Posts Tagged Security

Invention, Innovation and Entrepreneurial Thinking – Talk by Mir Imran


Mir Imran, CEO at www.incubelabs.com, spoke on “invention, innovation, and entrepreneurial thinking” at www.bio2devicegroup.org and www.eppicglaobal.org joint event at Wilson Sonsini, Goodrich & Rosati, Palo Alto.

There are many examples of innovation, in history, said Imran.  However, for the most part, innovation has been left to chance.  Imran said, it was important for him to think about how to turn innovation into a process, so that it can be made a daily practice inside an organization, and not be left to chance or a random occurrence.

Through examples and stories, Imran shared how innovation is practiced at Incube.  Incube is an applied research lab and was found in 1995.  Incube has evolved into a star incubator of companies, but is unlike other incubators, where external companies with promise, get incubated, in-house.  At Incube Labs, only in-house created companies are incubated, most of them originating from one or more of Imran’s patents.  

Imran said, “I am agnostic to technology”, and boasted of a world class multi-disciplinary team, at Incube Labs.  He said the only way one can excel while remaining agnostic to technology, is if one is a broad thinker and can embrace all technologies, so as to apply the most optimum solution for a problem.  At Incube Labs, all team members are compelled to work outside of their chosen field.  All team members pick up new skills and grow in breadth and depth, in the process.

Imran has found 28 companies, to date.  Twenty-six of them are in life science arena and 2 are in the area of security.  Despite his 400+ US patents and about 1500 foreign patents, according to Imran, filing patents, is not a measure of success, inventions don’t always translate into innovations; and even less frequently, they translate into entrepreneurial success.  Clearly, Imran has managed to translate his inventions into huge commercial success.

Some of Incube portfolio of companies

 VidamedPython MedicalPercusurgeZONAREPhysiometrixNfocus Medical

Imran discussed three different models of innovation.  Technology favored innovation model is frequently found in academic institutions.  The focus here is on finding applications and filing patents for a new technology that is invented, and then licensing the IP or starting a company around it.  The problem with this approach is that entire focus is on specific technology and on forcing it to fit a problem, said Imran.  Skill based innovation approach begins with applying a skill, and again it takes away from focusing on the problem.  

Imran then discussed his own need based model of innovation.  In this approach, innovation begins with identification of a poorly solved or unsolved problem.  Picking the right problem to solve, and framing it appropriately, assumes that one has the requisite broad background to understand the problem, and it is the single biggest challenge of innovation, said Imran.  Once the problem has been identified and defined, then one can focus on developing solutions and filing patents.  However, the entrepreneur must assume that an initial solution may be a partial solution.

The entrepreneur is called upon to analyze the commercial value of the solution and be prepared to “kill”, when a solution does not meet the required criteria.  Imran said, in previous models of innovation, the entire focus remains on the technology or the skill, and not on the problem.  One needs to be brutally honest when assessing the commercial viability of the identified problem, said Imran.  

Imran then discussed incremental vs. disruptive innovations.  An incremental innovation improves upon existing product or  service, resulting in an improved product or service.  In this model, there is lower risk, lower possibility of failure, and one operates in a crowded IP space.  Frequently large companies embrace this kind of innovation.  Disruptive innovation is when one develops a NEW way of describing a big problem, which may result in a highly impactful solution.  In this approach, there is higher risk, higher possibility of failure, and potential for strong IP.  Together, these two models form the innovation continuum, said Imran.  

At Incube, the process truly begins with finding worthy problems to solve.  It involves identifying the high level attributes of the problem, including the size of the problem, costs associated with the problem, identifying attributes of current solutions, including efficacy, side effects, cost, quality of life impact, understanding the progression of the disease, various biomarkers, genotypes and phenotypes that can be used for diagnosis and monitoring, and so on.   Even for viable problems, before launching a company, one must go through a focused risk analysis to identify market worthiness of solutions.  It should include detailed analysis for potential IP, efficacy and cost considerations, assessment of clinical trial length and costs involved, analysis of reimbursement issues, financing requirements, and potential for corporate partnerships.

Imran proceeded to discuss Incube’s commercialization process and how vertical integration at Incube enables efficient execution.  In recent years, because the cost of building life science companies has dramatically increased, there has been a compression of returns.  In order to reduce cost of building companies, Imran acquired Modulus, a contract manufacturing company.  This has enabled Incube companies to operate without requiring their own manufacturing capability, and has contained costs.  The venture funds, InCube Ventures and a crowd funding portal, VentureHealth, have enabled financing for the companies.

Imran shared examples and lessons learned from some of his past successes and how he has applied the lessons learned to his several current companies.  Neurolink  is focused on new pharmacologic drug therapy for epilepsy, with repurposing of an old cardiac drug.  One of his exciting new companies, Rani Therapeutics, is not focused on a specific disease, but on  delivering injectable drugs (biologics) orally, via smart pills and is thus providing a breakthrough solution for delivery of therapeutic peptides, proteins, antibodies, and vaccines and has demonstrated greater than 50% bioavailability in large animal models.  Imran said it is a truly disruptive, transformative technology, with strong patent position.  Intrapace is built around an implantable sensor based gastric pacemaker for the treatment of obesity. Nfocus Medical Nfocus Neuromedical developed endovascular neurosurgery solutions to treat intracranial aneurysms, and was recently acquired by Covidien.  Also, Spinal ModulationSpinal Modulation, which developed a novel therapy for the treatment of chronic pain, was recently acquired by St. Jude Medical.

One of Imran’s companies, Intella Interventional, a cardiology company, ran into difficulties.  Imran managed to salvage it but he said he learned an important lesson, to not fall in love with the technology, and to not rely solely upon physicians to give the right answers.  “Also, talk to the skeptics”, said Imran.  Imran said he also learned from the failures of two of his companies.  From the failure of Surface Genesis, which had a flawed licensing model, Imran said he learned that he needed to do business modeling, earlier in the process.  His company, MDIsource was launched about 3-4 months before the market crash of early 2000, and it failed on account of bad timing.  Sometimes events outside your control can also have an impact.    

Imran said that in the course of his innovation journey, he learned several important lessons.  It is important to be current with the literature, and also listen to the naysayers.  However, entrepreneurship is a lonely journey.  In the end, an entrepreneur must be his or her own guide, and must be willing to blaze their own trail.  Despite deep knowledge and extensive literature review, successful entrepreneurs understand that published articles do not account for total truth, and they understand that 50% of scientific data is likely to be flawed or limited in some way.  Entrepreneurs must be willing to take risks, be willing to fail.  In the pursuit of innovation, failure is a constant companion and success an occasional visitor, said Imran.  He said, “question everything, including what I have said”.  

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Sterilization Efforts for Healthcare Products


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.

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Harnessing Cloud Technology to improve Customer Engagement for Medical Device


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.

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TiEcon 2015 Tracks & Keynotes on Day 1


Scheduled keynotes for TiEcon 2015 are creating an exciting buzz.  On day 1, May 15, grand opening keynote guests are Jack Welch (ex CEO, GE) and Suzie Welch (co-author of “Real Life MBA”).  Following this dynamic duo, Aamir Hussain (EVP & CTO at Century Link), Tom Reilly (CEO, Cloudera), and Gary Gauba, (Founder & CEO Cognilytics) will discuss “Transformational Journey towards New Data Economy”.  If data has emerged as the new currency in this new economy, not all data is equally valuable.

Linking Open Data dataset cloud as of July 14t...

Linking Open Data dataset cloud as of July 14th 2009 (Photo credit: Wikipedia)

Data economy track will explore aspects about hidden opportunities and challenges among cheaper and fast growing next-gen data stacks which are augmented by machine learning and advances in IoT and Cloud Computing.  Phil LIbin, founder & CEO of Evernote, http://bit.ly/1Dc2UVD, will give track opening keynote.  Various sessions will cover aspects such as, fast evolving Big Data landscape, extracting value from industrial data, data as a service, how to convert data to dollars and more.  Anthony Deighton, CTO at Qlik will give afternoon keynote.

English: Cloud Computing Image

English: Cloud Computing Image (Photo credit: Wikipedia)

Cloud and Security track will explore operational challenges of cloud infrastructure, business and technical challenges of migrating to cloud and solutions to overcome security issues. Mark Interrante (SVP, HP) will give track keynote.  Various sessions will discuss market trends around cloud infrastructure, around cloud architecture and technology, and around compliance and security issues.  Suja Chandrasekaran, SVP, CTO, CDO at Walmart will give afternoon keynote and the day will end with keynote by Sandy Carter (GM, IBM).

Much hyped up Internet of Things track will start with track keynote, Johan Lodenius from MediaTek http://bit.ly/1E03sQp.  Success in IoT begins with picking the right software and hardware components for the ecosystem.  Track sessions will evolve around “designing compelling IoT solutions”, to “internet enterprise of things” to “examining criteria for getting funded”.  Learn what’s making waves in this growing field and how to get there.  Jay Vijayan, CIO, Tesla http://bit.ly/1Fw2qgt, will give afternoon keynote and Anand Oswal, VP of Engineering at Cisco will give an ending keynote.

Not only there is much to choose from and worry about missing exciting sessions (unless you find a way to clone yourself), speakers and sessions will address inter-disciplinary innovation opportunities and outside the sessions, there will be endless opportunities to network with investors, speakers and other professionals.   But WAIT!  This is only Day 1; more excitement awaits on Day 2 http://bit.ly/1bhXFKg .  Register through this link  https://www.123signup.com/register?id=ygszb&ref=4182698 to get a $100 discount on the two-day conference at the non-member rate.  When prompted, enter the promo code VOL500 at checkout. .

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