Innovative Deal Structures in Medtech Financing (2015 WSGR Med Device Conference)


WSGR 2015 Medical Device conference, focused on understanding the challenges facing the medical device industry, and highlighting the emerging strategies to navigate the new and complex world of medtech. Eminent team of panelists discussed “innovative deal structures” at WSGR medtech conference, in San Francisco.  The panel was moderated by Scott Murano, Partner at WSGR and panelists included Justin Klein with New Enterprise Associates, Evan Norton, Divisional VP at Venture Investments, Abbott Ventures and Mir Imran, Chairman and CEO at InCube Labs.  The panel shared insights from their recent experiences with corporate partnering transactions.

Justin Klein at NEA, with $3.1B fund, focuses on medical device, healthcare technology and biopharmaceutical investments.  Recently NEA funded three medical device companies, all of them in Atrial Fibrillation space.  “Scarcity of assets in AFib category positioned AFib as a very attractive category”, said Klein.  NEA was a strategic investor alongside others, including Abbott Ventures, in its more recent financing of Sunnyvale based VytronUS, with a proprietary cardiac imaging and ablation system to treat atrial fibrillation and other arrhythmias.  Although NEA funds companies from early stage, VytronUS is couple of years away from commercialization, said Klein.  NEA looks for interesting opportunities to syndicate with a broader variety of partners.

Evan Norton said his job at Abbott Ventures is to go out and find new business that Abbott can enter into.  Abbott Ventures focuses on emerging medical technology companies that have the potential to provide long term strategic growth options for Abbott.  Mostly AVI looks for early stage opportunities and makes it possible for early stage companies to gain critical access to capital, in return for bigger equity stake.  “Our job is to identify the next Spinal Modulation earlier”, said Norton, referring to Mir Imran’s company that was recently acquired by St. Jude.  AVI does not move to non-buying term sheet phase earlier, in the process.   “About a 4th of the capital in our syndicates, comes from China”, said Norton.

Among corporate venture funds, Abbott Ventures tends to be highly creative in putting together early stage deals.  AVI focuses on medical devices, drug/ device combinations, diagnostics and unique drug delivery technologies.  An absolute key aspect of putting together a deal is flexibility on both sides, said Norton.

Mir Imran, Chairman and CEO at InCube Labs, also runs VC fund at InCube Ventures, along with an online crowd funding platform at Venture Health.  Currently, there are about 9 companies that are incubated at InCube Labs.  The Spinal Modulation deal happened with SJM “because SJM was creative in putting together a deal they could live with and we could live with”, said Imran.  Most recent buzz has been around Imran’s company, Rani Therapeutics, which has developed a technology to convert injectable biologics (such as insulin and Humira) into pills, allowing millions to escape the needle prick.

“Rani has a powerful platform and many large pharma companies are talking with us to convert their injectable drugs into pills”, said Imran.  According to recent announcement, Novartis has joined previous investors Google Ventures, InCube Ventures and Venture Health, in a Series C round of more than $25M and similar deals are in the works with other investors.  The deal will allow Rani to evaluate Novartis molecules on the new platform, with equity investment and all expenses for testing of the molecules to be paid by Novartis, said Imran.  Imran avoided entering into license negotiations, at this stage.   “If the technology delivers expected results with Novartis molecules, then we can sit down and put a licensing deal at a later time”, said Imran.   

How has Imran managed to create mutually beneficial conditions for deal negotiations, with large pharma?  “From small company perspective, I don’t like to give away rights too early”, said Imran.  Most of Imran’s companies come out of R&D at InCube Labs.  “We keep our burn rate low and keep a relentless focus on execution”, said Imran.  

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2015 WSGR Medical Device Conference – Venture Capital Today


Wilson Sonsini Medical Device conference, this year, focused on understanding the challenges facing the medical device industry, and highlighting the emerging strategies that counterbalance the new and complex world of medtech. During the sold out dinner interview, on the night preceding the conference, Steve Blank joined David Cassak, in conversation on Lean Launch Pad approach to building Medtech startups. Here is link to my previous write-up on Lean Launch Pad http://bit.ly/11yF4EM .

Venture Capital Today – Panel

The conference began with a panel moderated by Casey McGlynn, with medtech investors sharing their insights on investing in the changing times. Early stage life science companies emerge in an environment of ever shrinking pool of investors. McGlynn was joined by Steven Hochberg from Deerfield Management, Alan Kaganov from US Venture Partners, Evengy Zaytsev from RIM Partners and Eric Milledge from Endeavour Vision Ltd.  Prolonged regulatory and reimbursement challenges and the need for real sales traction to attract interest from potential acquirers has made early access to large capital, imperative. Acknowledging the changing reality, the panel noted “our filters are tighter”.

However, the conversation was not all bleak. The panel also observed that “if you have a solution and a strong product, and strong IP, then it can’t fail”. Acknowledging the changing reality, it was also noted that partnering has become an important element of the new medtech world and financing through series A, B, C, D, E is not going to happen anymore. It was acknowledged that majority of the funds for future innovation are likely to come from outside the US. One of the panelists was bullish on medtech, and observed that people’s fundamental desire to live longer and healthier, is a huge driver for medtech innovation, and advised startups on having clear and strong IP position. “If you don’t have strong IP, you don’t have a business”, he said. Underscoring the importance of a good team, he further observed, “You have no room for a weak link, in a startup”.

Stay tuned for other blogs on the conference, in the coming days.  Medtech Jobs are posted at the link http://bit.ly/1EXGy7T .

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Rabbit Hole – NAATAK Play Review


Harish Sunderam Agastya has proved once again that he is an absolutely brilliant director, in “Rabbit Hole”, his 9th directorial venture with Naatak, based on a script by Pulitzer prize winning playwright, David Lindsay-Abaire.  Superb props by Savitha Samu and her team create a sterile environment, in sharp contrast to the messy affairs that are to unfold.  Every single performer has given their best, in telling of this story, centered around Indian American couple’s deep loss, heart soaking grief, and their gentle getting on with life.

RH-95-webDipika Sharma and Avinash Sharma are dealing with death of four year old boy, Dev.  Eight months after the loss, the best they are able to do is to talk at each other, rather than to each other, sidestep real issues, and argue over stuff that obfuscates real issues.  In contrast, Dipika’s sister, Ishika Kumar deals with every issue, head-on.  When she shares the news of her pregnancy from her boyfriend, with her sister, her sister feels that Ishika is too naive about the challenges of parenthood.  Ishika insists,“this is exactly the kind of thing that gives a person clarity”.  Dipika tries to give her dead son’s clothes to Ishika and Ishika tactfully denies them.

Ishika and Dipika’s mother Nandini Kumar breaks down while cleaning her grand son’s room, as she comes across his baby pictures.  However, she also gets flak from her grieving daughter, when she compares little Dev’s loss to the loss of her own son Adit, 11 years earlier, from drug overdose.

Meanwhile Dipika and Avi’s grief has enclosed them in their own distinctive shell.  Avi goes to a support group to help deal with the loss; he wants to feel his son’s presence in the home, through his pictures, his dog, his videos, and other stuff.  Avi also wants to resume physical relations with his wife.  Dipika wards off Avi’s advances saying she is not ready.  Dipika also refuses to go to the support group. She copes by becoming overly practical in her approach to life, through constant flow of activities pertaining to daily routine, and by removing all reminders of her son, from her immediate environment.  Her overwhelming grief finds an occasional outlet in outburst laced with anger and pain.

Jason Willette is the young man who was driving, when his car hit Dev.  Apparently young Dev ran after his dog on the street, and it was deemed an accident, and Jason is legally not considered to be at fault.  However, Jason is grief stricken and blames himself.  Jason wants to talk with the Sharmas, but Avi is not keen to talk with Jason.  Dipika however, decides to talk with Jason, and somehow in talking with him, her grief finds an outlet, as she breaks down sobbing.  After their little talk, a mild miracle happens.

This play is not about an earth shattering story.  This is an ordinary story of grief and loss that comes to life through absolutely superb performance.  This story of heart rending grief and loss of life, resonates with members of the audience.  The audience members were laughing with amazing Prathima Vadiraja, as Ishika Kumar, who was playful, fully self focused, and yet also totally tuned into other characters, and remarked on everything with candor that was both hilarious and endearing.  Geeta Rai gave a good performance as a grand mother saddened by the grief of her daughter and unable to stop herself from giving advice to her daughter, to get on with life.

Harish Sunderam Agastya, as a grieving father, Avinash Sharma, was simply remarkable.  His cluelessness on how to deal with his wife’s grief which is so very different from his own, was deeply moving.  Grayson Richmond in the role of Jason Willette brought such intensity in his short performance that it touched a deep chord and ignited a collective wish to somehow erase what had happened.  Every single performer gave their very best.  And yet in the end, it was Kamala Subramaniam, as Dipika Sharma, who will leave a lasting impression.  Members of the audience shared her grief so deeply, there were sniffles and attempts to find tissue to wipe the tears.  Collective tears of sadness brought on by her remarkable performance, found some solace, when in a mild, gentle way she emerged from her shell, to contemplate what life will be like without Dev.  Life must go on, and life, it seems, is after all lived one day at a time.

This is an absolutely not-to-miss performance of this theater season, in the bay area.  Get your tickets for tonight’s last show, at http://www.naatak.com .

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Question hangs amid red blood……


The Post and Courier's photo.

Flowing down the street, pulsating, throbbing,
Red blood that was in my veins, ain’t dead
Streaking everything in its wake, it’s staining
Asking innocently, is humanity alive or dead?

Look carefully, like the red blood inside you
The blood that was in my veins, it’s all red
My dark skin only a shell that houses my soul
My dreams and my love, it’s all here in my heart and my mind

My red blood flowing in the house of God
In tandem with the tears of those I have loved

I shall let my faith rise above evil and hate
Tho vanity of the color of your skin has you led

The most important question in the world
Hangs amid my red blood, in still acrid air
Will someone somewhere judge me, Not
By the color of my skin but my character?

On June 17, 2015 a young man casually brought out his gun and murdered nine people with whom he had just spent an hour, doing Bible study, at a landmark black church, in Charleston, SC.  The crime dubbed a hate crime, was carried out by Mr. Roof whose Facebook page showed his photo with white supremacist symbols.  The city that bores the scars from days of slavery to the civil war, is once again grappling with how racial hate is impacting lives, as is the nation grappling with this issue.

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The Addams Family – Play Review


You are in for a fabulously spooky treat, in “The Addams Family”, a musical comedy based on a book by Marshall Brickman and Rick Elice, based on a group of hilariously zany characters created by Charles Addams.  This gloomy musical will keep you smiling till the very end.  Tony Kelly has masterfully directed the show, with Musical Direction by our highly talented Allison F. Rich and Assistant Musical Direction by Ryan Stohs.  Andrew Lippa has provided music and lyrics.

“Intoxicating scent of graveyard”, err, intoxicating sight of graveyard, pervades on the stage, as each of the characters is introduced; after all, “living or dead, family is family”.  Grandma’s (Donna Federico) claim to fame – when she breaks wind, “it can start the windmills on an old Dutch painting”.  And in case you wonder about Uncle Fester (D. Scott Mcquiston), “what could a fat bald person of no specific sexuality know about love”, he is in love with the moon, and is preparing for a voyage, to meet his beloved.

The wacky and the macabre gets interestingly bizarre when you meet the “fabulous mother, She of skin so pale, eyes so deep, and dress cut down to Venezuela”.  Gomez Addams (Johnny Moreno) is deeply dedicated to his family and most of all, to his unpretentious gloomy wife, and mother of Wednesday (Courtney Hatcher) and Pugsley (Zac Schuman), the edgy and evocative, Morticia Addams (Allison F. Rich).

Wednesday has fallen in love with Lucas Beineke (Jeffrey Brian Adams) and has invited him and his family dine over at the Gomez’s and the stage is set for an extraordinary encounter between the conservative Midwesterners, living far out in the country and the highly sophisticated New Yorkers.  Wednesday pleads to her family,
  They’re normal people
  Not like you
  Not like me
  Please can’t we be a normal family!
  One normal night
  That’s all I want
  That’s all I need from you

Grandma says, “define normal” and it soon becomes clear that each family has its own unique quirks and its own unique brand of mid life crisis.  Wednesday’s concerned mother tells her husband, Wednesday is growing up. Gomez: She’ll be Thursday before you know it!”  Meanwhile Lucas’s mother Alice Beineke (Elise Youssef) sings,
   When I’m depressed
   Or feeling blessed
   A poem will get it off my chest
   They come to me
   They take no time
    They just pop out
     and always rhyme

This show is an absolutely stupendous undertaking by San Jose Stage, with a big cast, long list of creative team members, as well as the band for music.  Michael Cook has done a marvellous job with scenic design and Abra Berman’s work on costume design is equally fantastic.  Stage Manager and Assistant Stage Manager, Margaret Kayes and Nicole S. Langley deserve special kudos.  My best compliments are for Prop Master, T J Toribio, for absolutely fantastic work with props.  For any student of props, this is a must-watch performance.

Easily, I designate The Addams Family playing at San Jose Stage (www.thestage.org) as not-to-miss show of this theater season.

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“Fallen Angels” – Play Review


photograph by Kevin BerneJane (Rebecca Dines, left) and Julia (Sarah Overman, right ) indulge withthe help of Saunders (Tory Ross, center) in TheatreWorksTory Ross in the role of Saunders, the maid, steals the show in Noel Coward’s “Fallen Angels”, a comedy with wit, flamboyance, fashion, and style.  Sarah Overman and Rebecca Dines as wives Julia Sterroll and Jane Banbury were hilarious and their husbands Fred Sterroll and Willy Banbury (Mark Anderson Phillips and Cassidy Brown) were fabulous as low key, passionless British husbands who seemed to be more interested in golf than their wives.   However, the story line seemed to be lacking in depth and substance.  While the husbands are away, notice of impending arrival of Maurice Duclos (Aldo Billingslea), with whom both Jane and Julia had a premarital affair, is the primary focus point around which the play is centered.

Originally when the play opened in 1925, the audience found it entertaining, yet also shocking, given the provocative theme of young married women becoming giggly, drunk, and week at the knees, in eager anticipation of the rendezvous with their former lover.   However, for the audience of today, for someone like me, the first act seemed too drawn out, the story was not developing further, and felt like it was all much ado about nothing.  To the extent that the audience can identify with couples in many conventional relationships, devoid of passion, it was amusing, but lost the charm when it went on for too long.

The performance picks up pace and becomes far more engaging by the second act.  As is always the case at Theatreworks, the staging and light and sound were superb.  Special mention to Fumiko Bielefeldt for superb costume design that befits the era and also reflects the high class fashion and style of the British upper middle class.   Ross gets the biggest laughs as know-it-all maid, in this comedy.  However, it falls short of goals of an engaging witty comedy.  Although Coward uses paradox, similar to Oscar Wilde, the remarks don’t quite measure up to that level of depth, perception or electricity.  Although it generates laughs, it never quite generates rip roaring infectious laughter.

For tickets for “Fallen Angels”, got to www.theatreworks.org .

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વાત નાની, અસર મોટી “તમે એવાને એવા જ રહ્યા ” – Gujarati short story “when will you change”?


આ વખત ની “બેઠક” નો વિષય છે “તમે એવા ને એવા જ રહ્યા”. નીચે નાની વાર્તા છે અને જિંદગીની ઘણી વાર્તાઓની જેમ તે વાર્તા પણ અધુરી છે. થોડા પ્રશ્નો ઉપસ્થિત થયા છે તે પણ નીચે લખ્યા છે. તમારી comments દ્વારા તમારા અભિપ્રાય જણાવશો અને તે માટે પહેલીથી આભાર. મારા બ્લોગ ઉપર તમને બીજી ઘણી માહિતી મળશે, તપાસજો. અને આ વિષયના બીજા લખાણો http://www.shabdonusarjan.wordpress.com બ્લોગ ઉપર વાંચવા મળશે.

વાત નાની, અસર મોટી  “તમે એવાને એવા જ રહ્યા ” – Gujarati Varta

અરુણકુમારે કામ ઉપરથી આવીને રૂમમાં ટાય તથા મોજા ઉતર્યા અને બાથરૂમ માં નાવા ગયા.  બાથરૂમમાં બીજા કપડાનો ઢગલો કર્યો અને નાય ધોયને બહાર આવ્યા કે અવનીબેને રોજ પ્રમાણે ટકોર કરી “તમે પણ એવાને એવાજ રહ્યા. વળી રોજની જેમ ચારે બાજુ કાપડનો ઢગલો કર્યો. ક્યારેય બદલાશો કે નહિ?

વર્ષો પહેલા જુવાનીમાં અરુણકુમારે દામ્પત્ય જીવન નો બહુ વિચાર કર્યો નતો. મિત્રો સાથે મળીને ખુબ સમય વિતાવતા અને દર શનિવારે પાના રમવાનીતો જાણે એક નિયત પરંપરા બની ગયેલ. મિત્રોના ઘરવાળા બધાને તે સાંજ તો મિત્રો સાથેજ વિતાવવાની સાંજ છે તે ખબર. પરંતુ જયારે અરુણકુમાર લગ્ન કરીને આવ્યા ત્યારે અવનીબહેને ચોખું કહી દીધું કે આ રોજ પાના રમવાનું ન હોય. તે આદત તમારે બંધ કરવી પડશે. અરુણકુમારે સમજાવવાની કોશિશ કરી પણ આખરે નમતું જોખ્યું.  મિત્રોએ પણ ખુબ ટકોર કરી પણ અરુણકુમારે કહી દીધું કે જો ભાઈ દામ્પત્ય જીવનમાં આપણે રીતભાત બદલવી પડે. અને  અરુણકુમારે એજ માર્ગ અપનાવ્યો। તેમનું એવું માનવાનું થયું કે જીવનમાં rigidity એટલે અક્કડ રહેવા કરતા નમ્ય રહીને flexibility અપનાવવી વધારે અનુકુળ અને તેજ તેમના દામ્પત્ય જીવનનો પાયો રહ્યો. અવનીબહેન ને વાતવાતમાં ટકોર કરવાની ટેવ અને તુરંત અરુણકુમાર તેના કહ્યા પ્રમાણે કરે. આમ તો મોટે ભાગે તેમનું જીવન સુખી. બાળકો થયા નતા પણ તે સિવાય અરુણકુમારે કોઈ ખામી અવનીબહેન ને લાગવા દીધી ન હતી.

લગ્ન પછી તુરંતજ અવનીબહેન ને અને તેમના સાસુ વચ્ચે થોડી નાની મોટી તકલીફ ઉભી થવા લાગી. અરુણકુમાર ના બાપુજી નો સ્વભાવ દીકરા જેવો જ. તેમને પણ વિખવાદ બિલકુલ ગમે નહિ. અરુણકુમારે પહેલા બાપુજીને સમજાવ્યા કે આ રોજના વિખવાદ વધે તે કરતા બાજુમાંજ જુદું મકાન લઈને પાસે પાસે રહેવાનું કરીને પ્રેમ રાખવો સારો. બાપુજીએ તુરંત સહેમતી આપી અને નસીબ જોગે બાજુમાંજ સરસ મકાન મળી ગયું. અવનીબહેન ની બા એ પણ દીકરીને કહ્યું “અવની હવે તારે શી ખોટ? તું તો તારા ઘરની રાણી છો. હવે તારે બિલકુલ ટકોર નહિ કરવાની, એકજ વર ને સાંભળી લેવાનો છે”. પણ સ્વભાવ પડ્યો બદલાય છે? અવની બહેન ની ટકોર ચાલુજ હોય અને અરુણકુમાર વર્તણુક માં તેમને ગમે તેમ ફેરફાર કરી નાખે.

અવનીબહેન ના ભાઈ ને ધંધે લગાડવાનો હતો અને અવનીબહેને ખુબ જીદ કરી કે ભાઈને ધંધે લગાડવા માટે તમારા સાહેબ જોડે વાત કરો. અરુણકુમાર ને થોડો શક હતો કે સાહેબ આમાં કૈક ખોટું જોશે તો? પણ આખરે તેમણે વાત કરી અને જોગાનુજોગ સાહેબ ને તેમના સાળાનું કામ પસંદ આવ્યું અને તેના કામનો વહીવટ થઇ ગયો. ત્યારે પણ અરુણકુમાર ને થયું કે આતો વાત બની ગયી પણ વણસી જાત તો. તેમને થયું કે તેમની પત્ની જરાપણ ધીરજ થી સમજી વિચારીને વ્યવહારિક નિર્ણય લેવાની બદલે તેની જીદ અને ટકોરને ધોરણે જ નિર્ણય લેવડાવે છે. ક્યારેક અમુક વખત સુધી અરુણકુમાર ને આ ખુંચે પણ પછી તેમના સ્વભાવ મુજબ વાત ને જતી કરે.

આવા તો કેટલાયે ઉદાહરણો અને આવી તો કેટલીયે નાની મોટી ઘટનાઓ બનેલી. અરુણકુમાર હમેશા મનને મનાવે કે લોકોને તો કેટકેટલી મોટી મુશ્કેલીઓ આવતી હોય છે તો આ તો નાની એવી અમથી વાત છે કે તેમની પત્ની નો સ્વભાવ કર્કશા જેવો છે. હમેશા તેમને થાય કે જતું કરશે તો ધીમે ધીમે અવનીબહેન સમજશે અને ધીરજ અને સહનશીલતા કેળવશે. એવામાં થયું એવું કે મીરાબહેન કરીને એક બહેન અરુણકુમાર ની ઓફિસમાં કામે જોડાયા. ઓફિસમાં તો નાની મોટી વાત માં ઘણાય ફેસલા લેવાના હોય અને અવાર નવાર નાના મોટા મતભેદ થાય. મીરાબહેન બધાજ મતભેદ સહનશીલતાથી પતાવે. ક્યારેક પોતાની વાત ઉપર ખુબ અડગ રહીને સમજાવે અને ક્યારેક બીજાની વાત સાંભળીને પોતોનો મૂળ મુદ્દો જતો કરે. અરુણકુમાર ને અને મીરાબહેન ને ઘણી વખત સાથે કામ કરવાનો સંજોગ બને અને અરુણકુમાર મીરાબહેન જે સમજુતીથી નિર્ણયો લ્યે તેના ઉપર તાજ્જુબ થઇ જાય.

એકાદ બે વખત અરુણકુમારે ઘરે નિરાતે બેસીને અવનીબહેન ને સમજાવવાની કોશિશ પણ કરી, કે “જો અવની તું કોઈ પણ વિષય ઉપર બે વખત ટકોર કરે એટલે તે વાત કોઈના ગળે ઉતારવાની હોય તો પણ અટકી જાય. અને તું તો ક્યારેક ટકોર ઉપર ટકોર મારે છે. ક્યારેક નાની નાની વાત ને જતી કરને”. પણ અવનીબહેનના બદલવાની વાત તો બાજુ ઉપર રહી પણ અરુણકુમાર વાત કરે તે અવનીબહેન નિરાતે બેસીને સાંભળે પણ નહિ. તે ક્યે, “જુઓ મને કયો છો એના બદલે જરા તમેજ બદ્લોને”.

અરુણકુમાર હાલમાં થોડો વધુ સમય ઓફિસમાં વિતાવવા લાગેલ. મીરાબહેન ને આગળ પાછળ કોઈ નતું અને તે તો ઘણો વખત ઓફીસ ના કામમાં વ્સ્યસ્ત રહેતા. સાંજે મોડું થવા આવેલ અને અરુણકુમાર ઘરે જવા નીકળતા હતા ત્યાં પસાર થતા તેમની નજર મીરાબહેન ઉપર પડી અને અચાનકજ બોલી ગયા ” હું ઘરે જવા નીકળું છું, પણ તે પહેલા કોફી પીવાની ઈચ્છા હોય તો તમે પણ કામ બંધ કરો અને બાજુમાં શાંતિથી કોફી પીને પછી આપણે ઘરે જઈએ. મીરાબહેને કહ્યું “હું કામ આટોપવામાં જ હતી અને બંને કોફી પીવા ગયા. વીસેક મિનીટ સાથે બેઠા અને નિરાતે કોફી પીધી પછી બંને ઘર તરફ વિદાય થયા.

પણ આજે અરુણકુમાર નું દિલ કૈક આસમાનમાં ઉડતું હતું. અરુણકુમાર ને બિલકુલ અવનીબહેન ના નિયમોનો ખ્યાલ જ ન રહ્યો। એવામાં અવનીબહેને ટકોર કરી કે “તમે તો બદલ્યાજ નહિ, વળી જ્યાં ત્યાં કપડાના ઢગલા કર્યા ને મારે તે ઉપાડવાના। ખરેખર હવે તો કંટાળી ગયી છું. શું તમે કૈક સુધારશો કે પછી એવા ને એવાજ રહેશો?” અવનીબહેન નું બોલવાનું ચાલુજ હતું ને તેમણે જોયું કે અરુણકુમાર તો રોજ ની જેમ કપડા ઉપાડીને બરોબર જગ્યાએ મુકવાની બદલે બહાર જવાની તયારી કરવા લાગ્યા છે. અરુણકુમારે પાયજામાની બદલે પેન્ટ ચડાવ્યું અને મોજા પહેર્યા. અવનીબહેન થોડા મુંજાય ગયા અને બોલ્યા “આ શું કરો છો? પાછા બહાર જાવ છો? હું જમવાનું ગરમ કરું છું. હજી હમણાં તો આવ્યા ને પાછા ક્યાં ચાલ્યા? અરુણકુમાર બહાર પગ મુકતા બોલ્યા “બસ કંટાળી ગયો છું, તારી રોજની ટકટક થી” અને બારણું થયું બંધ. અવનીબહેન તાકતા રહી ગયા.

પ્રશ્નો

  • શું એવું બને છે ક્યારેક કે જે વ્યક્તિ બીજાને ટકોર મારે કે “તમે એવાને એવાજ રહેશો, કે પછી બદલાશો થોડા?” તે ટકોર કરતી વ્યક્તિ પોતેજ ક્યારેક રીજીડ હોય અને વખત પ્રમાણે અને સબંધને અનુર્ક્રમીને બદલવા ન માંગતી હોય?
  • એવું પણ બને છે ક્યારેક કે એક વ્યક્તિ ટકોર સાંભળી સાંભળીને એટલી હદ સુધી કંટાળી જાય કે પછી એક વખત એવો આવે કે એક નાની અમથી ટકોર એવું તોફાન સર્જાવે કે જીવન નૌકા હાલકડોલક થઇ જાય?
  • ક્યારેક કોઈક વ્યક્તિ ને બિલકુલ વિખવાદ પસંદ ન હોય તો કોઈ આગવી ચેતવણી વગર તેની સહનશક્તિ ની અચાનકજ હદ આવી જાય છે અને વાતાવરણ ને છિન્નભિન્ન થતા વાર નથી લાગતી। શું અરુણકુમાર ને પહેલા બોલવાની જરૂર હતી?
  • આખરે અરુણકુમાર કંટાળ્યા છે. શું પરિણામ આવશે હવે?
  • તમે લેખક હો તો આ વાર્તામાં આગળ શું મોટી ઘટના બને?
  • શું મીરાબહેન ની મુલાકાત થઇ તેથી અરુણકુમાર ને ટકોરની અસર જોરદાર થઇ? કે પછી મીરાબહેન ન મળ્યા હોત તો પણ એવો સમય આવત જ કે અરુણકુમાર કંટાળત?
  • આ નાની એવી વાત માં ઝીંદગી જીવવા માટેનો કયો મોટો અર્થ છુપાયેલો છે?

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Harnessing Cloud Technology to improve Customer Engagement for Medical Device


Aroon Krishna and David Judelson, co-founders at VirtuMed talked about the challenging environment for current medical device manufacturers and VirtuMed’s Synapse Mobile cloud based, on-demand, customer engagement platform solution to address the challenges, at a recent www.bio2devicegroup.org event.

Enumerating examples of challenges impacting medical device marketplace, Judelson, said Boston Scientific neuro modulation business has declined due to reimbursement challenges, Medtronic agreed to settle and stop the sales of pain med pump due to link with patient deaths, and big promise and subsequent failure of renal denervation solution has cut the growth among other device manufacturers.  There are challenges across the board from development to commercialization, said Judelson.  Hospitals are faring no better.  Nearly 40% of California hospitals received bad grade, constant M&A activity among hospitals, pressure from changing government initiatives, difficulties with privacy and security of EMR data has all led to medical device companies spending more money to get less and spending more in sales and marketing efforts is not the answer.

Five current headwinds are defining the existing environment.   Increased regulation and declining reimbursement from fee for service to bundling and changes in how CMS pays, is putting a lot of pressure on providers who pass the burden on to device manufacturers.  Second, there is a lot of variability in how different hospitals measure quality.  Third, aging population with increasing co-morbidities is leading to variability in clinical trials and making it challenging to assess the effects of interventions.  Four, challenges are increasing with decreasing hospital access for sales reps.  Five, huge global volatility with large swings in foreign exchange rates, government uprisings etc. is making it hard to estimate earnings.

Hospitals are often burdened with internal challenges of system integration, promise and challenges of mobile technology, problems of achieving seamless inter-operability, thinning margins, vendor management issues, physicians getting overburdened with administrative tasks, HIPPA issues and more.  All these challenges are compounded with sub par performance from medical device companies as they are delivering more failures in R&D, demonstrating lack of innovation with decreased ROI followed by decreasing investment in venture and M&A activity.

Currently, there are few solutions for comprehensive customer management, said Judelson.  Some general solutions like Salesforce, Oracle, imshealth, freshdesk, Veeva and Zendesk have been applied.  However, these require significant customization, often have complex pricing structure, are pricey for small to mid-sized enterprises, have complex IT integration and archaic mobile user interface, and are often based on limited knowledge of medical device econsyste.  There are no existing CRM solutions specially designed for medical device industry, said Judelson.

VirtuMed’s cloud based remote connectivity solution specifically fills in this gap, where device manufacturers can establish direct line with the customer, provide better, more timely customer support as a value added service, develop apps, and leverage knowledge of product users globally with access to real time outcomes data.  There are many gains from such timely information.  Research indicates that with timely physician access to post surgery recovery process and real-time conversation with patients, recovery occurs faster and patients remain more engaged in their recovery.  While there is a great deal of patient to patient interaction in social media, there are fewer tools for patient to provider engagement and that needs to change.

VirtuMed’s Synapse mobile solution helps build a connected ecosystem that combines commercial CRM, social networking, on demand communication, big data visualization, HIPPA compliant infrastructure, and enhances security with data changing hands while ensuring availability of data at the right time to the right people.  This solution aims to unite all key stakeholders on a single platform with primary objective for positive patient impact, said Krishna.  VirtuMed product is poised to offer support to companies of any size and its tech solutions can be applied at each stage in medical device life cycle, from early innovation to clinical stakeholder engagement, to customer engagement to CRM platform to enable growth in emerging markets; literally from ideation to discovery to clinical to commercialization, said Krishna.

The talk with followed with Q&A.

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JOBS – June, 2015


I have new opportunities in California and Texas in engineering in Quality, Manufacturing, and Mechanical and other job openings in Biochemistry, Physiologist with animal surgery experience and in manufacturing and document control of medical devices.  I will post details as and when I get full descriptions.  But I am looking forward to receiving resumes for the opportunities listed below and I am submitting them, as I receive them.  All opportunities are for candidates located in the United States.  When sending your resume, please include details on your current compensation and compensation expectations.  Also, include in the email a short summary of your background and your key strengths. Please send resumes to wd_darshana at hot mail dot com.

Senior Mechanical Engineer – San Jose, CA
12+ years of Class III medical device is required, with experience in machining, injection molding etc.

Senior Electrical Engineer – Austin/ San Antonio – TX

A company working on innovative range of products, has an immediate opening for senior electrical engineer with class III device experience.  Experience with closed loop, analog design hardware, microcontrollers, actuators  and ultra low power consumption circuit design highly desired.

Key Responsibilities
* Lead Electrical Engineering, primarily for long-term implantable drug delivery devices:
* on R&D- design and development of implantable and associated wearable and external hardware using mixed signal- analog and digital techniques, sensors and actuators and closed-loop control systems
* Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation esp for implantable electronics
* Develop Class III implantable electronics to be compliant with regulatory and QA standards (FDA and ISO), as well as be power-efficient, reliable for multi-year operation and pass EMI/RFI, be hermetically sealed and packaged and interface with rest of electronics systems for developed products
* Establish reliable suppliers and partners for manufacturing
* Work in a matrixed and multidisciplinary organizational structure to support multiple projects and technologies following appropriate QA system for each segment
* Document work output and use project and organizational documentation systems, including electronic systems
* Plan for and support existing and projected growth of the company.

Key Qualifications
* Designed and implemented electronics mixed-signal hardware, firmware and software for implantable medical devices and drugs. Combinatorial device and Class III experience desirable. 10-15 15 years desirable
* Bachelor’s degree in Electrical Engineering or in an equivalent field required
* Led and grown EE groups with a hands-on, leadership- by-example approach
* Demonstrated working experience and accomplishments with electronics hardware and software- analog/digital, sensors/actuators. Developed, selected and qualified sensors for both implantable device function and for measuring physiological parameters
* Familiarity and experience with other implantable device components such as connectors, leads, cables, interconnects, headers, electronics packaging, communication protocols and standards. Real-time microcontroller programming a plus.
* Excellent and demonstrated grasp and use EDA tools: sensor/circuit design, simulation, layout. Hands-on re: circuit and system prototyping and development
* Developed and implemented manufacturability, and related process flows and controls. Selected and qualified vendors for manufacturing Class III implantable device electronics.
* Working knowledge of biomaterials, drugs, drug delivery, and mechanical technologies in support of multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business.
* Strong technical and hands-on skills with demonstrated ability to provide solutions to a variety of technical problems of varying scope and complexity
* Analytical data-driven problem solver and team player, organized and an excellent communicator
* Supported multiple complex projects in a start-up environment: able to prioritize.

Key Job Parameters
* Full-time position located near Austin/ San Antonio, Texas
* Some travel (~10%) may be necessary to meet job responsibilities
* Report to VP, Product Development

Drug Safety Assistant – Contract 6 – 12 Months — Berkeley, CA

This contract position is responsible for processing serious adverse events (SAEs) in compliance with standard operating procedures (SOPs) and national and international regulatory safety and pharmacovigilance regulations, such as the Food and Drug Administration (FDA), International Conference of Harmonisation (ICH), World Health Organization, and country and regional regulations for the reporting of adverse events to regulatory agencies.  The contractor in this position will be responsible for implementing pharmacovigilance guidelines and ensuring the uniform and timely processing of adverse event data on investigational and post-marketing products, as assigned.

Responsibilities:

The level of incumbent will determine the level of independence for the following duties:  See complete details in JOBS category at http://www.darshanavnadkarni.wordpress.com

* Process SAEs in compliance with SOPs and national and international regulations, and assist or lead in preparing SAE reports for management and regulatory agencies, assist in the preparation of new drug application (NDA) updates, investigational new drug safety reports, investigator communications, product labeling/packaging inserts, and other reports as necessary,  Assist or prepare aggregate data for safety review sessions.
* Support audits and inspections; create and maintain audit-ready files including training files.
* Process and review safety narratives for adverse event cases as required.
* Perform reconciliation activities including performing review of source data of SAE files.
* Ensure all SAEs are handled in accordance with safety regulations and department procedures and communicate to internal/external groups as necessary during scheduled holidays as well as non-business hours.
* Provide back-up support to the Drug Safety Coordinator with the following duties:
* Maintain electronic/paper files including management of the central Drug Safety & Pharmacovigilance file room.
* May be responsible for daily on-site filing and retrieval of adverse event case files and maintenance of the Client adverse event file storage facilities within the Case Management Center.
* Responsible for scanning and uploading adverse event case information to our safety systems, monitoring electronic mailboxes for adverse event reports, responding to queries and follow-up local reference numbers when required.
* Perform other operational tasks in support of Drug Safety & Pharmacovigilance Operations as required by Management
* Responsible for monitoring the inbound mailboxes, fax machines and/or other inbound systems for adverse event cases, and forwarding to the appropriate DSP Manager for triage
* Maintain electronic/paper files including management of the central Drug Safety & Pharmacovigilance file room.
* May be responsible for daily on-site filing and retrieval of adverse event case files and maintenance of the Client adverse event file storage facilities within the Case Management Center.
* Responsible for scanning and uploading adverse event case information to our safety systems, monitoring electronic mailboxes for adverse event reports, responding to queries and follow-up local reference numbers when required.
* Perform other operational tasks in support of Drug Safety & Pharmacovigilance Operations as required by Management
* Responsible for monitoring the inbound mailboxes, fax machines and/or other inbound systems for adverse event cases, and forwarding to the appropriate DSP Manager for triage
* Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
* Other duties as assigned

Qualifications:
* For the Senior Associate, 8 plus years of related experience OR training in health-related fields such as nursing, pharmacy or medicine and 4 years of related experience. Strong communication skills including appropriate email etiquette is required
* Impeccable ethical standards and integrity.
* Knowledge of both domestic (FDA) and international (ICH) regulatory pharmacovigilance requirements.
* Able to maintain confidentiality (especially on patient records), quality and accuracy.
* Familiarity with medical terminology.
* Demonstrated attention to detail, follow-through and initiative.
* Strong team orientation and be collaborative, but must be able to work independently while processing adverse event cases.
* Required: demonstrated mastery of Microsoft Word, and a working knowledge of Microsoft Excel; familiarity with Argus, the MedDRA coding dictionary and the WHO Drug coding dictionary.  Note that this contract position does not require direct interaction with Argus but familiarity and understanding are essential.
* Must be effective working in a fast-paced environment and possess good judgment; must be flexible and quickly adapt to changing priorities.
* The person in this position must be able to remain in a stationary position 50% while operating a computer and/or other office equipment, occasionally move about the office to retrieve files and attend meetings.

Drug Product CMC Contractor – Pleasanton, CA

There is an immediate opportunity for Senior Drug Product CMC contractor at a revolutionary company bringing together high tech and biotech to discover and develop more effective medicines for treatment of cancer. We are changing the current paradigm of drug discovery and development.  This position will be responsible for managing drug product manufacturing activities for one or more of company’s clinical compounds. Travel will be required on an as-needed basis to liaise with CMO staff and oversee manufacturing activities. This can be either a part-time or full-time role, 2-5 days per week, for an initial term of 12 months.

Responsibilities:
* Implement CMC strategies for one or more compounds in clinical development (parenteral and oral solids)
* Manage, interact, and build relationships with CMOs for drug product process development & scale-up studies & manufacturing clinical trial material
* Design process development studies as appropriate to improve process robustness & understanding
* Write &  review development history reports
* Maintain all relevant files & reports for regulatory submissions
* Author and review CMC sections of INDs, CTAs, Annual Reports, NDAs etc. for global regulatory submissions
* Liaise closely with the CMC team including Process Chemistry and Formulation, Analytical and Stability groups as well as Quality Assurance for review of batch documentation and release of product
* Interact with Regulatory and Clinical team project representatives for CMC project deliverables
* Lead investigation activities for non-conforming materials and implement preventive actions
* Travel: Up to 15%

Qualifications:
* MS or PhD in Chemistry or a related pharmaceutical science is required
* Pharma/biotech industry experience in pharmaceutical development and manufacturing preferably with small molecules (minimum 10 years with a MS; minimum 5 years with a PhD)
* Thorough knowledge of drug product formulation and manufacturing is required
* Proficiency in either parenteral or oral solids manufacturing
* Proven track record of working with CMO partners to meet drug product manufacturing project milestones
* Process validation experience and knowledge of analytical methods and data is desirable
* Strong knowledge of global current Good Manufacturing Practices (cGMP).
* Experience preparing Chemistry, Manufacturing and Control (CMC) documentation for regulatory filings, particularly in Common Technical Document (CTD) format, is highly desirable
* Strong problem-solving and troubleshooting abilities
* Ability to work independently and in a team environment
* Excellent oral, written, and interpersonal communication skills

Senior Quality Engineer – San Jose, CA Requires 8-10 years medical device quality engineering experience and educational background in mechanical or electrical related engineering. Include brief summary of your background in the email and mention if you have class 3 device experience or if you have any sterile pharma experience.

Senior Manufacturing Engineer – San Jose, CA Required 8-10 years medical device manufacturing engineering experience and Bachelors or equivalent in mechanical or electrical related engineering area.  Include brief summary of your background in the email and mention if you have class 3 device experience or if you have any sterile pharma experience.

Document control – San Jose, CA Biologist/ Physiologist with large animal in-vivo experience – San Jose, CA

Polymer Chemist/Drug Formulation – San Jose, CA         

Mechanical Engineering Technician – San Jose, CA

Senior Mechanical Design Engineer – San Jose, CA

Electrical Engineering Technician – San Jose, CA

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JOBS – May, 2015


Please see below opportunities and send resume as an attachment to wd_darshana at hotmail dot.  My imminent full time openings are for Senior RA/QA and Senior Electrical, Mechanical, Quality and Software Engineering – most of these require strong medical device experience.  More opportunities and details on all opportunities coming soon.  All US opportunities are for US based and local candidates.  When sending a resume, please mention job you are interested in, in the subject line and in the email include a brief summary of how best the job description matches your background and where the gaps are.  Also include details on your current compensation and compensation expectations.

Data Manager – San Diego, CA (contract opportunity)

RESPONSIBILITIES:
* Database Development/Management
* Protocol review
* Develop or review database definition file to create CRFs
* Develop or review Edit Check Specifications
* Perform or oversee User Acceptance Testing (UAT) of the CRFs and Edit Checks for the database in development
* Manage change requests during the course of the trial after database is Live

Document/Documentation Development
* Write CRF Completion Instructions for in-house managed trials; review for outsourced trials
* Create the Data Management Plan (DMP) (hard copy and electronic) and update throughout the study for in-house managed studies; review/create for outsourced trials
* Write study-specific Manual Review Guidelines for in-house managed studies; review for outsourced trials
* Maintain Study Information Table
* Write and maintain Data Transfer Agreements with ancillary vendors

Data Management/Review
* Perform or oversee manual review of all CRFs generating queries as needed for in-house managed studies
* Ensure review and upload of all external data (e.g., labs and PK data)
* Medical coding for in-house trials; review for outsourced trials
* Track and resolve all queries for in-house trials; review for outsourced trials
* SAE reconciliation
* Produce and/or review data listings
* Provide Data Management summary reports to management and Clinical Operations
* Provide ad hoc reports from the database, as requested
* Ensure that database is closed and locked at the end of the trial

Administrative Duties
* Attend trial and project team meetings
* Serve as liaison between Data Management and other departments
* Manage Data Management timelines with outsourced vendors
* Other duties as assigned

REQUIREMENTS:
* Bachelor’s Degree in a science related field preferred
* Minimum 3 years data management experience preferably experience in cardiovascular, metabolic, neurological indications in the rare disease space
* Excellent written and verbal communication skills
* Proficient in MS Office
* Experience with Electronic Data Capture; BioClinica Express preferred
* Knowledge of CDISC standards and implementation of CDASH/SDTM
* Outsourcing management experience
* An ability to be productive and successful in an intense work environment
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More opportunities and more details on below opportunities will be posted by June, 1.

Director of Mechanical Engineering – San Jose, CA
Requires 20+ years experience in polymers, balloons manufacturing. Complete details will be posted soon.

Mechanical Engineer – San Jose, CA
Requires 5+ years medical device experience.  Details will be posted soon.

Quality Engineer – San Jose, CA
Requires BS in Engineering and 10+ years medical device QE experience.  Details coming soon.

Physiologist – San Jose, CA
Requires large animals survival surgery experience.  Details coming soon.

Biochemist – San Jose, CA
Requires PhD + 3-5 years industry experience.  Details will be posted soon.

Ruby on Rails VP level experience – San Mateo, CA

Senior Electrical Engineer – Austin/ San Antonio – TX

Senior RA/QA Leader – East Coast

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