Med-Tech Innovation Design


Figure 1: Evidence of noncompliance for various therapies


demonstrate that the most dramatic adherence declines occur within the first four months of the prescription being written. At the end of 24 months less than 50% of patients are still taking the drug, even in disease areas such as cancer.


When will the medical industry wake up to the fact that patients do not always do what they are told to do and instead do what they want? The issue is that many medical devices have not been designed with patients in mind; often the devices do not fit into their lifestyles, they have a stigma attached to them and are not easy to use. There are many stakeholders involved in getting a medical device to the patient. It has to be approved by the physician, then explained by an educator, accepted by the caregiver, well received by the pharmacist, compliant with the NHS procurement procedures and reimbursable by the insurance company (in the case of private healthcare). However, with point-of-care moving from the doctor’s offices to the home, power is shifting to the patients. Patients will now have more of a say in where their money is spent and as a result will have a greater choice of medical devices. No longer will they rely on the doctor to tell them which device to use, they will do their own research and select the one that best suits their lifestyle and meets their needs.


The answer to noncompliance


It seems obvious that if a device is easy to use it will have a huge impact on patient acceptance, dosage compliance and ultimately health outcomes. This means that patient experience should be a primary focus in the development of devices. As with consumer products, we do not merely buy things for what they are, we buy them for what they do for us on an emotional level. To have a more user focused approach med-tech companies and device manufacturers need to move away from the traditional way of developing devices, which is essentially based on “inside-out thinking.” This engineering-focused mindset involves developing new products based around technology and resources. The ultimate outcome is to gain profits through sales volume. But, being technology driven will not always lead to success in the marketplace. True innovation comes from “outside-in thinking.” Here, the starting point is the target customer, not technology and resources. Focusing on user needs throughout the product development process and considering how the end user will interact and emotionally relate to the end product will result in


www.med-techinnovation.com


Figure 2: The Zon hearing aid is described as an object of beauty


increased profits through customer satisfaction. An important motivator to improve the usability of medical devices is evident in the latest revisions to the Medical Device Directive (93/42/EEC), which was amended by Directive 2007/47/EC. The revisions highlight the need to consider ergonomic design. This is not mandatory and alternate methods for meeting the Essential Requirements of the Directive are possible, however manufacturers have an obligation to prove their products conform.


Another incentive to change the way products are designed and make them more appealing to the end user is the fact that many drugs will reach the end of their patent lives in the next five years. According to a report from market analyst Datamonitor (www.datamonitor.com), drug makers are facing “unrelenting generic competition” with medicines worth nearly $140 billion in sales due to lose patent protection by 2016.3


Financial analysts have


been cautioning for some time about the patent “cliff” that many large pharmaceutical companies are facing. Until now one patented medication has monopolised the market. The medication has been the same for everyone and is delivered in the same universally generic medical device. But soon generic drug companies will be fiercely competing with large pharmaceutical companies for their market share, armed with identical formulations. The only way to compete is through differentiation.


Building-in differentiation


A means of gaining a competitive edge in this tough marketplace and ensuring that devices are user friendly is through design. Many pharmaceutical companies and medical device manufacturers employ industrial design consultancies to help them develop innovative new devices. Although it is an investment and some members of the board may need persuading that it will be a worthwhile endeavour, in most cases the rewards are substantial and can have a massive impact on a company’s bottom line.


November/December 2011 ¦ 27


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