What we do

We are experts in all aspects of medical device & combination product development, from product definition to regulatory submissions.

Combination Product Development

Did you realize we’re already working with your product?

As a pharmaceutical industry client, you leverage our expertise across more than twenty combination product systems, including:

  • mechanical auto-injectors,
  • electromechanical drug infusion systems (both on-body and patient-held),
  • attached biosensors,
  • lyo-kits,
  • pre-filled syringes,
  • adherence support,
  • vial adapters, and
  • predictive modeling platforms.

Once you are discussing your program needs with us, you’ll soon realize that we already have experience with your components, your vendors, and your solutions. Are you working on projects with firm schedules? You’ll be impressed to learn that we’ve successfully completed billion-dollar drug launches ahead of schedule with the biggest players in “pharma”.

Medical Device Product Development

Most Suttons Creek team members come from a medical device background and the team has all the cross-functional experience needed to take a device from concept to market.

We have experience both working in and advising both small and large companies, everything from a startup team of 5 to a Fortune 500 division of 1500.

In recent months we have engaged a number of different clients in the pharmaceutical and biotechnology industries who are interested in bringing some of their drug delivery technology in-house. SCI can help your company set up a medical device development process, setting up design controls at the beginning of your project, thus eliminating the costly and time-intensive retrospective paperwork that many companies fall prey to when it comes time to submit their products to regulatory authorities.

In addition to providing guidance on product development itself, SCI can also help you staff your nascent medical device team and provide engineering leadership while it is getting acclimated to the new products and processes.

Regulatory Submissions & Remediation

First comes a proposed submission date from management. It is clearly impossible. Isn’t that apparent to all involved?

Yet regulatory submissions are the most critical milestones in your development program.

Quality submissions can accelerate time to market and bring the benefit of new treatments to patients sooner. You’ll only succeed if your submission, design history files, etc. are done right. So you’re looking for a team with a proven track record that will carry you over the finish line. We’ve covered all the angles: from submissions to standards analysis, from MAAs to RTQs, from essential design outputs to discussions with CDRH and CBER. Suttons Creek has helped launch programs with budgets over $1 billion USD.

We help you from your initial contact with regulatory agencies through the final submission, but there may be more challenges to overcome. Data may be weak, missing, poorly written, poorly organized or improperly formatted… What then? Suttons Creek sets up programs for success.

We implement processes that integrate the needs of regulatory teams throughout the development cycle, eliminating costly surprises. With published papers on driving regulatory need through the development process, we can ensure your next program doesn’t cause you to suffer like the last.

Business & Marketing Planning

Wouldn’t it be valuable if your business plan for a new product, division or company was informed by a strong clinical and engineering background?

Suttons Creek has been engaged to assist in the creation of business and/or marketing plans by established technology companies, emerging startups, and venture capital firms. Our business and marketing plan scales depending on your needs, but most of our engagement touch on the following components:

  • Market Assessment: Evaluating the potential for success given the target market characteristics: disease background, incidence, prevalence, alternative therapies, customer definition, distribution channels
  • Competitive Analysis: Advising on product positioning given current and emerging competitors and will describe the client’s best path to success
  • Regulatory Analysis: Indicating predicted risk classification by the FDA and a CE Competent Authority, predicate devices if applicable, least problematic method of submission for combination products, and expected testing necessary to support safety and effectiveness in a regulatory submission
  • Clinical Analysis: Gathering key opinion leaders in the target market to determine clinical adoption
  • Reimbursement Analysis: Evaluating possible codes, expected time to coverage and expected payment levels for the new product

Suttons Creek is different in our planning because unlike many other firms, our team has the expertise to not only execute on those plans, but also has the wisdom of understanding how a product evolves (whether or not by choice) from the initial planning phases.

Intellectual Property Analysis

Is it important for your legal and engineering teams to find unrivaled performance analyzing, developing, and defending innovation?

Suttons Creek team members are experienced across the patent lifecycle: in analysis of your portfolio, broadening that portfolio, and providing expert witness testimony.

Do you want your engineering teams to improve on disruptive and sustaining innovation? Is your team so busy that you need support for patent portfolio analysis? Are you looking for tested, expert witnesses that are compatible with your legal team and hold up under pressure?

These are all areas where Suttons Creek supports organizations and departments like yours, whether as experts or in working with your teams to reach their full potential.

Training

Are your teams operating as effectively as you would like? Is your organization, not just your project, in need of remediation?

Suttons Creek experts provide training in areas such as the following:

  • system engineering concepts
  • project management
  • risk management
  • requirements management (including DOORs and other tools)
  • portfolio management
  • resource management

Our training development staff can create custom courses to meet your unique training needs. Many of our customers request training that is integrated as a follow up to project remediation. Any courses can be provided on your campus or another designated location.