducted confidentially to avoid the loss of important IP. Dissemination to IP development organisations such as the UK NHS Innovation hubs will be an important function of SOCN.
Yet, it must be recognised that a clinician may be able to develop one or two medical devices in a professional career, whilst encountering thousands of cases of clinical need. Hence, there must be the availability to express those needs and thereby drive improvements in clinical practice from outside direct medical device development activities.
The Pilot
To see how SOCN can work, HT-KTN has developed a demonstrator concept that can be reviewed at www.clinicalneed.com. Visitors can review a list of current statements and watch videoed SOCNs including Professor David Wheatley from Glasgow Royal Infirmary (Glasgow, UK) explain how he must still rely on laborious suturing techniques developed 50 years ago for his cardiac operations. There is much scope for innovation here.
The SOCN process does seem to work. When orthopaedic surgeon Mr A. Murray (listed on the website) expressed his need for two K-wires to be locked in place by a single bone screw, Orthopaedic Innovation (Sheffield, UK, www.o-i.co.uk) was able to respond and begin discussions to produce the device.
Dr John Egan is Commercial Manager at Biomaterials and Tissue Engineering Centre of Industrial Collaboration Ltd, 3320 Century Way, Thorpe Park, Leeds LS15 8ZB, UK, tel. +44 113 284 0225, e-mail: john.egan@bitecic.com www.bitecic.com
