The industry that is helping fight the crisis is undergoing its own metamorphosis, and while most forecasts predict growth in this sector, new regulations and compliance requirements may prove to a bigger challenge than expected. Frontline workers are falling short on supplies, quality products required to fight the pandemic are unchecked; mass production of masks, sanitizers and medical equipment has led to people questioning the quality of these products. We have tried to highlight some of the challenges this sector may face post-pandemic and how one can act to curb the impact of these challenges.
impact of covid-19
– Delay in treatment: Hospitals are postponing elective surgeries, this in turn will have a knock-on effect for the medical devices industry, with a reduced need for systems.
– Cost implications: Cost of resources which are essential for the manufacture of equipments used in pandemic emergencies has skyrocketed and has resulted in increased costs of other equipments that use similar resources.
– Counterfeiting & quality crisis: The pandemic situation has led to huge increase in fake products, the quality of many products is not acceptable and is now seen as a greater risk to healthcare workers.
– Shortage of esssentials: The medical emergency has generated a void in resources; PPEs, emergency testing kits and many required medical devices and equipments are not available to front-line workers.
challenges that lay ahead
– Distribution and supply chain: Distributors, suppliers, manufacturers are facing grave issues in supply chain due to lockdowns and restriction of resources. Many non-essentials equipments are facing huge roadblocks and this may result in reduced business.
– New regulatory requirements: To upscale the quality of medical devices and the safety of medical personnel, nations may publish new regulations to comply with. European Union, FDA, ASEAN could soon be looking at introducing new reforms and regulations.
– Technology and security: Tele-Medical is going to be the new norm and information security concerns are high, technological advancement would need more investment
– Labour issues: Due to high risk in medical industries, companies have to ensure the safety and continued healthcare for all employees by introducing new systems and protocols. Healthcare workers are at high risk and getting them out of stress, out of required isolations post pandemic would be tedious for industries in this sector.
– Manufacturers would address the spike in demand by simply speeding and scaling up production. Governments utilizing accumulated stockpiles, and people switching to substitutes, could result in a gap between the supply and demand of these essential products.
ISO 9001 Certification
ISO 27001 Certification
ISO 20000 Certification
ISO 22301 Certification
ISO 21001 Certification
ISO 41001 Certification
ISO 50001 Certification
ISO 29001 Certification
ISO 14001 Certification
ISO 45001 Certification
ISO 22000 Certification
FSSC 22000 Certification
ISO 17025 Certification
ISO 13485 Certification
CE Mark Certification
– Internet-of-Things (IoT) enabled medical devices and surgical instruments that are high on innovation will see a boom.
– Research and innovation companies are big gainers as the crisis has led huge firms and government agencies to invest in medical R&D departments.
– In emerging markets, local medical device manufacturers are more successful as compared to their multinational counterparts; they offer better turnaround times and customization capabilities.
– Parallel venture: Lockdowns and this crisis have paved way for few governments to ease manufacturing regulations on a few medical essentials; this is a very good opportunity for manufacturers to enter new fields and markets for medical devices.
– Online medical consulting has resulted in reduced risk exposure of patients visiting doctors.
solutions to adopt post covid-19
– Overall reconstruction: Explore opportunities to transform the organization’s cost structure, increase flexibility and accelerate operational improvements such as shared services and automation.
– Regulatory preparedness: In order to meet current and future regulatory requirements, early adoption of systems and standards as per international markets is necessary.
– Digitization: Invest in digital platforms, for customer engagement (e.g., telesales, virtual rep in the operating room) as well as for internal training and team collaboration. Invest in tele-medicine and connected devices, including mobile diagnostics, data monitoring and device support, to virtually support real-time physician consultations.
– Supply chain responsibilities: Make supply- chain readiness a top priority. Communicate with vendors regularly to be informed of risks and, if needed, identify alternate suppliers.
Consider dual sourcing for critical products such as Active Pharmaceutical Ingredients (APIs) and excipients. Assess risks tied to the company’s sourcing and manufacturing footprint to ensure sufficient backup in case of future disruptions.
– Crisis governance: Establish a crisis governance model for decision making across sites. Determine which decisions site- staff can make themselves and those central- staff will make. Ensure clear communications systemwide.
– Consumer confidence and awareness: Post pandemic periods will see purchasing hesitance from end consumers and it will be imperative for smaller players in the field to build consumer confidence in markets. Adhering to best practices in production and having management systems and certifications to demonstrate product quality and consistency will be key to your success.
how we can help
We have services that primarily help with the resolution of a lot of challenges mentioned herein. As a part of our response to the current situation, we have teams dedicated to this industry who are available 24/7 to address any queries/requirements you may have. We have also ensured that our services are delivered with promptness and we have tried to keep the consulting and certification process itself as flexible as possible to meet your timeline needs. CE Marking Certification, ISO 13485, GLP, GDP, HIPAA are some of our services aimed at assisting organizations during this crisis.