WSGR 2017 Medical Device Conference

With shrinking pool of serious early stage life science investors and stringent capital requirements, the path for medtech companies has become greatly challenging.  As is the case every year, Wilson Sonsini Goodrich & Rosati 2017 Medical Device Conference provided a forum for addressing challenges faced by new medtech companies as well as opportunities presented by current trends.

Various speakers and panels addressed these issues from diverse angles and perspectives.  Following a welcome address by Casey McGlynn, an early morning panel moderated by Donna Petkanics addressed new models for medtech investing.  Panelists Andrew ElBardissi (Deerfield Capital), Eric Milledge (Endeavor Vision SA), Leighton Read (Brandon Capital Partners), and Valeska Schroeder (KCK Group)  discussed how the investors are adapting their financing strategies and business models in response to the newer challenges that medical device companies face.  Milledge opined that it is now crucial for medtech companies to get some regulatory approval before seeking to raise money. Even CE mark could help, said Milledge. ElBardissi offered that if the company is US based and focused on US commercialization strategy then EU approval does not help. He advised that medtech companies “keep the head down and focus on US approval UNLESS there is capital efficient advantage of focusing on EU”. Schroeder said their fund was “geographically agnostic” but they believed that for an early stage medtech company it is important that they not “simply throw capital without a plan”.  but there are values you can get out which may not be revenue based but you can get close to your customer base etc… not go in every country but choosing a small no. of country to go through. Read observed that a company seeking to create larger returns must go after larger markets.

With the current challenges medtech world has become more global as companies and investors are finding win-win solutions through newer models of partnering by going across continents and countries. Geographically, Pacific Rim has emerged as hot collaboration frontier. A panel moderated by Elton Satusky with CEOs Yue-Teh Jang (Medeon Biodesign), Kewen Jin (Serica Partners, Trevor Moody (M. H. Carnegie & Company), and Norman Weldon (Partisan Management Group), who completed such collaborations, financings and mergers with companies and investors in Asia discussed how these transactions may be structured.  Another panel moderated by Jack Moorman (US-Japan MedTech Frontiers – USJMF), with panelists Kenichi Hata (Terumo Corporation), Masazumi Ishii (AZCA Inc.), Yuichiro Morimoto (Enplas Corporation), and Richard Packer (Asahi Kasei Corporation) discussed collaborations between Japan and Silicon Valley.  Japan has emerged as a major partner in medtech OUS financing and growth strategy.  

Increasingly there is a pressure on medtech industry that is unlike most other industries, to show value. Many organizations have now come up with ways to define and measure value creation. Among them, AdvaMed has developed a new framework to assess the value of medical technologies and diagnostics in a broad, patient-centric approach. A panel moderated by Donald May (AdvaMed) with panelists Maneesh Arora (Exact Sciences Corp), Jeff Farkas (Medtronic), and Jo Carol Hiatt (Kaiser Permanente) addressed how companies may leverage value creation to make internal business decisions to allow for more efficient use of capital and to drive discussions with potential investors as well as to keep track of milestones during the commercialization process.

AdvaMed model focuses on following drivers of value creation, 1) clinical outcomes, effectiveness and utility measures 2) non clinical patient impact including impact on caregivers, families, ease of product use, ease of care, financial impact etc. 3) new drivers around value based purchasing, care delivery costs, reduction in readmissions etc. from provider perspectives, and 4) broader public impact on population and communities in terms of whether or not the technology reduces overall cost to the system, helps identify diseases, helps employers reduce absenteeism and so on. May said the model begins with the patient and goes on to incorporate multiple stakeholders and values for all may not always be aligned or the time frames may differ. As an industry, “we need to think of appropriate levels and types of evidence as we think of new value based models of integrated care”, said May. Speakers discussed the need to move away from one number and focus on broad picture with many factors that include clinical as well as economic value, in order to get better outcomes while reducing costs.

As is the case, WSGR medtech conference provides an excellent forum for investors, startups, and professionals in the industry to come together in a spirit of learning and collaboration. And compared to previous years, it seemed to be even more well attended with hallways abuzz with discussions on partnering. As always, the conference ended with short presentations from select few startups and the announcement of the $25,000 grand prize and Medtech Innovator Award.  But the best was reserved for the last. More networking happened and deals were done as attendees mingled with good food at the reception and as the best wines were uncorked and venture capitalists served as sommeliers and poured wine for the attendees.

 

Point-of-care Solution to Minimize Prescription Filling & Medication Dispensing Errors

Dr. Alan Jacobs, Founder and CEO of PerceptiMed talked about “preventing drug-related patient injury and death with advanced, cost-effective technology systems”, at www.bio2devicegroup.org event.

Medication dispensing error occurs when there is a discrepancy between a prescription and the medicine that the patient receives.  It can occur in pharmacies, hospitals, or nursing homes.  Such errors can occur at any stage during the long chain of events that transpire between the prescription that the pharmacy receives and the medication that the patient receives.  A prescription may be read incorrectly, transcribed incorrectly, dispensed erroneously or delivered to the wrong patient.

Pharmacies dispense enormous volumes of medications.  So, relatively low volumes of dispensing errors, in proportion to the medications dispensed, translate into huge numbers of erroneous medications that the patients receive, with serious consequences.  For instance, do you know that each year in the US, there occur almost 345 million medication dispensing errors?  These errors lead to 1.5 million patient injuries and staggering 7,000 deaths, each year.  Additionally, such mistakes are very costly.  These preventable medication errors cost $21 billion in wasteful healthcare spending, each year.

Pills (white rabbit) (Photo credit: erix!)

Medical dispensing system is a complex system.  Often prescriptions are filled by technicians or others representing low skilled workforce.  After the prescription is received at the pharmacy, and the patient profile is made, the pharmacist or the technician enters the prescription in the computer.  The technician then goes to the stock room, counts out the number of pills and fills in the medicine container, and appropriately labels it.  The pharmacist makes one last check, reviews the completed order, verifies drug name, strength, dosing directions, and then visually inspects the pills.  Finally, after verification that the prescription is filled for the correct patient, the medicine is dispensed.

Prescription filling errors can occur at any stage, in the process.  There are currently 10,000+ pills on the market.  About 2633 pills are white and round, 718 are yellow in color.  Despite the fact that following FDA ruling, every pill is marked with a special insignia, given the volume of similar looking pills, this is an error waiting to happen.  Typically, in a busy pharmacy, a pharmacist may fill out 200-300 prescriptions, a day.

PreceptiMed offers a breakthrough point-of-care product, IdentRX that provides real-time identification of individual pills and checks each pill against the patient’s prescription.  This solution is built upon state of the art pill identification algorithms and machine learning technology that enables the system to learn about each new pill that is introduced.  There is 100% identification of each individual pill as it is dispensed into the pill bottle.  The optical sensor reads 120 pills a minute.  Its error detection rate is 99.9% and it requires no calibration or modification of pill or any other special packaging.  This automatic, pour and go, first in class system correctly verifies all parameters, and checks for correct medication against patient information, dosage, and quantity.  It flags when there is an error the first time, unlike mechanical errors that go undetected for long periods and get further compounded.  Built in safe guard eliminates cross-contamination with sensitive products.

PerceptiMed has a broad IP and various other products for other uses in nursing homes and so on.  This point-of-care dispensing system does not require FDA approval.    Currently, almost 25% of the technician’s time is spent on making a mistake or correcting the mistake, as restocking of erroneous products is also a complicated process, further raising the possibility of errors.  PerceptiMed system makes it easy to restock erroneous products, saving enormous amount of time.  Additional products are in the pipeline.  For instance, Scrip Clip is a simple clip with a sensor that goes on top of the pill envelope and when the patient info is entered in the system, it lights up, allowing for easy pick up from all medications waiting to be picked up.  Also it makes it easy to restock the medications that are not picked up.  There are other fail safe products for use in nursing homes (for instance, eMAR), to ensure right medication, at correct dosage and time is given to the patient, and the date is entered immediately, to avoid overdosing.

This was a very interesting talk that included several videos that demonstrated the products.  The talk was followed by Q&A.
XXXXXXXXXXXXXXXXXXXXXXXXXXXX

Upcoming Healthcare events in Bay Area

http://www.bio2devicegroup.org features top notch speakers and many events are completely free.

Healthtechnology Forum conference http://www.healthtechnologyforum.com, focused on exploring pathways to sustainable health, is on May 20 in SF. Please register for the conference as my friend, with the discount code “HTF14-FriendOfOrganizer” and send me your first & last name at wd_darshana at hotmail dot com, to get $150 off the price of the ticket.

www.tiecon.org – If you are a professional  in #healthIT, #digital health,  #internetofthings, #cloud, #bigdata or related, I would say this is the conference, you don’t want to miss – It offers a fabulous opportunity to network with 3000+ professionals and listen to top notch speakers and panelists.  You can register for #TiEcon (May 16 & 17 at Santa ClaraConvention Center) at link http://tinyurl.com/kr2hkcw  as my guest & enter promo code tievalue to get $100 discount.

http://www.wsgr.com/news/medicaldevice/ – #WilsonSonsini, #WSGR annual medical device conference in San Francisco, June, 12.

JOBS: are posted at the link http://bit.ly/1o85CTM

Genetically Engineered Oncolytic Virus to Treat Glioblastoma

Glioblastoma or GBM is the most aggressive brain tumor for which currently there exists no cure.  Michelle Chen talked about targeted oncolytic virus therapy for these tumors.  These tumors are highly malignant because the cells reproduce quickly and they are supported by a large network of blood vessels.  There are approximately 25,000 new cases in Europe and US, each year.  Median survival in newly diagnosed patients who receive the best treatments is less than 14 months.  Most patients experience quick relapse and survival after 5 years is very dim.

Following the diagnosis, the current standard of care consists of surgery, radiotherapy, and chemotherapy with temozolomide.  FDA has recently also approved Avastin for recurrent GBM.  But new therapies for GBM are urgently needed.  There is a lot of activity in this space but currently active drugs have lot of safety concerns.

English: TAC_Brain_tumor_glioblastoma-Coronal_plane Italiano: Immagine TAC della zona cerebrale, identificando un tumore di tipo glioblastoma (Photo credit: Wikipedia)

DNX-2401 may be an elegant genetic engineered solution.  DNX-2401 is an engineered virus that is capable of selectively and effectively killing a broad range of tumor cells with defects in the retinoblastoma (Rb) pathway.  The virus enters cells by binding to specific types of integrins highly expressed on tumor cells and tumor endothelial cells.  Once it gets in, the virus replicates rapidly and the replicating viruses in turn kill host tumor cells.  Further cell killing is done by triggering of anti tumor immune response which is capable of eliciting tumor destruction.

DNX-2401 therapy has shown to improve survival in animal models.  Relapse of GBM is attributed to recurrence and persistence of tumor stem cells.  Is it possible that the virus kills the stem cells as well?  Indeed, results indicate that brain tumor stem cells are also susceptible to being killed by DNX-2401, said Chen.  Additionally, Delta 24 RGD + temozolomide seem to provide enhanced therapeutic benefit in combination therapy.

Early safety profile of DNX-2401 looks very good and early indication suggests it to be very efficacious and capable of selectively and effectively killing a broad range of tumor cells.  Expectations are that DNX-2401 will demonstrate therapeutic effects in a wide variety of cancers.  Currently DNX-2401 is delivered by direct injection into the tumor bed, guided by the MRI through the cranium or through surgical resection, into the walls of the resection cavity to kill residual tumor cells.

Chen went into more detailed explanation of the mechanism of action, and her talk was followed by Q&A.

+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

Other information and events below.

Jobs: There is a huge uptick in JOBS.  Check out new jobs posted for May at http://bit.ly/1o85CTM .

TiEcon: If you are a professional  in #healthIT, #digital health,  #internetofthings, #cloud, #bigdata or related, I would say this is the conference, you don’t want to miss – It gives fabulous opportunity to network with 4000+ professionals. Check out great agenda, top notch speakers & panelists at www.tiecon.org.  Register for #TiEcon (May 16 & 17 at Santa Clara Convention Center) at link http://tinyurl.com/kr2hkcw  as my guest & enter promo code tievalue to get $100 discount.

Healthtechnology conference & Code-a-thon http://www.healthtechnologyforum.com, focused on exploring pathways to sustainable health, is on May 20 in SF. Please register for the conference as my friend, with the discount code “HTF14-FriendOfOrganizer” and send me your first & last name at wd_darshana at hotmail dot com, to get $150 off the price of the ticket. There are $20K+ in prizes at the code-a-thon.

Dr. Sarvajna Dwivedi, founder of Pearl Therapeutics will talk on Tuesday, May 6.  Notice venue change & pre-register at  http://www.eppicglobal.org . Pearl Therapeutics was acquired by Astra Zeneca last year, for $1.15 B and was a winner of TiEcon’s TiE50 awards, two years in a row. It will likely be sold out event, so please pre-register.

http://www.bio2devicegroup.org meets every Tuesday in Sunnyvale, CA.  Morning meetings are free, wealk-ins welcome. Dr. Alan Jacobs, Founder & CEO, PerceptiMed will talk on “Preventing Drug-Related Patient Injury and Death With Advanced, Cost-Effective Technology Systems“.

Feel free to send me an email for any of these events at wd_darshana at hotmail dot com and you can follow my updates on Twitter @DarshanaN.

OncoProtein based Program for Early Detection of HPV induced Cervical Cancers

Dr Johannes Schweizer, VP of R&D at Arbor Vita Corporation talked about Arbor Vita’s proprietary OncoE6™ Cervical Test that Predicts Development of Cervical Cancer at www.bio2devicegroup.org event.  Information on 3 great upcoming conferences EPPIC, TiEcon, and HealthTechForum with great speakers on healthcare tracks, is posted at the end of the article.

Arbor Vita was found by Dr. Peter Lu, in 1998 with an aim to apply discoveries of the role of PDZ proteins to the development of novel therapeutics and diagnostics.  Numerous pathogens have been found to cause diseases by binding to a PDZ protein and thereby disrupting normal cell signaling.  The ability to regulate PDZ/PL interactions represents new opportunities in controlling multiple signaling cascades in complex diseases and have recently been a focus for human drug targets.  Arbor Vita has identified nearly all of the PDZ domains in the human proteome and has decoded most of them.  Arbor Vita’s platform technology is targeted towards several diseases.  Its stroke treatment asset was recently sold to NoNO, Inc.  Avian flu Dx is the first FDA cleared rapid Dx test.  At this event, Dr Schweizer discussed Arbor Vita’s diagnostic and treatment technology for HPV induced cancers.

Cervical cancer is a leading cause of mortality, worldwide.  HPV induced cancers are transmitted through sexual contact and kill over 275,000 women, every year.  These do not receive as much attention because the mortality rates are lower in the US and other developed countries.  But mortality from slow progressive cervical cancers peak in developing countries.  In India for instance, every 7 minutes, a woman dies from this disease.  The current mode of detection is through pap smears, which have poor sensitivity and poor specificity.  In the US, out of 100,000 women tested, 23,000 are likely to be hr-HPV positive.  But from these, only 6 women are likely to have cancer.  This indicates that the current screening methods are sensitive but are not sufficiently specific to detect pre-cancerous and cancerous activity and low specificity leads to over treatment.  Pap tests give about 20% false positive and false negative results.  The only reason it still work is because of the frequency of testing in the case of this very slow moving cancer, said Schweizer.  Also pap tests require lot of infrastructure and set up that is often not easily available in developing regions.

Arbor Vita’s OncoE6TM Test is the only test that specifically identifies the viral E6 oncoprotein that causes cervical cancer.  And it is simple to administer with specimen captured with a polyester tipped cervical swab, which can also be captured by the woman on her own as well.  Elevated E6 oncoprotein correlates to cancerous activity and development of high-affinity anti E6 mAb is a key to feasibility.  There are 15 HPV types that cause cancer.  Among these, HPV 16 and HPV 18 are leading causes of cervical cancers, worldwide.  This test is specific to these two viruses.  Further this test is robust and lends to easy storage at ambient temperature.  The entire process from sample collection to getting the results can be completed in 2.5 hours.

Schweizer shared some of the data from its clinical trials.  The data indicates that in a head to head comparison with OncoE6TM, the DNA test results in nine fold over treatment including colposcopies and biopsies.   OncoE6 Cervical Test on the other hand, has high specificity for women with high grade disease cancers.  OncoE6 Cervical Test efficiently identifies women in need of clinical follow-up, among the many more with clinically irrelevant HPV infections.  In a one year follow up, E6TM promised to be a solid predictive marker as high specificity and high PPV are keys to lower referral rates and clinical follow-up.  This was very interesting talk and was followed by Q&A.

_______________________________________XXXXXXXXX________________________________________

Please see below information on some excellent conferences and events coming up in the Bay Area, in next couple of months.

March 29, 2014 (day after tomorrow) EPPIC (www.eppicglobal.org) is hosting annual conference at SF, Westin.  Panels include Neglected & Rare Diseases – http://bit.ly/1c1vvTR, Innovations in clinical Development of Novel Agents, Point of Care gold rush and there will be speed pitch and SIG networking opportunities.  Promises to be a great conference.

May 16, 17, 2014 TiE SV (www.tiesv.org) will host TiEcon (www.tiecon.org) , the largest entrepreneurship conference.  This year it will feature #healthcare track with focus on Disruptive Technologies in Healthcare.

May 20, 2014 HealthTech Forum (www.healthtechnologyforum.com) will host annual conference around the theme “Pathways to Sustainable Health” at Parc 55 Wyndham, SF and will feature excellent panels and speakers on Medical Research in the Cloud, Patient Engagement in Behavioral Health, Improving Health in Global Underserved Communities and more.

www.bio2devicegroup.org meets every Tuesday and next Tuesday Dr. Russell Pachynski, co-founder, CombImmune, will talk about “Novel approaches to Immune Therapy and Monitoring”.

Check out new job opportunities 1) Embedded Software Engineer – Mountain View, CA 2) Quality manager – Mt Laurel, NJ – http://bit.ly/P1H0QK

 

OneMedForum – San Francisco, 2014

The OneMed forum conference was launched in January of 2008, when economy was showing all signs of progressing to new heights, with an objective to showcase innovation in medtech.  The conference aimed to bring together the companies and investors, during the large influx of healthcare investors and executives, during the JP Morgan Healthcare Conference, in San Franciso.  Fast forward to 2014 and we are perhaps just emerging from one of the worst recessions; a downturn that hit the medtech sector more than any other industry segment.

This year, the location of OneMed Forum was changed and the venue was moved further away from the JP Morgan Conference.  Since the weather in SF was gorgeous, it was not a problem; but if the venue continues to be further away in future, and in the event of cold and rainy weather, it can have an impact and lower the attendance at future OneMed events.  This year also OneMed event seemed to be sparsely attended, although that appearance might also be enhanced because the meeting rooms were spread out on two different floors and there wasn’t a single spill out location for the participants to meet and network – another problem with the venue.

There was also a palpable difference between the JP Morgan conference and the OneMed Forum, this year, in terms of optimism.  While biotech and pharma sector is returning to pre-recession levels with a large number of IPOs and higher numbers of dollars raised, medical technology companies have yet to see significant investment dollars.  On talking with the participants, I heard a note of disappointment regarding low attendance from VCs and other investors, just like in the last few years.

However, despite slow pickup and staggering growth in the medtech sector, it is transforming and the companies are learning to operate more efficiently.  It is also recognized that healthcare is at a critical point and medical innovation will have to address some key challenges.  Various panels and speakers at the OneMed Forum, addressed the changing healthcare landscape and how the future of health and medicine will need to be shaped, in the coming years to address the key issues. 

Major Highlights

Personalized Medicine Panel discussed the promise offered by customized diagnosis and treatments, in lowering the cost and increasing effectiveness.  Panel sessions addressing the JOBS Act and the Affordable Care Act, explored the impact of the legislation on cost of care and access to care.  Companies and solutions that may be poised to offer effective healthcare solutions and may also present interesting investment opportunities were highlighted.  In somewhat grim medtech landscape, digital health is emerging as the hottest new trend, with much potential.  The Digital Health panel discussed the impact of Affordable Care Act in increasing information transparency and empowered consumers taking greater control of their health information.  The changing role of the patients/ consumers will require change in the healthcare delivery and transformation in the business model.

A panel addressing “reimbursement strategy after the affordable care act”, discussed impact of medicare payment rules on medtech and hospital markets.  The panel also discussed trends in coverage and payment for newly emerging molecular diagnostic tests.  One key advice from the panel was that thinking upfront about the reimbursement strategy will be increasingly more important for companies with new, innovative products.  A panelist also suggested that during clinical trials, companies can also think about reimbursement and instead of doing only what may be required by the FDA, if they can also collect reimbursement data then they would come out ahead.  During innovation, the companies should relentlessly focus on disease management, and that would lead to them to appropriate and effective reimbursement strategy, advised the panel.

Financing and IPO issues were addressed in various panels.  One interesting panel on Crowdfunding discussed a handful of portals that are beginning to raise some capital for emerging growth companies.  One investor who was attending the panel, later told me, that it is too early to give an opinion on what kind of success this strategy would yield, but he had some grave concerns.    AdvaMed CEO’s Unplugged Panel featured some of top leaders of the MedTech industry, who shared their insights on key challenges facing the industry.  Stuart Randle, CEO of GI Dynamics advised startups to focus on crucial healthcare issues including obesity.  He also advise companies to pursue capital intensive strategy, and at least initially sell products outside the US.  Scott Brooks, CEO of Regenesis Biomedical, advised startups to get good legal and regulatory counsel early on.  Patrick Daly, CEO of Cohera Medical was optimistic about the future of MedTech.  “IPOs are coming back, M&A is picking up, and dollars are rolling in, big companies have record levels of cash, and I feel positive”, he said.

One of the most prolific financiers, Bill Hambrecht gave a keynote address.  Hambrecht has over 500 IPO’s to his credit that include seed level funding in nascent industries.  Although I did not attend the keynote, I heard some highly positive comments from an attendee.  Steven Burrill, who has been at the helm of innovation in healthcare and shares and who regularly shares his insights through his annual reports, gave a second keynote.  Again, I missed the address but both keynotes were major highlights of the event.  Throughout the conference, over 800 emerging companies gave presentations.  Following the presentations, partnering and breakout sessions gave the opportunity for conference delegates to meet the CEO’s of these companies.

Although it may seem hard to believe, it appears that now the MedTech sector has nowhere to go but up.  The industry has learned some hard lessons, the companies are lean, operating with greater efficiency, spending cash wisely, and instead of hawking next new technology, they are focused on key problems facing the healthcare industry, and on providing effective solutions.  If the healthcare providers are not eager to incorporate some of the solutions, then it will happen out of necessity.  It will become incumbent upon the healthcare industry to implement solutions offering greater ROI in terms of improved health and lower cost.  Healthcare providers will be looking for solutions that provide digital and point of care diagnosis and health monitoring and treatment options and solutions from personalized medicine and genomic health.  Let us stay tuned for some cool innovations from the MedTech sector in 2014.  Senior Analyst at Wells Fargo, Larry Biegelsen has also observed that not only acceleration in healthcare spending is expected in 2014 but there are number of other tailwinds including, “emerging technologies and emerging markets contributing more to growth and a more industry-friendly FDA, which should lead to faster approval times for medical devices”.   

 

JOBS – December, 2013

For the opportunities below, please send resume at wd_darshana at hotmail dot com.  Please indicate in the email how closely the job description matches your background and identify gaps, if any.  Also, indicate your current compensation and compensation expectations.  Please note: All below opportunities require several years of industry experience and are only for local candidates, with valid US work visa (when need arises for applicants with other types of visas, I will mention that).  Also note, opportunities at the top are hot and the ones lower down may be at various stages of being filled or not burning needs.  I am awaiting more job descriptions and will keep adding.   Leads appreciated.

ios/ Android Developers – Bay Area, CA
Immediate need for health-IT company.

Senior and Junior Bioinformatics Scientists – San Ramon, CA

An organization near San Ramon, CA, dedicated to leveraging a range of transformational digital medical technologies in medical imaging and information technologies, medical diagnostics, patient monitoring, disease research, drug discovery & biopharmaceutical manufacturing technologies, has an immediate openings for Bioinformatics Scientists at Senior and Junior level.  Below description is for senior role.

Responsibilities: Bioinformatics developer will work with scientists & engineers for development of systems software within medical diagnostics. The position may also develop distributed software application for subsystems that enable the business strategic imperatives.  Essential functions: Develop robust bioinformatics software solutions to support company’s medical diagnostic activities; Work closely with systems teams in requirements gathering & software design; Interact with global teams to promote consistency & maximize synergies across common software platforms; Design & build strong testing infrastructure to minimize dependency on hardware availability; Leverage DFR for software, Agile & Lean software development methodologies to drive reliability upstream into the product development life cycle.

Requirements: MS or Ph.D. in Bioinformatics or Molecular Biology with a minor in Computer Science, Statistics or Computational Biology; 5+ years experience in combining knowledge of chemistry, physics, and/or biology with software engineering; 3+ years experience in programming using Pearl and/or Python; 2+ years experience with SQL, preferably MySQL; 2+ years experience with statistical programming (e.g. R, MATLAB).

Regulatory Affairs Director – Mount Laurel, NJ, & Orangeburg, New York (and another similar opening in Bay Area, CA)
(mention location preference when sending in the CV)

There is an immediate opening for Regulatory Affairs Director in a medical device company with innovative treatment of chronic heart failure built around CCM technology.  RA Director Will be responsible for RA and for Quality systems.

Responsibilities: Domestic & international submissions & approvals for all new & existing products; Assuring compliance with domestic & international quality and regulatory requirements; Assistance with design & implementation of clinical trials to support new & existing products; Represent company with FDA, Notified Body &  international regulatory agencies regarding company’s regulatory strategies & submissions; Determine strategy, content & structure of domestic & international regulatory filings & quality assurance strategies; Maintain quality system & current product documentation & labeling in compliance with new standards, directives & requirements; Assist in design & implementation of clinical studies in support of new & existing products.  Act as liaison with clinical function; Represent the company with all domestic & international regulatory agencies including all verbal & written communication to & from the company; make all final decisions regarding all Quality System related activities; Review all product complaints & ensure timely reporting of those events to domestic & international regulatory agencies as necessary; Review & revise quality system documentations; Schedule, ensure completion of, manage & respond to all audits; Ensure training of employees on Quality Systems Regulation & key international regulations & standards; Manage the program for handling product returns, returned product evaluations (repair/rework, where applicable), complaints & customer feedback in accordance with internal policies and procedures; Maintain ISO 13485:2012 facility registration in accordance with applicable standards; Participate in product development teams on behalf of Regulatory & Quality Systems; Ensure that the Quality Systems function is carried out in accordance with GMP & ISO directives; Prepare &  submit regulatory submissions to obtain approval to conduct domestic & international clinical investigations & to seek regulatory approval to commercialize new & existing devices & their accessories.

Requirements: Bachelor in science / engineering with at least 5 years’ experience in Regulatory/Clinical/Quality area or related experience; Regulatory/Clinical/Quality experience with Class 3 medical device; Regulatory experience in the Implantable field – highly preferable; Excellent working knowledge of domestic & international requirements, regulations & standards applicable to medical electrical devices – highly desirable; Proven experience with at least one complete medical device submission to a EU Notified body and the US FDA involving a device subject to the 60601-1 3rd edition standard; Thorough understanding of the MDD (Medical Device Directive); Previous direct interaction with the FDA & an EU Notified Body; Excellent working understanding of requirements & implementation of Quality Systems compliant with US & international requirements for medical device manufacturers; Previous experience assuring that the Quality Systems function is carried out in accordance with GMP & ISO directives; Ability to analyze & perform commercial risk management in the context of regulatory & quality requirements.

Director of Quality Assurance – Palo Alto, CA

Details to follow.

Senior Manager/ Director of Mechanical Engineering – San Jose, CA

There is an immediate opening for hands-on Director of R&D Mechanical Engineering in an early stage company developing a novel approach for the oral delivery of large drug molecules.  This position will be responsible for building the team and effectively leading multi-project R&D efforts of the organization through technical expertise, interpersonal skills & a clear vision for execution.  Stock options and cutting edge technology makes it highly attractive opportunity for the right candidate.

Responsibilities: Manage resources to accomplish multi-project product research & development; Provide Mechanical Engineering support to meet R&D objectives; Remain current on developments in field(s) of expertise and industry trends; Actively pursue development of corporate IP; Identify future product opportunities; Develop plans & analyses for execution and review with leadership team; Maintain & update appropriate controlled documentation; Mentor junior staff members.

Skills & Experience: Demonstrated leadership of technical teams in medical device field; aptitude for & mastery of Mechanical Engineering principles; problem solving skills in a multidisciplinary environment; Proficient with statistical analysis for engineering and manufacturing; ability to work closely with team members across engineering & non-engineering disciplines such as biochemistry, physiology, pharmacology & chemistry; Knowledge of plastic manufacturing processes including injection molding, thermoforming, casting, machining, extrusion etc.; Knowledge of metals & alloys used in medical devices and processing techniques such as brazing, laser welding & cutting, electropolishing, electroplating, machining etc.; Deep experience in polymer processing, catheter design & fabrication, including knowledge of polymer joining, fusing, die cutting, adhesives etc.; Knowledge of biomaterials & coatings suitable for implantation; Knowledge of packaging & sterilization techniques; ability to interface effectively with professionals in the medical and biological sciences; knowledge of sound design principles, regulatory requirements, and product and process validation procedures; proficiency with computer aided design software & hardware. Formal training on systems & software is desired.

Also required: Bachelor’s degree or higher in Mechanical Engineering; 10+ years experience in engineering and product development with demonstrated capability & thorough understanding of the medical device product development process; Three years minimum direct personnel management & related project leadership experience; ability to map task interdependencies, multi-task, prioritize such tasks, meet deadlines & develop, monitor and live within budgets as well as ability to forecast major milestones. Must be skilled at delegation, follow-up, and team building.

Director Quality Engineering – San Jose, CA

There is an exciting opportunity for Director Quality Engineering with strong capability and experience developing quality innovative medical devices.  This position is responsible for effectively leading multi-project quality engineering efforts of the organization through technical expertise, interpersonal skills and a clear vision for execution.

Responsibilities: Manage resources to accomplish multi-project product research, development and manufacturing; Contribute to strategy and management of GMP/GLP operation; Provide Quality Engineering support as necessary to meet organizational objectives; Maintain quality management systems necessary for development, including clinical evaluation; Develop quality plans and data analyses for execution and review with leadership team; Develop test strategies DOEs and test protocols to test developmental medical devices and manufacturing processes; Work with R & D and Operations to establish quality requirements at all phases of product/process development and manufacturing; Design, schedule, and if necessary, performs specific testing for existing and new products including supporting design and process validations, qualifications and first article inspections; Conducts supplier evaluations including supplier audits; Ensure that appropriate level of quality/reliability in purchased components is specified; Identify product/process problems and ensure appropriate corrective actions are taken and verified to be effective in eliminating problem; Remain current on developments in field(s) of expertise and industry trends; Mentor junior staff members

Skills Required: Demonstrated leadership of technical teams in medical device field; Demonstrated aptitude for and mastery of Quality Engineering principles; Demonstrated problem solving skills in a multidisciplinary environment; Exemplary analytical, organizational, written and oral communication skills; Proficient with statistical analysis for engineering and manufacturing; Strong ability to operate independently and as a team member; Teamwork: ability to work closely and effectively with team members and colleagues across engineering as well as non-engineering disciplines such as biochemistry, physiology, pharmacology and chemistry; Knowledge of implantable medical device design control and manufacturing processes ; Deep experience in safety standards for a variety of medical device types; Knowledge of biocompatibility, packaging and sterilization quality assurance; Demonstrated ability to interface effectively with professionals in the medical and biological sciences; Demonstrated knowledge of sound design principles, regulatory requirements, and product and process validation procedures; Demonstrated proficiency with computer aided design software and hardware familiarity. Formal training on systems and software is desired.

Also required: Bachelor’s degree or higher in Engineering; Ten years minimum experience in medical device engineering (Quality, R&D and Manufacturing) with demonstrated capability and thorough understanding of quality management; Three years minimum direct personnel management and related leadership experience; ASQ Certified Quality Engineer certification preferred; Must have experience in GMP electro-mechanical product design and manufacturing; Requires highly developed leadership skills and experience, including the ability to map task interdependencies, multi-task, prioritize such tasks, meet deadlines, and develop, monitor and live within budgets as well as the demonstrated ability to forecast major milestones.  Must be skilled at delegation, follow-up, and team building.

Patent Attorney – Sunnyvale, CA

Innovative medical device company with a broad line of product portfolio, has an opening for Senior Patent Attorney for VP level position.  Must have 15+ years of medical device and biotech patent prosecution experience in a law firm.

Research Engineer – San Francisco, CA

A company that has developed advanced consumer health sensing technology, has an immediate opening for research engineer.  Responsibilities include, research and implement cutting edge physiological sensors and algorithms and work closely with research and device teams to integrate research into company’s consumer product portfolio.

Requirements: MS or PhD in biomedical engineering, electrical engineering, or related discipline; Minimum of 2-4 years (or academic equivalent) experience in physiological data collection, interpretation and analysis; Proficient in common signal processing techniques including time series analysis, adaptive filters, and noise cancellation; Demonstrated ability in a scientific computing language (e.g. Python, R, Matlab).
Also preferred: Experience developing algorithms for  physiological signals such as heart rate, temperature, perspiration or body motion accelerometry; Proficiency with machine learning and statistical modeling; Experience with data handling and storage, e.g. NoSQL database systems

Software Developers – SF Bay Area (contract, part-time)

Big data and machines are revolutionizing the way we operate. A software company that provides innovative, modular, scalable and world class solutions, in this industrial-internet paradigm, by leveraging state of the art sensor technologies, cloud computing, big data analytics, and complex event processing, is now scaling in pre-funding stage. Some of the clients include Cisco Systems, Applied Mateirals, Huawei, Agilent, HP, Foxconn, Fletronics, and Sanmina that are using this software to transform their engineering and manufacturing operations. The company is expanding core engineering and product development team and looking for high caliber, senior software developers, with interest in working with cutting edge technologies in a high energy entrepreneurial environment.

Responsibilities include: Being involved in all stages of SDLC including analysis, design, implementation, testing, documentation, and release; Participate in multiple projects with changing requirements; and Maintain contact with clients/ partners to provide solution support and updates.

Requirements include: 4-6 years of software development experience; Software Development experience; ASP.NET with MVC, JQuery; Comfortable in data modeling, developing stored procedures, and triggers; and Readiness to learn new technologies quickly. Windows Workflow Communication Foundation 4.0; Biztalk RFID server skills; Windows Mobile Development experience; and Exposure to Windows Azure.

The position is located in the San Francisco Bay Area. Telecommute is okay but may need to attend client team meetings. Duration: 6-12 months to full-time. Terms: 1099, corp-to-corp, contract-to-hire, no visa sponsorships but OPT visa may be ok. Pay: rate negotiable. Open to considering excellent part-time candidates.

FOLLOW ME ON TWITTER @DarshanaN

Twitter For Job Search (Photo credit: FunnyBiz)

OneMedForum SF 2013 – Healthcare & Finance Conference Highlights

The 6th Annual OneMedForum http://www.onemedplace.com/forum/ conference featured a theme “Profiting from Distuptive Changes in Healthcare and Finance” and ran concurrently with the JP Morgan Healthcare conference, in San Francisco, CA. It was a gathering of some leading investors and the rest management of promising emerging life science companies in Asia and North America. Through panels, workshops, and up-close programming with top industry leaders, attendees explored strategies for company growth.

Overall, there was a palpable focus at this conference on how best to navigate the turbulent market changes and challenges. During individual company presentations, I saw and heard some cool technologies.  But during almost all the panels, one cannot avoid noticing that these are challenging times for medical device industry. Panels explored bootstrapping and non-traditional approaches to navigate the companies in the environment of limited resources, little VC funding, uncertain regulatory and reimbursement climate, and looming tax changes.  The attendees walked away from the panels with excellent advice, resources, and tools that could help them better steer their companies during this time.  See highlights below from some of the panels.

 
China Forum

The conference began with China Forum on January, 7. The objective in first two panels was to educate attendees on challenges and opportunities for emerging healthcare companies for doing business in China, while panel 3 aimed at providing tactical approach to innovate joint venture structures.

In his opening remarks, Bin Li, Managing Director & Senior Research Analyst for China Healthcare, Morgan Stanley Research, gave an overview of China’s healthcare landscape. China market is primarily pharma market and not a device market and is the 3rd largest market, right after US and Japan. China’s pharma / biotech market cap is at $200B, with chem/drugs being the biggest sub-sactor. Medical device industry is relatively small in China and hospital and services is an even smaller industry but is the most exciting sector to watch, in the next ten years, said Li. Hong Kong market is a big piece of the pie. China market is heavily regulated and is expected to grow 15-20% for the next 5 years. There are 3 major insurance programs and are sponsored by the Government. Almost entire population (97%) has some kind of coverage and it ensures that everyone in the value chain receives some benefits. Hospital patient traffic volume has now reached historical highs. Some of the challenges of the China pharma industry are; it is a highly fragmented market, it is too tightly controlled, there are price control issues, and there is fierce competition in the low end generic market. Some of the challenges of China medical device industry are; while it is the fastest growing sector, it is not well regulated yet, and there are price control issues.

China Case Study Panels

Several important points were made, during the first panel session, focused on entering the China market, moderated by David Chen, Managing Director with BFC Group. The panelists included, Alan Paau, VP & ED at Cornell Center for Technology Enterprise & Commercialization, Jay Dong, GM with Asia Pacific Region, Cell Signaling Technology & Vice Chairman of BayHelix, Mark Xu, GM at Trout Group, Shanghi and Peter Luo, Founder & CEO of Adagene. China has had success in innovative products and while it continues to grow and there are some first in class drugs, most drugs are “me too-s”. China had 7 NDAs approved in 2011, in comparison to 30 in US. Approval times have greatly shortened in China. In China, similar to US, the primary focus is in oncology, followed by CNS. Many panelists talked about the importance of building trust, in order to do business in China, but cautioned against blind trust and instead advised “trust but verify”.

The next panel focused on operational issues, once a company is on ground, in China. Panelists in the next panel included, Landon Lack, CEO of China MedConnect, Tony Zhang, Chair of BayHelix & Sr. Research Fello, Eli Lilly, Jimmy Zhang, Managing Director, MSD Early Investment, Greater China at Merck, and Jie Liu, Corporate VP of BD & Corp Communications and President of Simcere of America. One issue debated extensively was whether a company should find one credible, trustworthy distributor and hand over issues to them or find several regional distributors. The panelists suggested various other options that are in between the two extremes. Other options that were suggested include, setting up a small commercial team that does not take up a lot of capital; instead of a distributor, find a local company in the similar area and partner with them; and explore how a medical device US company can grow with pharma distributors in China. The panelists suggested frequent travel with extended stays, cautioning that flying visits were not enough. It was also strongly advised that a company entering China market get IP protection, both in US and in China, else few Chinese potential partners would be interested. It was also advised to prescreen potential partners, establish a firm control over the brand and market, go through regulatory process upfront and have a clear understanding of how the deal is structured and its tax implications.

 
“Connected Health” Panel

Connected Health panel discussed recent trends, implications, challenges and opportunities in technologies that provide patients with ways to monitor their own health. Whether through iPhone apps or through chips implanted in a patient’s body, these technologies are aimed at improving the quality of life. But are they making a big enough difference that payors will pay and investors will invest? These and other issues were discussed in this panel, moderated by Andrew Colbert, Senior VP at Ziegler. The panelists included, Jack Young, Director of Qualcomm Life Fund, Qualcomm Ventures; Peter Neupert, Operating Partner at Growth Buyout Fund, Health Evolution Partners; and Dirk Lammerts, Managing Director at Digital Health, Burrill & Company.

According to Neupert, the whole area of connected Health is growing mature from delivery standpoint, with efficient and accessible technologies. However, the challenge is about inducing change. Additionally, lots of capabilities can generate a great deal of data but the industry has not matured enough to put this data to good use. They are weary of investing in this field. According to Young, however, this is the time to stay ahead of the curve and their fund has invested 50% or $1.4B of capital into digital health. This is invested into six sub segments; wellness & fitness, change driven management, transition care, aging in place, clinical trials, and primary care. There is a need for better data aggregation, said Young. According to Lammerts, the important question is; “what problem is a specific technology solving”? Its is not about cool engineering, but about identifying specific problem that is addressed.

In response to the question, if the area will develop as a payor provided or consumer engaged area, Lammerts said, it has to be consumer engaged, where the consumer is empowered with tools to better manage their health. According to Neupert, it is not about who pays but who has the skin in the game and if there is alignment of interest between physician, patients and provider. According to Neupert, budle payment model with pull adoptions may be the key to induce behavior change. In the end, the usefulness of growing wave of digital health technologies will materialize only through large scale adoption by consumers, and it seems, no one has yet unraveled the key to lasting behavior change.

“CEOs Unplugged” Panel

In a panel session moderated by Stephen Ubi, President & CEO of Advamed, the panelists, David Dvorak, President & CEO at Zimmer, Virginia Rybski, President, CEO, and Director at Regenesis, and Peer Schatz, Managing Director & CEO at QIAGEN, discussed some of the medical technology sector’s most critical issues with a great deal of initial focus on alternative sources of funding and cost containment in development, given the current paucity of VC funding.

Rybski shared that their company was cash positive but it required a lot of focus and instead of the VCs, they raised $15M over 10 years, from Angels. They are now looking into crowd funding opportunities. Also, if the product is for export then a company can get money from the Government to develop, said Rybski. According to Schatz, on the diagnostic side, even if there is clear value proposition, if the mechanism of reimbursement is not clear then it would be hard to get funding from any source. Dvorak shared that they contained costs through improving outcomes, helping hospitals better manage the inventory, and through better communication between the company, hospitals, and customers. “We have been more proactive at increasing operational efficiencies in all areas of our business”, said Dvorak. Rybski also shared that given the intense focus on cost containment, while they were not laying people off, they were also not hiring and not focusing on innovation but solely on sales.

The panelists discussed the importance of key partnerships as key source of information and sharing resources, to help navigate through the current challenges.

Bootstrapping: Bringing Medical Devices to Market with Limited Resources

Christian Haller, VP of Product Development at MPR Associates, moderated this panel and panelists included, Thom Rasche, Partner in Earlybird Ventures, Vicki Anastasi, Senior VP, Medical Devices at Aptiv Solutions and Ashley Wallin, VP of the Emerging Growth Company Council at AdvaMed.

FDA continues to be at the top of the challenge list for small companies. However, according to Wallin, FDA wants to support more innovation through various initiatives such as the Entrepreneurs in Residence program. Sequestration remains a threat, however, which has the potential to result in understaffing at FDA. Additionally, companies struggle with obtaining coverage and payment, and are even losing coverage they once had. Wallin suggested that companies look into reimbursement strategies, early on. Also companies need to keep track of what’s changing in terms of the Physician Payment Sunshine Act, OUS regulations and so on. One example of a strategy companies use to bootstrap is to first commercialize lower class and consumer devices to get to revenue more quickly, which in turn supports commercialization of more complex devices downstream, said Wallin. Also, there are a number of free resources to be leveraged; in addition, a tax break for exported products can be leveraged.

“Don’t worry about reimbursement”, said Rasche. If a company has technology that would improve patients’ lives, then it will get reimbursed, he assured. The goal should not be to get in the US first, but eventually. And it would be hard to tell what reimbursement scenario would look like in next 5 years. Digital health technologies may have an easier regulatory path but would not be easy to get reimbursement. A company can get CE mark easily and get to proof of concept. However, funding situation in Europe is as challenging, as in the US, he cautioned. He noted that private pay models,would have looming challenges of commercialization and test marketing and even bigger challenge would be clinical adoption.  However, if the technology offers the opportunity to find a private pay model in which patients and physicians are aligned then the company should pursue this strongly, said Rasche.

He suggested, companies try to outsource what they can and if they find a vendor willing to share the risk then it also looks good to the VCs. The path he suggested was, get regulatory approval in Europe, then tap into Asia market, and then come to US.

According to Anastasi, commercialization path would depend on the technology.  For a technology to have faster approval process, it has to have fewer safety issues, preferably a single use with valid predicate. While entry into Europe can be easier, each market in Europe is different and one needs to be knowledgeable about the markets. And the same holds true of Asia, advised Anastasi.

2013 J.P.Morgan Healthcare Conference, San Francisco, CA – Overview

2013 J. P. Morgan Healthcare Conference Overview– San Francisco, CA

(more details to be shared in next posts)

Whew!! The J. P. Morgan conference and all other related events are finally over. This conference is the largest and most important event of the year, for the health care sector. It brings together global industry leaders, investors, business analysts, emerging fast-growth companies, technology innovators, and other professionals in the industry. Despite 2012 year ending on a rather dismal note, improvement in the economic indicators point to a greater stability and the optimism at the conference was palpable. 2012 was a challenging year with weak domestic economy, ongoing financial challenges in Europe, contentious uncertainty of the long looming “fiscal cliff”, the big pharma dealing with patent expirations, and greater uncertainty in FDA regulations. Fundraising in 2012 lagged behind the pace in 2011. According to Bioworld Insight analysis, in 2012, approximately $14.3 billion was raised by biopharmaceutical public companies, compared with $18.9 billion, in the previous year. Public offerings accounted for $8.5 billion of this total figure, down from $10.2 billion in 2011. However, things seem to have greatly stabilized on many levels, towards the end of 2012. Market is showing signs of steady job growth, there is increasing stability in the financial markets, the fiscal cliff appears to be inching closer to complete resolution, and the big pharma has gone through restructuring and cost reduction to deal with the patent expirations and have promising pipelines that portend a sound and steady growth. In the next post, I will summarize some specific highlights from public and private company presentations.

In his opening remarks, Doug Braunstein, Chief Financial Officer for the firm, looked back at the first conference. Back in 1983, it featured 21 presenting companies, when US spent about $350 billion on healthcare. At the 2013 conference, a record 397 public and private companies presented and was attended by over 8,600 registered attendees that included over 4,000 investors. Braunstein observed that the U.S. expenditures in healthcare have increased “eight fold” to more than $2.8 trillion, which is also a driver for biotech companies to come up with technologies that are value differentiating.

For a dedicated democrat like me, politically speaking, JPM keynote presentations can be lonely affairs. But aside from the politics, the lunch time keynote presentations were made by influential figures and they did not disappoint. They included, Mr. Bob Woodward, Legendary Pulitzer Prize-Winning Journalist/Author and Associate Editor of The Washington Post, and Dr. William Frist, Surgeon and former U.S. Senate Leader, during the first two consecutive days. Quoting Sir William Osler, Frist observed, “variability is the law of life”, and emphasized the need for personalized medicine to help improve efficiency and lower healthcare costs. Frist demonstrated how the convergence of new technology with personalized medicine can help achieve dramatic results. While genome sequencing was very slow and expensive, now the cost is low enough, for it to be in common person’s reach and the process is much speedier. Big data however is a significant barrier, since we don’t yet know how to put the data to good use. Frist also wowed the audience with a dramatic demonstration of getting an instantaneous ECG recording of himself with Alive Cor iPhone app.

The palpable optimism and activity at J.P. Morgan Healthcare Conference, at the Westin, in San Francisco, resonated outward to dozens of other hotels, restaurants, bars and outdoor venues where meetings, lunches, and evening receptions, further facilitated deals between analysts, executives and other professionals. Concurrently occurring, the Biotech Showcase, an investor and partnering conference, devoted to providing private and small- and mid-cap biotechnology companies an opportunity to present to and meet with investors and biopharmaceutical executives, had attracted investors and biopharmaceutical executives from around the world. Also, simultaneously occurring OneMedForum, at Sir Francis Drake Hotel, attracted leading investors and management of some of the most promising emerging life science companies, with a slightly greater focus on medical devices. In one of the next few posts, I will discuss OneMedForum event, in greater detail.

Dedicated, passionate professionals in the healthcare sector know that for good health, playing is as important as working. The evening cocktail receptions sponsored by various law firms, banks, and other public and private companies, provided a much-needed respite from the breakneck pace of the J.P. Morgan Healthcare Conference and other events. There were anywhere between 50 and 60 evening receptions during the 3 days, taking place in various hotel penthouses and lobbies, art galleries, and stores like Saks Fifth Avenue. The receptions featured gifts, delicious finger foods served by waiters and waitresses, rare wine and expensive scotch at some events, and of course ongoing opportunity for deal making, well past into the mid-night.

In the next few posts, I will write about highlights from specific company presentations and also highlights from OneMedForum conference.

Pitfalls and traps in medical documentation

Pitfalls and traps in medical device & biotech documentation

Connie Hoy, VP of RA-QA at Cutera, discussed essentials of document writing to avoid the pitfalls and traps, 483s, consent decrees, lawsuits, and litigation, at http://www.bio2devicegroup.org event. With clear and precise examples, the presentation highlighted some of the common mistakes that are made in generating documentation that can lead to non-conformities during inspections and costly payments during litigation.

Any kind of vague and ambiguous language should be avoided in the documents. The traps described below, may seem easy to avoid but in reality, it is easy to fall into those traps.
1) Writing in a passive voice: This is a trap where the subject of the sentence denotes the recipient of the action, rather than the performer. For instance, “injury occurred to patient” instead of “the patient was injured”. Writing in a passive voice will make it more challenging to get past the FDA and it should be avoided in complaints, non conforming investigation, CAPA etc.
2) Not presenting the facts: Documents should contain facts. What would constitute facts? A fact is what can be checked and verified by the observer. For instance, “the drug was used in animal study comprising of 8 dogs and no side effects were observed”, as opposed to “the drug is safe” or “cause of the problem is due to user error”. A substantiated statement, consisting of a fact, provides justification for the reader to believe that what is written is, in fact true.
3) Incomplete or ambiguous documentation: Documents should not be incomplete, unfinished, imperfect, or left uncertain.
4) Too much information: Documents should be concise, complete, self-contained, an auditable. Too much information lends itself to the possibility of vagueness and ambiguity. If needed, additional information (e.g. back and forth email exchange) should be included in the addendum. Concise documentation should be appropriately filed so it is easy to retrieve, when needed. During an audit, how quickly documents are retrieved can often give an indication of their brevity and completeness.
5) Email sandwich: Avoid email sandwich where a document is followed by emails and that is followed by a document. When necessary, the emails should be referred to in the document and filed separately in the appendix.
6) Not distinguishing between correctness and corrective action: A correction is an action to eliminate a detected non conformity and may include, rework, upgrade, recall etc. A corrective action is an action to eliminate the cause of a detected non-conformity, and may involve design change to prevent recurrence of the issue. And a preventive action is an action to eliminate the cause of the potential non-conformity or other undesirable situation and it may include for instance, a design change to prevent occurrence of the issue.

The interactive presentation included many with real life examples and brainstorming with the group. In conclusion, Hoy shared real-life example where in 2010, Cutera had earned several adverse reports that were MDRs on its Titan Handpiece. She discussed the steps that were taken and included opening a CAPA, doing an investigation using returned handpieces and new handpieces, determining that the root cause was parts failure due to material used in the part, taking corrective action of redesigning the part, performing a health hazard evaluation that determined that the company needed to conduct a recall, recalling 100% of the handpieces and replacing defective parts i.e. doing correction, updating risk management file, and finally taking preventive action with new material to be used in all new designs.

The presentation was followed by Q&A. Connie Hoy can be reached at choy@cutera.com .

FDA Guidance on Clinical Data Standards

Thamar Draper, a 20 year pharma industry veteran with expertise in project management, clinical software implementation and training, and Senior Director of Professional Services at Omnicomm (www.omnicomm.com), talked about FDA guidance on clinical data standards at http://www.bio2devicegroup.org .

The current new draft of FDA Guidance on Standardized Study Data was released February 2012. The actual guidance is expected to come in 2013, NDAs are expected to conform by 2015, and INDs are expected to conform by 2016. This guidance establishes FDA’s recommendation that sponsors and applicants submit study data in a standardized electronic format. The guidance guidelines apply to collecting the data in electronic format and to standardization of data itself. Also when moving data around or integrating systems, it should be standardized and validated. Sponsors should consider during planning phase of study which data standards are applicable. Conversion of data to a standardized format at a later date reveals errors that could have been fixed earlier. Therefore, conversion of non standardized data to standardized format at a later date, is discouraged. For clinical and non clinical studies, sponsors should describe in the IND, their plan to submit standardized study data. Draper is a subject matter expert in the areas of EDC systems, clinical data bases and clinical data standards and is actively involved with CDSIC, a global, open, multidisciplinary, non-profit organization that has helped establish these standards to support the acquisition, exchange, submission and archive of clinical research data and metadata.

FDA uses certain review tools to review data and they want to review data in the same software. All data collected in the study are required to be submitted. Data validation is required and includes guidance on identifying issues early in data process and use manual inspection for data deficiencies. Technical validation guidance pertains to edit checks to validate the data and Business validation guidance pertains to supporting the data with meaningful analysis and finding errors in the data.

Draper then discussed Omnicomm’s Electronic Data Capture (EDC) and eClinical technologies with standards for Library, Data Collection, Data Exports, and Data Analysis, that can effectively and efficiently help companies comply with FDA guidance while also expediting clinical decisions and submissions. The talk was followed by Q&A.