The life science medical device industry is unique from many perspectives. Data security and integrity, complex lead-to-cash processes with bundled product and service offerings including new revenue models in leasing and subscriptions, service management with CAPA reporting, reverse logistics, post market surveillance, quality management and reporting. We explore these different areas below.
Data Security and Integrity
Data security and data integrity is becoming an increasing topic for any company. This is an even larger challenge for life science companies, as this industry is highly regulated. Data integrity, in the words of the FDA defined as the completeness, consistency, and accuracy of data, is crucial for applications and systems throughout the life sciences industry. Agencies, such as FDA for the USA and EMA for Europe, observe compliance with such regulations.
Working with a lot of sensitive information, such as patient data, medical records or intellectual property, companies need to ensure their compliance with rules and regulations. Patient consent needs to be requested and documented. Data privacy needs to be ensured throughout the entire process from the medical device to transmission and storage to end-user application.
Sales processes are getting more challenging for these manufacturers as well. Consolidation among hospitals and laboratories results in larger general purchasing organizations (or Integrated Delivery Networks) with bigger bargaining power. These GPO’s and IDN’s typically negotiate master agreements that cover pricing for various equipment and need to be adhered to by the company when creating quotes for the customers. This fosters the search for new business models with different revenue streams. Traditional offers will be replaced by comprehensive product bundles and usage-based service offerings – which requires both devices enabled to report usage/IoT data and intelligent organizational structures to determine the relevant actions to best serve their customers. Besides the product offer, innovations in the area of subscription-based offers and financing plans such as leases are quite common these days.
Service processes for manufacturers of medical devices require proper CAPA reporting (corrective action/preventive action) to record any kind of non-conformance. In this report, any issue or defect needs to be documented, as well as the steps taken to correct this issue and to prevent any such issue in the future. Typically, this is supported by a comprehensive system for service management to help automate case management, workflow, and field service action. The system should also track service contracts, warranties, and entitlements that the customer has purchased, to ensure that these are adhered to during a service incident. Product service bulletins (also known as safety recalls in other industries) are also commonplace, to ensure proper functioning of equipment in medical facilities.
Quality Management and Reverse Logistics tend to also be quite complicated. When products are returned a detailed quality assurance/root cause analysis (RCA) needs to be performed to ensure that the defect is not widespread and isolated to only the specific equipment. Depending on the global nature of the company and where such RCA is conducted, returns can get complicated to ensure that the return locations are properly identified. Quality management systems capture a lot of detailed information about incidents as they are responsible to report to health authorities (FDA or EMA) in the case of adverse events. Typically, every incident raised by an end customer that results in remote technical support or an onsite field action should also be reported to the quality management team.
In order to handle the obligation of Post-Market-Surveillance in a precise, efficient and timely manner a very precise, actual and consolidated knowledge about the manufacturer’s equipment records and the installed base is required. The detailed bill of material that is installed on the equipment is important to know and keep up-to-date based on corrective action that happens in the field. This can be especially important in the case of a mass update / recall scenario to proactively prevent any adverse events from occurring.
Last but not the least, the expectations of the customers in the B2B engagement model have been largely influenced by B2C trends. Excellent customer experiences available on a variety of devices is the norm. Providing the customer with a variety of self-service and e-commerce options are minimum expectations these days.
As mentioned above, business processes are rapidly evolving and can be complex in the Life Sciences industry. A comprehensive approach to digital transformation of the Customer Experience is needed and what ECENTA and SAP can provide.
The combination of SAP’s CX applications and the adequate industry expertise will enable you to implement efficient lead-to-cash and services processes. Powerful extensions, like the ECENTA After Market Portal which augments SAP Commerce Cloud with self-service and after-market sales capabilities help you to unleash the power of meaningful customer experiences.
To accelerate your digital transformation, we implement suitable solutions for:
- Bundles with products, software and services, and product configuration
- Pricing, including lease pricing, subscription pricing, contract pricing and adherence
- Quotation, order, and contract management
- Integration into back-office processes for logistics, service, and revenue management
- ECENTA After Market Portal, to extend SAP Commerce Cloud by comprehensive sales and services capabilities
These solutions are able to support existing and new business models, such as:
- One-time invoicing / recurring billing
- Pay-per-use billing
- Subscription management
ECENTA's consulting team is happy to assist you in the development of possible business scenarios through to the implementation of the best suitable solutions, to help you evolve your high-level Life Science processes.
Would you like to learn more? Just get in touch.