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National Leadership Council Taps Local Professional

Janet Kwiatkowski, president of MAE Consulting Group LLC of Manchester, was invited to join the National Small Business Association’s SBA Leadership Council.

The NSBA Leadership Council is a nonpartisan network of business owners who meet regularly to identify key issues in the small business community. Then they advocate with U.S. Congress, the administration, state and local governments, and the media to offer solutions, representing the 70 million Americans who work for or run small businesses.

As a successful business leader and entrepreneur in two primary NSBA focus areas, Janet Kwiatkowski was invited to work with both the Economic Development and the Health and Human Resources Committees.

“This is a special opportunity for our company to be part of this unique leadership group. I am excited and look forward to the prospect of shaping and influencing, along with my colleagues in the NSBA, key policies that are so vitally important in sustaining a rich and healthy small business environment,” Kwiatkowski said.

MAE founder Kwiatkowski has more than 17 years of regulatory affairs and compliance leadership and experience at Fortune 500 and start-up companies. Among the Class I, II and III medical devices and in vitro diagnostics products she has developed and implemented include OB/GYN, surgical, cardiovascular, gastroenterology, hematology, immunology and radiology among other medical specialties.

Kwiatkowski has a BS in mechanical engineering, an MBA, and an MS degree in regulatory affairs and international studies. She was awarded VIP Woman of the Year by the National Association of Professional Women.

We’re Growing! MAE Consulting Expands to Europe

Piccadilly Gardens

MAE Consulting Group of the United States and now the United Kingdom, is a business service provider specializing in offering domestic and international regulatory, clinical and compliance services to healthcare companies.

With expertise in commercializing medical and in vitro diagnostic devices, MAE Consulting can market your product globally and across the Atlantic — in either direction.

The new MAE office in Manchester, England is strategically located to take full advantage of the UK government’s Northern Powerhouse initiative supporting innovation and the MedTech community in northwest England.

UK advantages include its centrality to Europe and the USA, a growing economy, and a highly educated and technically skilled talent pool.

The American marketplace is challenging to companies seeking to bring products to market, and to export and import them, particularly in the tough regulatory environment surrounding medical and diagnostic devices.

With MAE Consulting, there’s no need to “mind the gap.” Our specialists have expertise navigating the alphabet soup of regulatory acronyms, from FDA (Food and Drug Administration) to the BIS (Bureau of Industry and Security) and the EAR (Export Administration Regulations) to the ISO 13485 Certification necessary to deliver MedTech innovations to the global marketplace.

The world of import and export licensing and compliance is complex. Trade compliance and medical regulations vary from the USA to the EU and the UK. With MAE Consulting’s presence in England, clients are ensured that their intellectual property, sensitive medical devices, and technical imports and exports reachthe global marketplace in full regulatory compliance.

The UK has a vibrant and growing global MedTech ecosystem. MAE’s team of professional consultants is proud to offer signature specialist support to companies seeking to strategically market their innovative MedTech devices to the USA and the world.

castlefieldEuropean HQ Address:
MAE Consulting Group (Europe) Ltd
MedTech Centre
Greenheys Business Centre
Manchester Science Park
Pencroft Way
Manchester M15 6JJ

Business Development Contact:
Steve Ives
Tel: +1 603.340.7078
Email: stevei@maeconsultinggroup.com

Media Contact:
Lisa Landry
Savvy Workshop, LLC
55 So. Commercial Street
Manchester, NH 03101
Tel: +1 603.792.0080
Email: lisa@savvyworkshop.com

 

Changes expected with the Indian Medical Device Regulations

Yasheshr_smThe government of India is planning to develop an in-depth regulatory framework for medical devices. The current system lacks distinctive regulatory system and medical devices are either regulated as drugs or are unregulated. Medical devices that are regulated are under the Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO); part of the Ministry of Health and Family Welfare,

The regulatory framework for medical devices is based on drug regulations under the Drugs and Cosmetic Act of 1940, and Drugs and Cosmetic Rules of 1945. Currently, 22 medical devices are “notified” under the Drugs & Cosmetics Act. Devices notified (regulated) by the Indian government must register with the CDSCO. Non-notified (unregulated) devices do not require CDSCO registration, and may be imported into India according to formal customs rules.

The Ministry of Health plans to issue a set of new guidelines to define and regulate medical devices as a separate category. These guidelines will be finalized in consultation with Association of Indian Medical Device Industry (AIMED) and will be issued by the Ministry. The new guidelines will make medical device regulations stringent for both the manufacture and importation of medical devices. The National Pharmaceutical Pricing
Authority (NPPA) Department of Pharmaceuticals, responsible for current medical device regulation in India, has issued the Draft National Medical Device Policy recommending formation of an autonomous National Medical Device Authority (NDMA). The NDMA will be authorized for promoting the local device sector, enforcing stricter safety standards, and installing price controls for devices, including surgical instruments, implants, and diagnostic equipment.

Recent Update:
– In January 2016, CDSCO implemented an online portal “SUGAM” to file applications for various services including application for registration certificate and import license application for notified medical devices. From 15th February 2016, it is required that all the applicants submit the applications online along with the hard copies.

– In June 2015, the Health Ministry approved the ‘Materio Vigilance Programme of India’ (MvPI) which would monitor Medical Device associated Adverse Events (MDAE) and can be coordinated by the Indian Pharmacopoeia commission in collaboration with CDSCO.

Future:
– The new regulations aim to bring India’s regulatory requirements in compliance with International environment. CDSCO recently issued changes to the country’s good manufacturing practices. The new standards are drafted to align to ISO 13485, which may streamline the approval of devices.

– The medical device registration and import license approval timeline will be affected, as new medical device regulations will be implemented by CDSCO. However, it is anticipated that it will take at least two years to develop and implement a proper medical device regulatory structure in India.

Yashesh Rawal is a Regulatory Affairs Specialist at MAE Consulting Group. Contact Yashesh at Yasheshr@maeconsultinggroup.com

Square Hole in a Round Peg

For a while I had been thinking about starting my own business, partly because I thought I could be successful and partly because I never quite fit with the corporate structure. So when the opportunity presented itself, I decided to dive into the deep side of the pool. It was actually a relief as I made the commitment and thought; finally, I will make it based on my abilities, determination and skills….or it will be a bust and I will be back in the corporate world again. Which, truth be told, made my stomach churn.

I have never quite understood why I always felt different working in corporations. Perhaps I never felt I fit in with the structure, bureaucracy or limits. Whenever walking into work, no matter how successful, I could feel tightness around my throat, which made me gasp for air. Many of my friends like the structure and the security of the corporate life, which on the one hand I understand, but on the other striking out on your own, without a net is very liberating and exhilarating with a hint of terror.

“To thine own self be true,” says Polonius in Hamlet by Shakespeare. Okay, if I truly believe in the essence of those words then I must be true to myself and accept that I am not a perfect fit in the corporate world. Perhaps I found the corporate world too confining, perhaps it was the decision making process, perhaps is was the no decision making process or perhaps I could see opportunity that was not in line with the direction of any given company. Now I get the chance to put my thoughts and ideas into practice.

I know I’m not saying anything new but when you are “it” – you succeed or fail by your own decisions, your own strategy and your own execution from finance to marketing to operations. I absolutely Love It!!

As I grow my business, I am thoroughly enjoying marketing, networking, sales, developing partnerships and alliances, and most importantly growing long-term relationships with my clients. I know this is the right decision for me. I enjoy flying the plane and even if I crash and burn – at least I’m in the cockpit.

It’s okay to admit you don’t fit into a system or a dynamic, it’s okay to think differently, it’s okay to try to add value to a business even if it is “not the job you were hired for” and it’s okay to believe in yourself.

It’s okay to be a square hole in a round peg – enjoy it and be different!!!!

 

round peg in square hole

 

 

The Importance of Article Selection for Meeting the MedDev 2.7.1 Rev 3 Requirements

Posted By: By Donna Mitchell-Magaldi, Nerac Analyst

On March 20, 2010, the revised Guideline; MedDev 2.7.1 Rev 3 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies became a requirement for obtaining and maintaining a CE Mark for all classes of devices marketed in the European Union. An important component of the MedDev 2.7.1 Rev 3 is the evaluation of the clinical literature (European Commission, 2009). The literature search is used to identify clinical data that is outside the manufacturer’s possession and can be used to assist in the evaluation of the device in question. The literature can address the specific product or an equivalent device (MedDev 2.7.1 Rev 3).

This can be a daunting task, as many devices may not have been evaluated clinically, or may have been around for so long that there is a plethora of information pertaining to the device.  The selection of appropriate articles is a key component for a successful evaluation. This is especially true if the clinical literature evaluation will serve as the bulk of your clinical evidence.

Although it’s tempting to include any and all articles pertaining to your device or a competitive equivalent, not all articles are created equal.  It’s important to focus on articles that are going to provide the best possible clinical evidence. Non-clinical studies such as animal studies, in vivo studies, in vitro studies (unless the device is an in vitro diagnostic device) and cadaver studies should not be included. Although the information in these studies is important, they are not included in the clinical literature review as the focus of proving safety and efficacy is on human subjects and must be consistent with the intended use of the device.

Bias and Confounding: A Question of Validity

Two elements that affect the validity of the data are bias and confounding. Both can significantly impact the quality of the study.  Three different types of bias we will discuss (there are many more) are selection bias, measurement bias, and analysis bias.  Selection bias occurs when subjects are allocated to a treatment group in such a way that produces a group that does not accurately represent the population, or in such a way that treatment groups are systematically different (collemergencymed). Measurement bias occurs when outcome is inaccurate due to instrument bias (may not have been properly calibrated), or biased expectations of study participants, researchers or care staff (collemergencymed).  Analysis bias occurs when relevant information is omitted or miscalculated. Examples of possible analysis bias are when patients are withdrawn and omitted from the analysis, or data is missing or inaccurate which leads to in inaccurate analysis and incorrect conclusions (May, 1981).

Confounding variables are variables in which the researcher cannot control and can affect the accuracy of study outcomes through misinterpretation of accurate measurements. A confounding variable is also known as a confounder. Confounders can be known or unknown. The adverse effects of a known confounder can be mitigated though designing a study that uses statistical methods to adjust for the confounding issue.  An unknown confounder, on the other hand is much more difficult to address by the shear nature of it being unknown. With an unknown confounder, there is always a risk that any association between a risk, intervention or outcome is being mediated through the unknown confounder (collemergencymed).

Importance of Clinical Study Design in Mitigating the Affects of Bias and Confounding Variables

Randomization is the best defense against confounding variables and bias (collemergencymed) (Farb, 2010). It accomplishes this by removing the potential bias in allocation of study subjects to different interventions, ensures study groups are compatible, can account for both known and unknown confounders, and ensure the validity of the statistics used to interpret the results.

Blinding or masking is also a tool used to reduce bias.  Studies that are single-blinded allow the investigator to know which patient received specific treatments, while the patient is unaware of which treatment they received (Kahan, 2009). In a double-blind study, both the Investigator and the subject are not provided with the treatment information. A modified double-blind study is in which the Investigator is not blinded, but the patient and observer who is responsible for assessing safety and efficacy are blinded to which patient received a particular treatment (Kahan, 2009).

Non-randomized trials, on the other hand, allow for opportunity of possible bias, provide data that may be inaccurate and may lead to misinterpretation of the data (Farb, 2010).

A cohort study is observational and not randomized; instead, treatment is decided by the patient’s provider. The study measures the same characteristics in patients. Patient groups may vary in their makeup by one characteristic for example, invasive procedure or noninvasive procedure. The study may use various multivariate analyses in order to correct for any possible confounding factors. The validity of the data is subject to selection bias (Sullivan & al, 2008).

Review articles provide much relevant background information on the device, but lack the clinical details required to critically evaluate the quality of the data presented. As a result, the data may not be as strong as the data presented in a randomized or blinded trial.

Published case series and case reports should be included, as the adverse events cited in these instances can help add valuable information that may not have been caught in the clinical studies. They can report rare events and even help identify early trends. However, it is not advised that the bulk of your evidence be comprised of case reports and case studies because these are single instances of adverse events and should not be used alone to evaluate overall performance and safety of the device in question.

This list of study designs is not exhaustive but covers most basic designs

Figure 1 provides a ranking of study designs types and their ability to provide qualified, accurate and effective evidence.

Figure 1: Ranking of Clinical Evidence Types

Weighing the Evidence

MedDev 2.7.1 Rev 3; Guidelines on Medical Devices Clinical Evaluation: A Guide for Manufacturers and Notified Bodies address the quality of articles in Appendix D.  The guidance provides a good example of the weighing Schedule D1. Schedule D1 takes into account the device, the intended use, the intended population and the quality of the data.  The Guidance further addressed evaluating the quality of the date with Schedule D2.  It’s important to note that the very first criterion on the D2 schedule addresses the issue of appropriate study design (European Commission, 2009).

 Upcoming Changes

The European Commission is currently in the process of ratifying the new Medical Device and In vitro Diagnostics Regulatory Framework (European Commission, 2013). These regulations will replace the directives and guidance that are currently in place. The draft regulations indicate that even more medical devices and some non-medical devices will require a clinical literature evaluation and that even more scrutiny will be placed on this process. Therefore, it’s imperative that the clinical literature evidence you provide in your evaluation consists of the most relevant, qualified and accurate data possible.

Bibliography

Collemergencymed. (n.d.). Bias and confounding. Retrieved March 5, 2013, from collemergencymed.ac.uk: http://www.collemergencymed.ac.uk/CEM/Research/technical_guide/biasconfound.htm

Farb, A. (2010, Sept 30). When is a randomized clinical trial appropriate vs a historical control vs. a performance goal. Retrieved March 5, 2013, from FDA.gov: http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM240786.pdf

Kahan, J. S. (2009). Medical Device Develpment Regulation and Law; Chapter 6. PAREXEL.

May, G. a. (1981). The Randomized clinical trial: Bias in analysis. Circulation Vol 64 , 669-673.

Sullivan, B. M., & al, e. (2008). Overview of Study Designs in Clinical Research. Retrieved Marh 5, 2013, from nuh.edu: http://www.nuhs.edu/media/4133/5.1bAppraiseOverviewofStudyDesignsLecture.pdf

Telemedicine: A Tool for Reducing the Cost of Delivering Medicine

Posted By Roz Sweeney, Ph.D., Nerac Analyst

Global economic weakness beginning in 2008, along with an aging population, has intensified the need to reduce healthcare costs. There is a general consensus that the rate of increase in healthcare spending is not sustainable. Since 2009, the annual rate of healthcare spending increases have dropped in the United States; however, it is not clear if this is a temporary phenomenon, or if spending increases will resume to previous levels as the economy improves.

Our view is that telemedicine is a possible lever for reducing healthcare spending by enabling patient interaction at more appropriate intervals (e.g. monitoring patients with chronic conditions) and by facilitating appropriate access to care (e.g. easier access to specialists, collaboration among doctors). Telemedicine does not necessarily represent a new market for medical device companies and healthcare providers; instead it is a new mode of delivering medicine utilizing existing devices and infrastructure that involves some modification to existing practices and infrastructure. In order to remain competitive in the coming years, clinicians, healthcare service providers and payers will need to adapt and become proficient at delivering telemedicine in situations where it can improve patient outcomes and reduce costs.

There are several situations where telemedicine for care delivery has been shown to reduce costs and improve access to care:

  • Prison environments

Remote consultations with specialists are much more cost-effective and logistically easier than transporting patients outside the prison walls.

  • Combat environments

Transporting the soldier can be difficult to coordinate and is dangerous to patients and transport personnel in combat situations.

  • Rural environments

In situations where the patient is not in physical proximity to an appropriate specialist, remote consultations can save patients the time and expense of travel.

  • Acute care/ ICU situations where a specialist is not located in geographic proximity

In some situations, it is not cost-effective to have certain specialists on staff. For example, it may not be feasible for a rural ER to have a psychiatrist on staff. Telestroke networks and teleradiology services are other potential cost-saving tools for rural or under-staffed medical facilities.

  • Chronic care monitoring

Remote monitoring of patients with certain chronic conditions (COPD, ESRD) has enabled patients to be seen by a provider at more appropriate times (e.g. prior to an exacerbation), rather than at pre-defined intervals.

There are other potential markets being explored by start-up companies and by clinicians and payers in pilot studies. We view these markets as having signification potential if regulatory and reimbursement hurdles can be overcome and if cost-savings and/or improved outcomes can be demonstrated.

  • Primary care

As the Affordable Care Act begins to expand access to healthcare, there is predicted to be a shortage of primary care providers. Several companies are addressing this challenge. For example, MDAligne is a web-based provider of outpatient primary care services directed towards self-pay patients. The idea is to increase access to a doctor for minor conditions (e.g. cough, sore throat) that constitute a significant proportion of primary care encounters.

  • Remote monitoring of home health patients with diabetes, CHF, and a variety of other chronic conditions

While it has not yet been proven conclusively to reduce costs and improve outcomes, it is possible that remote monitoring could reduce the number of in-person visits or lead to ‘smart’ visits, only when the patient needs intervention or is otherwise having difficulty. Companies active in this space include Bosch (Home Buddy monitoring system), Cardiocom, Biotronik, and Honeywell.

Remote monitoring/telemedicine is also gaining use during care transitions (e.g. patient discharged from hospital).  Due to new Medicare penalties around readmissions, hospitals are exploring ways to improve care post-discharge through telemedicine and remote monitoring.

Exhibitors at the American Telemedicine Association (ATA) meeting in Austin, TX .

Nerac attended the American Telemedicine Association (ATA) meeting in Austin, TX (May 5-8, 2013) to get a better understanding of recent telemedicine trends and companies active in the space. This was the largest trade show in ATA’s history, and it continues to grow every year with 30% year-over-year growth since 2009. Some presenters and exhibitors commented that there has been more progress in the telemedicine space in the last 18 months than in the last 5-10 years.

According to several attendees and conference organizers, there is significant churn in the exhibitors each year. We attribute this churn to the low barriers to entry in this market, creating a situation where there is downward pressure on pricing that leads to a fragmented market. This is particularly true for many of the start-ups in the mobile health space.

Within the telemedicine industry, there are several different types of companies that deliver services and equipment for patients and providers to connect and share remotely, to monitor progress, and to coordinate care delivery. The following types of companies were well-represented at the trade show and represent companies involved in the telemedicine industry.

  • Remote monitoring and telehealth systems
  • Mobile health (mHealth) (We believe mHealth can be useful in helping patients track their own health and manage their conditions. However, it can be overwhelming for providers to track so much data from individual patients. Methods for summarizing data and making it more efficient for providers to interpret are needed.)
  • Outsourced Clinical Service Providers
  • Teleradiology
  • Videoconferencing
  • Health Information Technology
  • Hardware, software and equipment.

For more information on the exhibitors click here.

Barriers

Despite many predictions of phenomenal growth, telemedicine has not lived up to all expectations. The market is believed to be worth $3-$8B currently, depending on which specific segments are included. Growth projections for the future vary widely, depending on the organization making the predictions. We see the following three barriers as the key to understanding future growth and acceptance of telemedicine.

  • Reimbursement

Payment for telehealth interactions is believed to be the main barrier to more wide-spread acceptance. However, presenters stressed the need to continue pushing for reimbursement with private payers and Medicare. In 1997, a Medicare law was passed stating that telemedicine should get the same reimbursement as other services. Initially, this didn’t happen in practice because of how the law was interpreted. However, as Medicare implements more quality and cost metrics, we believe that telemedicine interactions will become a standard of care and face less reimbursement scrutiny. In addition, Medicare/Medicaid systems have different payment models that vary from state to state.

  • Regulatory

Key regulatory issues include licensing requirements for doctors that vary from state to state and HIPAA Privacy and Security Concerns. Regulations on the security of patient data vary from state to state. This places an additional burden on service providers to ensure compliance. For example, Texas has more regulation regarding patient data than other states and the federal government.

As one example, there are multiple electronic health records (EHR) platforms, making it difficult for doctors to merge information from multiple platforms (e.g. a patient’s primary care doctor, pharmacy, and specialist doctors may all use different platforms).

  • Compatibility of platforms

As one example, there are multiple electronic health records (EHR) platforms, making it difficult for doctors to merge information from multiple platforms (e.g. a patient’s primary care doctor, pharmacy, and specialist doctors may all use different platforms).

The strategy of incompatible platforms is intended to carve out a niche for EHR companies by limiting the competition’s ability to interface with their platform; it believed that this practice limits switching by healthcare providers. However, the lack of industry standards appears to be hurting adoption of telemedicine overall and may be short-sighted on the part of industry.

Drugs and Biologics in Cosmetics – Who’s Paying Attention?

According to the Food and Drug Administration’s (FDA) website, “FDA’s legal authority over cosmetics is different from other products regulated by the agency, such as drugs, biologics, and medical devices. Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives. However, FDA may pursue enforcement action against violative products, or against firms or individuals who violate the law.”

FDA’s website states further, “Cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing.” The FDA does regulate cosmetic labeling under the authority of the Federal Food, Drug and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act.

But what happens when a cosmetic includes a drug or biologic as the active ingredient? What are the regulations? According to the FDA, such products must comply with the requirements for both cosmetics and drugs.

The FD&C Act defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)].

The FD&C Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)].

Per FDA regulations, a cosmetic is also a drug when it is intended to cleanse, beautify or promote attractiveness as well as treat or prevent disease or otherwise affect the structure or any function of the human body and “articles intended for use in the … cure, mitigation, treatment, or prevention of disease … and … articles … intended to affect the structure or any function of the body …”(Sec. 201(g) and (i), FD&C Act and Sec. 509, FD&C Act).

This definition is applicable to biologics as well since the FDA considers biological products as a subset of drug and as such both are regulated under provisions of the FDC Act. Therefore, a biologic or drug product must be reviewed/approved by the FDA prior to placing on the market in the US.

The FDA is issuing Warning Letters to cosmetic companies that are making drug/biologic claims.  Below is a link to the FDA website providing a list of all Warning Letters issued since 2002. Notice the increase in 2012; from 2002 to 2011 there have been thirteen Warning Letters issued spanning nine years whereas, in 2012 eleven letters were issued to companies such as Lancôme and Avon.

To see the Warning Letters associated with drug and biologic claims made for products marketed as cosmetics click here.

Some excerpts from the Warning Letters where the FDA concluded the products are intended to affect the structure or function of the body based on claims include:

  1. “Formulated to boost shock-absorbing proteins to help strengthen skin’s support layers.”
  2. “Improve fine & deep wrinkles up to 50%. Immediately plumps out wrinkles and fine lines. Within 48 hours begins boosting collagen production.”
  3. “[B]oosts the activity of genes and stimulates the production of youth proteins.”
  4. “A powerful combination of unique ingredients – Reconstruction Complex and Pro-Xylane™, a patented scientific innovation– has been shown to improve the condition around the stem cells and stimulate cell regeneration to reconstruct skin to a denser quality.”
  5. “Immediate lifting, lasting repositioning. Inspired by eye-lifting surgical techniques . . . helps recreate a younger, lifted look in the delicate eye area.”
  6. “Blemish Free Skin in Just 3 Days!”
  7. “Organic Plant Stem Cells … reactivate your body’s own dormant and weak skin stem cells, pushing them to regenerate.”
  8. “[T]riggers your body’s own skin regeneration activators”
  9. “[R]epairs sun damaged tissues at the cellular level”
  10. “Long-term repair – 5% each of two additional peptides with anti-oxidants stimulate production of collagen and elastin… helping to repair structural damage to deeper layers of the skin.

I understand the balance between revenue, risk and compliance faced by corporations. However, when a drug or biologic is added to a cosmetic it makes the threshold of safety that much more critical. We are not talking about a one-time application of a cosmetic; we are talking about decades and decades of application of creams, foundation, lipstick, eyeliner, etc with little to no scientific evidence demonstrating the safety and effectiveness of the active ingredient(s). Not only do consumers deserve to know that the products they are using are safe but they also have the right to know the products they are using actually comply with US laws.

After what appears to be a lull of enforcement activity in 2013, it is uncertain if the FDA will refocus its attention on cosmetic companies en masse or if they will continue to enforce a particular company through website trolling, but either way if your company happens receive a letter in the mail, the negative impact on revenue and company reputation will be felt immediately. That, quite clearly, is the down side of business risk.

 

The Truth About Planning in Project Management

Have you ever had to go to a meeting to try to explain why your project is delayed? Remember the knot in your stomach? As you are taking the last few steps down the corridor to enter the conference room you’re thinking, “how am I going to explain to executive management that the revenues they were planning on this fiscal year is not going to happen?” How do you do that and not come out of the meeting looking like the Headless Horseman? Project Management is key not only to monitor project status but more importantly, setting clear expectations at the start of the project.  There are multiple benefits to creating a clear, concise project management plan ranging from the qualitative to quantitative. A few of these include direction, accountability, resource allocation, project costs vs. budget, employee development, skill discovery and lessons learned. However, all of those benefits are in competition with corporate expectations of meeting project deadlines that are aggressive, budgets that are tightly controlled and resources that are typically overwhelmed and understaffed. The first step in developing a solid project plan is for the project manager to spend the necessary time in the beginning stages to ensure the project is properly understood and agreed to in terms of scope, resources, time and budget by the sponsors, project manager and project team. Then, developing the actual project plan with the team is invaluable for buy-in as the project gets underway. Proper project planning can also proactively sound the alarm when the project encounters resource constraints, cost overruns, time conflicts, etc. This allows for the sponsors and the project team to make informed decisions regarding the completion of the project without unpleasant surprises. The project manager is the bridge between corporate sponsors and the project team. The project manager must navigate between the tugs of aggressive deadlines to launch a product or announce a new line extension at the next conference and the pulls with the actual project timelines, realities and constraints. Successfully juggling these forces will mean success with the project, the team, the corporation and the project manager’s sanity.

Marketing Your Medical Device Globally and Export Compliance

Congratulations – you just received your Clearance Letter from the FDA after months of hard work by a team of dedicated professionals. That Clearance Letter, the CE Marking, and ISO 13485 Certification are the gateway to international markets. You can now move forward to submit dossiers and market your product globally.

As you look to ship your product to the four corners of the world, you have just entered the realm of export compliance. However, prior to making the first shipment outside of the United States, you must classify your product including components and subassemblies to determine if you need an export license. Factors that are included in this determination are the product’s technical characteristics, destination, end-user and end use.

The Department of Commerce’s Bureau of Industry and Security (BIS) is responsible for implementing and enforcing the Export Administration Regulations (EAR) that regulate the export and re-export of most commercial items. BIS regulates items known as “dual-use” which means items that have both commercial and military or proliferation applications.

Just in case you’re wondering – any item that is sent from the United States to a foreign destination is an export. Items include commodities, software or technology, materials, product, blue prints, design plans, packages and technical information, etc.

How do you determine if your product requires an export license? Start by making certain your product falls under the Department of Commerce jurisdiction. If it does, then classify the product using the Commerce Control List (CCL) and determine the Export Control Classification Number (ECCN). Then cross-reference the ECCN Controls against the Commerce Country Chart (CCC) to see if a license is required. If a license is required you should work with BIS to determine if your export qualifies for an exception or if not, you must apply and secure the license prior to the product leaving the United States.

The world of import and export compliance is complex. Whether you are just starting to ship products internationally or have been marketing your products globally for years, you must take into consideration trade compliance regulations in addition to the familiar medical regulations promulgated by the US, EU and other government agencies. Shipping a product to a country such as China or India may be very beneficial to your company but product registrations are only half of the equation, you must know and understand the trade side of the equation if your company is to maintain a good standing with all customers, including the US government.