MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Women in Medtech: Deborah Kilpatrick - The Bioengineer

Deborah Kilpatrick Cardio DXDeborah Kilpatrick, PhD, is senior vice president at genomic diagnostics company CardioDx, which has been recognized in the Wall Street Journal Technology Innovation Awards, TIME Magazine's Top 10 Medical Breakthroughs, and the 2012 Edison Awards. Deborah was formerly at Guidant Corporation as a Director of R&D and New Ventures, and she currently has various advisory roles for the Georgia Institute of Technology, the Dystonia Medical Research Foundation, and the Association of Women in Science. In 2011, Deborah co-founded the inaugural MedtechVision conference, focused on highlighting women leaders from all facets of the medtech sector.


MD+DI: How did you get your start in the medical device and technology industry?


Deb Kilpatrick: I realized in graduate school, during my PhD research in cardiovascular bioengineering, that I wanted to work in industry and not in academics. Given my technical focus and interest, the medtech sector was the obvious choice for me, however, I did not know what that actually meant in terms of what I would do. So I moved to Silicon Valley and did consulting for two years while I figured out where I would fit. I joined the R&D team at Guidant Corporation in 1998, which was a super exciting time to be a part of medtech and at Guidant. This whole series of decisions was such an important determinant of my career, and I am thankful for all the opportunities I have had to date and for the many people who provided them for me.

MD+DI: What important challenges does the medtech industry face in the next 5 years?

DK: We clearly have no shortage of innovative ideas, cutting edge technologies, or new products from what I can see. However, there are very complex questions about how to navigate the relationships between emerging products and the regulatory and reimbursement hurdles they face in the US market. So given that so much is happening globally, more and more of the daily dialogue is about international activity--not just clinical trial work, but broad commercialization strategies in many geographies. The challenge for management teams, especially in emerging companies, is that the ideal choice of where to place your commercial footprint is now less obvious than ever before. Though reimbursement hurdles are often highlighted as challenging innovation, I hold the view that these can often be good for innovation in terms of forcing us to integrate new efficiencies into our products and the way we deliver them. I have personally learned a tremendous amount in my role at CardioDx by delineating cost savings and cost effectiveness of our technology as key innovations we are bringing the system. Finally, I think some of the most intriguing challenges the medtech sector faces in the coming decade is how to deliver more advanced products into the settings of primary care and patient-centered medical homes. We are entering an era of major patient empowerment from all directions, the implications of which we must all seriously consider.

MD+DI: How can more women get involved in the medtech industry?

DK: I will first give a simple answer to this: "Just ask." We sometimes need to be more comfortable simply asking for guidance and advice to pursue our specific career interests. I have rarely been given a "no" when I have asked for such guidance, and honestly, those people who give you a "no" are unlikely to be the best help for you in the long run, anyway. I think this is one area where social media has really moved the ball fast and far downfield for women in the medtech sector. Like everywhere else, colleagues from all over the world with the same professional interests now have unprecedented access to simply finding one another--however, what is also notable is the degree of access this provides to colleagues at all levels and stages of their careers. For example, our MedtechWomen LinkedIn group has broad representation among founders/owners, executives, directors and managers, and individual contributors. I would argue that getting professional advice and guidance, which can be the key first step to getting access inside any industry, has never been easier.


MD+DI: Are there barriers for women in medtech?

DK: This is such a multifaceted question, but one can at least start by looking at numbers. There are comparable numbers of men and women at entry- and mid-level ranks among companies and firms in the medtech sector. If you consider, for example, student demographics in the major biomedical engineering programs at US universities, there are more women than men in some of these programs. Yet, as is the case in many sectors, there is quite a difference in the numbers of women and men in leadership roles of medtech companies and firms--despite the fact that many major corporations are genuinely seeking ways to change historical patterns and diversify management. In medtech, we have needs for deep domain expertise (e.g., reimbursement, regulatory) typically found in smaller, heavily networked communities where who you know can drive what opportunities come your way. In part, this is a good thing, because medtech has so many types of risk, that hiring experts you know is a pretty straightforward means of risk mitigation. And given so much startup/emerging company activity in medtech, risk mitigation is critically important to ensure our most innovative products do make it to the bedside--especially in this economic climate. But all of these factors, taken together, can create hurdles for diversifying leadership among medtech companies and firms, in that historical patterns for management hiring are slower and harder to change. In the end, we all agree that we need the best talent in the medtech sector--the tricky part is how to find those leaders, get their ideas in the spotlight, and ensure they are chosen for the right key roles.


MD+DI: What advice for women would you give for pursuing a medtech career?

DK: The single piece of advice I find myself most often giving other women, in any sector or field, is "Know your stuff." If you want to be part of the conversation, so to speak, you need to be sure you have something meaningful to say. When we founded the 2011 MedtechVision conference ( http://medtechwomen.org/ ), this was our most important premise: that we were highlighting these women leaders in medtech, not because they were women, but because they were experts at the top of their game. I take this very seriously myself and spend a great deal of time self-educating, which means I have to read constantly and not be afraid to ask a lot of questions. Healthcare has become such a complex part of the global economy, and it can be tough to just monitor all the drivers of change. And that brings me to the most important advice when hiring a team: consciously surround yourself with people who know way more than you do, give them resources, and then get the heck out of their way.
 

Informed Consumers Feel Ripped Off by User Fee Deal

Informed Consumers Feel Ripped Off by User Fee Deal

And this sense of disillusionment pervaded strongly in a springtime FDA public hearing on the FDA–medical device industry agreement about the next five years of industry user fees.

dollars
Image from Wikimedia Commons

Based on their testimony, both patient and consumer groups feel ripped-off by the agreement, which calls for $595 million in user fees over five years, plus inflation adjustments, and contains a plan to hire over 200 additional full-time equivalent employees by the end of those five-years.

In exchange for this, FDA agrees to:

  • achieve reductions in total review times.
  • achieve significant performance improvements for PMA and 510(k) applications relative to current performance.
  • leave “no submission behind” by requiring it to meet with companies if a PMA or 510(k) performance goal is missed and work out a plan for finishing work on the submission.
  • provide a substantive interaction with applicants halfway through the targeted time for completion of review, ensuring that a company can have time to properly respond to appropriate questions.
  • implement an analysis of FDA’s management of the review process by an independent consulting organization, coupled with an FDA corrective action plan to address opportunities for improvement.


All very nice for industry, if it transpires as intended — but the obviously well-informed attendees at the March 28 hearing wanted to know what’s in it for the end users of medical devices?

Women’s Health Network program coordinator Kate Ryan did not see the agreement as much of a win-win for patients. She told the hearing it reflected almost none of the group’s comments or priorities offered during a stakeholder meeting before the intense negotiations began. “We will continue to advocate for Congress to establish a seat at the negotiating table for patients and consumers so the concerns of these important stakeholders will be addressed during future reauthorizations,” she said.

“Small companies are also paying more than their fair share and the larger device companies are not paying their fair share.”

“The proposed recommendations,” Ryan continued, “do not address concerns we raised about protecting and promoting the health of patients and consumers by strengthening the FDA’s capacity to assure the safety and efficacy of medical devices throughout the device life cycle. It does not propose allocating user fees to support the development of more rigorous premarket review standards or the expansion of post-market safety surveillance. Instead, it focuses primarily on streamlining premarket reviews, which is clearly a priority of the device industry.”

Ryan said the user fee agreement should have included device safety provisions for improving FDA’s passive surveillance system (MedWatch), and allowing CDRH to participate in the agency’s newer active surveillance system (Sentinel initiative). “An adequate surveillance program is necessary because many devices are placed on the market without undergoing clinical trials,” she said. “A unique device identifier program must be put in place before devices could be included in the Sentinel program, yet no user fees are allocated for this.”

National Research Center for Women & Families president Diana Zuckerman said her group’s main concern was the adequacy of resources for CDRH. She was particularly concerned that industry lobbying on Capitol Hill add more work and pressure on the Center as part of the MDUFA legislation: “we don't see how the resources available under the user fee measure will be adequate to handle all that work," she said. “Small companies are also paying more than their fair share and the larger device companies are not paying their fair share."

“We think it would make more sense," Zuckerman said, “to have larger increases particularly with PMA user fees. We think that the 510(k) fees are small enough that even the smallest companies can afford to pay more than that.” Additionaly, she said, there are concerns that the de novo reviews only have a 510(k) fee when more work is needed on these and should have higher fees, adding that her group is working with Congress to correct the fee structure.

National Research Center for Women & Families government relations manager Paul Brown said the user fee agreement should have scrapped the third-party review program altogether. “It is FDA’s job to review safety and effectiveness of devices,” he said. “Third-party reviewers have inherent conflicts of interest. We know that device companies can shop around and find the most lenient reviewer. Also, with the current third-party review program, FDA often finds the reviews scientifically inadequate, which slows down the science process.”

Additionally, Brown said his group would like to see additional user fees paid to help support FDA’s post-marketing surveillance. “And if a device is recalled, there should be another user fee paid to help FDA manage the recall… The user fees that CDRH will receive in this agreement are much too low to support the additional performance goals.”

A Positive Perspective from Industry Representatives

During the hearing, industry representatives said they were very pleased with the agreement. “We believe [it] has the potential to enhance the efficiency and predictability of FDA’s medical device review process through much-needed process improvements in exchange for new resources which will allow the agency to meet the commitments in the agreement,” said AdvaMed executive vice president Janet Trunzo.

“The user fee agreement is a win for the medical technology industry and for FDA, but most importantly, it is a win for American patients who will benefit from more timely decisions on submissions for the innovative devices and diagnostics that save and enhance their lives…The medical technology industry is committed to working with Congress, FDA, and other stakeholders to help make sure the agreement – along with legislative reforms that increase the opportunity for success at the agency – wins approval before the current user fee program expires on 9/30.” 

Women in Medtech: Sharon Higgins - The View from Ireland

Sharon Higgins is director of the Irish Medical Devices Association (IMDA), which represents the interests of medical technology companies within the Irish Business and Employers Confederation (IBEC). At a national level she represents IBEC and IMDA on the (Irish) Life Science Alliance and is currently the chair of the Irish Convergence Council. She also plays a key role on the Irish Medical Technology Code of Ethics taskforce.
 
 
MD+DI: How did you get your start in the medtech industry?
 
Sharon Higgins: I completed a degree and research masters in industrial chemistry at the University of Limerick and then started my first job as a validation/ technical engineer at Élan Pharmaceuticals in Athlone, Ireland in 1994. While I was primarily focused on drug delivery technologies during that time, I also worked on the nicotine patch, which was my first true introduction to medical technology.
 
I subsequently joined the Irish Business and Employers Confederation (IBEC) in 1996. IBEC is the umbrella representative organisation for business and industry sectors in Ireland. My initial role in IBEC was as technical director of Pharmachemical Ireland. In 2000 I became director of the Irish Medical Devices Association (IMDA). At the time, IMDA was a small group representing the needs of some 30 or so medical device and diagnostics companies in Ireland. Twelve years later, the industry, our membership, and the executive team working with me have all expanded significantly.
 
In fact, Ireland’s medical technology sector has now evolved into one of the leading clusters for medical device and diagnostic products globally. With exports to the value of €7.3 billion ($9.7 billion US), and 250 companies involved in developing, manufacturing, and marketing a diverse range of products and services from implants including pacemakers, orthopaedic products, contact lenses, and stents to micro-electronic devices, disposable plastic, and wound care products.
 
Nationally, the IMDA board and executive represent the medical technology sector on various groups including Irelands Life Science Alliance the national Convergence Council. Internationally, we are active in the European network, where we are the Irish representatives on the European National Association Network in Eucomed and EDMA. In my role as chair of the Eucomed SME Taskforce I have most recently had the honour of representing the industry position on the EU Commission Steering Group on Active and Healthy Aging during 2011.
 
MD+DI: Where do you see the industry going in the next five years?
 
SH: In weathering the global economic downturn, the medtech sector has become more productive, innovative, and competitive. Here in Ireland we see the sector as a key driver of Ireland’s export-led growth in coming years fuelled by diverse talents, entrepreneurial spirit, and an ability to collaborate efficiently across different disciplines.
 
Now, more than ever, the future of the sector is full of global challenges. A convergence of emerging global trends and reforms is placing strain on the industry, ultimately compelling many companies to revisit their business models and innovate the way they do business. Global healthcare expenditure is coming under mounting pressure, requiring the industry to demonstrate the value of its technologies in helping achieve efficiency. New products are being developed for new markets as the industry responds to the demographic challenges posed by an ageing population and increasingly caters to global emerging markets. Furthermore, the regulatory environment is under review, in particular in the EU the Medical Devices Directive is being revised.
 
Given the industry’s existing capacity to adapt, it is well placed to address these challenges. In an Irish context, tremendous growth opportunities await, not least at the intersection of healthcare and information technology.
 
MD+DI: How can we get more women involved in the medtech industry?
 
SH: The medtech industry is extremely broad, driven by people with diverse educations, skills, and backgrounds from engineering to marketing. It is true to say that there are some areas of the industry that have been dominated in the past by men, particularly the technical R&D and engineering roles. However, more and more women are joining the sector, bringing new skills, insights, and ways of doing business.
 
The medtech industry is a good employer and also has the major attraction of making products that save and enhance the lives of people around the world every second of every day. What can we do to ensure higher levels of involvement and to recruit excellence? We should:
  • Highlight the diverse range of careers that exist in the industry and the opportunities for development and career advancement in it.
  • Highlight the stability of the sector and its reputation as a good employer. Medical technology products are required at all times and in the majority are not luxury items.
  • Appeal to prospective employees at an emotional level. This is particularly effective when recruiting women.
  • Dispel the notion that engineering roles are for men!
  • Highlight strong female role models at all levels in the industry from graduate engineer to CEO.
  • Provide career guidance for teachers and, most importantly, parents - who are instrumental in shaping the decisions that are made by students - with the information and tools to assist them in providing advice about careers and opportunities.
 
MD+DI: Are there barriers to women entering the medtech field? How can they be overcome?
 
SH: Speaking from an Irish standpoint, I would say that there are no longer any barriers that are specific to women. I have certainly never encountered any. At a broad level, inappropriate advice from parents and career guidance teachers, taking irrelevant academic courses and, most importantly of all, lack of experience are potential barriers to entry. In Ireland we are running graduate internship programs to help graduates gain important experience.
 
MD+DI: What advice would you give to women who want to enter the medtech industry?
 
SH: Again, my advice would be to both men and women. If you are already experienced in another industry and looking for a job in med tech first make sure that you individualize your resume to show how your academic background and experience will be relevant to the role you are looking at now. Find courses that can help you fill gaps in your resume. This is a highly regulated sector and many companies will require knowledge of that environment.  If you can, get some experience in the role that you would like to work in. Look to internships etc.
 
If you have not yet made a decision about the college courses that you would like to take, think carefully about the type of role you aspire to and choose accordingly.

MD+DI Wins a Maggie!

Per the WPA's Web site: "One of WPA‘s primary objectives is to promote the pursuit of excellence among publishing professionals... WPA believes recognition is the best way to honor achievement. For more than fifty-eight years, WPA has bestowed awards of excellence to deserving individuals and companies whose work is deemed 'The Best in the West' in a wide variety of publishing categories."

Other finalists in the category included American Journal of Critical Care, September; Critical Care Nurse, April; Dimensions of Dental Hygiene, January; IVD Technology, Nov/Dec, and MedEsthetics, May/Jun.

 MD+DI's May issue was also selected as a finalist for best cover.

The December issue is a product of the dedication of an extremely talented group of editors, artist, and designers. I'd list their names, but I'm sure I'd forget someone important. 

Suffice it to say that, as a group, the team at MD+DI thanks you for your continued readership and support.

Heather Thompson, Editor-in-Chief

5 Questions with Denise Dion: Vallidation Spreadsheets and Databases

1. Why does FDA require validation of spreadsheets and databases?

Denise DionTo put it simply, the purpose of validating any software or computerized system is to establish trust in the data or electronic record. Spreadsheets and databases are automated data processing systems under 21 CFR Part 820.70(i) and if used as part of production or the quality system, as software they need to be validated for their intended use. If used as part of the quality system, then they are also creating and maintaining electronic records required by another FDA regulation or the Food, Drug and Cosmetic Act 21 CFR Part 11.1(b) so they need to be validated per  21 CFR Part 11.10(a). 21 CFR Part 11 states that the purpose of validation is to “ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.”
 

2. If I use Access or Excel for a spreadsheet or a database, do I have to validate Access or Excel?

No. FDA only requires you to validate the spreadsheet or database you create using these general purpose off-the-shelf software packages. In many ways, you may be doing a sort of black box test of portions of these software packages but truly you only need to validate the spreadsheet or database you created against your documented requirements for your spreadsheet and databases. Your requirements must address the security of the record (both logical and physical) and ensure that you will be aware of any changes made to the data or record (either authorized or not) or to any loss or corruption of the data or record.
 

3. Do I have to validate a spreadsheet or a database that is just keeping records?

Yes. There is a misconception out there that only spreadsheets with formulas need to be validated for intended use. However, the medical device quality system regulation (QSR) makes no such distinction. It states very simply that “when automated data processing systems are used as part of…the quality system…” they need to be validated for their intended use. If the spreadsheet or database is used to create, maintain, archive, modify, retrieve or transmit data or records that are required by the QSR or any other FDA regulation, then they need to be validated for their intended use.
 

4. How do I validate a spreadsheet?

That’s a very good question and the answer is, it depends. It depends on your intended use of the spreadsheet. Start your development with documented requirements. Again, be sure to include requirements for the security of the record (both logical and physical) and ensure that you will be aware of any changes made to the data or record (either authorized or not) or to any loss or corruption of the data or record (FDA calls this an “audit trail.”) FDA’s ORA Laboratory Manual has a section on validating spreadsheets for laboratory use, Volume III - 4.5 Development and Validation of Spreadsheets for Calculation of Data. I would use that as a reference on how much you may need to do.

5. What kind of objective evidence do I have to have to validate a spreadsheet or a database?

Objective evidence is data that can be reproduced by a second individual if they perform the same set of instructions in the same manner. It is not the words “pass/fail,” “yes/no,” “as expected,” or “true/false.” Those words are conclusions. Objective evidence demonstrates proper performance and functionality. It can include printouts, screen shots, videos running in the background, key captures, or written descriptions of what occurred or what was observed by the tester. It is important that you have sufficient evidence that the spreadsheet or database will do what you intend for it to do and that it performs as you need it to and expect it to.
 

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

Denise D. Dion has been with EduQuest, Inc. since December 2002after 18 years with FDA. At FDA, she served as the medical device investigator liaison between the Office of Regulatory Affairs (ORA) and CDRH as well as between ORA headquarters and the field staff. She was one of the designers, authors, and trainers of the Quality System Inspection Technique and training materials. She served on FDA’s Design Control Inspection Strategy Team, was the editor of the Investigations Operations Manual for five years, and participated in FDA’s basic medical device and process validation training. Dion was ORA’s final reviewer for on-line basic investigator training courses and worked on the development of FDA’s Risk Management and Computer System Validation on-line training courses. With EduQuest, Inc., Dion offers courses in Quality Systems Regulation, Design Controls, CAPA and Failure Investigations, risk management and Computer Systems Validation. You can learn more about EduQuest and its activities at www.eduquest.net.

Report from CMEF: China's Medtech Industry Must Embrace Innovation

While attending the China International Medicinal Equipment Fair (CMEF) in Shenzhen, CMDM Associate Editor Helen Zhang took the opportunity to gauge the pace of innovation among smaller domestic medical device manufacturers. While the government has introduced a number of positive measures to bolster healthcare, China's medtech industry suffers from an innovation deficit, concludes Zhang.

"While industry icons such as GE, Philips, the Weigao Group and Mindray impressed attendees with an array of innovative products, too many domestic medical device manufacturers are hobbled by a lack of focus on R&D and a “me-too” business strategy," she writes in an article posted on medtechinsider.com. A post-show report published by J.P.Morgan explains why, Zhang adds.

Read the full article on medtechinsider.com.

Norbert Sparrow