Posts Tagged PMA
Medical Device industry has been facing enormous and unprecedented challenges during the last several years. Only now it is emerging from the dark tunnel of funding dryout, layoffs, and lackluster job scenario. The 2014 Wilson Sonsini Medical Device Conference reflected some cautious optimism based on recent uptik in the industry. The challenges are not gone but companies have learned to work with the complexities. The conference this year focused on understanding the challenges still facing the Medtech startups and the new strategies that are emerging as response to these challenges. The conference was a sold out event with 600+ attendees that included CEOs, venture capitalists, investment bankers, market analysts, and industry strategists. Below are the highlights from one of the panels.
Funding Strategies for Entrepreneurs
Dried up funding continues to be a challenges for medtech start-ups. This panel was moderated by Casey McGlynn, Partner, Wilson Sonsini Goodrich & Rosati. McGlynn said he is increasingly seeing companies getting funded, even PMA projects are getting funding. One of the strategies for PMA is to have a believable path to an existing market in Europe that will adopt the product. Building product is not the challenge, but for these, the regulatory approval process in the US, becomes a big hurdle. For bite size consumer facing, wearable type, or health IT projects, crowdsourcing could be a good strategy, said McGlynn.
The panelists included CEOs who shared their experiences in search for capital. The panelists also discussed how interests of the investors are changing.
Laura Dietch, President and CEO, BioTrace Medical, shared about the technology that emerged from the Stanford BioDesign program. BioTrace is developing a temporary cardiac pacing device to treat reversible symptomatic bradycardia, during general surgery for percutaneous valve procedures. This is a 510K device. BioTrace raised $3.5M from 5 investors. Dietch’s advice to the entrepreneurs? “You have to be tenacious, have good target partners, be willing to take a lot of rejections, be organized, and be creative. She also advised entrepreneurs to stay lean, whenever possible, have a physician on the team, and be clear from the beginning regarding the exit strategy.
Qool Therapeutics offers patented cooling technology to induce therapeutic hypothermia. This minimally invasive technology has applications in stroke, cardiac arrest, traumatic brain injury, sports injuries and so on. President and CEO, Beverly Huss shared how the company raised $1.5M from small investors that included COO at American Airlines, General Counsel at EBay, an executive at Dish Network and so on. She said these relationships were developed over the years. “Early stage investing is a labor of love and can come from people who believe in your ability to deliver on a technology they like”, said Huss. She also advised that entrepreneurs be relentless and follow every path and see where it takes them, and be open to learning the lessons from each path they pursue. What has changed is how we are bringing therapeutics devices to a consumer market, said Huss.
Dr. Daniel Burnett, President and CEO at TheraNova also talked about how the climate has changed. With his first company, they raised funding without any animal or human data; next company required huge clinical data and since then most companies need some human data, before money can be raised. TheraNova turned to corporations and also had 4 SBIR grants. Since 2006, Burnett raised or helped raise, over $95M for six venture-backed TheraNova spinouts, BAROnova, Novashunt, Velomedix, EMKinetics, Channel Medsystems, and Potrero Medical. For Channel MedSystems, he partnered with Mir Imran’s Venture Health Crowdsourcing platform. His advice to entrepreneurs was to be lean and mean and to focus on both cost saving and improved outcome. Burnett said he avoids PMAs. Angel investors have been beaten up badly and still recovering but he advised that entrepreneurs can go to crowdsourcing platforms like Venture Health or DealLabs.
Doug Wall, Managing Director, Volcano Capital talked about some of their portfolio companies. All in all, market for early stage investors is pretty lonely, said Wall. There was virtually no competition from 2009 to 2011 but that is now changing. There are some VC funds now taking an interest in early stage deals. Most successful companies are the ones that think outside the box. Answering the question regarding what would be more important market or people, Wall said, “we are flexible on market size, but most important thing to us is the management team, and then we look to see if the milestones are thoughtful, and if the team shares the strategy to be capital efficient”. He said, they avoid PMS entirely to mitigate the regulatory risk factors.
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on May 16, 2013
Connie Hoy, VP of Regulatory Affairs at Cutera, shared detailed preparation plan to follow during the two weeks prior to the FDA audit at www.bio2devicegroup.org event.
“Hello, it’s the FDA”, this simple phone call can start a frenzy of preparation for a life science company’s next scheduled inspection. There will be less panic, with better prep. Hoy said, your overarching goal should be to get the auditor out of your facility in the shortest time possible. Their presence is disruptive, stressful, and debilitating to the functionality. Here is a step by step guide to prepare for the audit methodically, so they can come, get their job done, and leave.
Hoy suggested, first inquire and understand if it is routine audit or QSIT. While a routine audit is broader, in QSIT audit they would focus on 4 main aspects pertaining to quality systems, but frequently it also can end up being broader. Ask if it is a follow up audit resulting from the complaint letter, if it is a factory audit for PMA, or if it is a CDRH audit. CDRH audit pertains to ultra scans, lasers, x-rays, MRI and catscan machines. Understanding the focus of the audit, is the first step in preparation.
Next, get to know your auditor. Take down the name of the inspector and email and other contact information. You can also go to fdazilla.com and learn more about the inspector, see the kinds of warning letters issued by them, and understand what kinds of things they are more likely to focus on. An inspector with engineering background can likely focus more on design control and one with an MD under the belt, can focus more on clinical trials, and so on. You can also call your friends and ask anything more they can share about the inspector. Finally, you can look up blogs with RAPS members (new warning letters get posted every Tuesday after 9 am PST).
Immediately inform executive management and the directors and managers in the company, about the upcoming audit. Everyone should know about basic quality policy pertaining to their job, and they should be instructed to tell the truth. Everyone should be able to answer the question, how do they know what is required of them in their job, by pointing out that it is defined in the job description, told through instructions, by following appropriate procedures, and knowing how to access procedures and instructions. Regardless of how small a piece of work they do, for instance, tightening screws, they should know where the product ends up and how it impacts the patients.
Guess the upcoming auditor’s schedule and plan accordingly. Plan for an opening meeting with the executive team, arrange a factory tour, focus on corrections and removals, complaints, AE, MDR, CAPA, management review, and review of previous 483 corrective actions. Plan for auditor’s arrival from the moment they step into the office. The receptionist should sit the inspector and call management representative immediately. Prior to the arrival of the auditor, remove every single piece of product literature from the lobby. Plan where the auditor will be seated and keep them close to the document control, to coffee, and to the restroom. Set up all the necessary one on one meetings with key employees, after considering carefully if they have been audited before, they know what to expect, and their fears and questions are addressed. Remind them to read their SOPs and give them your cell phone no. so they can call with any last minute questions and are not stressed out.
After the auditor arrives, make a short presentation that explains the business, the products, history of the company, how long the company is in the market, where are the head quarters, where is the manufacturing done, which employees are directly involved with product line, show organizational chart of the management team with names, RA/QA structure of the department, information about annual sales etc. Also, prepare and give product chart, product names, technology, 510K status, date etc. and hand out on-label product brochures. Use flow charts in SOPs. With this upfront information, you could save hours that they would otherwise spend asking you questions. You can also ask them prior to arrival, if you can send some information they can look at in advance. Remember that the auditor may not be an expert in your field. They might have audited cheese, cat food, mascara, and more, in the last month. Explain your products in clear, non technical way. Patent brochures may be good to hand out as well. Ask them if they prefer to receive electronic records or on paper. Make sure the room is set up with access to network, projector, and printer. Ensure that there is a backup and a runner. The goal is to have them spend as short an amount of time as possible, at the company site. With through preparation, ” you can then relax and your FDA audit may not be a panic driven event”, said Hoy.
For the opportunities below, please send resume to wd_darshana at hotmail dot com. Candidates must be based in the USA and have valid US work visa. More opportunities will be added soon.
Clinical Data Manager – Redwood City, CA
There is an immediate opening for Clinical Data Manager for San Carlos, CA based medical device company. Responsibilities include, design, develop and enhance clinical databases and data reports and perform validation of databases and reports to ensure data accuracy, completeness and integrity of data entry, discrepancy database management, study documentation and data auditing. Job functions include, participating and providing support for data management activities, investigator meetings, DSMB meetings and regulatory submissions, assisting study team with the preparation of data collection forms and charts for the reporting of research data, supporting international and FDA regulations and company goals, policies and procedures, and complying with Quality System.
Requirements include, knowledge in regulatory requirements, FDA, ICH, GCP etc. guidance, experience using Commercial Off the Shelf Clinical Data Management and/or Electronic Data Capture products (e.g. Clindex, Oracle Clinical, Phase Forward, eTrials, etc.) is required. Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) is a plus. Also required, a Bachelor’s degree in related field with minimum 3 years experience in clinical data management supporting clinical trials, including experience in regulatory submission of drugs or medical devices (510K, class III devices, PMA).
Sales Rep Opportunity – Orange County, Los Angeles, CA
This position will play a visible role in drug rep industry, by developing critical relationships, primarily with doctors of many disciplines to share the availability of breakthrough pharmaceutical grade pain management option that would diminish pain, aid in sleep, and enhance quality of life as a holistic alternative to addictive and sometimes life threatening drugs. Specific responsibilities will include, provide field based scientific exchange and communication regarding the product, broad interdisciplinary background and proven ability to establish relationships with doctors across variety of disciplines, tenacity and drive to reach out to new doctors, and ability to work the referrals, and to network and partner with medical practitioners. Requirements include, pharma or medical industry sales background, strong sales success track record, consummate professionalism including understanding of sensitivity of subject along with ability to deal warmly with high powered, industry-leading medical professionals, strong entrepreneurial spirit and passion for the vision of managing pain with a holistic alternative. Compensation will include commission, bonuses, and stock options during the first 60 days and then will include cash based compensation. This position is located in Los Angeles, Orange County, CA.
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on June 24, 2012
The panel was moderated by Elton Satusky, Partner at WSGR and focused on the impact that China’s growing middle class is having on healthcare services. The panel addressed strategies to best navigate China’s complexities and challenges, in order to successfully access the burgeoning Chinese medical device market. China is a very exciting place to be to do business said, Landon Lack, Founder of China MedConnect. MedConnect focuses on representing small US companies, to achieve access in China market. It is important to understand China market. A product well suited for US market, may not be well suited for China market. Also, china is big and diverse, and is extremely fragmented, said Lack. Lack advised that companies have a legal presence in China, or at least get a legal agent, in china. If a company expects China to be a good market, then planning a clinical study early on in China, would not be highly expensive and would add value, according to Lack. Also, in China, there is a greater value for US PMA approval than EU CE Mark. Getting IP protection is very important, in China. Even Chinese partner values the US company more, if it is protected in China. Regarding reimbursement, Lack opined, that it is tricky in China and it can be based on a procedure or on a device.
Kraig Black, COO and EVP, Corporate Development at Medafor said, China is an important market but it took them a few years to figure out to deal with China. Not filing for original patent protection in China, was a mistake, he said. Majority of the billion dollar hemostatic market in China is geared toward low end but it is rapidly changing, said Black. In doing a clinical study, he advised that companies use vetted FDA approved hospitals and it would not be difficult because in straight numbers, there are more top tiered hospitals in China, than in the US.
Also alluding to China’s rising status, Nick Pliam, Venture Partner with Decheng Capital & Bay City Capital, said that the old expectation that generation minus one device would work in China, is not true any more. Chinese market now demands the best. China is spending 4.5% of its GNP, on health insurance. China cannot afford to replicate the US healthcare system, and is in the process of figuring out the model that would work well. Pliam also emphasized, the importance of protecting the know-how in China. A partner in China should not be given all the pieces of the puzzle or he could go and do it all on his on, said Pliam. Additional problems in China are corruption and huge economic disparity. But as middle class is growing the trend in China is towards more, higher quality devices.