We are pleased to confirm that in March we successfully moved our office from Freiburg to Königswinter (just outside Bonn). In Königswinter we are much more central, with greater access to you all, and with plentiful space to grow our team and services. Still, it was with some trepidation and much excitement that we have left behind our roots in the Schwarzwald (Black Forest) and moved north up the Rhein.
Freiburg is known to be one of the prettiest spots in Germany, but in Königswinter we have found another fantastic location.
You will now find us nestled between the Rhein river and the vineyards of the Siebengebirge (seven hills) national park.
Patient care has benefited substantially from technological advances over the last decades. Each year, more and more previously complicated conditions and diseases are becoming treatable. More available treatments, however, do not increase a payer’s budgets, but rather place an increased burden on already scarce resources. This is where value-based healthcare has grown to be an essential part of the decision-making process for both industry and payers. Health-economic assessment informs decisions on how to utilize available resources (e.g., time and money) to achieve the greatest benefit for a target population, taking both budget impact and quality of life into account. Such an assessment requires data on health benefits and efficient, easy methods for their collection.
In the modern era, ever-increasing amounts of data are becoming available to inform decisions. There is growing concern, however, that a focus on p-values and “statistical significance” that accompany analyses of these data is resulting in a misrepresentation of reality and leading to poor decision-making. The problem is so widespread as to have led some prominent authors to call for abandoning of the term “statistical significance” altogether.
Last time we introduced Digital Health and its rapid growth, with over 200 health apps per day being released to app stores. Earlier apps were focused on wellness and wellbeing, but many are now transitioning to disease management and even informed decision making. These now make up 40% of the health apps market! With the explosion of Digital Health and the data that it collects and processes, regulators are taking steps to regain control.
Last year GDPR was introduced into EU law and there is no doubt that for many businesses it has mandated substantial changes in policies and practices. For healthcare companies doing business in the USA it may, though, be that not much has changed: HIPAA (Health Insurance Portability and Accountability Act) and GDPR (General Data Protection Regulation) share many traits.
Together Everyone Achieves More: putting together the right TEAM is crucial. To reach the top, your internal team needs to be supported by Key Opinion Leaders or KOLs and external experts. KOLs add respectability and clinical quality to your evidence. Experts in value-based healthcare can transform this evidence into a persuasive value proposition, developing a narrative that your marketing team can leverage. It should say “using our device, you can reach your performance goals with little/no/positive impact on your bottom line”.
Digitization of healthcare is here. It is clear that more and more healthcare-related products and services are moving online: Digital Health as it is known. Digital Health contains different sub-categories such as mHealth (mobile), eHealth (electronic), sensors, telemedicine, and telecare for example (Figure 1). Most healthcare companies are already developing or even marketing Digital Health solutions, so it is important to understand how these will interface with current data and healthcare regulations.
The constant innovation in medical products can be both a blessing and a curse for healthcare systems. On the one hand, it is a key factor in improving patients’ lives, on the other hand, payers are confronted with justification for ever-increasing costs. To address this dichotomy, health technology assessment (HTA) has been widely established to evaluate innovative medical products and determine whether their implementation would be both beneficial and affordable. While the HTA process is generally well defined for pharmaceuticals, the methodology for the assessment of medical devices is underdeveloped.
Have you ever been asked, “how does your product compare to [your competitor]”? How do you answer if there are no or few direct trials comparing the two? Enter network meta-analysis, to answer that question and provide a statistically sound estimate of comparative effectiveness.
Reimbursement is one gateway to medical device sales. It is not always attainable, and devices often fall under procedure codes. This makes it imperative to have a rounded sales strategy that has a value narrative from concept to long-term value. Here are some key items to keep in mind when building the three pillars of medical device value for your own product.
Are you using the best evidence to support your products value and price? Are your colleagues? To identify the strongest data and to keep everyone on message, a value dossier can be very advantageous. In brief, value dossiers are documents providing compilations of evidence to support the value of an intervention. Such value can be economic (e.g. cost-savings and cost-effectiveness), or patient outcomes (e.g. mortality, pain, and adverse events). The dossier can be written directly for provision to your customers or for use internally as a “product bible”.
“I need a model”! It is one of the most common starting points for a conversation with Coreva Scientific. Next follows the discussion of which type of model would make most sense given the business situation. Budget impact for commercial payers and insurers, cost-effectiveness for national providers. Now, though, the discussion is becoming less pertinent as the two systems converge towards… wanting both!
If a picture is worth 1,000 words then an interactive picture is priceless. Having taken the time to develop a comprehensive health economic model, prepare the publication, and ready the marketing team – there is still the question of how to quickly and simply communicate your key messages. One approach is to distil the complex model down to an easy to digest web or tablet app. The example here gives a taste of exactly what can be achieved.
The good times are over! Where previously, companies could gain market approval for their medical product and pass it on to marketing to sell, there are now requirements: continued clinical benefit, strong economic value, and physician/patient acceptance in real-world use. These three sectors are now the pillars of evidence on which sales success is built.
Cyber security and healthcare patient data: almost 50% of companies have had a HIPAA-related security breach in the past two years.
As more and more data and data processing goes online, cyber security is becoming increasingly important to healthcare companies.
Supporting evidence is essential for each product, but equally important is communicating that evidence to the relevant stakeholders. This is not only the responsibility of your marketing team, but also of the internal and external data teams that compile the evidence. Peer-reviewed journals, professional congresses, and expert meetings, where should evidence be communicated to make the biggest impact?