Posts Tagged Security
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on August 13, 2015
Jeff Sauter, Business Development Manager at Nutek, talked about sterilization efforts for healthcare products and medical devices, atwww.bio2devicegroup.org event.
Most commonly used forms of sterilization are EtO, Gamma and E-Beam with X-ray sterilization as an emerging ‘new’ technology. Nutek is an E-Beam sterilization facility that is FDA and DEA registered and is ISO 13485 and ISO 11137 certified and is going through ISO 11135 certification for EtO, said Sauter. While Nutek is known in the industry as a niche player and is sought out world-wide to solve complex sterilization issues, they also have the capability to sterilize large volumes of product.
Sauter discussed various sterilization modalities. SmartEO Ethylene Oxide Sterilization or EtO is effective and cheap modality for R&D testing as a well as for high volume and low volume production. It is used for terminal sterilization of devices. With EtO, it is important that the packaging is breathable where it may be torturous route for microbes to get in but gas can still get in for sterilization. Primary challenges are with residuals and significant environmental concerns have led to EU mandates to exhaust all other sterilization methods before resorting to EtO.
Gamma radiation method is effective and cheap and can also do high volume. However, there are significant security issues surrounding gamma. In December 2013, in Mexico,hijackers opened the canisters being transported in a truck and disappeared unaccounted for, said Sauter. If it falls into the hands of the terrorists, they could potentially make a dirty bomb. Gamma also needs to be disposed of properly and it is buried permanently deep in the earth.
E-Beam has some advantages over Gamma. E-Beam is less harsh to the product as compared to Gamma, said Sauter. In case of Gamma, the product resides in the Gamma chamber and is exposed to radioactive energy for several hours. Whereas E-Beam, typically a high energy electron beam goes over the product in less than a minute. E-Beam also offers more flexibility in processing of sensitive drugs or biologics. E-Beam offers advantage of continuous temperature control, split dose processing, and intelligent tooling. It also offers more scalability for processing differing volumes and turnaround times can be much faster, compared to Gamma. E-Beam is also environmentally friendly and poses no security risk.
The technology in X-ray has only recently caught up to make it a practical modality, in sterilization, said Sauter. X-ray is also emerging as a more obvious choice over Gamma. X-ray delivers doses rapidly, allows for greater temperature control, allows for maintaining tight dose range, can penetrate all types of product packaging including foils, and causes no damage to sterile seals on product packaging. Nutek is moving a new facility in Fremont, which will include state of the art X-ray sterilization modality.
All modalities have their place, their advantages and limitations, said Sauter. If any product contains Teflon or electronic components then EtO is the more likely methodology to go with. It is very important to consider sterilization modality earlier in product development. Sometimes a wrong modality is chosen and the result is good, viable products don’t see the light of the day, said Sauter. Some of the important considerations in choice of a sterilization modality are: material compatibility and product functionality, product and packaging qualification, bioburden issues and dose selection, modified atmosphere packaging considerations, security and environmental risks, future sustainability, and cost considerations.
The session was followed by Q&A.
Aroon Krishna and David Judelson, co-founders at VirtuMed talked about the challenging environment for current medical device manufacturers and VirtuMed’s Synapse Mobile cloud based, on-demand, customer engagement platform solution to address the challenges, at a recent www.bio2devicegroup.org event.
Enumerating examples of challenges impacting medical device marketplace, Judelson, said Boston Scientific neuro modulation business has declined due to reimbursement challenges, Medtronic agreed to settle and stop the sales of pain med pump due to link with patient deaths, and big promise and subsequent failure of renal denervation solution has cut the growth among other device manufacturers. There are challenges across the board from development to commercialization, said Judelson. Hospitals are faring no better. Nearly 40% of California hospitals received bad grade, constant M&A activity among hospitals, pressure from changing government initiatives, difficulties with privacy and security of EMR data has all led to medical device companies spending more money to get less and spending more in sales and marketing efforts is not the answer.
Five current headwinds are defining the existing environment. Increased regulation and declining reimbursement from fee for service to bundling and changes in how CMS pays, is putting a lot of pressure on providers who pass the burden on to device manufacturers. Second, there is a lot of variability in how different hospitals measure quality. Third, aging population with increasing co-morbidities is leading to variability in clinical trials and making it challenging to assess the effects of interventions. Four, challenges are increasing with decreasing hospital access for sales reps. Five, huge global volatility with large swings in foreign exchange rates, government uprisings etc. is making it hard to estimate earnings.
Hospitals are often burdened with internal challenges of system integration, promise and challenges of mobile technology, problems of achieving seamless inter-operability, thinning margins, vendor management issues, physicians getting overburdened with administrative tasks, HIPPA issues and more. All these challenges are compounded with sub par performance from medical device companies as they are delivering more failures in R&D, demonstrating lack of innovation with decreased ROI followed by decreasing investment in venture and M&A activity.
Currently, there are few solutions for comprehensive customer management, said Judelson. Some general solutions like Salesforce, Oracle, imshealth, freshdesk, Veeva and Zendesk have been applied. However, these require significant customization, often have complex pricing structure, are pricey for small to mid-sized enterprises, have complex IT integration and archaic mobile user interface, and are often based on limited knowledge of medical device econsyste. There are no existing CRM solutions specially designed for medical device industry, said Judelson.
VirtuMed’s cloud based remote connectivity solution specifically fills in this gap, where device manufacturers can establish direct line with the customer, provide better, more timely customer support as a value added service, develop apps, and leverage knowledge of product users globally with access to real time outcomes data. There are many gains from such timely information. Research indicates that with timely physician access to post surgery recovery process and real-time conversation with patients, recovery occurs faster and patients remain more engaged in their recovery. While there is a great deal of patient to patient interaction in social media, there are fewer tools for patient to provider engagement and that needs to change.
VirtuMed’s Synapse mobile solution helps build a connected ecosystem that combines commercial CRM, social networking, on demand communication, big data visualization, HIPPA compliant infrastructure, and enhances security with data changing hands while ensuring availability of data at the right time to the right people. This solution aims to unite all key stakeholders on a single platform with primary objective for positive patient impact, said Krishna. VirtuMed product is poised to offer support to companies of any size and its tech solutions can be applied at each stage in medical device life cycle, from early innovation to clinical stakeholder engagement, to customer engagement to CRM platform to enable growth in emerging markets; literally from ideation to discovery to clinical to commercialization, said Krishna.
The talk with followed with Q&A.