Thank the organizers for the invitation to participate in this panel discussion. It was approximately 10 years ago that I started the process of developing a new medical product. 10 years later and a lot of water under the bridge I am an older, perhaps wiser man. Many people have asked me if I would do it again knowing the challenges that would be faced along the way and I have to say that I have found it stimulating and challenging but also enjoyable.
My perspective is that of a physician. I am a gynaecologist who did subspecialty training in Urogynaecology at the Univ of Southern California in 1989 returning to join the faculty at Dalhousie university in 1990. Urogynaecologists care for women with urinary incontinence, bladder leaking, and are first and foremost surgeons. But early in my career I developed an interest in conservative treatments, in particular the use of pessaries which I will explain briefly in the next few minutes. This interest is what lead me to develop and commercialize a medical device.
1 in 10 start-up companies in North America succeeds. The other 9 founder along the path. There are many reasons for these failures. Some ideas are not really very original or good and will not succeed in the market place. Anyone who has watched the popular TV show Dragon’s Den will understand.There is not much you can do about that problem. But many others have good ideas which don’t reach fruition because of a lack of a clear process to follow and the access to the necessary expertise . When I started the process of commercialization 10 years ago, Dalhousie had very little to offer. I had to find my way without much help. But things have changed a lot since then.
Before I talk about how to go about commercializing your invention, I ‘d like to begin with a brief cautionary tale
But if a woman wants to avoid surgery you can do it with a pessary which is a device inserted into the vagina. Early my career I started to use the incontinence ring pessary which you see illustrated here. When properly fitted It supports the urethra and stops the leaking. But there were problems. I t didn’t work for all women.
These short-comings prompted me todevised a new pessary model. Anxious to get this pessary into clinical use I sent the idea to the largest pessary manufacturer in the US thinking that they would want to conduct clinical trials and collaborate withj me. I received a call from the CEO to say that they liked it and planned to make a prototype.
By the time I had my next idea I had learned my lesson. I didn’t send my idea to a company but this decision raised a problem : how do you get from a simple concept to a finished product?
One could argue that the easiest part of the process is the idea, the invention. Once you have an idea then you need to answer a number of questions.
As a member of a university faculty your options will depend upon the university policy regarding intellectual property. At Western the intellectual property associated with an invention developed independent of any third party belongs to the faculty member. The policy is called “inventor-owned”. The only caveat is that the faculty member must report the invention to Western for discussion of commercialization. Faculty member may retain the rights or assign them to Western.So the options are to go it alone; I will highlight some of the challenges with this route. You can sign a contract with the university in which you assign the rights in return for some form of compensation or you can share the rights and continue to collaborate in the development of the invention. The sophistication of the services the university can offer will certainly be a significant deciding factor.If you assign the rights then you had better be certain that the university intends to develop the product.
Regardless of the above choice either you alone or the university will have to achieve the following.Funding is necessary to achieve all of the milestones from acquiring a patent right through to designing your packaging and marketing your product You will need either mentors or consultants to help you with patent applications, business plan development, regulatory requirements, marketing and distributionI will highlight in a minute what venture capitalists will look for when considering your product for investment.They will certainly look for strong intellectual property protectionYou will need to have developed and tested a prototype of your invention. For medical devices, clinical trials are necessary. FDA categories.The final version must be appealing to the consumer and you must find ways to get your product to the consumer, most often through some form of commercial venue.Finally the consumer must be made aware of the product- marketing.
Because Dalhousie did not have the resources to be of much help 10 years ago, I began by incorporating a company.
Mentorship early in the game came from a friend who had recently retired from business.
Personal funds, family and friends and colleagues bought into the idea and provided sufficient fund to carry us through the initial hurdles.
We found a patent lawyer who guided us through the application process leading to successful acquisition of a Canadian patent.
Find a manufacturer who can develop prototypes and facilitate production of samples for clinical testing
Once you have a prototype in hand you can begin your clinical trials
After ethical approval we were allowed to conduct a pilot study of the urestapessary over the course of two years.Read slide. Given that the long term success of surgery is approximately 65% these results are good. These results were published in the American Journal of Obstetrics and Gynecology giving the product clinical credibility.
Now you know you have a product that works and you are ready to sell it. You need regulatory approval. This can be a very complex process, particularly in the US and will require expert guidance.
Now you are finally ready for some serious financial support. We were fortunate to receive support from two government organizations to the tune of $3 million dollars.
This is when reality really sinks home. There is a business variation on the golden rule.Go through slide.At this point you are often obliged to give up a significant proportion of the company as well giving preferred creditor status to your investors.
Now you’ve got the money and a proven product you must develop distribution channels. How does the consumer get your product? In our case etc
The university, like an individual, must be motivated by something to undertake this process of commercialization of the intellectual property of its faculty. Those motivations include:AltruismPublic relations opportunitiesFinancial gainThe same factors motivate the faculty member who has the option of keeping the rights to their intellectual property
The university, like an individual, must be motivated by something to undertake this process of commercialization of the intellectual property of its faculty. Those motivations include:AltruismPublic relations opportunitiesFinancial gain
Dr. Scott Farrell
The Role of the University and Research Institution in building a Medical Technology Industry<br />Medical Technology Innovation Symposium<br />London, Ontario, June 10-11, 2011.<br />Dr. Scott Farrell <br />Professor, Dalhousie University<br />VP Medical, Eastmed, Inc.<br />Halifax, Nova Scotia.<br />
My Background<br />Urogynaecologist – fellowship trained at University of Southern California<br />Professor - Department of Obstetrics and Gynaecology – Dalhousie University <br />Patient population – women with urinary incontinence<br />Specialty – conservative management of urinary incontinence with pessaries<br />
The Problem<br />High failure rate of commercial translation<br />The path is not clear and the resources are difficult to find<br />The University can play a key role<br />
The Problem with a Great idea!<br />Will the authorities approve it?<br />Where do I go for prototyping and manufacture?<br />What do I call it?<br />Invention!<br />Where does the money come from?<br />How do I protect my idea?<br />
Two Options for University Faculty at Western<br />“Inventor owned”<br />Go it alone<br />Contract with the University<br />Sell it outright<br />Collaborate<br />
Steps from Conception to realization<br />Funding<br />Mentoring and/or consultation<br />Protect your intellectual property – USA vs Canada<br />Develop a prototype<br />Clinical trials – 510K vs PMA<br />Design and packaging<br />Distribution channels<br />Marketing<br />
The clinical Trial<br />32 women enrolled<br />21 women successfully fitted ( 66%)<br />16 women completed 12 month follow-up (76%)<br />
What about Medical Device Regulations?<br />Health Protection Branch of Health Canada<br />Regulatory expertise<br />
Funding and Mentorship<br />Innovacorp<br />BDC<br />
Golden Rule of Business Investment<br />“ He who has the gold makes the rules”<br />What is the size of the market?<br />What is the competition in that market?<br />What share of the market do you expect to get?<br />What is your strategy to develop the market?<br />Do you have intellectual property protection?<br />How strong and how pervasive is that protection?<br />Can you achieve regulatory approval?<br />
The Opportunity<br />University motivations<br />Altruism<br />Public relations<br />Financial gain<br />Encourage innovation – rights to intellectual property are key<br />Establish the resources to facilitate the process of commercialization<br />
Office of Technical Translation<br />Resources – legal, business, manufacturing, regulatory<br />Develop models of collaborative agreements <br />Help find funding forearly stage activities<br /> intellectual property protection- patents<br />development of prototype,<br /> clinicaltesting, <br />regulatory approval<br /> business plan development<br />Provide the mentoring ( or contract expertise)<br /> Intellectual property process<br /> Business expertise – business plan<br /> Regulatory expertise<br />Liaison with venture capital community<br /> Fair agreements, Exit strategy<br />
Stress Incontinence: A Problem for Many Women<br />Stress incontinence is bladder leaking with coughing, laughing or physical activity<br />Up to 1 in 3 women worldwide suffer from the problem<br />Recognized by World Health Organization (WHO) as the “last medical taboo”<br />
Private and Confidential<br />The Problem/Opportunity<br /><ul><li>1 out of every 3 women have Stress Urinary Incontinence (SUI)
157 million in the developed world; of which 43 million women with SUI in North America
Minimal technical evolution over the past 20 years
Existing treatments (medications, surgery) not satisfactory
Pads (hide the problem) are currently the only treatment option for many – US$2B market in North America; US$5B global
81% want to be notified when product was available</li></ul>♣<br />
Existing Treatment Productsfrom healthcare providers<br />Doctors tend to either dismiss the problem or recommend drugs or surgery<br />TVT sales $250,000,000<br />Pessaries are effective but are rarely offered to women.<br />
Existing Treatment Productsavailable “over- the- counter”<br /> Continence care market (retail) – limited products for many years, no new developments<br />Current over-the-counter marketplace offers mainly absorbent garments: $2.7 billion by 2007<br />
Private and Confidential<br />Uresta is a More Effective Solution<br />Current SUI Pessaries<br />♣<br />
Private and Confidential<br />Distribution Channels<br /><ul><li>Strong initial interest from:</li></ul>-SCA Healthcare Tena, J&J, P&G, Bayer<br /><ul><li>SCA indicated interest to be a distributor </li></ul>-Largest incontinent pad/undergarment products manufacturer in Europe, 2nd in N. Am. <br />-NDA has been signed with SCA<br />♣<br />
Private and Confidential<br />Competitive Advantage<br />Treatment Effectiveness<br />Source: <br />1Obstet Gynecol, 2005<br />2British Journal of Obstetrics and Gynecology, 2002<br />British Medical Journal, 1997<br />3 Reviews in Urology vol.6 supplement 3, 2004<br />4 Journal of Obstetrics and Gynecology, 2004<br />International Urogynecol Journal, 2004<br />5 IWK Health Centre, Clinical Trial, 2004<br />91%5<br />50%4<br />35%3<br />28%2<br />24%1<br />Traditional Pessaries<br />Kegel<br />Surgery<br />Drugs<br />% reporting significant decreased incontinence<br />♣<br />
Strategic Partnerships<br /> Marketing - Magis Communications<br /> Communications Design - Form:media<br /> Business planning – Deloitte-Touche<br /> Accounting – Hunter-Belgrave-Adamson<br /> Securing distribution partner – Partner International<br /> ISO/FDA regulations – Can Reg Inc.<br /> Manufacturing – VIF Mould & Plastics Ltd.<br />Legal – A. Mark David, Q.C.<br />Web Development – Nicom Ltd.<br />Financial support – ACOA, private investors<br />
Milestones<br />Business plan by Deloitte<br />ACOA loan $21,000 pending<br />Business plan<br />US market study by consultant<br />Investment Opportunity Overview by consultant<br />Feasibility study completed by consultant<br />Feasibility study completed by consultant<br /> $20,000 initial equity<br />ACOA loan $123,000 <br />marketing and product dev<br />Phase I 12 mo. clinical trial begin<br />IWK Health Centre<br />Product branding Uresta name and logo trademarked<br />Phase II 12 mo. clinical trials begin<br />ACOA grant $7,500<br />US marketing study<br />ACOA grant $1,560<br />Investment Opportunity Overview<br />ACOA grant $6,750<br />feasibility study<br />ACOA grant $6,750<br />feasibility study<br />$135,000 initial investment round<br />Winter<br /> 2003/04<br />Feb<br />2002<br />Spring<br /> 2003<br />Fall<br /> 2003<br />Summer 2002<br />Fall<br /> 2004<br />2005<br />Spring<br /> 2004<br />Canadian patent issued<br />CanReg engaged to begin Health Canada and FDA ISO approval<br />Education website launched<br />(www.womensbladderhealth. com)<br />Marketing plan by consultant<br />US patent filed<br />Incorporation<br />
The Problem with a Great idea!<br />Will the authorities approve it?<br />Clinical trials<br /> ISO 13485<br />How do I <br />Protect my idea?<br />What do I call it?<br />Canadian Patent,<br />US Patent pending<br />Uresta®<br />Invention!<br />Who can make my device?<br />VIF Industries Ltd<br />Business<br />Development<br />Bank<br />Where does the money come from?<br />
Impact on quality of life<br />Urinary incontinence has a significant impact on quality of life and perceived ability to socialize<br />Women experience embarrassment and feel like ‘failures’:<br />Often do not discuss with their doctor<br />Would prefer to self-manage the problem<br />Seek out discreet, non-invasive options<br />
Women seek a better solution!<br />Pads protect but make women feel old and like failures<br />Surgery is invasive and frightening<br />Drugs have side-effects<br />Current pessary designs are difficult to handle and fit (usually require a physician)<br />