Outsourcing BioTech & Drug Discovery Innovation to India – Event Preview

Outsourcing work to India has been big business.  In 2005, outsourcing was a $10 billion industry in India.  It has since, more than doubled.  But can innovation be outsourced, particularly innovation in life sciences, an industry obsessed with regulatory issues, stringent patents; an industry with extremely high bar for performance?   It is one thing to get chemistry synthesis or early stage pre-clinical work done in India but does India have the systems and processes where innovation can thrive, a freewheeling environment, an open environment, yet an environment that can ensure patent protection and adherence to regulatory requirements, and does India have experience to bring out market worthy ideas and maximize the returns on ideas?  It seems that India has indeed evolved from a place to get the work done cheaply and efficiently, to a place for R&D innovation.  With extremely highly trained chemists and other professionals pouring out of top notch Indian academic institutions like IISCs and IITs and experienced biotechnology professionals from the US and Europe returning to India in sizeable numbers, although biotech R&D innovation is yet at early stages, India is emerging as a worthy partner, in innovation.

An illustrious panel will discuss the opportunities and challenges of outsourcing innovation to India at www.eppicglobal.org event from 6pm to 9pm, on Wednesday, September, 18^th at WSGR, Palo Alto.  The event will be moderated by Shalabh Gupta, Founder and CEO of BioCycive, a California based biotech focused on bringing new drugs to the market.  An MD by training, previously Gupta worked at Genentech and is currently also serving as a member of EPPIC executive committee.

Panelists include, Ajay Bharadwaj, Founder and CEO of Anthem Biosciences, a leading Discovery Research Alliance Partner (DRAP), who had returned to India, after completing his MS on a fellowship, in the US.  Bharadwaj later joined Biocon when its annual sales were less than $50,000 and 21 years later when he left, Biocon’s annual sales had grown to $225 million and the company did business in 45 countries.  Ganesh Sambavasivam, Co-founder and CSO of Anthem Biosciences, ranked in the top 20 at all India level at the completion of his undergraduate degree in Chemistry, and after completing his Ph.D. in Chemistry, joined Syngene (Biocon group company), where he rose to VP and CSO level.  Panelist, Anjali Pandey is Vice President of Chemistry at Portola Pharmaceuticals.  She has over 30 scientific publications and 25+ patents to her name, provides scientific due diligence to various venture capital firms, and holds a Ph.D. in Organic Chemistry.  Brian Robbins, Vice President of DavosPharma, is a partner and co-founder of various other companies including Innovative Pharma Solutions, Portsmouth Therapeutics, Sentinal Biotech, and Portsmouth Technologies.

To register for the event, go to www.eppicglobal.org

 

English: Worldwide Offshoring Business Deutsch: Weltweites Offshoring Business (Photo credit: Wikipedia)

 

 

Marketing Insights for Commercial Success in Medical Device Market

Wilson, Sonsini, Goodrich, and Rosati 2013 Medical Device Conference (www.wsgr/news/medicaldevice.com) focuses on understanding the opportunities and challenges in medical device sector.  A panel of experienced CEOs discussed the challenges of getting a new medical technology to market, in the current environment, and shared insights to help overcome early challenges and obtain commercial success.

David Bruce, President and CEO of Arstasis www.arstasis.com  shared about how they implemented strategies to accelerate the commercial growth phase of the company.   Companies need to define their market and pick the customers, and then figure out how to get through to them, said Bruce.  Arstasis was clear that they needed to succeed in the US market and reach the customers with direct sales force.  Arstasis offers self-sealing access for femoral catheterizations, securely, without leaks, and with drastically reduced complications.  Bruce said that innovative product requires education and going after early innovative types, the risk takers, and sales reps trained to walk away from targets that are not good.

English: Balloon catheter for anorectal manometry Русский: Балонный катетер для аноректальной манометрии (Photo credit: Wikipedia)

Waiting for tubal ligation, Guatemala (Photo credit: NewsHour)

Keith Grossman, President and Director at Conceptus www.conceptus.com , discussed the challenges that come with lack of clear focus.  Conceptus, a medical device provider of women’s health market, has a non invasive tubal ligation device that can be placed non-surgically and is more effective than having the tubes tied.  It is also allows the doctor to make more money, while being less expensive for the payer.  Yet it hit a wall.  The company had a lot of people on the ground and was putting a lot of money into sales and marketing efforts.  However, there was little clarity on how the customers were segmented and while a lot of customers were being trained and lot of new customers were generated, the company was not doing enough work with existing customers.  The sales people were selling more and more products with single digit margins.  After clarifying the focus, dramatic changes were made and within 6 quarters it led to double digit growth.  Learning from the mistakes, Grossman said, they started too broad and were not penetrating the market deep enough because sales team lacked a guiding strategy.  There was misalignment between the marketing message and the sales strategy and there was confusion regarding whether they were looking for penetration or profitability.

B0007766 Popliteal aneurysm: reconstructed CT scan (Photo credit: wellcome images)

Christopher G. Chavez, Chairman, President, and CEO of TriVascular www.trivascular.com , discussed the technology that focuses on serving patients with aortic disease.  Traditionally abdominal aortic aneurysm required high invasive open surgical procedure with high risk of mortality and other complications.  EVAR or endovascular aortic repair procedures dramatically reduced complications. Trivascular’s initial product offerings are novel endovascular grafts focused on significantly advancing EVAR and addressing this $1B+ market.  This is a hugely compelling, underserved, unmet need, said Chavez.  They are seeing excellent outcomes in trials and are going into first in man, later this year.  To address the marketing challenge, the company plans to focus on creating service excellence, in addition to strong field rep training program and building direct sales force in US and Germany.

Tom Prescott, Director, President, and CEO of Align Technology http://www.align.com shared that the company vision is to help people get beautiful smiles.  Align Technology pioneered the invisible orthodontics market, with the introduction of the Invisalign system, in 1999.  “Be patient for success, be impatient for patient success”, said Prescott.  Marketing is about behavior change and it happens with energy, effort, and commitment.

English: Invisaling aligner (Photo credit: Wikipedia)

Promise & Challenges of Digital Health

Digital Health has been an emerging sector in medical device arena.  A panel at Wilson Sonsini Medical Device Conference (www.wsgr/news/medicaldevice.com) discussed the challenges and opportunities in this area.  Moderator Milena Adamian is founder and executive director of the Life Sciences Angel Network, which is focused on early-stage investing and entrepreneurial activities in medical devices and healthcare information technology arena.   Having spent 20 years in medical device development, she brings the perspective of a clinician and academic researcher and opened the panel with historical background and broad overview.  Panelists included Chilukuri Sastry, Associated Principal at McKinsey & Co., Jonathan Javitt, CEO & Vice Chairman at Telcare, Jay Silverstein, Co-founder of Oxford Health Plans, and Lisa Suennen, Co-founder and managing member of Psiolos Group.

Silverstein raised a key question, right upfront.  “Show me it works”, he said.  While there are some neat ideas and lot of hope, it is not yet backed up by reality, he said.  Sastry said, there is an evolution under way, with a focus on data interpretation from earlier focus on data accumulation.  According to Javitt, it is a matter of making a business case and applying technology, to increasing efficiency.  Suennen pointed out the shift that is happening broadly in the industry, with the entrepreneurs focusing on enabling consumers to engage in matters of their health, more cheaply.  Currently, 7 out of 10 dollars in healthcare are spent on management of chronic diseases and about 5 thousand kids with asthma, die on the way to the hospital, where there is an opportunity to make an impact, pointed out Javitt.  The challenge is to make healthcare sensing as ubiquitous as auto sensing.  Disconnected medical devices will not help transform healthcare, he said.

Silverstein pointed to the gorilla in the room, the challenge of patient engagement.  The panelists had several perspectives on dealing with this challenge.  Silverstein stressed the need to incentivize health, Javitt suggested combining healthcare with gaming.  Suennen pointed out that gaming might attract short term focus that may not have a lasting impact, as people get bored of games.  Silverstein emphasized the need for segmentation so that there can be constant communication, marketing, and efforts to engage patients with specific needs, on a continuing basis.  Sastry said, while behavior modification is challenging, the new and emerging technology will allow for better patient engagement.

Sharing advice for entrepreneurs in this sector, Silverstein suggested that they carefully pick customers and value proposition.  They should not claim to be good for payer, investor, physician, but instead find a niche.  Suennen said, right now it is too easy to start a company in this area; all they need is an iPhone and a starbucks card; but failure is also fast.  A big lesson, observed Javitt, is that a lot of great ideas are poorly marketed and poorly packaged and do not take into account that an average consumer needs 3+ touches, to be noticed.  Sastry stressed the need to become a data scientist.

Adamian concluded the panel saying that as an investor, she would consider the team, look at the market, sustainability, analytics and suggested that entrepreneurs be mindful of regulations and also focus on how to engage patients.  The area of preventative medicine is a whole other area that will be of a lot of interest, said Adamian.

Crowdfunding – New Source of Capital for Medical Industry

Wilson, Sonsini, Goodrich, and Rosati 2013 Medical Device Conference (www.wsgr/news/medicaldevice.com) focused on understanding the challenges that Medtech startups encounter in the current environment, and the emerging strategies to respond to these challenges.  It was heavily attended by industry CEOs, venture capitalists, industry strategists, investment bankers, market analysts, and life science industry professionals.

Wilson Sonsini Goodrich & Rosati (Photo credit: Wikipedia)

Below are some highlights from panel on crowdfunding.  Crowdfunindg is emerging as a source of potential new source of capital for early stage and emerging growth companies.  The panel was moderated by Phil Oettinger, partner at WSGR and the panelists included Andrew Farquharson, Managing Director at InCube Ventures, Scott Jordan, Partner at S. Jordan Associates, Greg Shearer, Managing Director at Healthios, and Ben Lee, Director of Business Development at CircleUp.

Oettinger gave a background on Crowdfunding.  He also discussed impact of JOBS act that is expected to enable advertising for private investment offerings and allow unaccredited investors to participate in online equity crowdfunding.  Thus far, crowdfunding has not lived up to the hype of being a startup panacea.  It caps an amount an issuer can raise to $1M, in any 12-month period and caps the amount a person can invest in all crowdfundings over a one year period at 10% of annual income or net worth of the investor.  Shares issued in crowdfunding transactions are subject to a one-year restriction, and there are other restrictions that render non-US companies ineligible to participating in crowdfunding.  Crowdfunding also must be done through a registered broker-dealer or registered “funding portal”, who cannot solicit investments and law requires extensive due diligence, including background checks on management and large stockholders.  None of the challenges however, have dampened the enthusiasm.  SEC has already stated that equity crowdfunding portals are exempt from certain restrictions and more changes are on the way.

Scott Jordan is an accomplished life sciences business development and investment banking professional with over 20 years of corporate experience in negotiating strategic corporate alliances, securing international licensing agreements, building national sales teams, and contributing to successful product development, approval, and launch.  In partnership with Greg Shearer, Managing Director at Healthios Capital Markets, and CrowdConnect, Jordan and Associates, launched Healthios Xchange fund, with an aim to assist emerging growth healthcare companies raise capital from accredited investors, and non-dilutive financing from foundations.  It offers three large value propositions, said Shearer.  Open access eliminates selection bias and does not curate the deals going on the site.  “Crowd” anchors the continuum.  H/X scoring based on sophisticated algorithms, makes it heavily data centric, similar to LinkedIn.  Healthios charges fees to companies that raise money on its portal, except in certain cases where it offers carry-free, fee-free feature allowing investors an opportunity to directly invest in companies, eliminating transaction expenses.  The fees will likely fall in the 5-10% range.  The fee structure will be different for non-profits.  Each company gets a company pitch page.  Several features including e platform button, e signature of docs, e regulatory assessment etc., enhance ease of use.

Ben Lee, a developer of innovative teeth whitening products at GoSmile, and founder of TaskRabbit, an online services marketplace, joined CircleUp, which offers consumer companies an access to funding through passionate, sector focused investors.  “Very simply, crowdfunding is a numbers game and it offers an opportunity to reach out to large number of people, who are looking to invest”, said Lee.  CircleUp has launched a highly active, fast growing portal and has gained considerable credibility.  Lee said, “We are 100% focused on branded consumer products” where there is little institutional investment.

Prior to his current role at Incube Ventures, Andrew Farqharson, a serial entrepreneur had co-founded Operon with no venture capital and sold it for $150M.  He also had launched a company in microfludics, Innovadyne, and had held several roles in research operations at Genentech.  At InCube, with Mir Imran and Talat Imran, Farqharson co-founded VentureHealth, a crowdfunding portal, to enable physicians and other accredited investors to invest in “compelling biomedical inventions”.  Farqharson said, this emergence of crowdfunding is very exciting and enables entrepreneurs to be less dependent on VCs, while it unlocks a lot of latent capital, and also gives investors more degrees of freedom.  Unlike other equity crowdfunding portals on the panel, VentureHealth has adopted a carried-interest business model.  They do not charge fees to the companies that raise capital but charge the investors; just like a venture fund.  In this model being driven by carried interest, they make money only if their investors do.  Clearly, they have an incentive to only support the most promising companies, unlike many broker/dealer sites that may have lesser interest in screening for quality, as their primary incentive may be to raise capital for as many companies as they can.  It will be interesting to see which approach holds more long-term promise.  My initial thoughts are, if I, as a rather naive investor, were to risk my money, specifically in the complex class 2 and class 3 devices, with many regulatory, reimbursement, and marketing challenges, I would prefer to risk it where some prior due diligence is done by seasoned and serial entrepreneurs like Imrans and Farqharson.  Explaining the success of InCube Ventures, Farqharson said, despite the challenging environment, they have had 3 exits this year.  BodyMedia was acquired by Jawbone, NFocus Neuromedical was acquired by Covidien and most recently Spinal Modulation was acquired by St. Jude.  Exists led to $700M+ in 2013, said Farqharson. They are actively screening investors.

Image via CrunchBase

 

 

EPPIC 2013 Annual Life Science Conference Highlights

EPPIC 2013 Annual Life Science Conference Highlights

The annual EPPIC Life Science Conference (www.eppicglobal.org) takes place on the day before the start of the J. P. Morgan Healthcare Conference, each year, and offers a forum for information, networking, and mentoring. This year, the conference took place at the Westin SF Airport Hotel on January 6, 2013 and was jointly chaired by Ramani Aiyer, EPPIC President & Principal at Shasta Bio Ventures and Geetha Rao, CEO of Springborne Life Sciences and VP of Corporate Development at Triple Ring Technologies. The Gold sponsors of the event were Global Industry Analysts http://www.strategyr.com, Camargo http://www.camargoblog.com, Merchant & Gould http://www.merchantgould.com, Morrison Foerster http://www.mofo.com, Vivo http://www.vivoventures.com, and WSGR http://www.wsgr.com. Below are the highlights from the conference.

Plenary Talk – Carlos Olguin

The conference opened with plenary remarks by Carlos Olguin, Head of Bio/Nanotechnology/Programmable Matter Group at Autodesk and was moderated by John Cumbers, Head of Synthetic Biology & Resource Utilization in Space at NASA Ames. If you are wondering what has Autodesk to do with life sciences, the talk was an eye opener about interesting things happening on the boundary between bio-nano technology with 3D visualization, simulation, and design. Autodesk professionals bring design and engineering knowledge and look at ways to program matter, through scan, modify, and print pattern, said Olguin. Scan in the case of molecular biology is akin to sequencing DNA, modify refers to modeling, simulation, and optimization and print alludes to synthesizing the DNA. Looking beyond molecular biology, design and engineering in manufacturing as a whole may shift from being top down to self assembled, from being inert to being alive, from being generic to personalized, and from being product oriented to being service oriented, said Olguin. The talk was a clear indication that interesting, cutting edge stuff is happening on the boundaries between disciplines and that is where we will see some breakthrough advances take place in the years to come.

Personalized Medicine Panel

Personalized Medicine Panel was moderated by Sara Kenkare-Mitra, SVP of Development Sciences at Genentech. Brian Naughton, Founding Scientist, 23 and Me, Eric Sasso, VP of Medical and Scientific Affairs at Crescendo Bioscience, and Deborah Kilpatrick, Chief Commercial Officer at CardioDx discussed the implications of efforts in personalized medicine for chronic diseases.

Crescendo Bioscience is a molecular diagnostics laboratory focused on rheumatology. Currently,  assessment of rheumatoid arthritis disease activity depends on subjective clinical indicators and is a time consuming process. Crescendo is developing quantitative, objective, biology-based tests intended to provide rheumatologists with deeper clinical insights, said Naughton. The blood test, commercially available since  2010, integrates the concentrations of 12 serum proteins associated with rheumatoid arthritis disease activity into a single objective score to help physicians make more informed treatment decisions.

CardioDx offers Corus CAD blood test that can quickly and safely identify symptomatic patients unlikely to have obstructive coronary artery disease (CAD). However, getting physicians to think differently about using these tests versus imaging based tools, is a challenge, and “we are asking them to trust biology and not just an image”, said Kilpatrick. Currently, 75% of its commercial use is by primary care physicians and about 25% by cardiologists. Cardio Dx works the referral channel from an advocacy standpoint. An additional benefit observed by CardioDx is that after the test, the compliance to statins among patients is dramatically improved. Thus the test leads to a behavior change that would not otherwise occur.

23 and Me has an exciting story and it will again be covered in greater detail in my JPM post. The exciting development is in dramatic reduction of cost. Naughton shared that now it is within the reach of everyone and for $99, any consumer can get all sorts of information about their genetics, including increased risks for diseases like AMD, Alzheimer’s and others The panelists discussed their strategies for broadening the use of their tests with partnership opportunities and for other indications. Hearing about advances in personalized medicine, beyond oncology, was exciting.

Panel on Repurposing of Drugs

Mahendra Shah, partner with Vivo Ventures, moderated the panel that focused on repurposing of drugs. While new drugs cost upwards of $1.1B to develop and bring to market, and take over 10 years, once approved, there is no guarantee that they would be commercially successful, said Shah. The knowledge accumulated, can be analyzed to see the effectiveness of old drug for new usage. NIH is also planning to make an extensive database of old drugs available, to enable scientists to look for new indications.

Ken Phelps, CEO of Camargo Pharmaceutical Services, talked about the regulatory pathway in repurposing of drugs. Camargo specializes in FDA’s 505(b)(2) drug approval process. In 2011, more 505(b)(2) NDAs were approved than 505(b)(1) compounds, said Phelps. Sharing the history of 505(b)(2), Phelps emphasized that currently over 3000 drugs are still on the market that were introduced prior to 1962, when they were not required to be shown to be efficacious, and they are for taking. There are also compounds with new chemical entities and new indications that are available. He observed that it is important to identify compelling commercial differentiation and then take the knowledge available in the public domain, think outside the box, and use it effectively.

Warren Cooper, President at Coalescence was CEO of Prism Pharmaceuticals, a venture backed company that he led from inception to sale of the company to Baxter in 2011. According to Cooper, in repurposing a drug, same criteria should be used as NCE; identification of well defined clinical need, market value, and willingness to adopt and obtain reimbursement, technical feasibility, ability to protect from generics for meaningful period of time, and positive financial justification. What is different from NCE is that compound has a history and sometimes that is helpful and sometimes a hindrance. The deeper the history, the higher the challenge it may cause in the regulatory pathway of repurposing. Cooper discussed the example of injectable amiodarone that was originally developed for use in cardiac arrhythmias and was transferred at Prism Phrama, into NEXTERONE, from IV to ready to use pre-mixed product. The regulatory challenges required rewriting of the label and negotiations with FDA on labeling.

Jaisim Shah, Board Director at Igdrasol, discussed the key drivers for drug repurposing that include, reduction in cycle time, lower cost, better success rate, and quicker ROI for investors. Drug repurposing sales are up, to $20 B this year, said Shah. In 2012, as Chief Business Officer of Elevation Pharma, Shah led the sale of the company to Sunovian for upto $430 million, contingency based deal. The company took glycoyrrolate, a generic drug, approved decades ago by the FDA, and reformulated the compound for use with a nebulizer for chronic obstructive pulmonary disease (COPD), which includes emphysema and chronic bronchitis. It is found to be a well tolerated, tasteless, and stable formulation.

Panel on Technology Innovations that Shorten Therapeutic Product Development Life-Cycles

Moderated by Mohan Srinivasan, Director at Bristol-Myers Squibb, the panel discussed diverse and new technology adaptations aimed at compressing lifecycle and boosting success rates for drug development. Currently, for each new therapeutic, the product life-cycle ranges between 9 to 15 years and costs over a billion dollars. Can this be significantly shortened by adapting technology advancements in other sectors?

Chunlin Wang is Senior Scientist & Director of Informatics at Stanford Genome Technology Center. In last several years, Wang has been analyzing sequencing data generated by 454 FLX, I1-lumina GAIIx, HiSeq, MiSq, Ion Torrent and Pacific Bioscience platforms for various projects including drug-resistant mutation detection, whole genome sequencing, immune repertoire sequencing, high resolution high-throughput HLA genotyping and new virus discoveries. Using novel sequencing approaches to speed up drug development is one of the best ways to reduce costs, said Wang.

Scott Turner is EVP of R&D at Kinemed Inc. focused on the field of stable isotope research. Turner is leading the research into novel in vivo applications of stable isotopes in diseases. With its patented isotopic tracer technology, Kinemed enables its clients to track key chemical pathways within living systems and look at bio-chemical processes that are targets of drugs. Focusing on study in intact organism provides integrated systems biology information underlying the root causes of disease, said Turner.

Nikesh Kotecha is CEO of Cytobank Inc., a company focused on providing scientific, informatics and software solutions for cytometry. Cytobank focuses on analyzing single cell technologies and has created Cytobank, a cloud-computing platform for flow cytometry data. The Cytobank project grew out of Kotecha’s focus in Dr. Garry Nolan’s lab at Stanford University in developing a diagnostic for juvenile myelomonocytic leukemia and on analysis methods for single cell assays. Thus they take an interdisciplinary approach to address biological and clinical problems to help companies bring together their laboratory bench work and informatics needs. Cytobank is taking this beyond flow cytometry to mass cytometry, for identifying biomarkers, useful in personalized medicine, said Kotecha.

Pradeep Fernandes, co-founder and President of Cellworks Group, was most recently VP and GM of Synthesis Solutions at Cadence Design Systems, following its very successful $120M acquisition of Get2Chip in 2003.  Currently, a great deal of data is being generated.  Software is a tool that can be leveraged to manage and visualize large data, extract trends, generate insightful data and eventually predict information from large data sets, said Fernandes.  CellWorks takes in vivo and in vitro data and clinical trends and tries to build dynamic models that simulate disease phenotypes in computers and can be used to perform mechanistic studies.  This information is used to predict effects of new therapy and gain new biological insights regarding toxicity and biological efficacy of drugs.  CellWorks has an internal pipeline of therapies and is in collaboration with Astra Zeneca, Genentech and other companies interested in driving selection of therapies.

Speed Pitch, Accent on Youth, Speed Networking

In Speed Pitch, early stage life sciences companies were given the stage for a quick 5-minute pitch about their idea, technology, or company. The companies presented to the entire audience and obtained quick feedback from the distinguished VC panel and gained exposure to showcase to various potential collaborators, partners, and investors. Selected presentations are highlighted on the EPPIC website and other promotional material.

The Youth Panel was An Eppic Annual Conference First. This panel gave an opportunity to budding high school and college age scientists to showcase their outstanding research and later ask questions of each other’s research and future goals etc. The purpose of this panel was to inspire excellence among young people but these exceptionally bright, charming youngsters inspired the audience and left everyone spell bound.

Finally the Speed Networking event gave an opportunity to meet conference attendees in quick three-minute introduction and card exchange rounds.

This was a great conference that provided wonderful networking opportunity and was followed by more relaxed networking and wine reception.

Challenges and Opportunities in the US Spine Market

A panel moderated by Justin Klein, Partner with NEA, addressed issues and challenges in the spine market, at WSGR Annual Medical Device Conference.   Just a few years ago, the spine represented the fastest growing segment of the orthopedic industry, and venture capital funded dozens of new companies each year in this space. The US spine market was growing rapidly and was estimated to exceed $8 billion by 2016. Today the U.S. spine market is flat or declining, despite the unmet needs of patients with spine conditions and related pain issues. New percutaneous and MIS technologies—accessible to both interventional pain specialists as well as spine surgeons—are gathering increasing evidence in the clinic and are emerging on the radar of strategics.

Panelists at WSGR annual medical conference on spine, Matt Alves, VP of Strategic Development with Stryker, Alex DiNello, President & CEO with Relievant Medsystems, and Earl Fender, President & CEO, Vertiflex, discussed the challenges and opportunities in this rapidly evolving spine market. Overall view from the panel was that payers are increasingly looking at clinical outcome data and there is’nt much data on appropriate clinical outcomes, particularly in chronic back pain treatment studies. Studies need to be put together that look at the effectiveness and also do cost effectiveness comparison, said DiNello. There continues to be growing scrutiny in the US on the justification for and prevalence of spinal fusion procedures. Though insurance companies are pushing back on fusions, these patients are not going anywhere and are not getting better and are finding their way back into other pain management avenues. So clearly the need exists.

According to Alves, data is pointing towards the benefits of early intervention in terms of requirement of a less invasive treatment and saving cost. Fender said that Vertiflex device is showing many advantages in terms of cost saving, less blood loss, less trauma, and no infections. It seems clear that although demand for spinal implant procedures is there and is growing, the cost-constrained environment will continue to affect the market over the forecast period. Minimally invasive approaches to spinal fusion continue to gain in popularity due to less blood loss, decreased patient trauma, and faster recovery times and all this in turn resulting in cost savings.

2012 WSGR Annual Medical Device Conference – opening panel

Each year, Wilson Sonsini, Goodrich, and Rosati Medical Device Conference, brings together industry CEOs, venture capitalists, industry strategists, investment bankers, market analysts and other professions to understand the challenges and opportunities facing the medtech industry. The conference this year, focused on gaining insights and a deeper understanding of the challenges facing the Medtech start-ups and the strategies that can be effective in responding to these challenges.

The opening panel was moderated by Marty Waters, Partner at WSGR and focused on where the medtech investment is happening. Despite over $2.8 billion invested in medtech venture deals in 2011, clearly the major common agreement among panelists was that medtech funding is significantly down. Mike Carusi, General Partner with Advanced Technology Ventures explained, “we have investors too” and they are not investing significantly in medtech funds. When they do invest, Carusi elaborated, they look for opportunities addressing a drug market and his advice was that entrepreneurs figure out ways in leveraging the ecosystem. Yuval Binur, Managing Parnter at Orchestra Medical Ventures, advised that entrepreneurs focus not only on unmet clinical areas but also focus on unmet strategic needs. As VCs, he elaborated, “we need to fund strategic partners who can help with commercialization” and he advised that entrepreneurs pay attention to and build relationships with strategic partners. Using anecdotes, analogies, and terminology from Hollywood, John Friedman, Managing Partner & Founder with Easton Capital, said, “we need to go back to the future”, and if VCs see many companies being funded in the same area, they need to move away from it. Voicing a slightly different opinion from Binur, Friedman said, VCs should invest in companies that focus on fundamentally unmet needs or are developing standard of care at 10-20% of the cost. He said VCs are moving away from early stage and are looking at deals which are capital efficient. Strategically, it is much more important to dominate the region locally, which is also easier and more effective, said Friedman. Opining on emergence of wireless technology, he advised that in more of a serviceable model, the leaner the IP, more protectable it is.

Bill Harrington, Managing Partner with Osage University Partners, agreed, the age of incrementalism and me-too’s is gone. Basic, hypothesis based research is happening in Universities and their fund focuses on capturing that. They have an increasing database of university partners with access to participating companies. Harrington added, that while device companies mostly have one formidable asset, with pharma companies, there is more of a possibility to do licensing deals or license assets. There is greater interest in late stage deals because with market traction, there is some indication if it is strategically advantageous and how it is doing, said Harrington. A lot of companies highly underestimate the risks and costs of commercialization. Speaking on emergence of wireless technology, Harrington said that outside the medical field, technology is rapidly moving ahead but they still lack intelligent ways to use the data and there are opportunities in that area. Dirk Kersten, Partner with Gilde Healthcare Partners, said, they are looking at companies with reasonably good products serving real market needs. With wireless technology, there are huge opportunities in home health care, to provide better care, cheaper and for longer duration, said Kersten.

The blogs that follow will focus on other discussions.